# Modernization of Swine Slaughter Inspection

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A2019-20245

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** October 1, 2019
- **Citation:** 84 FR 52300

## 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:

Final rule.

SUMMARY:

The Food Safety and Inspection Service (FSIS) is amending the Federal meat inspection regulations to establish an optional 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 making several changes to the regulations that will affect all establishments that slaughter swine, regardless of the inspection system under which they operate or the age, size, or class of swine. These changes will allow all swine slaughter establishments to develop sampling plans that are more tailored to their specific operations, and thus more effective in monitoring their specific process control, unlike the current requirements in the regulations.

DATES:

Effective date:
December 2, 2019.

Notification date:
All market hog establishments will initially have until March 30, 2020 to notify their FSIS District Office (DO) of their intent to operate under the New Swine Slaughter Inspection System (NSIS). Establishments that do not notify their DO of their intent by March 30, 2020 will be deemed to have chosen to continue operating under their existing inspection system. For additional information, see section II.G. Implementation.

Applicability dates:
The regulations that prescribe procedures for controlling contamination throughout the slaughter and dressing process in 9 CFR 310.18(c), and the regulations that prescribe recordkeeping requirements in 9 CFR 310.18(d), will be applicable as follows:

(1) In large establishments, defined as all establishments with 500 or more employees, on December 30, 2019;

(2) In small establishments, defined as all establishments with 10 or more employees but fewer than 500 employees, on January 29, 2020; and

(3) In very small establishments, defined as all establishments with fewer than 10 employees or annual sales of less than $2.5 million, on March 30, 2020.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

Executive Summary

On February 1, 2018, FSIS published a proposed rule to modernize swine slaughter inspection (83 FR 4780). This final rule adopts, with modifications, the provisions in the proposed rule.

FSIS is establishing an optional new inspection system for market hog slaughter establishments, NSIS, informed by the Agency's experiences under its Hazard Analysis and Critical Control Point (HACCP)-Based Inspection Models Project (HIMP). FSIS is establishing NSIS to improve the effectiveness of market hog slaughter inspection; make better use of the Agency's resources; and remove unnecessary regulatory obstacles to industry innovation by revoking maximum line speeds and allowing establishments flexibility to reconfigure evisceration lines. NSIS may also facilitate pathogen reduction in pork products and improve compliance with the Humane Methods of Slaughter Act (HMSA) (7 U.S.C. 1901
et seq.
).

Because this final rule requires establishment personnel in NSIS establishments to sort and remove unfit animals before ante-mortem inspection by FSIS inspectors and trim and identify defects on carcasses and parts before post-mortem inspection by FSIS inspectors, the Agency's inspectors will be presented with healthier animals and carcasses that have fewer defects, allowing them to conduct a more efficient inspection of each animal and each carcass. As a result, under NSIS, FSIS can assign fewer inspectors to online inspection, freeing up Agency resources to conduct more offline inspection activities that are more effective in ensuring food safety, such as verifying compliance with sanitation and HACCP, as well as humane handling requirements.

Key elements of the NSIS include: (1) Requiring establishment personnel to sort and remove unfit animals before ante-mortem inspection by FSIS inspectors and to trim and identify defects on carcasses and parts before post-mortem inspection by FSIS inspectors; (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 to develop, implement, and maintain written procedures in their HACCP system to ensure that animals and carcasses sorted and removed for disposal do not enter the human food supply and are properly disposed of according to 9 CFR part 314; (3) requiring establishments to maintain records to document the total number of animals and carcasses sorted and removed per day and the reasons for their removal; (4) requiring establishment personnel to immediately notify FSIS inspectors if they identify, while conducting sorting activities, an animal or carcass that they suspect has a reportable or foreign animal disease (
e.g.,
African swine fever, classical swine fever, or Nipah virus encephalitis); (5) shifting Agency resources to conduct more offline inspection activities that are more effective in ensuring food safety, which allows for up to two offline verification inspectors per line per shift and reduces the number of online inspectors to a maximum of three per line per shift; (6) requiring establishments to maintain records documenting that products resulting from their slaughter operations meet the new definition of ready-to-cook (RTC) pork product, which is any slaughtered pork product sufficiently 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 (7) 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 for carcasses during the slaughter operation. FSIS retains the ability to slow or stop the line, as needed (9 CFR 310.26(c)). Based on its experience under HIMP, the NSIS is unlikely to result in a higher prevalence of
Salmonella
on market hog carcasses and may result in a lower prevalence of
Salmonella
on market hog carcasses, which in turn may lead to fewer human illnesses. In addition, FSIS expects that the new inspection system will improve animal welfare and compliance with the HMSA because more FSIS resources will be available to verify the humane handling of animals.

Under the NSIS, establishment sorters will be required to incise mandibular lymph nodes and palpate the viscera to

detect the presence of animal diseases (
e.g., Mycobacterium (M.) Avium
) as part of their sorting activities before FSIS post-mortem inspection (9 CFR 310.26(b)). The Agency determined that it needs more information on the public health impact of these sorting activities before it can allow establishments to decide, on a lot-by-lot basis, whether establishment sorters need to incise lymph nodes and palpate the viscera to detect the presence of animal diseases. To gather this information, FSIS has decided to allow establishments that operate under the NSIS to apply for waivers to 9 CFR 310.26(b) under 9 CFR 303.1(h). As a condition of the waiver, establishments operating under waivers are required to submit data to FSIS. FSIS then assesses that data to determine whether changes to the regulations are appropriate and necessary. The Agency will announce the criteria for these waivers in a future
Federal Register
document.

Under this final rule, market hog slaughter establishments that do not choose to operate under the NSIS may continue to operate under traditional inspection (
i.e.,
inspection described in current regulations). Establishments that slaughter swine other than market hogs are not eligible to operate under the NSIS unless they obtain a waiver under the
Salmonella
Initiative Program (SIP) (79 FR 633, January 6, 2014).

Under this final rule, FSIS is also making several changes that will affect all establishments that slaughter swine, regardless of the inspection system under which they operate. Specifically, all official swine slaughter establishments must develop, implement, and maintain in their HACCP plans, sanitation standard operating procedures (sanitation SOPs), or other prerequisite programs (hereafter collectively referred to as their “HACCP systems”), written procedures to prevent the contamination of carcasses and parts by enteric pathogens, and visible 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.

As part of their written procedures, establishments will be required to collect and test two carcass samples for microbial organisms, 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 low-volume establishments, a single post-chill carcass sample. Establishments that bone their products before chilling (
i.e.,
hot-boned products) will be required to collect the pre-evisceration sample and a sample after the final wash instead of at post-chill, because these products are not chilled before further processing.

Under this final rule, establishments, except for very low-volume establishments, are required to collect carcass samples and test for microbial organisms pre-evisceration and post-chill, or, for hot-boned products, pre-evisceration and after the final wash, at a frequency of once per 1,000 carcasses. Very low-volume establishments are required to collect at least one carcass sample during each week of operation starting June 1 of each year. If, after consecutively collecting and testing 13 weekly carcass samples, very low-volume establishments can demonstrate that they are not exceeding their upper control limit for microbial organisms and that they are effectively maintaining process control, they can modify their sampling plans to collect samples less frequently. FSIS provides more information on upper control limits in its guideline titled
Developing Effective Microbiological Sampling Programs in Swine Slaughter Establishments to Assess Process Control and Sanitary Conditions
(hereafter referred to as the sampling guideline). The sampling guideline is available on FSIS's website at
https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index.

This final rule rescinds the current requirement that swine establishments test carcasses for generic
E. coli
post chill to monitor process control and replaces this requirement with the new testing requirements described above. The new testing requirements will allow establishments to develop sampling plans that are more tailored to their specific operation, and thus more effective in monitoring their specific process control than the current generic
E. coli
criteria. This final rule also removes the codified
Salmonella
pathogen reduction performance standard for hogs (carcasses) because verifying the codified standard was not a good use of Agency resources. As FSIS explained in the proposed rule (83 FR 4780, 4786), the Agency discontinued its
Salmonella
verification sampling program for market hogs in 2011 because the estimated prevalence of
Salmonella
on hog carcasses was low, and FSIS did not find enough pathogen positives to justify the resources needed (
e.g.,
time and supplies) to conduct carcass swabbing.

This final rule does not allow establishments to collect samples for microbial organisms at alternative sampling locations or frequencies, as was proposed. FSIS made this change from the proposed rule in response to comments that it may be too difficult for inspection personnel to review and verify sampling plans with alternative sampling locations or frequencies. Establishments that currently operate under SIP waivers from the former generic
E. coli
regulations may continue to conduct process control sampling at the alternative frequencies provided for in their waivers. All other SIP waivers (
e.g.,
waivers for 9 CFR 310.1(b)(3)—line speed; 9 CFR 310.25(b)—Salmonella performance standards; 9 CFR 310.18(a)—contamination of organs; and 9 CFR 310.14—handling of bruised parts) will end. FSIS will allow other establishments that would like to experiment with alternative sampling locations and frequencies to submit waiver requests under the SIP to FSIS. FSIS will announce new waiver criteria in a future
Federal Register
document. This final rule also does not require swine slaughter establishments to develop, implement, and maintain in their HACCP systems written procedures to prevent contamination of the pre-operational environment by enteric pathogens, as was proposed. FSIS has decided to withdraw this part of the proposal until the Agency considers its options and timing for gathering more data on contamination in the pre-operational environment. A summary of changes to the proposed rule is included below under section I. Background.

In Table 1 below, FSIS presents the estimated costs and benefits of the final rule. The regulatory impact analysis section below contains an explanation of the assumptions, provides alternative adoption scenarios, and includes a discussion of the uncertainty surrounding the net benefits associated with how much of the industry will choose to adopt NSIS.

Table 1—Net Costs and (Benefits)
[M$]

Number of
establishments

One-time
Recurring

Costs to Industry

$3.14
$22.72

Voluntary *
** 40
0.84
22.15

Mandatory
612
2.30
0.58

Health Benefits ***

(9.33)

Industrial Efficiency

(87.64)

Impacts to Agency's Budget

2.80
(8.73)

Totals

One-Time Cost
$5.94

Recurring Cost
(82.98)

Annualized Costs, Assuming a 3% Discount Rate Over 10 Years
(62.56)

Annualized Costs, Assuming a 7% Discount Rate Over 10 Years
(60.00)

* Further explanation and details on the NSIS adoption rate are provided in section G. Potential Cost of the Final Rule, Table 6: NSIS Adoption Rate and section J. Net Benefits, Table 26: 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. Potential Benefits of the Final Rule, Table 18: Health Benefits from Averted Cases of
Salmonella.
The value of health benefits ranges from a $6.33 million decrease to a $24.62 million increase in health benefits, with a mean increase in benefits of $9.33 million, assuming a cost per illness of $3,682.

**** Note, some of the totals may not equal the sum due to rounding.

Table of Contents

I. Background

II. Comments and Responses

III. Executive Orders 12866 and 13563

IV. Regulatory Flexibility Act Assessment

V. Executive Order 13771

VI. Congressional Review Act

VII. E-Government Act

VIII. Executive Order 12988, Civil Justice Reform

IX. Executive Order 13175

X. USDA Nondiscrimination Statement

XI. Environmental Impact

XII. Paperwork Reduction Act

XIII. Additional Public Notification

Final Regulatory Amendments

I. Background

FSIS began experimenting with new approaches to slaughter inspection based on HACCP principles shortly after publishing the Pathogen Reduction/HACCP rule in 1996. In 1997, the Agency developed the HIMP pilot study to determine whether applying new government slaughter inspection procedures, with new establishment responsibilities, could promote industry innovation and provide at least the same food safety and consumer protection as the other available slaughter inspection systems. FSIS initiated the HIMP pilot 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 an optional new 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.

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 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.

Proposed Rule

On February 1, 2018, FSIS proposed to amend the meat inspection regulations to establish an optional new slaughter inspection system for market hog establishments (83 FR 4780). FSIS also proposed several changes to the regulations that would affect all establishments that slaughter swine, regardless of the inspection system under which they operate or the age, size, or class of swine.

The proposed rule's comment period closed on May 2, 2018, 90 days after its publication. After reviewing comments on the proposed rule, FSIS is finalizing, with some changes, the provisions in the February 2018 proposed rule. In this final rule, the Agency is modifying its proposal to:

• Establish a phased approach to implement the NSIS;

• Establish separate applicability dates for large, small, and very small establishments to comply with the provisions in the rule that prescribe the new recordkeeping and microbiological sampling requirements that will apply to all establishments that slaughter swine. The applicability dates will provide additional time for small and very small establishments to comply with these provisions;

• Revise the disposal requirements to require establishments operating under the NSIS to develop, implement, and maintain written procedures in their HACCP systems to ensure that animals and carcasses that have been sorted and removed for disposal do not enter the human food supply and are properly disposed of according to 9 CFR part 314;

• Require establishments operating under the NSIS to maintain records to document the total number of animals and carcasses sorted and removed per day and the reasons for their removal and make these records available for review and evaluation by FSIS;

• Clarify that all establishments operating under the NSIS must provide a mirror at the carcass inspection station;

• Clarify that establishments that bone their products before chilling (
i.e.,
hot-boned products) must collect a carcass sample pre-evisceration and after the final wash instead of at post-chill. These establishments must also collect a sample at the pre-evisceration point in the process;

• Withdraw the proposal to allow establishments to use alternative sampling locations and sampling frequencies;

• Revise the sampling regulations to require very small establishments that slaughter more than 20,000 swine, or a combination of swine and other livestock exceeding 6,000 cattle and 20,000 total of all livestock to collect two carcass samples, one at pre-evisceration and one at post-chill, at a frequency of 1 per 1,000 carcasses, instead of a single post-chill sample;

• Require establishment sorters to incise mandibular lymph nodes and palpate the viscera to detect the presence of animal diseases (
e.g., M. Avium
) as part of their sorting activities before FSIS post-mortem inspection;

• Revise the definition of “RTC pork product” to clarify that the standard is a performance standard for non-food safety defects and not a zero-tolerance standard; and

• Withdraw the proposed requirement for swine slaughter establishments to develop, implement, and maintain in their HACCP systems written procedures to prevent contamination of the pre-operational environment by enteric pathogens.

Hog HIMP Report

The proposed rule was informed by the Agency's comprehensive analysis of data collected from HIMP market hog establishments. In 2014, the Agency evaluated inspection findings in market hog slaughter establishments participating in HIMP to determine whether the HIMP inspection system performs as well as the existing inspection system in terms of safety and wholesomeness of the products produced and of overall consumer protection. FSIS summarized its findings in its report titled “Evaluation of HACCP Inspection Models Project (HIMP) for Market Hogs” (hereafter the “Hog HIMP Report”)
1

and in the proposed rule (83 FR 4780, 4789). The Hog HIMP Report concluded that market hog slaughter establishments participating in HIMP are performing as well as comparable large non-HIMP market hog establishments.

1
The 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.

The Hog HIMP Report is based on two time periods: The years CY2006-CY2010 and the years CY2012-CY2013. The evaluation compared 5 HIMP market hog establishments with a comparison set of 21 non-HIMP market hog slaughter establishments selected to be comparable with HIMP market hog establishments with respect to production volume, line speed, and days of slaughter operation.

The Hog HIMP Report found that HIMP market hog establishments received more off-line food safety related inspection verification checks than the traditional non-HIMP market hog establishments. HIMP market hog establishments had higher compliance with Sanitation SOP and HACCP regulations, lower levels of non-food safety defects, equivalent or better
Salmonella
verification testing positive rates than traditional non-HIMP market hog establishments, and lower levels of violative chemical residues. The Hog HIMP Report also found that under HIMP, market hog establishments received an increased level of Sanitation SOP and HACCP inspection. Based on these findings, HIMP has been demonstrated to provide public health protection at least equivalent to the traditional inspection system.

Risk Assessment

The proposed rule was also informed by FSIS's
Assessment of the Potential Change in Human Risk of Salmonella Illnesses Associated with Modernizing Inspection of Market Hog Slaughter Establishments.
The risk assessment
2

used available data from FSIS's microbiological baseline studies
3

and the Agency's
Salmonella
verification results from swine slaughter establishments. 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,
4

and (2) contamination of hog carcasses with
Salmonella.
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.
5

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.

2
As FSIS explained in the proposed rule, the Agency used a similar approach to estimate the public health benefits associated with the final rule titled
Modernization of Poultry Slaughter Inspection
(79 FR 49565).

3
FSIS baseline data is available at:
https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/baseline/baseline.

4
Scheduled procedures are assigned to inspectors at an establishment by the Public Health Information System (PHIS). Before FSIS implemented the PHIS, scheduled procedures were assigned by the Performance-Based Inspection System (PBIS). Unscheduled procedures are performed according to inspector needs at an establishment and may include verification checks for fecal material, 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.

5
For the risk assessment, FSIS used data from 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
).

As with any risk assessment, FSIS's risk assessment relies on a number of assumptions. FSIS assumed that the differences between the approach to slaughtering hogs and slaughtering poultry would not alter the relationship between the presence of
Salmonella
contamination on carcasses and the likelihood of contamination of meat and human illness. Furthermore, hog slaughter establishment specialization has been facilitated by vertical integration within the industry, much like the poultry industry.
6

FSIS also assumed, for the purpose of this risk assessment, that the relationship between
Salmonella
contamination of hog carcasses and downstream products such as pork parts (
e.g.,
pork chops) and ground pork closely mirrors that of the established relationship between
Salmonella
contamination of poultry (
e.g.,
chicken) carcasses and downstream products such as chicken parts and ground chicken. On the other hand, the likelihood of positive Salmonella findings on hog carcasses is significantly lower than on chickens. While FSIS did not conduct any specific analyses to examine this assumption, the Agency has conducted numerous peer-reviewed analyses of the relationship between Salmonella contamination frequency on chicken

carcasses and chicken parts.
7

These analyses indicate that the prevalence of
Salmonella
contamination on downstream products (
e.g.,
parts) often exceeds the frequency of measurement of
Salmonella
contamination in upstream products (
e.g.,
carcasses), and the Agency expects this relationship would apply to other amenable species slaughtered in FSIS establishments. The assumption of higher prevalence is logical given that samples of downstream products contain primals from multiple carcasses, increasing the likelihood of a single sample being contaminated.

6
Muth, M. (2007). Pork Slaughter and Processing Sector Facility-Level Model.
https://www.rti.org/sites/default/files/resources/muth_pork-slaughter_final.pdf.

7
Ebel, E.D., Williams, M.S., Tameru, B. (2019) Relatedness of Salmonella contamination frequency on chicken carcasses and parts when processed in the same establishment.
Food Control
100: 198-203.

The regression analysis of the 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 from carcasses. 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 the Agency expects to lead to fewer human illnesses. FSIS will evaluate policy effectiveness by routinely analyzing inspection task data in PHIS (
e.g.,
NRs for regulations on the PHR list, including NRs for HACCP, sanitation SOP, and Livestock Zero Tolerance tasks).

In April 2018, the Agency conducted an external peer review of the risk assessment. On August 6, 2018, FSIS posted a revised version of the risk assessment on its website at
https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register/proposed-rules.
The revised risk assessment addressed reviewers' comments that FSIS should have used different modeling approaches. The revised risk assessment also included an in-depth power analysis, multicollinearity diagnostics, model parameters and estimates when more complex crossover and mixed-effects modeling approaches were applied, and a summary of all alternative models (Appendix H). The revisions made in response to the reviewers' comments did not produce changes to the risk assessment's conclusions that would require modifications of the proposed rule. However, the Agency gave interested persons 30 days (until September 5, 2018) to comment on the changes made to the risk assessment. To be transparent, FSIS has decided to add text to the risk assessment to better characterize the two different models that were conducted (see Tables 13 and 14 in the risk assessment and accompanying text). Specifically, FSIS has added additional language to the risk assessment—both in the summary and in the discussion—to highlight the results of the modeling without simulated data. To that end, the results of the modeling with simulated data—which, as would be expected, had less uncertainty around the estimated change in illnesses—are not used in support of this rule. The modeling without simulated data is now carried through in the Regulatory Impact Analysis. The result of those additions is that the uncertainty around estimated illnesses avoided is greater; however, the most likely estimated illnesses avoided are not affected. Notably, FSIS received a comment questioning FSIS's use of simulated data. FSIS believes that this change addresses the commenter's questions.

Additionally, minor edits and corrections for clarity and consistency were made in the main body of the risk assessment report. The most likely estimates of illnesses avoided from converting from traditional inspection to the NSIS did not change with incorporation of these additional analyses and other minor changes to the risk assessment.

The final risk assessment is available on FSIS's website at
https://www.fsis.usda.gov/wps/portal/fsis/topics/science/risk-assessments.
FSIS is responding to comments received regarding the risk assessment in Part C of section II. “Comments and Responses” below.

II. Comments and Responses

FSIS received over 83,000 comments in response to the February 2018 proposed rule and five comments on the revised risk assessment. Most of these comments were form letters submitted as part of various write-in campaigns initiated by consumer advocacy organizations, animal welfare organizations, labor unions, and worker advocacy organizations. FSIS also received individual comments from private citizens.

In addition to the form letters and individual comments, the Agency also received comments from trade associations representing the meat industry, companies that conduct swine slaughter operations, consumer advocacy organizations, public health organizations, animal welfare organizations, labor unions, worker advocacy organizations, foreign countries, FSIS inspectors, an environmental organization, and a State Department of Agriculture. Below is a summary of the comments and FSIS's responses.

A. Requests for Public Meetings, Comment Extensions, and Documents

Comments:
Several consumer advocacy organizations, labor unions, and worker advocacy organizations stated that FSIS should have held public meetings to discuss the proposed rule. According to the comments, public meetings focused on the proposed rule may have helped to clarify the pros and cons of important proposed changes. A few consumer advocacy organizations argued that FSIS should have submitted the risk assessment for peer review before publishing the proposed rule, or, at least, extended the comment period for the proposed rule until all stakeholders had the opportunity to read and respond to the peer reviewed version of the risk assessment.

Response:
Rather than hold a public meeting on the proposed rule, the Agency held two webinars in March and April 2018, to provide an overview of the proposed rule and provide the public with an opportunity to ask questions about the proposed rule. (Transcripts of the webinars are available on the FSIS website at
https://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings/past-meetings.
) During the webinars, FSIS provided the public with all the information that it would have provided during a public meeting.

The Agency explained during the webinars and monthly consumer and industry stakeholder meetings that it would reopen the comment period for the proposed rule if the Agency had to make significant changes to the risk assessment based on peer review comments. And, even though FSIS did not have to make significant changes to the risk assessment, the Agency reopened the comment period on the risk assessment for an additional 30 days to give stakeholders an opportunity to comment on the revised document.

In total, stakeholders had 90 days to review and comment on the proposed rule and 120 days to review and comment on the risk assessment. Executive Order (E.O.) 12866, as supplemented by E.O. 13563, states that agencies are to “afford the public . . . with a comment period that should generally consist of not less than 60

days.” The Agency believes that the public had ample time to consider the issues raised in the proposed rule and risk assessment to develop their comments.

Comment:
A few worker advocacy groups argued that FSIS should have reopened the comment period on the proposed rule because, according to the commenters, the Agency relied on an unpublished data set of Occupational Safety and Health Administration (OSHA) logs to compare worker injury rates between HIMP and non-HIMP establishments.

Response:
In the proposed rule, FSIS explained that the Agency compared injury rates between establishments operating under traditional inspection and HIMP (83 FR 4796). FSIS's analysis showed that HIMP establishments had lower mean injury rates than non-HIMP establishments. The analysis used injury rate data available on OSHA's website.

FSIS further explained that the survey captured data from OSHA logs of workplace injuries and illnesses, maintained by employers as mandated by regulations (
see
29 CFR part 1904), and that 56 FSIS inspected market hog slaughter establishments submitted their injury rate data to OSHA (83 FR 4796). From these 56 establishments, FSIS explained that it excluded 27 low-volume establishments, leaving 29 establishments (5 HIMP and 24 Traditional). The low-volume establishments were excluded to provide a better comparison group of traditional establishments because all HIMP establishments are high-volume establishments. The results showed HIMP establishments had a lower mean number of injuries using three OSHA injury rate measures: Total Case Rate (TCR); Days Away, Restricted or Transferred (DART); and Days Away from Work (DAFW). However, FSIS noted that factors other than line speed may affect injury rates (
e.g.,
automation and number of sorters per line) and requested comments on worker safety issues in the proposed rule as a result.

All the information that FSIS used in its analysis is publicly available. FSIS does acknowledge that it did not provided the web address for OSHA's Establishment Specific Injury and Illness Data, which is available at
https://www.osha.gov/pls/odi/establishment_search.html.
However, it is easy to find on OSHA's website under the “Data” tab.

And, while FSIS did not post the exact data that the Agency pulled from its Public Health Information System (PHIS) to select swine slaughter establishments present in the OSHA data set, the same information can be found in other formats on FSIS's website. Establishment level production volume information is available at
https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/data.
This data would allow interested parties to identify the high-volume establishments. Additionally, the list of establishments participating in HIMP is available at
https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/haccp/haccp-based-inspection-models-project/HIMP-list-of-participating-plants.

Although FSIS conducted an analysis of injury rates during the development of the proposed rule, FSIS did not use the analysis to draw conclusions on worker safety in HIMP or non-HIMP establishments or whether there is an associated impact on food safety. As discussed in more detail below, while FSIS recognizes that working conditions in swine slaughter establishments is an important issue, the Agency does not have the authority to regulate issues related to establishment worker safety. OSHA is the Federal agency with statutory and regulatory authority to promote workplace safety and health.

Comment:
A few commenters argued that FSIS violated the Administrative Procedure Act (APA, 5 U.S.C. 551
et seq.
) because the Agency did not identify the 21 non-HIMP establishments that it used to conduct its comparisons for the Hog HIMP Report or post all the raw data that it used to develop the Hog HIMP Report. According to the commenters, the APA requires reasoned decision-making based on an examination of relevant data articulated in a satisfactory explanation. The commenters argued that because FSIS did not provide all its raw data, the Agency failed to provide the public a meaningful opportunity to participate in the rulemaking process.

Response:
The APA does not require Federal agencies to post all their raw data. That said, FSIS is committed to being transparent and responsive to stakeholders. FSIS clearly explained in the Hog HIMP Report that FSIS selected the 21 non-HIMP establishments because they were large, high-volume market hog slaughter establishments that had similar production volume, line speed, and days of slaughter operation to the five market hog slaughter HIMP establishments. FSIS also clearly explained in the Hog HIMP Report and the proposed rule (83 FR 4780, 4789) the Agency's analysis of its inspection data and its conclusions based on the data. Moreover, FSIS made every effort to respond to FOIA requests related to the proposed rule before the close of the comment period. The Agency has added all the information that it has recently released to its FOIA Electronic Reading Room.
8

8
FSIS's FOIA Electronic Reading Room is available at
http://www.fsis.usda.gov/readingroom.

B. HIMP

Comment:
Several consumer advocacy organizations, public health organizations, animal welfare organizations, worker advocacy organizations, and private citizens questioned whether data collected under the HIMP pilot study should be used to inform the NSIS. The commenters argued that the USDA's Office of the Inspector General (OIG) was critical of HIMP in its 2013 report.
9

The commenters stated that OIG found that FSIS: Did not adequately oversee the HIMP program because it did not evaluate whether the program resulted in a measurable improvement of the inspection process; allowed one HIMP establishment to forgo the standard FSIS policy to manually inspect viscera; and did not have formal agreements with the HIMP establishments.

9
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.

According to the commenters, OIG's audit report also raised issues with the Agency's enforcement policies at all hog slaughter operations, finding that FSIS's policies did not deter establishments from becoming repeat violators of food safety regulations and that FSIS could not always ensure the humane handling of animals.

In September 2013, the U.S. Government Accountability Office (GAO) followed the OIG with a report entitled,
More Disclosure and Data Needed to Clarify Impact of Changes to Poultry and Hog Inspections.
10

According to the commenters, GAO found that FSIS did not collect comparable data from establishments participating and not participating in the HIMP pilot study. The commenters also stated that GAO found that the use of volunteer facilities raised questions about self-selection bias and that information collected from the five market hog slaughter HIMP establishments would not provide reasonable assurance that any conclusions could apply more broadly to all swine slaughter establishments because of the small sample size.

10
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.

Response:
FSIS addressed OIG's concerns in the Agency's responses to the audit. In response to the OIG audit,

FSIS updated its SIP letters (
i.e.,
formal agreements), requiring all HIMP establishments to conduct the same viscera inspection procedures, and implemented PHIS, enhancing the Agency's ability to better track trends in NRs.

In addition, the Agency implemented required supplemental training after the release of the updated Directive 6900.2,
Humane Handling and Slaughter of Livestock,
to improve inspectors' objective observation and assessment skills. The Situation Based Humane Handling training modules (Module I and Module II) effectively teach inspectors how to interpret an egregious or non-egregious inhumane handling event objectively, and to take appropriate enforcement actions. The training modules contain fictional scenarios of inhumane and egregious events and describe in detail how an inspector is to proceed with regulatory enforcement.

Furthermore, in October 2013, FSIS announced that it hired a Humane Handling Enforcement Coordinator, who conducts ongoing reviews of relevant NRs, suspensions and Notices of Intended Enforcement (NOIEs).
11

To accomplish this, the Humane Handling Enforcement Coordinator maintains a database to track the review of NRs and the review and tracking of suspensions and NOIEs pertaining to violations of the HMSA. The Humane Handling Enforcement Coordinator also conducts correlations with inspectors to help them improve their objective analysis when enforcing the HMSA and related regulations, which serves to reduce subjective interpretation of inhumane events and their regulatory outcome.

11

https://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-and-transcripts/news-release-archives-by-year/archive/2013/nr-102313-01.

To deter repeat violators, the Agency changed the way that it schedules its in-depth reviews of establishments' food safety systems, known as food safety assessments (FSAs).
12 13

In 2015, FSIS implemented its Public Health Risk Evaluation (PHRE) methodology, which consists of a decision-making evaluation that helps Enforcement, Investigations and Analysis Officers (EIAOs) and DOs determine if an FSA needs to be scheduled and conducted or if enforcement action is warranted for a particular establishment. The decision criteria used in the PHRE include factors such as pathogen testing results, recalls, outbreaks, regulatory findings, and inspection results at an establishment. The PHRE methodology and the decision criteria are described in detail in FSIS Directive 5100.4.
14

12
See FSIS Directive 5100.1,
Enforcement, Investigations and Analysis Officer (EIAO) Food Safety Assessment (FS) Methodology
available at
https://www.fsis.usda.gov/wps/wcm/connect/31bb8000-fb33-4b51-964b-1db9dfb488dd/5100.1.pdf?MOD=AJPERES.

13
See FSIS Directive 5100.4,
Enforcement, Investigations and Analysis Officer (EIAO) Public Health Risk Evaluation (PHRE) Methodology
available at
https://www.fsis.usda.gov/wps/wcm/connect/6c30c8b0-ab6a-4a3c-bd87-fbce9bd71001/5100.4.pdf?MOD=AJPERES.

14
FSIS Directive 5100.4, Enforcement, Investigations and Analysis Officer (EIAO) Public Health Risk Evaluation (PHRE) Methodology available at
https://www.fsis.usda.gov/wps/wcm/connect/6c30c8b0-ab6a-4a3c-bd87-fbce9bd71001/5100.4.pdf?MOD=AJPERES.

Rather than schedule routine FSAs every four years, FSIS's Office of Planning, Analysis and Risk Management (OPARM) provides DOs with a prioritized list of establishments for PHREs once per month based on public health risk triggers (
e.g.,
if an establishment has produced adulterated product). EIAOs review historical data on the listed establishments and coordinate with inspection program personnel assigned to the listed establishments to determine if an FSA or other enforcement action is needed. DOs can still schedule for cause PHREs at establishments not on the prioritized list (
i.e.,
if there is an illness or outbreak, significant or repetitive contamination or adulteration incidents, or repetitive microbiological sampling failures). The use of the PHRE methodology allows FSIS to better target establishments for FSAs based on risk and to more effectively deploy its investigational resources (EIAOs).

In addition, FSIS developed PHIS alerts for inspection personnel that are triggered when an establishment receives a certain percentage of NRs for regulations on the Public Health Regulation (PHR) list.
15

The PHR list, which is updated annually and posted on the Agency's website, consists of regulations and specific provisions of regulations that historically have higher rates of noncompliance three months before a pathogen positive or enforcement action. Each month OPARM calculates a PHR NR rate for each meat and poultry establishment and determines if an establishment will be issued a PHR alert or if they should be considered by the DO for a PHRE, which may lead to an FSA. PHIS alerts have helped FSIS better identify trends that may warrant an FSIS enforcement action.

15

See
FSIS Notice 15-18,
Public Health Regulations and Alerts for use in Determining Inspection Program Personnel Actions and Public Health Risk Evaluation Scheduling in Meat and Poultry Establishments
available at
https://www.fsis.usda.gov/wps/wcm/connect/8f218f5b-197e-4813-bf92-be29be36ec08/15-18.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=8f218f5b-197e-4813-bf92-be29be36ec08.

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

While it is true that the five market hog slaughter HIMP establishments represent a small sample size of establishments, they collectively represent diversity in geography, corporate structure, management styles, product distribution patterns, and other variables. FSIS believes that the volunteer market hog slaughter establishments participating in the HIMP pilot study, viewed collectively, are typical of the broader industry.

Comment:
Some consumer advocacy groups questioned why the Agency did not use a third-party contractor to conduct its evaluation of the hog HIMP pilot study.

Response:
FSIS did not hire a third-party contractor to draft the Hog HIMP Report because the model and the resulting inspection data had already been reviewed by third-party contractors. As FSIS explained in the proposed rule, the 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 pilot study before they implemented HIMP (83 FR 4780, 4788). These baseline data reflect the performance of these five establishments under traditional inspection before they implemented HIMP and provided the basis to establish HIMP performance standards for food safety defects and non-food safety “Other Consumer Protection” (OCP) defects.

FSIS also explained in the final rule to modernize poultry slaughter inspection (79 FR 49566, 49573) that in 2002, the Agency contracted with a third-party technical review team (review team, henceforth) selected by the National Alliance for Food Safety to review and evaluate the data collected from young chicken establishments operating under HIMP. The review team focused on the validity of the HIMP pilot study design and method to

determine whether FSIS could use the organoleptic and microbial data collected under HIMP to compare the performance of establishments operating under HIMP to the performance of establishments operating under non-HIMP inspection systems. Overall, the review team found that the HIMP study design and method were valid and provided a useful and legitimate comparison of the performance of establishments operating under HIMP and non-HIMP inspection systems. The review team's findings are described in the report titled
Review of the HACCP-Based Inspection Models Project by the National Alliance for Food Safety Technical Team
(The Hargis Report).
16

While the review team did not review data collected from the market hog establishments operating under HIMP, the poultry and market hog HIMP models and the resulting inspection data are very similar. Therefore, FSIS determined there would be no benefit in hiring another review team to evaluate the HIMP market hog inspection data.

16
The Hargis Report is available at
https://www.fsis.usda.gov/OPPDE/nacmpi/Nov2002/Papers/NAFS97.pdf.

Comment:
A few consumer advocacy organizations stated that the data used in the Hog HIMP Report is now stale as the Agency analyzed data from CY2006 through CY2010 and then CY2012 through CY2013.

Response:
FSIS disagrees. FSIS has not made any significant changes to the HIMP model since 2013, and FSIS inspectors are still performing the same inspection tasks. The Hog HIMP Report findings from CY2006 through CY2010 and CY2012 through CY2013 were very similar. This shows that not much changed over a seven-year period, and that the model is stable. No significant changes in swine slaughter, FSIS inspection, or related regulations have occurred since CY 2013. Therefore, FSIS has no reason to believe that the data in the Hog HIMP Report is no longer useful simply because of the passage of time.

Comment:
One consumer advocacy group noted that the Hog HIMP Report shows that there was an increase in total offline verification tasks in HIMP establishments during CY2012 and CY2013. However, according to the same commenter, tables 3-2 and 3-3 in the Hog HIMP Report show that inspectors performed fewer verification tasks in HIMP establishments than they did in non-HIMP establishments for more than half of the PHRs in CY2012 and CY2013. According to the commenter, the Agency treats a total pooled increase in inspection tasks across all regulations as outweighing the decreases in some inspection tasks. The commenter argued that FSIS needs to justify why a decrease in any inspection task for any regulation will not be detrimental to food safety. The commenter further argued that FSIS did not explain why the PHRs are relevant.

Another consumer advocacy group complained that the Hog HIMP Report did not indicate which inspection tasks were scheduled or unscheduled. The same commenter stated that FSIS did not demonstrate that the increased offline verification tasks in HIMP establishments were statistically significant, as opposed to a product of chance.

Response:
The Agency uses PHIS to assign scheduled or “routine” inspection tasks. Inspectors in large, high-volume market hog slaughter establishments receive the same number of routine inspection tasks in both HIMP and traditional establishments. Unscheduled or “directed” inspection tasks are initiated by the inspector or their supervisor.

The Hog HIMP Report was not generated to evaluate the benefits of performing more scheduled versus unscheduled offline inspection verification tasks. The risk assessment discussed above evaluated, among other things, the effect of increased offline inspection verification tasks in swine slaughter establishments. The objective of the Hog HIMP Report was to determine whether the HIMP inspection system performs
as well as
the traditional inspection system in terms of product safety and wholesomeness, and overall consumer protection. As FSIS explained in the proposed rule (83 FR 4780, 4790), the Hog HIMP Report found that inspectors at HIMP market hog establishments are performing more off-line food safety related inspection verification tasks than inspectors at traditional market hog establishments, including an increased level of Sanitation SOP and HACCP inspection verification tasks. The Hog HIMP Report also found that HIMP market hog establishments have higher compliance rates with Sanitation SOP and HACCP regulations, lower levels of non-food safety defects, equivalent or better
Salmonella
verification testing positive rates, and lower levels of violative chemical residues, as compared to traditional non-HIMP market hog establishments.

FSIS disagrees that the Agency needed to indicate which offline inspection verification tasks were scheduled and unscheduled or demonstrate that the increased number of offline verification tasks in HIMP establishments were statistically significant and could therefore be used to evaluate whether HIMP market hog establishments performed as well as traditional market hog establishments. FSIS explained in the Hog HIMP Report that inspectors conducted more offline inspection tasks in HIMP establishments largely due to the increased inspection for visible fecal material, ingesta, and milk contamination under 9 CFR 310.18. FSIS inspectors at hog HIMP establishments inspect a sample of 24 carcasses when they perform a Zero Tolerance verification task specifically for 9 CFR 310.18, whereas FSIS inspectors at traditional market hog establishments inspect a sample of 11 carcasses. These Zero Tolerance verification tasks are required every shift.

Tables 3-2 and 3-3 in the Hog HIMP Report show the number of times that FSIS inspectors verified compliance with a regulation. These tables do not necessarily show the number of times a task was performed. FSIS inspectors verify whether establishments meet requirements in 9 CFR part 417 when they conduct HACCP tasks; whether establishments meet requirements in 9 CFR 416.1-6 when they conduct sanitation performance standards (SPS) tasks; and whether establishments meet requirements in 9 CFR 416.11-17 when they conduct Sanitation SOP tasks. And, while inspectors receive the same routine tasks, not every regulation in tables 3-2 and 3-3 needs to be verified in every establishment. For example, FSIS inspectors would only verify whether establishments meet requirements in 9 CFR 416.16(b) if the establishment maintains records on a computer. In addition, inspectors would only check 9 CFR 417.3(a)-(c) in PHIS if they were verifying whether establishments met corrective action requirements after a deviation. So, the fact that table 3-2 and 3-3 show that FSIS inspectors verified fewer 9 CFR part 417 regulations in HIMP establishments does not mean that FSIS performed fewer HACCP inspection verification tasks in CY2012 and CY2013. Rather, it could mean that inspectors found fewer deviations that required the subsequent verification of corrective actions. Therefore, tables 3-2 and 3-3 do not support the commenter's argument that FSIS conducted fewer tasks in HIMP establishments, which they claimed could be detrimental to food safety.

As FSIS explained in the proposed rule (83 FR 4789) and above, the PHR list is relevant because it consists of regulations that have higher rates of noncompliance three months before a pathogen positive or enforcement

action. The PHR list allows FSIS to focus on specific health related provisions of regulations that may be the most informative for prioritizing PHREs and FSAs. FSIS compared the number of verifications of PHR regulations in HIMP and traditional establishments because non-compliance with these regulations was determined by OPARM to be an important indicator of subsequent food safety issues and loss of process control.

Comment:
One consumer advocacy group argued that the increased offline regulation verifications under HIMP are probably the result of greater reporting, rather than an actual increase in verifications. The commenter stated that they have received information that inspectors find that entering data into PHIS is cumbersome, so they do not enter data for unscheduled tasks unless they find problems. According to the commenter, there has been a significant drop in the number of verification tasks performed since the implementation of PHIS.

Response:
FSIS inspectors in both HIMP and non-HIMP establishments use PHIS. FSIS provides instructions on how to use PHIS in its directives and notices. As FSIS explained above, an inspector at a large, high-volume slaughter establishment operating under HIMP would receive the same tasks as an inspector at a large, high-volume slaughter establishment operating under traditional inspection, except that the inspector in the HIMP establishment is instructed to schedule more carcass verification tasks. The documentation requirements for inspectors are also the same for HIMP and non-HIMP establishments. The key difference is that FSIS inspectors in HIMP establishments routinely document fewer condemned animals, carcasses, and parts because establishments conduct sorting procedures before FSIS inspection. Additionally, comments on inspectors not wanting to document completion of tasks in PHIS are outside the scope of these regulations.

Comment:
A few consumer advocacy groups stated that they found 32 instances in which establishments were cited for violating 9 CFR 311.16(a)—Carcasses So Infected that Consumption of the Meat May Cause Food Poisoning. According to the commenters, these instances occurred in HIMP establishments rather than establishments operating under traditional inspection because establishment sorters on the slaughter line presented carcasses to FSIS that were unfit for processing. The commenters argued that the Hog HIMP Report should have compared NRs for 9 CFR 311.16(a) in HIMP and traditional establishments.

One consumer advocacy group noted that the Hog HIMP Report shows that there were statistically significant differences in the weighted, health-related Sanitation SOP and HACCP NRs for the five Hog HIMP establishments as compared to those establishments operating under traditional inspection for a combined four years. The commenter noted that while the Agency indicated in tables 3-9 and 3-10 that the total NRs for Sanitation SOP and HACCP PHRs were lower in CY2012 and CY2013 for the 5 HIMP establishments, these establishments had more NRs for non-compliance with other regulations. The commenter argued that for certain regulations like 9 CFR 417.3(a)(2), the five HIMP establishments had higher and statistically significant NRs compared to the 21 comparable non-HIMP traditional establishments. The commenter stated that the five HIMP establishments had an 11-fold and three-fold higher rate of violating 9 CFR 417.3(a)(2) in CY2012 and CY2013, respectively. The commenter noted that 9 CFR 417.3(a)(2) is a measure of whether an establishment is maintaining control over a critical control point. The commenter argued that because the five HIMP establishments received more NRs for this regulation, they were not adhering to their HACCP plans, and were out of control more frequently than the 21 comparable non-HIMP traditional establishments.

The same consumer advocacy group stated that they conducted their own analysis of NRs issued in the five HIMP establishments and five comparably-sized non-HIMP traditional establishments from CY2012 to CY2016. The commenter noted that, based on their own analysis, the five HIMP establishments had more NRs for non-compliance with 9 CFR 310.18, 416.3-416.5, 416.13, and 417.2. The commenter highlighted an NR that was issued to a HIMP establishment in 2017 because an establishment sorter did not identify a carcass with a food safety defect. The commenter also noted that OIG found that from FY 2008 to 2011, three of the 10 swine slaughter establishments cited with the most noncompliance records (NRs) were HIMP establishments. The commenter argued that these NRs demonstrate that the HIMP inspection system is not as effective as the traditional inspection system.

Response:
FSIS disagrees that these NRs prove that HIMP establishments lose process control more often than traditional establishments. In Table 3-9 in the Hog HIMP Report,
17

PHR noncompliance rates in CY2012 at the five HIMP market hog establishments were statistically significantly higher for four regulations, statistically significantly lower for five regulations, and not statistically significantly different for eighteen regulations. Overall, the CY2012 PHR noncompliance rate for Sanitation SOP and HACCP regulations (9 CFR parts 416 and 417) in the five HIMP market hog establishments was statistically significantly lower than that for the 21 comparison non-HIMP market hog establishments. In Table 3-10 in the Hog HIMP Report, PHR noncompliance rates in CY2013 at HIMP market hog establishments were statistically significantly higher for three regulations, statistically significantly lower for five regulations, and not statistically significantly different for nineteen regulations. Overall, the PHR noncompliance rate in CY2013 for Sanitation SOP and HACCP regulations in the five HIMP market hog establishments was statistically significantly lower than that for the 21 comparison non-HIMP market hog establishments. The Sanitation SOP and HACCP regulations are among the regulations most strongly related to public health.

17

https://www.fsis.usda.gov/wps/wcm/connect/f7be3e74-552f-4239-ac4c-59a024fd0ec2/Evaluation-HIMP-Market-Hogs.pdf?MOD=AJPERES.

Under HIMP, if an establishment does not adequately sort for carcasses showing signs of septicemia or pyemia, FSIS issues an NR for 9 CFR 311.16(a). FSIS does not issue NRs for this regulation under traditional inspection because FSIS inspectors are responsible for identifying and removing food safety and non-food safety defects.

As is explained above, under HIMP, FSIS inspectors inspect a sample of 24 carcasses when they perform a Zero Tolerance verification task as opposed to inspecting a sample of 11 carcasses under traditional inspection. In addition, the Agency's offline inspectors in HIMP establishments perform more offline inspection activities that FSIS has concluded are more effective in ensuring food safety than offline FSIS inspectors perform in non-HIMP establishments operating under the traditional inspection system. Therefore, FSIS inspectors in HIMP establishments have more opportunities for detecting noncompliance with regulatory requirements that are directly related to public health than inspectors do in non-HIMP traditional establishments.

Comment:
Several commenters argued that until FSIS can compare and

evaluate HIMP and non-HIMP establishment performance using compatible data, the same data reporting period, and an equal number of establishments, and show a marked superiority of HIMP establishment performance, FSIS must not finalize the proposed rule.

Response:
FSIS maintains that the data collected during the HIMP pilot study was valuable for evaluating whether the HIMP inspection system performs as well as the traditional inspection system. As stated above, FSIS did compare data from the same reporting periods and compared establishments with similar HACCP size and production volume. As stated in the Hargis report, “[t]he review team noted some issues related to optimal design and interpretation, but finds that overall the data collected were both meaningful and useful and that the study was designed and conducted under real-world conditions and limitations.” The review team also concluded that “the overall design and methodology . . . were perhaps the best available options to allow for comparison of organoleptic data between the traditional and HIMP systems.” FSIS disagrees that the Agency needs to show that the HIMP system is superior to the traditional inspection system before it can finalize the proposed rule.

C. Risk Assessment

Comment:
The risk assessment used FSIS microbiological testing and inspection data from 2010-2011 and data from the HIMP pilot study. A few consumer advocacy organizations and public health organizations argued that the data has the following problems: (1) The data is generated through regulatory programs designed to verify process control within a given establishment at a specific point in time; (2) the data is at least seven years old and may not be representative of current industry practices, and (3) there were only five market hog slaughter establishments that volunteered and agreed to meet the additional requirements in the HIMP pilot study, resulting in a biased sample and results that are not generalizable to all non-HIMP market hog slaughter establishments.

Response:
For purposes of the risk assessment, data from HIMP establishments were combined with data from traditional establishments to get a more complete picture of the possible combinations of establishment characteristics, inspection procedures, and
Salmonella
prevalence. The assessment produced estimates of
Salmonella
illnesses under scenarios where inspectors perform more offline food safety activities as compared to traditional inspection. As FSIS explained above, the data FSIS used in the Hog HIMP Report and risk assessment are still useful, despite the passage of time, because the HIMP inspection model has not changed since 2013 and FSIS is still conducting the same inspection procedures. FSIS also explained above that the Agency does not believe that the results are biased because there is evidence that the volunteer establishments participating in the HIMP pilot study are typical of the broader industry.

Comment:
One public health organization stated that the model predicts that maximum reduction in the percentage of
Salmonella
positive samples and market hog-attributable salmonellosis cases occurs when the average numbers of offline inspection procedures performed (Scheduled and Performed (SP) and Unscheduled (U)) increase 25 percent and the numbers of Scheduled but Not Performed (SNP) and NR inspection procedures decrease 50 percent and 46.67 percent, respectively. The commenter also stated that FSIS concluded that all establishments under NSIS are expected to achieve greater process control in response to increases in FSIS offline inspection tasks in addition to industry-wide commercial and technological innovation that will likely occur over time. According to the commenter, these results assume that resources will be re-allocated within an establishment in such a way that the FSIS offline inspection resources increase by 25 percent and the number of scheduled but not performed FSIS tasks decreases by 50 percent. The commenter questioned if this is achievable given FSIS's current inspection resources. The commenter stated that if inspection resources are lost, through attrition or budget cuts, these assumptions may not be realistic.

Response:
The predicted increase in offline inspection resources and decrease in scheduled but not performed activities are achievable with FSIS's current inspection resources. In fact, NSIS will allow FSIS to better use its inspection resources. FSIS discusses the impact of attrition and budget in more detail in section “I. Potential Budgetary Impacts on the Agency.”

Comment:
One consumer advocacy organization stated that the risk assessment shows that the five HIMP establishments had higher NRs (9.4-times more, when weighted by volume) than the non-HIMP traditional establishments. According to the commenter, the risk assessment also shows that NRs are the strongest and a statistically significant indicator of human illnesses related to consuming contaminated pork.

The same commenter stated that decreasing NRs in all market hog establishments would have the effect of reducing illnesses by 3,893, or 4.7 percent. The commenter argued that this reduction would be 1.5 times greater than the reduction FSIS expects will be possible (2,533) by increasing offline verification tasks under NSIS. According to this organization's analysis, FSIS would reduce more illnesses by decreasing NRs, compared to redeploying inspection resources under NSIS.

Response:
As FSIS explained in the risk assessment, NRs were included in this assessment for theoretical evaluation only as a possible decision variable because of inclusion in the NPIS risk assessment. For this assessment, the variables associated with offline inspection tasks represent the sum of each type of category across the various inspection procedure codes in an establishment on each day that a
Salmonella
sample was collected. Unlike SP, SNP, and U, NRs depend on noncompliance by establishments and are strictly not an FSIS decision variable. Historic occurrences of establishment non-compliance may help explain variability in pathogen performance that already has been observed. However, because future NR rates depend on the behavior of establishments, it is not feasible to assume that the NR rates can be varied (like SP, SNP, and U) solely by reallocating Agency inspection resources. Therefore, FSIS considers implementation scenarios that simulate future changes in the NR variable infeasible, but the theoretical examination of NRs offers potential risk management insights.

Comment:
A consumer advocacy organization asked, if conducting more offline procedures at HIMP establishments reduces
Salmonella
contamination, why didn't FSIS find a statistically significant reduction in
Salmonella
in HIMP establishments as compared to non-HIMP traditional establishments? The commenter noted that from CY2006 through CY2009 the
Salmonella
percent positive for market hogs was lower in HIMP establishments than in non-HIMP establishments, but it was higher in the HIMP establishments in CY2010. According to the commenter, data from a baseline
Salmonella
study from August 2010 through August 2011 found that the
Salmonella
percent positive for carcasses in the HIMP establishments was almost one-half the value of the rate in comparable non-HIMP

establishments—0.69 percent and 1.35 percent, respectively—but the difference was not statistically significant. According to the commenter, FSIS did not explain why the
Salmonella
percent positive for carcasses are sometimes higher in HIMP establishments and sometimes lower as compared to non-HIMP establishments.

Response:
The risk assessment was not conducted as a comparison between HIMP and non-HIMP establishments operating under traditional inspection. It was a regression analysis that looked at the numbers of FSIS inspection procedures conducted and
Salmonella
prevalence at all swine slaughter establishments together. The risk assessment did show a statistically significant relationship between increased offline inspection procedures and reduced
Salmonella
contamination for carcasses. In contrast, the Hog HIMP Report compared the average
Salmonella
percent positive between the five HIMP establishments and twenty-one non-HIMP comparison establishments. The latter analysis did not detect statistically significant differences between these two establishment groups across years, and this is likely attributable to the small sample size (number of HIMP and non-HIMP establishments) relative to the low number of
Salmonella
percent positives at the post-chill carcass sampling point.

Comment:
A few consumer advocacy organizations and public health organizations noted that the risk assessment that informed the modernization of poultry slaughter inspection final rule also predicted that conducting more offline tasks would likely result in food safety benefits. According to the commenters, microbial sampling conducted since NPIS's implementation has not supported this prediction. A few commenters noted that in a preliminary assessment of NPIS provided to stakeholders last fall, FSIS indicated that
Salmonella
and
Campylobacter
percent positives were similar between large establishments that volunteered to operate under NPIS and large establishments that decided not to change their inspection systems. One consumer advocacy organization argued that recent data reveal that NPIS establishments are more likely to fail FSIS
Salmonella
performance standards than establishments that have not converted to NPIS. The commenters argued that like NPIS, NSIS will not have food safety benefits.

Response:
As noted by the commenters, in a preliminary assessment of NPIS, FSIS found that carcass
Salmonella
and
Campylobacter
percent positives for the group of establishments that had converted to NPIS were comparable to those for similar establishments that had not converted to NPIS.
18

This assessment included all establishments that had converted to NPIS at that point in time, including the former HIMP establishments. The assessment also found that the former HIMP establishments had lower carcass
Salmonella
percent positives than both non-NPIS establishments and non-HIMP NPIS establishments, suggesting that carcass
Salmonella
percent positives are lower in establishments with more experience operating under HIMP and NPIS inspection systems. The Agency will continue to track FSIS carcass
Salmonella
percent positives as more establishments convert to NPIS.

18
Update on Preliminary Analysis of Modernization of Poultry Slaughter, October 2017 available at:
https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/haccp/haccp-based-inspection-models-project/himp-study-plans-resources/poultry-slaughter-inspection.

The October 2017 preliminary analysis mentioned by the commenters compared 39 large NPIS establishments, 23 of which were former HIMP establishments, to 126 large non-HIMP and non-NPIS establishments. Poultry establishments continue to convert to NPIS, allowing for a more meaningful comparison between NPIS and non-NPIS establishments. FSIS analyzed the data and found no statistically significant difference in the proportion of establishments that fail to meet carcass
Salmonella
performance standards between those operating under NPIS and those operating under the traditional inspection system. Considering uncertainty, the 95 percent confidence interval for the difference in proportions includes zero. This provides supporting empirical evidence independent of the risk assessment model that in practice the NPIS provides an equivalent level of food safety protection compared to traditional inspection. FSIS disagrees that the current data shows that there will be no food safety benefits related to NPIS, and therefore, there will be no food safety benefits related to NSIS. Especially since the October 2017 preliminary analysis found that FSIS inspectors are performing approximately four times more offline verification tasks for visible contamination in NPIS establishments than in non-NPIS establishments. FSIS will continue to evaluate the public health impact associated with NPIS as more establishments convert and experience is gained with operating under NPIS.

Comment:
One consumer advocacy organization noted that FSIS's uncertainty analysis indicated that there is a 12.5 percent chance that there will be increased illnesses simply by increasing the number of scheduled-performed verification tasks. The commenter argued that FSIS should not finalize a rule that would not improve public health.

Response:
The risk assessment analyzed data on specific types of inspection activities and the prevalence of
Salmonella
in market hog slaughter establishments. The results suggest that, because inspection personnel assigned to NSIS will conduct more of the type of inspection activities that were correlated with lower
Salmonella
prevalence, NSIS will potentially result in fewer human illnesses than would be expected if not implemented. Therefore, FSIS needs to publish and implement this rule to be able to shift resources and realize the predicted benefits. In addition to the estimated values, the analysis provides the statistical uncertainty of the estimated number of averted illnesses by reporting the upper and lower confidence bounds around the estimates to acknowledge that uncertainty always will exist in such models.

Comment:
One public health organization stated that FSIS did not assess the public health impact of increasing establishments' line speeds in the proposed rule. The same commenter stated that FSIS should explore the public health impact of increasing line speeds before finalizing the proposed rule.

Response:
While the relationship between line speed and
Salmonella
prevalence was not incorporated into the risk assessment model, FSIS did consider the impact of line speed on HIMP establishment performance in the Hog HIMP Report. The Hog HIMP Report estimated that in CY2013, line speeds at the 5 HIMP market hog establishments varied from 885 to 1,295 head per hour (hph), with an estimated average line speed of 1,099 hph. The 21 non-HIMP comparison establishments had estimated line speeds of 571 to 1,149 hph, with an estimated average line speed of 977 hph. The Hog HIMP Report found that even with slightly faster line speeds, HIMP market hog establishments had higher compliance with Sanitation SOP and HACCP regulations, lower levels of non-food safety defects, equivalent or better
Salmonella
verification testing positive rates than the 21 traditional non-HIMP comparison market hog establishments, and lower levels of violative chemical residues.

Comment:
A few commenters urged the Agency to redo the risk analysis model using data from FSIS's
Salmonella
pork cuts and comminuted pork exploratory testing after that project has been finalized.

Response:
Data from the Agency's pork cuts and comminuted pork exploratory testing project would not improve the risk assessment. While the pork parts data may prove useful for monitoring and evaluating process control during further processing, it will not be useful for measuring process control during slaughter operations. Processing establishments purchase primals from multiple slaughter establishments. Because establishments comingle primals during processing, they may become contaminated during processing. As a result, the
Salmonella
percent positives during processing would not be reflective of
Salmonella
percent positives or pathogen contamination at the end of slaughter operations.

Comment:
One animal welfare group argued that the risk assessment and peer review were too narrow in scope. The commenter argued that the risk assessment should not have been limited to
Salmonella
risk but should have included every potential food safety and public health risk. The commenter was especially concerned about the risk of
Yersinia enterocolitica
and influenza.

Response:
FSIS selected
Salmonella
because it is the most common cause of foodborne illness associated with pork products and interventions targeted at reducing
Salmonella
have been shown to be effective at reducing contamination by other enteric pathogens, such as
Yersinia enterocolitica.
FSIS did not include swine influenza in the Agency's risk assessment because swine influenza has not been shown to be transmissible to people through eating pork products.

Comment:
One consumer advocacy organization commented that FSIS had not adequately considered the peer review comments and cited Reviewer E's comment about whether using simulated data is “a statistically legitimate approach.”

Response:
After additional internal review, FSIS has decided to add language to the risk assessment to highlight the results of the modeling without simulated data (
see
Table 13 in the risk assessment). FSIS is confident that it has addressed reviewers' comments on the risk assessment.

D. NSIS

Comment:
Comments from swine slaughter establishments, trade associations representing the pork industry, and a few private citizens supported the proposed rule. These comments stated that NSIS will enhance FSIS inspection procedures and increase industry efficiency while ensuring safeguards are in place to promote worker safety and animal welfare.

However, comments from consumer advocacy organizations, labor unions, public health organizations, animal welfare advocacy organizations, worker rights advocacy organizations, and private citizens objected to NSIS for various reasons. Many of these commenters objected to NSIS because they view NSIS as a system that “privatizes” inspection by replacing FSIS inspectors with establishment employees.

Response:
FSIS is not privatizing swine slaughter inspection. The new inspection system will not eliminate FSIS inspection. NSIS simply requires establishments to take additional steps
before
FSIS inspection to ensure that their products are safe and wholesome.

As FSIS explained in the proposed rule, most market hog establishments under traditional inspection already voluntarily conduct sorting activities before FSIS ante-mortem inspection (83 FR 4780, 4783). Under NSIS, 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. Under NSIS, FSIS will continue to conduct ante-mortem inspection. The key difference is that establishment sorting activities will be mandatory.

Under 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. Rather, under traditional inspection, establishments are required to assign competent assistants to take such actions as directed by FSIS online inspectors after the inspectors have conducted the initial inspection activities (see 9 CFR 307.2(g)). Therefore, under traditional inspection, establishments rely on FSIS online inspectors to effectively control and direct their processing.

Under NSIS, FSIS inspectors will still be stationed on the evisceration line and these inspectors will continue to inspect every head, viscera, and carcass as required by the FMIA. FSIS offline inspectors will also continue to conduct food safety related inspection activities and evaluate establishment process controls. However, FSIS will require establishments operating under NSIS to take a more proactive role in removing contamination and identifying defects before FSIS post-mortem inspection.

Comment:
A few consumer advocacy groups argued that the proposed rule's ante-mortem condemnation provisions violate the FMIA. One consumer advocacy group stated that 21 U.S.C. 603 and 9 CFR 301.9(a) require FSIS inspectors to examine and inspect each animal before it can be slaughtered for human food. The consumer advocacy group argued that FSIS completely disregards this requirement by allowing establishment employees to “bypass” antemortem inspection for 90 to 95 percent of all moving animals not deemed suspect by the establishment.

Several commenters noted that a former chief veterinarian for FSIS spoke out against the ante-mortem portion of the proposal, suggesting that it would increase the risk that FSIS veterinarians could miss the early signs of a large-scale animal disease outbreak. The commenters stated that an outbreak could impact food safety while having devastating economic consequences for U.S. animal producers. According to the commenters, a large outbreak of Foot and Mouth Disease (FMD) has the potential to shut off all foreign markets to U.S. beef and pork, costing American producers an estimated $128 billion over a 10-year period.

Two foreign countries requested clarification on the role of the FSIS Public Health Veterinarian (PHV) and inspectors in the context of ante-mortem activities under the NSIS. The commenters questioned if FSIS inspectors or veterinarians will inspect all animals or carcasses removed by the establishment sorters.

Response:
As FSIS explained in the proposed rule, animal sorting procedures under HIMP and NSIS are virtually the same as animal segregation procedures used voluntarily by most market hog establishments under traditional inspection. FSIS has allowed establishments operating under traditional inspection to voluntarily implement animal segregation procedures since at least the 1980s without adverse economic consequences.

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.
19

Therefore, 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 undergo additional FSIS inspection. FSIS requires these establishments to document their segregation procedures in their HACCP plans or prerequisite programs.
20

FSIS inspectors examine all animals found by the establishment to be normal at rest, and five to ten percent of those animals in motion.
21

19

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.

20
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.

21
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.

FSIS disagrees that this inspection scheme violates the FMIA. FSIS inspectors still conduct 100 percent ante-mortem inspection.
22

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” and “U.S. Suspect” pens. FSIS inspectors observe establishment employees performing animal segregation procedures at least once per month.

22

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.

As mentioned above, the key difference, as compared to traditional inspection, is that sorting procedures are mandatory under NSIS. All establishments operating under the NSIS must 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 central nervous system (CNS) conditions or pyrexia. Establishments under NSIS that do not adequately sort for these food safety defects before FSIS ante-mortem inspection will receive an NR for noncompliance with 9 CFR 309.19.

Regarding the questions from the foreign countries, FSIS inspectors inspect every market hog offered for slaughter. However, an establishment may decide to divert hogs that do not meet its market specifications to another slaughter facility, where they will receive 100 percent ante-mortem inspection by an FSIS inspector. This is not a change in policy. Establishments operating under traditional inspection may also divert hogs to other establishments operating under traditional inspection. If establishments decide to divert hogs, they are required to follow the Animal and Plant Health Inspection Service's (APHIS's) regulations governing the movement of live animals.

Under the NSIS, FSIS inspectors will observe establishment employees performing sorting procedures. During this time, FSIS inspectors will 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.

Comment:
Several comments asserted that revoking maximum line speeds conflicts with the purposes or provisions of the FMIA because faster line speeds will make it more difficult for FSIS inspectors to effectively conduct online inspection. A consumer advocacy organization stated that the FSIS inspectors must provide a “critical appraisal” of all carcasses (
AFGE
v.
Glickman,
215 F.3d 7, 11 (D.C. Cir. 2000)). According to the comments, revoking maximum line speeds will make it extremely difficult, if not impossible, for FSIS to conduct a critical appraisal of each hog.

Comments from consumer advocacy organizations and an animal welfare organization further argued that FSIS does not have the statutory authority to conduct rulemaking to increase efficiencies for the government and industry.

Response:
Based on FSIS's experiences under HIMP, online inspectors in HIMP establishments can conduct an effective online inspection of the head, viscera, and carcass of each hog when operating at faster line speeds. To ensure that online inspectors will be able to conduct effective online inspections, FSIS PHVs in all NSIS establishments are authorized to direct establishments to operate at reduced line speeds when, in the PHV's judgment, a carcass-by-carcass inspection cannot be performed within the time available due to the way that the hogs are presented to online inspectors, or because the establishment is not maintaining process control (9 CFR 310.26).

FSIS has the authority to change its regulations to conduct more efficient inspections and to reduce unnecessary regulatory burdens on industry. As FSIS explained in the proposed rule (83 FR 4780, 4782), 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. In addition, this rulemaking is consistent with E.O. 13563, which directs Federal agencies to review existing rules that may be burdensome, unnecessary, and outdated and to modify, streamline, expand, or repeal them accordingly.

Comment:
Several comments from consumer advocacy organizations, public health organizations, worker advocacy organizations, labor unions, and private citizens objected to FSIS's requirement that establishment employees sort carcasses and parts before they are presented for FSIS inspection because the commenters believe that establishment employees will miss many food safety and OCP defects. A few commenters referenced affidavits from three FSIS inspectors who worked in HIMP establishments who stated that because of excessive line speeds and lack of training, establishment sorters routinely miss many food safety and wholesomeness defects. The commenters argued that FSIS must more thoroughly evaluate the proposal to allow establishment employees to perform preliminary sorting before the Agency implements NSIS.

Response:
The Hog HIMP Report found that the overall performance of HIMP establishments was as good as non-HIMP establishments. Results from offline inspections in HIMP establishments, which are conducted after establishment employees have completed the initial sorting of carcasses and parts, show that the rates of carcasses with food safety defects (
e.g.,
septicemia, toxemia, pyemia, and cysticercosis) and visible contamination from visible fecal material, ingesta, and milk in HIMP establishments were very low, well below the levels set by the HIMP performance standards. In addition, as explained in the proposed rule, OCP defect rates identified on carcasses and parts in HIMP establishments average about half the corresponding OCP HIMP performance standard. Therefore, the data from the HIMP pilot study show that establishment employees do effectively sort carcasses, trim defects, and identify

carcasses for disposal before FSIS post mortem inspection.

Comment:
Several consumer advocacy groups and a public health organization recommended that FSIS establish training for establishment employees performing sorting activities and require sorters to prove proficiency in performing their duties.

Members of industry stated that establishments operating under HIMP have been successful at training employees to sort for food safety and non-food safety defects. These commenters commended the Agency for creating its sorter guide. The commenters stated that the sorter guide is comprehensive and consistent with current practices under HIMP. However, the commenters stated that the sorter guide could be improved by defining several pathological conditions and veterinary terms not well-known to industry personnel, as well as updating photos and diagrams.

Response:
FSIS is not prescribing specific sorter training or certification. FSIS made some editorial changes to its sorter guide to simplify the guideline. The Agency did not make any significant changes to its sorter guide in response to comments. FSIS did not think it was necessary to add the pathological conditions, veterinary terms, or pictures mentioned in the comments because they are not commonly found or used. However, FSIS PHVs will be available to discuss conditions and terms if an establishment has any questions. The guide is available on the FSIS website at:
http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatorycompliance/compliance-guides-index.
As FSIS explained in the proposed rule, the guide that the Agency has developed is based on the training that FSIS provides to its online inspection personnel that are responsible for sorting carcasses under the existing inspection systems.

Comment:
Members of the pork industry and a trade association representing members of the pork industry requested that FSIS clarify when NRs will be issued by offline inspectors for carcasses contaminated with visible fecal material, ingesta and milk. The commenters noted that the proposed rule stated that FSIS will issue NRs for every carcass contaminated with fecal material, ingesta, and milk. According to the commenters, this policy is not consistent with FSIS Directive 6420.2, which instructs inspection personnel to issue NRs based on a specific sampling procedure during carcass verification checks.

Response:
FSIS is clarifying that, consistent with FSIS Directive 6420.2, only offline inspectors will issue NRs for fecal material, ingesta, or milk contamination if they observe the contamination on sampled carcasses when performing the Livestock Zero Tolerance Verification task. FSIS online inspectors will not issue NRs if they observe fecal material, ingesta, or milk contamination on the carcasses. Rather, online inspectors will stop the slaughter line to allow for trimming of the carcass by establishment personnel and reinspection of the carcass by the inspector, unless the establishment has provided a rail-out loop. FSIS did not intend to change these inspection procedures with the implementation of this rule.

Comment:
Members of the pork industry and trade associations representing the pork industry stated that the proposed requirement to immediately denature carcasses that have been sorted and removed from slaughter is overly burdensome and unnecessary. One trade association stated that imposing specific denaturing requirements may discourage establishments from adopting NSIS. That commenter suggested that FSIS amend the proposed 9 CFR 309.19(c) to read “the establishment must dispose of the carcass according to 9 CFR part 314.” A HIMP establishment recommended FSIS require that establishments maintain procedures to control and isolate carcasses and parts removed from slaughter and demonstrate that they do not enter the human food chain or immediately denature in accordance with 9 CFR part 314.

Response:
FSIS has considered these comments and believes they have merit. Therefore, FSIS has revised its proposed disposal requirements and will instead require establishments to develop, implement, and maintain written procedures to ensure that animals and carcasses that have been sorted and removed for disposal do not enter the human food supply and are properly disposed of according to 9 CFR part 314.

Comment:
Members of the pork industry and trade associations representing members of the pork industry noted that APHIS uses FSIS animal disposition data, collected and maintained through PHIS, to monitor animal disease rates and identify trends. These commenters all agreed that these data are useful and should not be lost in the transition to NSIS. According to these commenters, it would not be overly burdensome for establishments to keep records of the specific reasons why hogs are removed from slaughter because they already produce similar records. The commenters recommended that FSIS work with establishments on a procedure to transfer disposition information to APHIS on a regular schedule to ensure the ongoing utility of APHIS's swine health surveillance programs.

Response:
In response to these comments, FSIS has amended its proposed record keeping regulations to require swine slaughter establishments to maintain records to document the total number of animals and carcasses sorted and removed per day and the reasons for their removal. FSIS has created a form to collect disposition data from establishments. Establishments may provide the same information as requested on the form electronically if it is submitted in a format approved by FSIS; FSIS will provide further instructions on submitting this data electronically via PHIS later. FSIS will need establishments to submit their electronic data in a format that is compatible with PHIS so that the Agency can quickly analyze the data and share it with APHIS. FSIS has updated its Paperwork Reduction Act analysis to account for this new requirement.

Comment:
Members of the pork industry, trade associations representing the pork industry, and a foreign country urged the Agency to allow establishments the discretion to incise lymph nodes when conducting carcass sorting activities based on their own hazard analysis. One member of the pork industry stated that they have demonstrated through testing and a supplier risk assessment that there is no value in incising lymph nodes to identify pathological conditions.

The foreign country noted that this approach aligns with the visual-only inspection methodology already implemented by other World Trade Organization (WTO) members. According to the foreign country, on-farm practices (husbandry, biosecurity, etc.) have evolved and improved to a point that disease transmission risks can be greatly reduced through effective on-farm controls. The foreign country stated that palpating and incising the mandibular lymph nodes has been shown to contribute to cross contamination of pork products by food safety hazards such as
Salmonella
and
Yersinia.
Therefore, the foreign country argued that moving to a routine visual-only inspection, supported by supply-chain information from primary production facilities, would improve food safety systems.

One trade association stated that the administrative hassle involved in collecting, organizing, and presenting

supply-chain information to FSIS to demonstrate that animal diseases like
M. avium
are not reasonably likely to occur would be unnecessarily arduous and not worth the benefits related to not incising lymph nodes.

Response:
This final rule requires that establishment sorters incise mandibular lymph nodes and palpate viscera to detect the presence of animal diseases as part of their sorting activities, as was proposed (9 CFR 310.26(b)). However, establishments that operate under NSIS may seek waivers (9 CFR 303.1(h)) under the SIP to 9 CFR 310.26(b). Establishments would need to submit documentation supporting that the presence of animal diseases like
M. Avium
is not reasonably likely to occur. Should FSIS grant these waivers, establishments would be permitted to decide, on a lot-by-lot basis, whether to incise mandibular lymph nodes and palpate the viscera to detect the presence of animal diseases. The Agency has decided to grant waivers, when appropriate, to gather more information on the public health impact of such sorting activities to support potential future rulemaking.

Comment:
A foreign country requested clarification on the requirement (9 CFR 310.26(a)) for establishments with fewer than three inspection stations to have a mirror at the carcass inspection station. The commenter questioned whether all NSIS establishments will have to have mirrors at the carcass inspection station. The foreign country was concerned that this requirement will be more burdensome than necessary, particularly for small establishments operating at slower line speeds.

Response:
FSIS is requiring all NSIS establishments to provide a mirror so that FSIS can adequately inspect carcasses. Large, high-volume market hog slaughter establishments under traditional inspection are already required to provide mirrors to assist FSIS inspection (
see
9 CFR 310.1(b)(3) and 307.2(m)(6)).

As FSIS explained in the proposed rule, the Agency does not expect very small establishments to convert to NSIS because of the costs of hiring and training establishment sorters.

E. Line Speed

Comment:
Members of the pork industry and trade associations representing members of the pork industry supported FSIS's proposal to revoke maximum line speed limits for establishments operating under NSIS. Some of these commenters noted that line speeds were originally established to define the number of FSIS online inspectors required to inspect carcasses based on the number of carcasses an individual could reasonably evaluate in a given period. According to the commenters, when these limits were set, animal disease prevalence was much higher, so inspectors needed more time to complete inspection. The commenters agreed with FSIS's conclusions that innovations in animal housing, genetics, and processing have been implemented and have improved livestock conditions at slaughter; therefore, the current line speed limits are outdated and unnecessary.

Members of the pork industry and trade associations representing the pork industry also stated that revoking maximum line speeds will allow establishments to better adapt their line speeds to slaughter conditions. These commenters argued that line speeds can be adjusted to optimize efficiencies without jeopardizing worker safety, animal welfare, food safety, or quality. These commenters noted that the Hog HIMP Report found that HIMP establishments do not operate at line speeds that are significantly faster than the current maximum line speed for market hogs.

Response:
This final rule revokes the maximum line speeds for establishments operating under NSIS. 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 study 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 a 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 hog establishments operating under traditional inspection.

NSIS is informed by the Agency's experiences under HIMP, and establishments operating under HIMP have demonstrated that they are capable of consistently producing safe, wholesome, and unadulterated pork products while operating at line speeds above the current maximum line speeds (for market hogs under traditional inspection). HIMP establishments also have consistently met pathogen reduction and other performance standards when operating without prescribed maximum line speeds. Moreover, NSIS incorporates additional measures that will apply to all swine slaughter establishments. These measures, which include carcass testing for microbial organisms at pre-evisceration and post-chill (or for hot-boned product, pre-evisceration and after the final wash), are designed to ensure that establishments maintain process control. As a result, FSIS has decided that line speed limits are not necessary for establishments operating under NSIS.

Comments:
Members of the pork industry and trade associations representing the pork industry stated that increased line speeds will not present greater risks for worker safety. One company that owns a HIMP establishment commented that they have not found a correlation between line speeds and worker safety issues in their establishment. According to this commenter, their company's Total Recordable Incident Rate (an OSHA reporting category) has shown a significant decline in recordable injuries since they started operating under their line speed waiver. The commenter also stated that their findings were consistent with the proposed rule's comparative analysis of injuries, which found that HIMP establishments had lower mean injury rates than non-HIMP establishments.

Members of the pork industry and trade associations representing the pork industry stated that establishments continuously evaluate worker safety. According to the commenters, establishments actively work to reduce injuries by implementing ergonomic programs, modifying processes, and creating additional job positions to distribute manual tasks among workers.

However, comments from worker advocacy organizations, labor unions, consumer advocacy organizations, an environmental advocacy organization, and private citizens asserted that revoking maximum line speeds will increase risks to worker health and safety in establishments that operate under NSIS. The comments referenced studies, reports, and other data on work-related injuries in the meat processing industry. The most commonly referenced information sources included:

• Documents published by OSHA that state that musculoskeletal injuries and disorders are prevalent in the meatpacking industry. In the documents, OSHA recommends that establishments should reduce line speeds and production rates to decrease injury rates.

• 2016 BLS data showing that employer reported injury rates for meat establishment workers who were injured or made ill at work are 2.4 times the rate of workers in other private-sector industries.

• Reports published by the GAO that concluded, among other things, that injury rates in the meat slaughter industry continue to be higher than the rates for others in the manufacturing industry, that meat workers may under-report illnesses and injuries because they fear losing their jobs, and that employers may underreport worker injuries because of concerns about potential costs.

• Various reports from worker advocacy organizations on worker safety in meat processing establishments. These reports include statements from slaughter establishment workers that have suffered illnesses and injury from the fast-paced repetitive tasks associated with the current line speeds.

The comments stated that the available studies, reports, and data contradict FSIS's analysis of worker illness and injury in the proposed rule.

Response:
While FSIS agrees that safe working conditions in swine slaughter establishments are important, the Agency has neither the authority nor the expertise to regulate issues related to establishment worker safety. FSIS has been delegated the authority to exercise the functions of the Secretary of Agriculture under the FMIA, the Poultry Products Inspection Act (PPIA; 21 U.S.C. 451
et seq.
), and the Egg Products Inspection Act (EPIA; 21 U.S.C 1301
et seq.
) (the Acts). Under these Acts, FSIS protects the public by verifying that meat, poultry, and egg products are safe, wholesome, not adulterated, and properly marked, labeled, and packaged. The Acts authorize FSIS to administer and enforce laws and regulations solely to protect the health and welfare of consumers.

The Department of Labor's OSHA was created by the Occupational Safety and Health Act of 1970 (29 U.S.C. 651
et seq.
) to assure safe and healthful working conditions for men and women by setting and enforcing standards and by providing training, outreach, education, and assistance. OSHA is the Federal agency with statutory and regulatory authority to promote workplace safety and health. FSIS's authority with respect to working conditions in slaughter establishments extends only to FSIS inspection personnel.

FSIS has worked with OSHA to develop a poster that establishments must display providing information on the signs and symptoms of occupational injuries and illnesses experienced by market hog slaughter workers, and about workers' rights to report these conditions without fear of retaliation (see 9 CFR 310.27). This final rule also requires establishments operating under NSIS to submit on an annual basis an attestation to the management member of the local FSIS circuit safety committee stating that the establishment maintains a program to monitor and document any work-related conditions of establishment workers (9 CFR 310.27). Because OSHA is the Federal agency with statutory and regulatory authority to promote workplace safety and health, FSIS will forward these annual attestations to OSHA for use in its own enforcement program. FSIS employees, however, will not be responsible for determining the merit of the content of the attestation or for enforcement of non-compliance with the attestation provision. OSHA and FSIS will continue to partner through a Memorandum of Understanding,
23

to strengthen collaboration between FSIS inspectors and OSHA enforcement staff and ensure identification and reporting of safety hazards impacting working conditions of FSIS inspectors and those of establishment employees.

23
The MOU is available at:
https://www.osha.gov/laws-regs/mou/1994-02-04.

Comments:
Comments from animal welfare advocacy organizations and private citizens concerned about animal welfare asserted that revoking maximum line speeds for establishments that operate under NSIS will have adverse effects on the humane handling of swine. The comments expressed concern that faster line speeds would increase the potential for workers to force animals to move faster than normal walking speeds and for ineffective stunning. Most of these comments referenced an undercover video that was taken at a HIMP establishment in 2015. According to the commenters, the video showed hogs that were beaten and electrically prodded to move to keep up with the slaughter line speed. The commenters claimed that the video showed hogs that were conscious when they entered the scalding tank because they were improperly stunned.

Several animal welfare groups also claimed that establishment employees are pressured by establishment management to never slow the slaughter line. A few commenters stated that they found a Memorandum of Interview (MOI) issued in 2017 to a HIMP establishment that stated that an FSIS inspector observed that hog handlers were driving animals too fast and with more excitement than necessary, in violation of 9 CFR 313.2. According to the commenters, the MOI also stated that the inspector's concerns had been raised at least twice at weekly meetings with establishment management. The commenters argued that the MOI shows that hogs are routinely forced to move too fast in HIMP establishments.

One commenter supported FSIS's decision to add a second offline inspector to conduct additional offline activities such as monitoring compliance with the HMSA. However, the commenter opposed FSIS's decision to decrease the total number of FSIS in-plant personnel.

Response:
FSIS disagrees that revoking line speeds will have a negative effect on animal welfare. As the Agency explained in the proposed rule, FSIS was able to conduct more offline humane handling verification tasks under HIMP as compared to traditional inspection. As is the case under HIMP, more inspection resources will be available to verify whether establishments meet humane handling requirements as an offline activity under NSIS.

Regarding the undercover video, multiple FSIS experts—including trained veterinarians and humane handling experts—reviewed the video and determined that there was unacceptable rough handling and inappropriate use of a rattle paddle to drive animals. FSIS took immediate regulatory action against the establishment and required it to respond with acceptable corrective actions to prevent a recurrence.

While a person in the video suggests that animals were conscious after stunning, FSIS found that the animals appeared properly stunned and insensible to pain, as required by Federal law. The video was reviewed by a professor of animal science, who reached the same conclusion.

FSIS reviewed the 2017 MOI that stated that an FSIS inspector observed that hog handlers were driving animals too fast and with more excitement than necessary. FSIS has instructed its inspection personnel to properly document noncompliance in NRs and not MOIs.

Comment:
One animal welfare organization noted that they submitted a petition in 2014 requesting that the Agency require all swine slaughter establishments to immediately and humanely euthanize non-ambulatory disabled (NAD) pigs. According to the petition, prohibiting the slaughter of NAD pigs would improve inspection efficiency and compliance with the HMSA, as well as reduce
Salmonella
risks. The animal welfare organization argued that FSIS must respond to their petition before finalizing the proposed rule.

Response:
After carefully considering the issues raised in the petition, along

with the referenced information and other letters received in support of the petition, FSIS has concluded that its existing regulations and inspection procedures are sufficient and effective in ensuring that NAD pigs are handled humanely at slaughter and in preventing diseased animals from entering the human food supply. Consequently, the Agency is denying the petition. The Agency's final petition response is available at
https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/petitions.
FSIS denied a similar petition in 2013 requesting that the Agency prohibit the slaughter of all NAD livestock. That petition response is also available at
https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/petitions.

F. Ready-to-Cook

Comment:
Members of the pork industry and trade associations representing members of the pork industry generally support the proposed RTC pork product standard. However, the commenters requested that FSIS amend the definition to include language such as “reasonably free,” or “sufficiently free,” to clarify that the RTC standard is a standard for non-food safety defects and not a zero-tolerance standard.

These same commenters recommended that the Agency allow establishments to apply the RTC standard at any appropriate location at or before the point of packaging or to clarify that the Agency intends this type of flexibility if that is the case. One trade association said that because an establishment may apply processes targeting RTC criteria and other quality issues at various locations after the cooler, FSIS should not inspect for RTC criteria before the cooler. The commenter argued that there is no food safety concern associated with carcasses and parts that may not yet meet the RTC standard entering the cooler.

Members of the pork industry, trade associations, and a foreign country asked FSIS to clarify when FSIS inspectors can slow or stop the evisceration line because of non-food safety defects in establishments operating under NSIS. These commenters also asked FSIS to clarify how the Agency will document noncompliance with RTC standards. According to the commenters, online inspectors should be instructed to stop the line only to remove food safety defects after the establishment's final control, and NRs should only be given after offline personnel assess and confirm a loss of process control.

A trade association noted that several processing defects covered in the RTC definition are listed under 9 CFR 310.18(a), which applies to all swine establishments and is typically enforced as a zero-tolerance standard. The commenter also noted that 310.18(a) is regularly categorized as a PHR. The commenter was concerned that if an NSIS establishment receives an NR for 9 CFR 310.18(a) for failure to meet RTC standards, it will unjustly influence the establishment's PHR rate. Rather than cite 9 CFR 310.18(a), the commenter suggested that inspectors should cite 9 CFR 310.26(d)(1) for products not meeting RTC standards at NSIS establishments to delineate NRs for non-food safety issues from NRs for food safety issues.

Response:
Under NSIS, establishments will have the flexibility to design and implement measures to address OCP defects that are best suited to their operations. They will also be responsible for determining the type of records that will best document that they are meeting the RTC pork product definition. The records will be subject to review and evaluation by FSIS offline inspectors (9 CFR 310.26(d)(1)).

FSIS has decided to amend the definition of RTC pork product to clarify that it is not a zero-tolerance standard. RTC pork product will now be defined as “any slaughtered pork product
sufficiently
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.”

FSIS also is clarifying that the RTC definition applies to pork products at the end of the slaughter process and before carcasses and parts enter the cooler. This is consistent with the Agency's requirements under HIMP and NPIS.

FSIS will issue instructions to its inspectors on how to verify the RTC pork product requirements using the routine and directed PHIS Swine RTC task. When conducting the routine task, FSIS offline inspectors will verify that an establishment maintains records as required by 9 CFR 310.26(d)(1). FSIS will issue an NR for 9 CFR 310.26(d)(1) if an establishment does not have records to document that the products resulting from its slaughter o

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2019-20245. Public record. Not legal advice.