Modernization of Swine Slaughter Inspection, 52300-52349 [2019-20245]

Download as PDF 52300 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations 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. DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Parts 301, 309, and 310 [Docket No. FSIS–2016–0017] RIN 0583–AD62 FOR FURTHER INFORMATION CONTACT: Roberta Wagner, Assistant Administrator, Office of Policy and Program Development; Telephone: (202) 205–0495. SUPPLEMENTARY INFORMATION: Modernization of Swine Slaughter Inspection Food Safety and Inspection Service, USDA. ACTION: Final rule. AGENCY: jbell on DSK3GLQ082PROD with RULES4 Executive 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 SUMMARY: VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 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 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 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-tocook (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 E:\FR\FM\01OCR4.SGM 01OCR4 jbell on DSK3GLQ082PROD with RULES4 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations 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- VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 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 postchill, or, for hot-boned products, preevisceration 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 lowvolume 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/regulatorycompliance/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 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 52301 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. E:\FR\FM\01OCR4.SGM 01OCR4 52302 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations TABLE 1—NET COSTS AND (BENEFITS) [M$] Costs to Industry .............................................................................................................. Voluntary * ................................................................................................................. Mandatory ................................................................................................................. Health Benefits *** ............................................................................................................ Industrial Efficiency .......................................................................................................... Impacts to Agency’s Budget ............................................................................................ Number of establishments One-time ............................ ** 40 612 ............................ ............................ ............................ $3.14 0.84 2.30 ............................ ............................ 2.80 Recurring $22.72 22.15 0.58 (9.33) (87.64) (8.73) Totals One-Time Cost ................................................................................................................................................ Recurring Cost ................................................................................................................................................. Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ................................................................ Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ................................................................ $5.94 (82.98) (62.56) (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 jbell on DSK3GLQ082PROD with RULES4 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 VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 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 PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 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 postchill. These establishments must also collect a sample at the pre-evisceration point in the process; E:\FR\FM\01OCR4.SGM 01OCR4 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations • 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 preevisceration 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. jbell on DSK3GLQ082PROD with RULES4 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. 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 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. VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 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 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/datacollection-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. PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 52303 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. 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 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-93aef3e67ff045bb/Baseline_Data_Market_Hogs_20102011.pdf?MOD=AJPERES). 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. E:\FR\FM\01OCR4.SGM 01OCR4 jbell on DSK3GLQ082PROD with RULES4 52304 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations 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. 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 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. VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 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 PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 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 E:\FR\FM\01OCR4.SGM 01OCR4 jbell on DSK3GLQ082PROD with RULES4 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations 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 lowvolume 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 VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 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/regulatorycompliance/haccp/haccp-basedinspection-models-project/HIMP-list-ofparticipating-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 PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 52305 Agency has added all the information that it has recently released to its FOIA Electronic Reading Room.8 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. 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. Response: FSIS addressed OIG’s concerns in the Agency’s responses to the audit. In response to the OIG audit, 8 FSIS’s FOIA Electronic Reading Room is available at http://www.fsis.usda.gov/readingroom. 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. 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. E:\FR\FM\01OCR4.SGM 01OCR4 jbell on DSK3GLQ082PROD with RULES4 52306 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations 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. To deter repeat violators, the Agency changed the way that it schedules its indepth 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 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 11 https://www.fsis.usda.gov/wps/portal/fsis/ newsroom/news-releases-statements-andtranscripts/news-release-archives-by-year/archive/ 2013/nr-102313-01. 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. 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/8f218f5b197e-4813-bf92-be29be36ec08/1518.pdf?MOD=AJPERES&CONVERT_ TO=url&CACHEID=8f218f5b-197e-4813-bf92be29be36ec08. VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 that may warrant an FSIS enforcement action. 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 thirdparty 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 E:\FR\FM\01OCR4.SGM 01OCR4 jbell on DSK3GLQ082PROD with RULES4 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations 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 nonHIMP 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 HACCPBased 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. 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 16 The Hargis Report is available at https:// www.fsis.usda.gov/OPPDE/nacmpi/Nov2002/ Papers/NAFS97.pdf. VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 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 PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 52307 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 E:\FR\FM\01OCR4.SGM 01OCR4 jbell on DSK3GLQ082PROD with RULES4 52308 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations 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 VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 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, healthrelated 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 comparablysized 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 noncompliance 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 PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 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. 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 nonHIMP traditional establishments. Comment: Several commenters argued that until FSIS can compare and 17 https://www.fsis.usda.gov/wps/wcm/connect/ f7be3e74-552f-4239-ac4c-59a024fd0ec2/EvaluationHIMP-Market-Hogs.pdf?MOD=AJPERES. E:\FR\FM\01OCR4.SGM 01OCR4 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations jbell on DSK3GLQ082PROD with RULES4 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 realworld 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 VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 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 (9.4times 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 PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 52309 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 E:\FR\FM\01OCR4.SGM 01OCR4 jbell on DSK3GLQ082PROD with RULES4 52310 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations 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 nonHIMP 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 nonHIMP 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 VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 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. 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 nonNPIS 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. 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/haccpbased-inspection-models-project/himp-study-plansresources/poultry-slaughter-inspection. PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 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 scheduledperformed 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. E:\FR\FM\01OCR4.SGM 01OCR4 jbell on DSK3GLQ082PROD with RULES4 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations 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 VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 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 PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 52311 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 largescale 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 E:\FR\FM\01OCR4.SGM 01OCR4 52312 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations jbell on DSK3GLQ082PROD with RULES4 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 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. 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 19 See FSIS Directive 6100.1, Ante-mortem Livestock Inspection available at http:// www.fsis.usda.gov/wps/wcm/connect/2b2e7adc961e-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/2b2e7adc961e-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/2b2e7adc961e-4b1d-b593-7dc5a0263504/ 6100.1.pdf?MOD=AJPERES. 22 See FSIS Directive 6100.1, Ante-mortem Livestock Inspection available at http:// www.fsis.usda.gov/wps/wcm/connect/2b2e7adc961e-4b1d-b593-7dc5a0263504/ 6100.1.pdf?MOD=AJPERES. VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 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 PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 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 E:\FR\FM\01OCR4.SGM 01OCR4 jbell on DSK3GLQ082PROD with RULES4 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations 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, VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 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 PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 52313 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, onfarm practices (husbandry, biosecurity, etc.) have evolved and improved to a point that disease transmission risks can be greatly reduced through effective onfarm 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 visualonly inspection, supported by supplychain information from primary production facilities, would improve food safety systems. One trade association stated that the administrative hassle involved in collecting, organizing, and presenting E:\FR\FM\01OCR4.SGM 01OCR4 52314 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations jbell on DSK3GLQ082PROD with RULES4 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 VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 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- PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 evisceration and post-chill (or for hotboned 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 workrelated 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 privatesector industries. E:\FR\FM\01OCR4.SGM 01OCR4 jbell on DSK3GLQ082PROD with RULES4 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations • 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 underreport 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 VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 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. 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 23 The MOU is available at: https:// www.osha.gov/laws-regs/mou/1994-02-04. PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 52315 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 inplant 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 E:\FR\FM\01OCR4.SGM 01OCR4 52316 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations 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. jbell on DSK3GLQ082PROD with RULES4 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. VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 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 nonfood 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 operation meet the definition of RTC pork product. If FSIS online inspectors believe that the presentation of persistent unattended trim or processing defects indicates a lack of process control, they will notify the PHV. The PHV may then tell an offline inspector to conduct a PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 directed PHIS Swine RTC task. FSIS offline inspectors will follow the same method and apply the same criteria that the establishment uses to check that they are meeting the RTC standard. FSIS will issue an NR for 9 CFR 310.26(d)(1) if the results exceed the criteria set by the establishment or if the establishment did not take the necessary corrective actions to restore process control when the evaluation criteria was exceeded. If the PHV determines that the presentation of persistent unattended trim or processing defects indicates a loss of process control that affects the online inspectors’ ability to adequately conduct a carcass-by-carcass inspection, the PHV will direct the establishment to reduce its line speeds. The PHV will then issue an NR citing 9 CFR 310.26(d)(1). FSIS inspectors will use PHIS to link all NRs that are issued for the failure to meet the RTC pork product standard and associated documentation requirements. If establishment management is unwilling or unable to take the necessary steps to re-establish control of its process to meet RTC regulatory requirements, FSIS inspectors will discuss the issue with their supervisor and the DO. The DO will notify the establishment in writing that repeated NRs may lead the Agency to take a regulatory control action (9 CFR 500.2). In the rare case that FSIS online inspectors identify a carcass so affected with non-food safety defects (e.g., malignant lymphoma, icterus, or uremia) that the entire carcass must be condemned, they will stop the line for carcass condemnation unless the establishment provides a rail-out loop to rail carcasses offline for reexamination and condemnation. G. Implementation Comment: One member of the pork industry supported the NSIS implementation strategy suggested in the proposed rule. However, the pork producer requested more information on whether two shift operations must convert both shifts to NSIS at the same time. The same commenter also requested more information on what would happen if an establishment that converted to NSIS decided it wants to move back to traditional inspection. A trade association noted that FSIS’s implementation plan for NPIS was phased in with close coordination with DOs and establishments. The commenter stated that FSIS should follow a similar implementation plan for NSIS, with an initial notification period for establishments that want to adopt NSIS and an algorithm to E:\FR\FM\01OCR4.SGM 01OCR4 jbell on DSK3GLQ082PROD with RULES4 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations determine transition order. This commenter also suggested a phased-in approach for the mandatory provisions for all swine establishments based on establishment size. The same trade association stated that establishments should submit for approval unique transition plans to the DO when providing notification that they intend to adopt NSIS. The trade association suggested that FSIS identify and provide acceptable examples of transition plan elements. According to the commenter, pre-approved elements should include transitioning single inspection stations in succession, one shift at a time, one inspection focus area (i.e., head inspection) at a time, RTC monitoring before transitioning inspection activities, and others. Consumer advocacy organizations stated that only establishments that have their HACCP plans approved by FSIS should be allowed to implement NSIS. The commenters suggested that FSIS should review every establishment’s HACCP plans to determine if their tailored microbiological testing programs are valid before allowing them to convert to NSIS. Response: All market hog establishments will initially have six months to notify their DO of their intent to operate under NSIS. Establishments that do not notify their DO of their intent to transition during this time will be deemed to have chosen to continue to operate under traditional inspection. Market hog establishments that decide that they would like to convert to NSIS after the initial notification date may notify their DO of their intent at any time after that date. The Agency will implement NSIS in the additional establishments that intend to convert on a schedule consistent with the availability of Agency resources and establishment readiness. The Agency intends to implement NSIS in all market hog establishments that choose to operate under this new inspection system, regardless of when the establishment notifies FSIS of its intent to transition to NSIS. However, the initial implementation wave will only include those establishments that submit their intent to convert to NSIS within the initial notification period. Because there are fewer market hog establishments than poultry establishments, the Agency does not think it will be necessary to use an algorithm to determine transition order. FSIS also does not think it is necessary to require establishments to develop formal transition plans. Establishments will need to transition all shifts and inspection stations to NSIS at one time. VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 However, FSIS DOs will work with establishments to ensure a smooth transition from traditional inspection to NSIS. And, if necessary, FSIS DOs will work with establishments to ensure a smooth transition from NSIS back to traditional inspection. FSIS does not think it is necessary to review HACCP plans before establishments convert to NSIS. FSIS already has inspection tasks in place to verify that establishments are properly implementing their HACCP systems in accordance with 9 CFR part 417. The Agency is establishing separate applicability dates for large, small, and very small establishments to comply with 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). The applicability dates will provide additional time for small and very small establishments to comply with these provisions. H. Environmental Assessment Comments: Comments from an animal welfare advocacy organization and an environmental advocacy organization stated that before FSIS can finalize the proposed rule, the Agency must prepare an Environmental Impact Statement (EIS), as required under the National Environmental Policy Act (NEPA; 42 U.S.C. 4321 et seq.) because, according to these commenters, allowing market hog slaughter establishments to increase line speeds will result in significant environmental impacts. The commenters stated that faster line speeds would mean more hogs slaughtered per shift. According to the commenters, more hogs slaughtered would mean more waste and more water use. The commenters asserted that these are all significant environmental impacts, with both individual and cumulative effects at the local, state, and national levels. The commenters also stated that FSIS cannot claim the categorical exclusion from the preparation of an Environmental Assessment (EA) or an EIS under 7 CFR part 1b of the USDA regulations. Response: FSIS maintains that this rulemaking is categorically excluded from NEPA requirements. Federal agencies may identify classes of actions that normally do not require the preparation of either an EA or EIS because such actions do not have a significant effect on the human environment, either individually or cumulatively (40 CFR 1507.3(b)(2)). Such classes of actions are ‘‘categorically excluded’’ from NEPA PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 52317 requirements (40 CFR 1508.4). Under 7 CFR 1b.4, all FSIS actions, including inspection functions, are categorically excluded from preparation of an EA or EIS unless the Agency head determines that a particular action may have a significant environmental effect. Accordingly, FSIS is not required to prepare an EA or EIS unless it anticipates that this rule may have a significant environmental effect. The Agency does not anticipate that its decision to revoke maximum line speeds for establishments that operate under NSIS will have individual or cumulative effects on the environment. As FSIS explained in the proposed rule, expected sales of pork products to consumers will determine the total number of hogs that an establishment slaughters, not the maximum line speed under which it operates. The Agency has no authority to determine an establishment’s production levels. An establishment may decide to increase production hours to slaughter more hogs in response to market demand, regardless of its maximum line speed. Revoking maximum line speeds allow establishments to slaughter hogs more efficiently but will not directly affect consumer demand for the establishment’s pork products. In some instances, an establishment operating under NSIS may be able to reduce its hours of operation while maintaining production at a rate necessary to meet market demand for its meat products. Thus, revoking line speeds is not expected to determine the number of hogs slaughtered or result in more waste or more water use, as suggested by the commenters. In addition, all slaughter establishments, regardless of line speed, are required to meet all local, State, and Federal environmental requirements. Sampling Comments: Comments from consumer advocacy organizations and public health organizations supported FSIS’s decision to require establishments to develop written procedures to prevent and mitigate microbial contamination of carcasses throughout the entire slaughter and dressing operations and incorporate the intervention strategies into their HACCP systems. These same commenters stated that sampling at preevisceration and post-chill will make it easier for establishments to see if their process control system is working. According to the commenters, microbial testing at the end of the process encourages industry to focus primarily on post-slaughter interventions, while the new approach encourages them to focus on prevention and mitigation of E:\FR\FM\01OCR4.SGM 01OCR4 jbell on DSK3GLQ082PROD with RULES4 52318 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations microbial contamination throughout the slaughter process. Response: FSIS agrees that requiring establishments to keep written records to document the implementation and monitoring of their process control procedures is a positive step forward for public health. This ongoing documentation will allow both the establishment and FSIS to identify specific points in the production process where a lack of process control may have resulted in product contamination or insanitary conditions. This will allow the establishment to take the necessary corrective actions to prevent further product contamination. Comments: Comments from members of industry stated that FSIS should revise the proposed rule to remove sampling schemes based on establishment size. According to the commenters, basing sampling frequency on the size of the establishment is not supportable from a statistical sampling point of view. The commenters suggested that FSIS propose a minimum sampling frequency for all establishments based on the number of head slaughtered, over a certain time period. Response: FSIS changed its proposed sampling frequency to remove the exception for very small establishments. Under this final rule, very small establishments will need to sample carcasses at pre-evisceration and postchill (for hot-boned product, carcasses sampled at pre-evisceration and after the final wash) at a frequency of one per 1,000 carcasses. However, FSIS has decided to keep the exception for very low-volume establishments. This change makes the sampling requirements for swine slaughter establishments more consistent with the sampling requirements for poultry slaughter establishments. Additionally, if FSIS adopted a sample frequency of one per 1,000 carcasses for very lowvolume establishments, many of these establishments would not have to sample at all. Comment: Several consumer advocacy organizations and one public health organization objected to FSIS’s proposal to allow establishments to develop their own sampling and testing protocols and to use alternate sampling locations and frequencies. These same commenters argued that it would be too difficult for FSIS inspectors to verify sampling plans that use alternate sampling locations and frequencies. Two consumer advocacy organizations argued that FSIS’s Salmonella performance standards remain a core element of HACCP and should not be eliminated under the proposed rule. VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 One consumer advocacy organization argued that FSIS must not move forward with proposed inspection changes without maintaining a pathogen-specific performance standard. The commenter argued that modernized, HACCP-based inspection cannot function adequately without such a performance standard. The commenter further stated that uniform microbial testing is necessary to evaluate the impact of FSIS’s planned inspection changes, as the Agency will not be able to verify trends in pathogen rates caused by the inspection changes without an effective national testing program. One consumer advocacy organization argued that FSIS should maintain the current generic E. coli testing standard. Although the commenter did not oppose substitution of another indicator organism for generic E. coli, they argued that FSIS must ensure that any newly permitted testing program is evidencebased and equal or superior to the prior generic E. coli standard for fecal contamination detection. The commenter recommended that FSIS require establishments who seek to use an alternative testing program to the generic E. coli standard to apply for a regulatory waiver, which would allow for pre-implementation Agency review. Response: The purpose of the new sampling requirement is to ensure that establishments monitor and evaluate the effectiveness of their procedures to prevent contamination of carcasses by enteric pathogens, and visible fecal material, ingesta, and milk on an ongoing basis. It is not intended to generate data to compare establishment performance across the industry. However, FSIS has determined that it may be too difficult for inspectors to review and verify sampling plans that use alternate sampling frequencies and locations. As a result, FSIS is withdrawing the proposal to allow establishments to use alternate sampling frequencies and locations. Establishments that still wish to use alternate sampling frequencies and locations may submit a SIP waiver request to FSIS for review.24 As is noted above, FSIS will provide information about waiver criteria in a future Federal Register document. As FSIS explained in the proposed rule, FSIS discontinued its Salmonella verification sampling program for market hogs (carcasses) in 2011 to make better use of its resources. Because 24 See FSIS Compliance Guideline Procedures for New Technology Notifications and Protocols available at https://www.fsis.usda.gov/wps/wcm/ connect/c64d8f3b-56aa-49c9-91f3-daf0caaba6bd/ New-Technology-Protocols042015.pdf?MOD=AJPERES. PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 verifying the codified performance standards for market hogs was not a good use of Agency resources, and the standards have not been used since 2011, FSIS is removing the carcass Salmonella performance standards for market hogs. With that said, FSIS is currently testing pork cuts and comminuted pork products for Salmonella and expects to decide in 2019 whether to develop new pathogen performance standards for these products or take other actions to address Salmonella in these products.25 FSIS pathogen test results for pork products are posted quarterly on the FSIS website: https://www.fsis.usda.gov/wps/ wcm/connect/df529ce7-575a-43e7-921948be29c80fa5/Sampling-Project-ResultsData.xlsx?MOD=AJPERES. Establishments may continue to sample for generic E. coli. FSIS considers the requirements under the former regulations for generic E. coli to be a scientifically validated ‘‘safe harbor’’ for monitoring process control, specifically for fecal contamination. FSIS previously granted waivers under the SIP to the generic E. coli testing regulations for establishments that want to test for other indicator organisms. Establishments operating under these waivers have demonstrated that they are able to effectively maintain process control based on their SIP sampling data. Comments: Several members of industry, trade associations, and a State Department of Agriculture objected to the proposed pre-operational environmental sampling requirements. One HIMP establishment stated that environmental sampling would be an expensive change with little value. The commenter argued that current HIMP establishments have not been required to conduct environmental sampling beyond those tests that may also meet the Sanitation SOP requirements, and these establishments have shown consistent or better performance controlling for Salmonella. A few public health organizations stated that requiring facilities to monitor and assess food contact surfaces for enteric pathogens is a reasonable measure given that recent investigations of Salmonella foodborne illness outbreaks revealed food contact surfaces to be contaminated with the outbreak strain. The commenters stated that requiring pre-operational environmental sampling should help ensure that 25 See U.S. Govt. Accountability Office, GAO–18– 272, Food Safety: USDA Should Take Further Action to Reduce Pathogens in Meat and Poultry Products (March 2018). https://www.gao.gov/assets/ 700/690709.pdf. E:\FR\FM\01OCR4.SGM 01OCR4 jbell on DSK3GLQ082PROD with RULES4 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations surfaces are sanitary and free of enteric pathogens. Response: This final rule 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. In response to concerns about the regulatory burden, FSIS has decided to withdraw this part of the proposal until it considers options and timing for gathering more data on enteric pathogen contamination in the pre-operational environment. FSIS agrees that current HIMP establishments have shown consistent performance controlling for Salmonella. Comments: Several members of industry, industry trade associations, and private individuals objected to certain content in the sampling guide. These commenters argued that the language in the sampling guide is prescriptive in both tone and language and implies mandatory requirements. The commenters stated that the sampling guide includes unhelpful and problematic sampling methods, techniques, and analysis, as these depend on individual establishments’ sampling programs. For example, several commenters argued that, absent codified standards, Table 4 in the sampling guide would be a de facto performance standard, contrary to the objectives in the proposed rule. The commenters stated that the sampling guide should be revised to promote sampling programs tailored to each establishment. One industry commenter further argued that the word ‘‘compliance’’ should be removed from the document title to be consistent with recent changes to other FSIS guidance documents and because the document provides best practice recommendations and not regulatory requirements. Response: FSIS guidance documents are intended to provide best practices and, in some cases, safe harbors based on the most current science available to Agency stakeholders to help them comply with regulatory requirements, and when applicable, meet performance standards. The sampling guide explains that FSIS considers the requirements under the former regulations for generic E. coli to be a scientifically validated ‘‘safe harbor’’ for monitoring process control for very low-volume establishments. The sampling guide also includes recommendations to assist small and very small establishments to meet regulatory requirements, and recommendations to develop a custom approach that are not dependent on establishments’ available resources. For example, the sampling guide provides VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 baseline information for those establishments that may need a starting place from which to calculate their own control limits. However, control limits change over time as establishmentspecific data is collected and analyzed. FSIS has removed Table 4 and replaced it with a new table (Table 2) to provide better guidance for establishments that may want to use data from the 2010– 2011 market hog baseline survey as an initial starting point from which to set their upper control limits. Therefore, the information provided in the document is not a performance standard. In response to the comments, FSIS has revised the sampling guide to, in part, further clarify the purpose of the document, which is to assist small and very small establishments to comply with the new microbial organism sampling requirements that apply to all swine slaughter establishments under this final rule. The sampling guide has also been revised to include additional information on the intended use of provided methods, techniques, and analyses; and to remove the word ‘‘compliance’’ from the document title and clarify that the document does not constitute regulatory requirements. Additionally, the Agency moved the example control charts from the sampling guide from the sampling guide to Appendix 2 of the guideline and clarified how establishments can use control charts. The Agency did not recommend a specific control chart format. Finally, the Agency removed all references to pre-operational environmental sampling. The updated sampling guide is available at https:// www.fsis.usda.gov/wps/portal/fsis/ topics/regulatory-compliance/ compliance-guides-index. Comments: Several commenters objected to certain information provided in the sampling guide related to indicator organism sampling and testing. One industry commenter stated that both the proposed rule and the sampling guide, as written, could mandate a shift from analyzing market hog carcasses for enteric pathogens of concern, such as Salmonella, to monitoring a surrogate, such as Aerobic Plate Count (APC). The commenter argued that this process control approach is too singular, and FSIS should clarify in the sampling guide that establishments will maintain the flexibility to select for one or more indicator organisms. In addition, several commenters argued that FSIS should revise the sampling guide to remove sampling schemes based on establishment size. They stated that, from a statistical sampling viewpoint, establishing sampling frequency based PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 52319 on the size of the establishment is not supportable. These commenters also stated that generic E. coli testing should not remain a ‘‘safe harbor,’’ even for small and very small establishments, because no scientific correlation exists between microorganism presence/ growth and facility size. Finally, one industry commenter noted that the sampling guide does not summarize all known control points for Salmonella, as the document claims it does. Response: The sampling guide provides flexibility and monitoring options for establishments, and it makes clear that establishments may select one or more indicator organisms to monitor. To address the comment about the singular process control approach, the sampling guide provides a link to the December 2013 FSIS guideline for controlling Salmonella in market hogs, which describes potential control points for Salmonella in the pre- and postharvest production process. The potential control points described in that 2013 guideline may or may not be applicable to a specific establishment’s process. Comments: Several commenters expressed concerns with information provided in reference and example charts throughout the sampling guide. One member of the pork industry and one trade association representing the pork industry argued that establishments should not compare process control results to a nationwide geometric mean displayed in one chart. The commenters argued that market hog data is an inappropriate basis for developing upper control limits, as it is not applicable to all swine establishments. Further, they stated that these data from 2011 are outdated. One commenter stated that ‘‘under NSIS’’ should be removed from one table column heading, as the information would apply to all swine establishments. Response: FSIS revised the sampling guide to remove the table that provided averages that represented the 80th percentile limits for each indicator organism included in FSIS’s 2010–2011 market hog baseline survey. The Agency also removed the ‘‘under NSIS’’ language from the table that provides information for all swine establishments In cases where an establishment does not have the resources or capacity to initially develop its own statistical control limits or analytical procedures, an establishment can utilize the aggregated data from the FSIS Nationwide Market Hog Microbiological Baseline Survey. The 2010–2011 baseline survey provides a wealth of microbiological data specific to swine E:\FR\FM\01OCR4.SGM 01OCR4 52320 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations jbell on DSK3GLQ082PROD with RULES4 carcass sampling; these data are meant to provide a starting point for an establishment to develop its own control limit parameters over time. During the survey, FSIS collected two carcass samples at pre-evisceration and post chill. Comment: One member of the pork industry and one trade association representing the pork industry recommended that FSIS remove from the sampling guide information related to finished product standard (FPS) waivers, as the subject is unrelated to the sampling guide. Response: FSIS has removed the FPS waiver information from the sampling guideline. I. Economic Assessment Comment: One company that owns a HIMP establishment said that the cost of additional employees has been their most significant cost from the HIMP pilot study, and that they have had to hire and train up to 11 employees per shift to staff and maintain the inspection process. Response: FSIS incorporated information from this comment into section III.G.1.a by revising the upper bound estimate from 10 employees to 11 in the description of additional establishment workers likely to be required by establishments that adopt the NSIS. Comment: One industry commenter estimated that a full-time position, per slaughter shift, would be required to collect, record, and analyze data required to verify that an establishment’s products meet the definition of RTC. Response: While establishments are free to design their own process control monitoring systems, FSIS finds the estimated time and labor requirement provided in this comment to be inconsistent with FSIS’s observations of HIMP establishments verifying OCP performance standards. FSIS explained in the proposed rule that pork carcasses that meet the HIMP OCP performance standards would meet the RTC pork product definition. Large swine establishments can verify OCP performance standards by taking 24 carcass samples per shift, requiring roughly one hour to collect, record, and analyze the data. Comments: Several comments from members of the pork industry stated that they own establishments that operate under SIP waivers and conduct process control sampling at alternate frequencies. Response: FSIS incorporated the information from these comments into section III.G.2.b of the final rule and VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 used it to revise the cost estimate associated with changes to requirements for microbial organism process control sampling and analysis. This revision caused a slight decrease in potential industry savings. Under the SIP, 11 large swine establishments currently sample at an alternative frequency and the Agency assumes that these establishments will continue to do so when the applicability dates for this final rule arrive. As such, these establishments are not expected to change their process control sampling and will not experience a change in associated costs. Comment: One member of the pork industry claimed that process control sampling requirements would increase cost. Response: As is detailed in section III.G.2.b of the final rule, overall, the changes in process control sampling requirements were estimated to reduce industry wide sampling costs by about $0.57 million annualized over 10 years, applying a three percent discount rate. Comment: One member of the pork industry reported that all six of their company’s facilities have written sanitary dressing plans. Response: FSIS incorporated information from this comment into section III.G.2.a of the final rule to reduce the cost estimate associated with developing, composing, training, monitoring, recording, and verifying written sanitary dressing plans to reflect that six establishments already have written sanitary dressing plans. Comment: One company stated that many small and very small establishments are unlikely to adopt the NSIS due to the program’s costs. Response: FSIS agrees that many small and very small establishments are unlikely to adopt the NSIS. The Agency’s cost benefit analysis assumes that very small establishments that exclusively slaughter market hogs do not have a high enough production volume to justify incurring the costs of converting to the NSIS. Comment: One company participating in HIMP stated that it invested in capital expenditure projects to add or relocate inspection stations and reconfigure lines. Response: The NSIS may require a minor capital improvement if the establishment does not already provide a mirror at the carcass inspection station. All the large high-volume establishments are already required to provide mirrors under existing regulations. Providing a mirror is a minor potential cost for a limited PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 number of establishments.26 If an establishment believes that additional capital expenditures will result in a benefit, they may voluntarily reconfigure or update their facilities to fully capture all the potential production efficiencies offered through participation in NSIS. Examples of such changes include line reconfiguration, which can cost between $10,000 and $250,000 and the creation of an inspection station, which can cost between $5,000 and $6,000. Establishments may reduce these costs by coordinating these facility updates with previously planned establishment renovations. Comment: A few consumer advocacy organizations claimed that the Agency’s cost benefit analysis understated training costs because the industry has a high turnover rate, necessitating that training take place more frequently than once per year. Response: FSIS used BLS’ industry turnover rate for non-durable manufactured goods to estimate annual training costs. Section III.G.1.a of the final rule provides additional details on how the cost benefit analysis estimates industry’s training costs, which includes training new employees given the industry’s turnover rate. Comments: Several commenters stated that the Agency’s guidance documents will likely need to be translated into additional languages. One commenter claimed that industry would be forced to hire translators to translate the Agency’s guidance documents, the cost of which was not included in the cost benefit analysis. Response: The Agency plans to make translated guidance documents publicly available as the need arises at no cost to industry. The cost of translating these documents is already within the Agency’s budget. As such, the cost is not expected to increase the Agency’s budgetary needs and is therefore not included in the rule’s cost analysis. III. Executive Orders (E.O.s) 12866 and 13563 E.O.s 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, 26 The cost was estimated to be very small because all 22 large high-volume establishments and potentially several of the 13 small high-volume establishments are already required to provide mirrors. As such, any new expense would be negligible compared to the industry costs included in the cost-benefit analysis. E:\FR\FM\01OCR4.SGM 01OCR4 52321 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule has been designated a ‘‘significant’’ regulatory action under section 3(f) of E.O. 12866. Accordingly, the rule has been reviewed by the OMB under E.O. 12866. A. Updates to the Regulatory Impact Analysis (RIA) FSIS updated the proposed rule’s RIA to reflect the changes made in the final rule in response to public comments. The changes to the costs and benefits sections incorporate the following factors: • The Agency removed the mandatory pre-operational environmental sampling requirement. • Establishments currently operating under SIP waivers conduct process control sampling at an alternative frequency and the Agency assumes that they will continue to do so when the applicability dates for this final rule arrive. Therefore, these establishments have been removed from the cost estimate associated with changes to requirements for microbial organism process control sampling and analysis. • Additional information from the risk assessment that more transparently demonstrates the potential uncertainty, is now reflected in the cost-benefit analysis. However, the anticipated net benefit did not change. • One company reported that all 6 of its establishments already have written sanitary dressing plans. As such, the annual cost estimate associated with developing, composing, training, monitoring, recording, and verifying written sanitary dressing plans has been revised down by approximately $87,000. • The highest number of establishment employees to be hired to meet the needs of NSIS has been revised up to 11, based on an industry comment. • The per head margin has been updated to rely on the North American Meat Institute’s (NAMI’s) 2017 Meat and Poultry Facts.27 establishments that exclusively slaughter market hogs, the current regulations that require FSIS to focus on non-food safety issues prevent FSIS from efficiently allocating resources, which inhibits food safety improvements and humane handling hazard prevention. Therefore, while traditional inspection is generally sufficient for low-volume establishments and for establishments that slaughter classes of swine other than market hogs, a modernized swine slaughter inspection system is needed, one that is less prescriptive, creates incentives for establishments to develop and invest in advancements in food safety and quality controls and procedures, and allows FSIS to improve inspection methods. B. Need for the Rule Baseline The swine slaughter industry in the United States has evolved since Congress enacted the Wholesome Meat Act in 1967. Many of today’s producers have invested in farm to table quality and food safety controls that effectively address health risks and consumer quality issues.28 For these producers, the prescriptive nature of some FSIS regulations inhibits efficient production and the adoption of improved production methods and restricts their ability to adopt new technologies. Further, at large and high-volume C. Overview of the Market U.S. pork production has increased at a moderate pace as seen in Table 2. Much of the additional growth in domestic production has been used to satisfy increasing export demands, which increased 43 percent between 2009 and 2018.29 According to the Food and Agricultural Organization (FAO), pork is consistently ranked as the top meat in per-capita consumption worldwide 30 and is ranked third in the United States.31 TABLE 2—U.S. PORK SUPPLY AND DEMAND [Carcass weight, million pounds] 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 Consumption U.S. production Year ..................................................................................... ..................................................................................... ..................................................................................... ..................................................................................... ..................................................................................... ..................................................................................... ..................................................................................... ..................................................................................... ..................................................................................... ..................................................................................... Imports Exports Domestic 22,999 22,437 22,758 23,253 23,187 22,843 24,501 24,941 25,584 26,315 834 859 803 802 880 1,011 1,116 1,091 1,116 1,042 4,094 4,223 5,196 5,379 4,986 5,092 5,010 5,239 5,632 5,870 19,869 19,077 18,382 18,607 19,104 18,836 20,592 20,892 21,034 21,497 Per capita * 65 62 59 59 60 59 64 65 65 66 jbell on DSK3GLQ082PROD with RULES4 * Measured in carcass weight, pounds. Source: Livestock and Meat Domestic Data, All supply and disappearance, Historical, WASDE Pork-Full. USDA ERS Livestock and Meat Domestic Data. <https://www.ers.usda.gov/data-products/livestock-meat-domestic-data/livestock-meat-domestic-data/#All%20meat%20statistics> accessed on 6/12/2019. Last updated on 5/29/19. In 2016, there were approximately 612 swine slaughter establishments under Federal inspection, Table 3.32 Combined, these establishments process roughly 118 million hogs annually. FSIS divides swine into the following 27 Nalivka, J.S., The 2017 Meat and Poultry Facts, NAMI August 2018. 28 Key, Nigel and William McBride. 2007. The Changing Economics of U.S. Hog Production. USDA Economic Research Service (ERS.). Report No. 52. 29 Livestock and Meat Domestic Data, All supply and disappearance, Historical, WASDE Pork-Full. USDA ERS Livestock and Meat Domestic Data. <https://www.ers.usda.gov/data-products/livestock- meat-domestic-data/livestock-meat-domestic-data/ #All%20meat%20statistics> accessed on 6/12/2019. Last updated on 5/29/19. 30 FAO Livestock commodities. <http://www.fao .org/docrep/005/y4252e/y4252e05b.htm> Accessed on 11/29/16. 31 Livestock and Meat Domestic Data, All supply and disappearance, Historical. USDA ERS Livestock and Meat Domestic Data. <https://www.ers.usda .gov/data-products/livestock-meat-domestic-data/ livestock-meat-domestic-data/#All%20meat%20 statistics> accessed on 6/12/2019. Last updated on 5/29/19. 32 USDA, FSIS, Public Health Information System (PHIS). VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 E:\FR\FM\01OCR4.SGM 01OCR4 52322 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations production categories for data collection purposes: Roaster swine, market hog, sow, and boar/stag. Today, the majority (97%) of the pork products available in the market are derived from market hogs.33 TABLE 3—NUMBER OF SWINE SLAUGHTER ESTABLISHMENTS BY SIZE, 2016 HACCP processing size Number of establishments Total swine slaughter (head count) Total market hog slaughter (head count) Percent market hog Large ........................................................................................................ Small ........................................................................................................ Very Small * ............................................................................................. 28 105 479 105,678,519 11,862,341 903,009 105,321,950 8,497,891 625,863 99.66 71.64 69.31 Total .................................................................................................. 612 118,443,869 114,445,704 96.62 Source: Public Health Information System (PHIS). * Two establishments classified as N/A were included in the category total for Very Small establishments. As shown below in Table 4, many establishments now exclusively slaughter market hogs, a species sub class which, because of technological and animal management improvements, such as improved genetics, nutrition, and medical services, generally presents fewer food safety and quality issues.34 D. Overview of the Final Rule’s NSIS Several of the final rule’s provisions apply to only those establishments that choose to participate in the optional NSIS. Meeting these provisions will likely increase an establishment’s labor and training costs. Only market hog slaughter establishments are eligible to participate in the NSIS. Due to the economic constraints, FSIS expects that only large and small high-volume establishments that exclusively slaughter market hogs will choose to participate in the optional NSIS. In 2016,35 there were 40 high-volume establishments that exclusively slaughtered market hogs: 27 36 large 37 (5 HIMP + 22 non-HIMP) 38 and 13 small establishments, Table 4. These establishments account for 93 percent of total swine slaughter annually, Table 4. Given their large share of the market and the ability to slaughter a sufficient number of market hogs to justify the likely costs associated with the NSIS, these 40 market hog establishments are expected to choose to implement the optional NSIS. Therefore, this analysis calculates the costs and benefits associated with the NSIS provisions for these 40 market hog establishments. However, because the 5 HIMP establishments already meet NSIS requirements, they are not expected to incur any additional new costs nor contribute to any increase in quantified benefits associated with adopting the NSIS. TABLE 4—HEAD COUNT DISTRIBUTION ACROSS TYPES OF ESTABLISHMENTS, 2016 Number of establishments Total swine slaughter (head count) Percent of total head count Type of establishment HACCP size High-Volume Market Hog Only ..................... Large—HIMP ................................................ Large—Non-HIMP ........................................ Small ............................................................. Very Small .................................................... Large/Small .................................................. Very Small .................................................... 5 22 13 71 93 408 17,517,254 87,746,770 4,617,680 32,360 7,659,156 870,649 14.79 74.08 3.90 0.03 6.47 0.74 ....................................................................... 612 118,443,869 ........................ Low-Volume Market Hog Only ..................... Mix of Species and Swine Sub Classes ...... Grand Totals .......................................... * HACCP sizes were combined so as to not reveal proprietary information. Source: PHIS. E. Overview of the Final Rule’s Mandatory Components All swine slaughter establishments will need to comply with the two mandatory provisions of the final rule discussed below. 1. Written Sanitary Dressing Plans jbell on DSK3GLQ082PROD with RULES4 FSIS is amending 9 CFR 310.18 to require swine slaughter establishments to develop, implement, and maintain as 33 Source: PHIS. Nigel and William McBride. 2007. The Changing Economics of U.S. Hog Production. USDA ERS. Report No. 52. 35 Establishment level data from 2016 was used in both the Preliminary Regulatory Impact Analysis (RIA) and the Final RIA. 34 Key, VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 part of their HACCP systems, written procedures to ensure that no visible fecal material, ingesta, or milk is present by the point of FSIS post-mortem inspection of swine carcasses. This requirement will address a weakness of the current traditional inspection system, which is that verification checks performed at the end of the slaughter and chilling process encourage industry to focus its activities on post-process interventions to reduce contamination rather than prevention throughout the slaughter process. Prevention throughout the slaughter process is preferred because it promotes containing contamination close to its origin, which reduces cross contamination of multiple carcasses. The existing regulations require that establishments prevent swine carcasses contaminated with visible fecal material 36 In 2016 there was 1 large establishment that did not exclusively slaughter market hogs. As such, this analysis assumed they would not choose to participate in the optional NSIS and were excluded from the relevant sections in the analysis. 37 HACCP size: Very Small Establishment = Less than 10 employees or less than $2.5 million in annual sales; Small Establishment = 10–499 employees; Large Establishment = 500 or more employees. 38 In 2016, there was 1 large establishment that did not exclusively slaughter market hogs. PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 E:\FR\FM\01OCR4.SGM 01OCR4 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations jbell on DSK3GLQ082PROD with RULES4 from entering the cooler. While preventing swine carcasses contaminated with visible fecal material from entering the cooler is an important safeguard for reducing the prevalence of pathogens on swine carcasses, this result generally cannot be effectively accomplished unless establishments implement appropriate measures to prevent contamination from occurring throughout the slaughter and dressing operation and implement process control procedures for preventive measures. Requiring establishments to keep daily written records to document the implementation and monitoring of their process control procedures is a positive step forward for public health. This ongoing documentation allows both the establishment and FSIS to identify specific points in the production process where a lack of process control may have resulted in product contamination or insanitary conditions. In addition, it will allow the establishment to implement corrective actions that could include the addition of preventive control measures to prevent recurrence of similar product contamination events or insanitary conditions. Based on public comment, the final rule assumes all but six establishments will need to develop written sanitary dressing plans. 2. Process Control Sampling and Analysis for Microbial Organisms Under this final rule, instead of following a prescribed microbiological testing program, each establishment will be responsible for developing and implementing its own microbiological sampling plan. Each establishment, except very low-volume establishments, is required to include carcass sampling at pre-evisceration and 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 hot-boned products, carcass sampling at pre-evisceration and after the final wash. The microbiological standards prior to the final rule prescribed that all establishments monitor process control by sampling for generic E. coli. Highvolume establishments were required to take one sample per 1,000 carcasses or request an alternative frequency. Very low-volume establishments were required to take 1 sample per week of operation up to 13 times a year. Several commenters from industry reported that 39 Viator, C. et al. 2015. Meat Industry Survey in Support of Public Health Risk-Based Inspection. P5–42. Question 3.1. VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 52323 each of their establishments operating under SIP conduct process control sampling at an alternative frequency. In addition, an industry survey found that many establishments elect to perform other microbiological tests in addition to testing for generic E. coli.39 components. The 35 establishments that the Agency assumes will adopt the NSIS portion of the rule have similar characteristics to the 5 HIMP establishments, such as volume and sub species slaughtered. Given the successful participation of the 5 HIMP establishments in the pilot program and F. Overview of the Impact of the Final industry’s continued interest in Rule on the Agency increasing the number of establishments This analysis, in part, takes into participating in the HIMP pilot study, consideration potential impacts to the the potential benefits from adopting Agency’s budget. FSIS’s budget is NSIS are expected to outweigh the expected to be impacted by changes in potential costs. This analysis assumes staffing and training requirements for that very small establishments that those establishments that choose to exclusively slaughter market hogs do operate under the NSIS. Under not have a high enough production traditional inspection, each slaughter volume to justify incurring the costs of line requires up to 11 full-time converting to the NSIS. While the 5 positions. Generally, these positions HIMP establishments are expected to include both a supervisory and nonsupervisory Public Health Veterinarian, adopt the NSIS, they have already (PHV) (OPM Veterinary Medical Science implemented the changes associated with the NSIS by their participation in Series, 0701); a supervisory and nonthe HIMP pilot study and are not supervisory consumer safety inspector, (CSI) (OPM Consumer Safety Inspection expected to incur any new or additional expenses. As such, they are not Series, 1862); and up to 7 Food included in the group of establishments Inspectors, (FI) (OPM Food Inspection expected to incur an increase in costs Series, 1863). There are currently 418 associated with NSIS. The following full-time equivalent units (FTE) analysis also excludes further assigned to slaughter inspection at the consideration of the costs of submitting 22 large non-HIMP (27 large—5 HIMP) and 13 small swine slaughter an attestation of work-related conditions establishments expected to convert to due to its small estimated cost.40 Costs the NSIS, Table 5. When these examined generally fall under three establishments convert to the NSIS, categories: Labor, capital expenses, and Agency personnel will require NSIS developing written procedures. training. Additionally, the number of In the following sections, this analysis Agency personnel required to inspect presents the costs and benefits the slaughter process will likely be generated over a range of assumptions reduced. See Agency Staffing section for with respect to how much of the details. industry chooses to adopt the NSIS TABLE 5—CURRENT FSIS SLAUGHTER within five years. As was done with the LINE POSITIONS AT NON-HIMP ES- NPIS, this analysis assumes a 5-year adoption period with roughly consistent TABLISHMENTS THAT SLAUGHTER annual adoption rates. These estimates EXCLUSIVELY MARKET HOGS are scaled for an illustrative calculation and assume that 35 of the 40 Number of OPM job code establishments that are likely to adopt positions the NSIS will incur additional costs 1862 (CSI) ............................ 120 associated with adoption. Using this 1863 (FI) ............................... 245 illustrative calculation was supported 0701 (PHV) ........................... 53 by one public comment, which Total .................................. 418 suggested that adoption timing and rate are difficult to estimate without a final Source: PHIS. rule. As is stated above, the 5 HIMP establishments are not expected to incur G. Potential Costs of the Final Rule any additional costs associated with 1. Costs Associated With the NSIS adopting the NSIS and are therefore Components of the Rule excluded when calculating potential This analysis estimates the costs costs of the NSIS components of this associated with the final rule’s NSIS final rule. 40 It was estimated that submitting such an attestation would require a Quality Control Technician with a labor compensation rate of $68.52 per hour, 2 minutes per year. Combined, PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 submitting an annual attestation would cost all 27 large and 13 small establishments likely to adopt the NSIS approximately $91.36 annually (2 minutes * $68.52 per hour * 40). E:\FR\FM\01OCR4.SGM 01OCR4 52324 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations TABLE 6—NSIS ADOPTION RATE Total number of establishments adopted Year Large 1 2 3 4 5 ................................................................................................................................................... ................................................................................................................................................... ................................................................................................................................................... ................................................................................................................................................... ................................................................................................................................................... jbell on DSK3GLQ082PROD with RULES4 a. Costs of Additional Establishment Workers This analysis expects establishments operating under the NSIS to experience an increase in labor costs. Under the NSIS, establishments will be required to dedicate labor to sort and remove unfit animals before ante-mortem inspection; trim and identify defects, such as dressing defects, contamination, and pathology defects, on carcasses and parts before post-mortem inspection; 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 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; maintain records to document the total number of animals and carcasses sorted and removed per day and the reasons for their removal; while conducting sorting activities, notify Agency inspectors if they suspect that an animal or carcass has a reportable or foreign animal disease; and maintain records documenting that products resulting from their slaughter operations meet the new definition of RTC pork product. Based on observations 41 of HIMP establishments and a comment from industry,42 this increase in work is expected to require an increase in labor demand ranging from 6–11 additional workers per line per shift at large establishments. This analysis assumes each large establishment that converts to the NSIS will require 9 additional workers per line per shift. Due to data limitations, this analysis assumes small establishments that convert to the NSIS will require 1 additional worker per line per shift. Costs associated with this 41 Observations were obtained through a survey conducted, in February 2016, through the Salmonella Initiative Program and conversations with industry at a meeting, which took place in February 2016, with the North American Meat Institute. 42 One corporation reported in a comment to the proposed rule that they hired and trained up to 11 employees per shift. VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 Percent adopted Small 4 8 12 17 22 2 4 7 10 13 17 34 54 77 100 labor fall into 3 categories: Wages and benefits, training, and continuing education. estimates take into consideration the fact that some establishments operate multiple lines and multiple shifts. Establishment Labor Wage Increases Many of the 22 large and 13 small non-HIMP market hog establishments that are assumed to adopt the NSIS operate multiple lines and shifts. Taking these multiple lines and shifts into consideration, the number of industry positions is estimated to increase by 383 if all high-volume establishments that have a history of exclusively slaughtering market hogs, adopt NSIS. The majority of these, 369, are attributable to the large establishments (41 (number of lines) × 9),43 Table 7. The remaining 14 positions are attributable to the small establishments (14 (number of lines) × 1),44 Table 7. According to the BLS, the estimated hourly wage for a Slaughterer and Meat Packer occupation (‘‘production employee’’) is $13.00.45 A benefits and overhead factor of two was then used to estimate the total labor costs. The total hourly labor costs to industry for a production employee including benefits and overhead, is $26.00 per hour ($13.00 × 2 46). Based on data obtained through PHIS, the average large establishment slaughters swine 269 days annually. Assuming workers work 8hour shifts, the total annual remuneration cost to these 22 large establishments is approximately $20.65 million, (369 × $26.00 × 269 × 8), Table 7. The average small establishment slaughters 244 days annually. Again, assuming workers work 8-hour shifts, the total annual remuneration cost to these 13 small establishments is approximately $0.71 million, (14 × $26.00 × 244 × 8), Table 7. These cost Costs for Training Online Sorters and Carcass-Inspection Helpers Establishments are expected to incur costs associated with initially training employees to fill online sorter and carcass-inspection helper positions, annual replacement training, and continuing education training. This analysis assumes the cost to train online sorters and carcass-inspection helpers are similar to the costs of training production employees in HACCP, which range from $274 to $823 with a midpoint average of $549 per new employee.47 To ensure a conservative estimate and account for employee rotation patterns as well as leave, FSIS assumes that establishments will train 4 employees for each new position. Under these assumptions, large establishments will need to train approximately 1,476 (369 × 4) employees, while small establishments will need to train approximately 56 (14 × 4) employees. The cost of this training ranges from $419,768 to $1,260,836, with a midpoint estimate of $0.84 million (1,532 × $549), Table 7. To account for estimated turnover of establishment employees, FSIS projects that establishments will have to train approximately 452 (1,532 × 0.295) replacement employees annually, 435 at the large and 17 at the small establishments.48 The additional annual training cost for new employees was estimated to also be similar to the costs of HACCP training. Therefore, FSIS estimates the combined annual training costs due to turnover to be approximately $0.25 million (452 × 43 Source: PHIS. PHIS. 45 BLS Occupational Employment Statistics, Occupational Employment and Wages, May 2016. 51–3023 Slaughterers and Meat Packers https:// www.bls.gov/news.release/archives/ocwage_ 03312017.pdf Accessed on 12/04/18. Last modified 3/31/17. 46 To be consistent with analyses done by the Department of Health and Human Services, this analysis accounts for fringe benefits and overhead by multiplying wages by a factor of 2. 44 Source: PO 00000 Frm 00026 Fmt 4701 Sfmt 4700 47 Viator, C. et al. 2015. Costs of Food Safety Investments. Table 4–4. Training Costs for Management and Production Employees. 48 This estimate was rounded up. This analysis uses the industry turnover rate for non-durable manufactured goods to estimate separations. Source: BLS Economic News Release Table 16. Annual total separations rates by industry and region, not seasonally adjusted. https:// www.bls.gov/news.release/archives/jolts_ 03162017.htm Accessed on 12/04/18. Last updated on 3/16/17. E:\FR\FM\01OCR4.SGM 01OCR4 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations $549), with large establishments accounting for approximately $0.24 million (435 × $549) and small establishments accounting for approximately $9,333 (17 × $549), Table 7. FSIS assumes that 1,080 (1,532 × 0.705) retained employees, 1,041 at the large and 39 at the small establishments, will require annual continuing education. This analysis assumes annual continuing education costs to be similar to annual HACCP refresher training costs, which range from $12 to $36 per employee, with a mid-point of $24.49 Using the mid-point value, this analysis estimates the combined average recurring cost for continuing education is $25,920 (1,080 × $24), with large establishments accounting for approximately $24,984 (1,041 × $24) 52325 and small establishments accounting for approximately $936 (39 × 24). Under the assumed adoption rate as set forth in Table 6, annualized wages and training cost to industry for staffing additional online personnel is approximately $16.61 million, applying a 3 percent discount rate 50 over 10 years, Table 7. The majority of this cost is attributed to wages and benefits, Table 7. TABLE 7—ESTABLISHMENT LABOR COSTS [M$] Number of personnel One-time cost Recurring cost 369 1,476 435 1,041 ........................ $0.81 ........................ ........................ $20.65 ........................ 0.24 0.02 14 56 17 39 ........................ 0.03 ........................ ........................ 0.71 ........................ 0.009 0.001 One-Time ............................................................................................................................................................................................. 0.84 Recurring Cost ..................................................................................................................................................................................... 21.63 Annualized Costs, Assuming a 3% Discount Rate Over 10 Years .................................................................................................... 16.61 Annualized Costs, Assuming a 7% Discount Rate Over 10 Years .................................................................................................... 15.97 Type of establishment Type of expense Large ............................................................... Wages ............................................................ Initial Training ................................................. Training Due to Labor Turnover .................... Continuing Education ..................................... Small ............................................................... Wages ............................................................ Initial Training ................................................. Training Due to Labor Turnover .................... Continuing Education ..................................... Totals b. Costs of Capital Improvements jbell on DSK3GLQ082PROD with RULES4 The NSIS may require a minor capital improvement if the establishment does not already provide a mirror at the carcass inspection station. All the large high-volume establishments are already required to provide mirrors under existing regulations. The following analysis excludes further consideration of the costs of requiring a mirror due to its minor potential cost for a limited number of establishments.51 If an establishment believes that additional capital expenditures will result in a benefit, they may voluntarily reconfigure or update their facilities to fully capture all the potential production efficiencies offered through participation in the NSIS. Examples of such changes include line reconfiguration, which can cost between $10,000 to $250,000 52 and the creation 49 Viator, C. et al. 2015. Costs of Food Safety Investments. Table 4–4. Training Costs for Management and Production Employees. 50 As is explained in Circular A–4, a discount factor should be used to adjust the estimated benefits and costs for differences in timing. For regulatory analysis, net benefit estimates should be provided using a 3 percent and 7 percent discount rate. Source: Circular A–4, OMB, September 17, VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 of an inspection station, which can cost between $5,000 and $6,000.53 Establishments may reduce these costs by coordinating these facility updates with previously planned establishment renovations. c. Costs of Developing Ante-Mortem Written Procedures Under the final rule, establishments operating under the NSIS are required to develop and maintain in their HACCP systems (HACCP plans, sanitation SOPs, or other prerequisite programs) written procedures for the segregation, identification, and disposition of animals suspected of having one of the condemnable generalized diseases or conditions listed in 9 CFR 309. This analysis assumes establishments will coordinate this work and costs with the development of written procedures to prevent the contamination of carcasses 2003, https://www.whitehouse.gov/sites/ whitehouse.gov/files/omb/circulars/A4/a-4.pdf. 51 The cost was estimated to be very small because all 22 large high-volume establishments and potentially several of the 13 small high-volume establishments are already required to provide mirrors. As such, any new expense would be negligible compared to the industry costs included in the analysis. PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 and parts by enteric pathogens, and visible fecal material, ingesta, and milk throughout the entire slaughter and dressing operation, a mandatory component of the final rule. Details of these costs can be found in the sanitary dressing costs section III.G.2.a. d. Costs Associated With Ready-to-Cook Pork Standards Under the final rule, establishments operating under the NSIS are required to collect, record, and analyze documentation to demonstrate that the products resulting from their slaughter operation meet the definition of RTC pork products. This analysis estimates the labor costs to collect, record and analyze such documentation under two assumptions. First, FSIS assumes that establishments will assign the task to a quality control (QC) technician, with an hourly compensation rate, which 52 In a May 2004 study, ERS estimated the cost of compliance per establishment with the PR/ HACCP rule. Capital expenditures in Hog Slaughter establishments were estimated to be $251,800. Ollinger, Moore, Chandran (2004). Meat and Poultry Establishments’ Food Safety Investments. USDA, Economic Research Service. 53 Modernization of Poultry Slaughter Inspection; Final Rule, 79 FR 49566 (2014). E:\FR\FM\01OCR4.SGM 01OCR4 52326 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations includes wages, benefits, and overhead, of $68.52.54 55 Second, FSIS assumes that this work will take 1 hour at a large establishment and 1⁄2 hour at a small establishment per day. As is explained in the Draft Market Hogs HIMP paper, 56 large swine establishments can verify they meet OCP performance standards by taking 24 unit samples, requiring roughly 1 hour to collect, record, and analyze the data. Based on information obtained through PHIS, the average large swine establishment operates 269 days per year. This equates to an annual cost of approximately $18,432 (269 × 1 × $68.52), or approximately $0.41 million for all 22 non-HIMP establishments ($18,432 × 22). Similarly, the cost to an average small establishment, which based on data obtained through PHIS operates 244 days a year, is approximately $8,359 (244 × 0.5 × $68.52), or approximately $0.11 million for all 13 small establishments ($8,359 × 13). Combined, under the assumed adoption rate as set forth in Table 6, these costs are expected to increase NSIS establishments’ annual labor costs by approximately $0.39 million, applying a 3 percent discount rate over 10 years, Table 8. TABLE 8—COST OF RTC REQUIREMENTS [M$] Number of establishments Type of market hog only establishment Large .................................................................................................................................................................... Small .................................................................................................................................................................... Recurring Labor 22 13 $0.41 0.11 Recurring Cost ..................................................................................................................................................................................... 0.51 Annualized Costs, Assuming a 3% Discount Rate Over 10 Years .................................................................................................... 0.39 Annualized Costs, Assuming a 7% Discount Rate Over 10 Years .................................................................................................... 0.38 Totals * * Note, some of the totals may not equal the sum due to rounding. jbell on DSK3GLQ082PROD with RULES4 2. Costs Associated With Requirements for All Swine Slaughter Establishments The mandatory costs of the final rule will apply to all 612 swine slaughter establishments and begin on the effective date for these requirements. These costs are associated with (a) written procedures to prevent visible fecal material, ingesta, and milk contamination; and (b) sampling and analysis for microbial organisms to monitor process control for enteric pathogens. swine, FSIS is requiring that all official swine slaughter establishments develop, implement, and maintain in their HACCP systems written procedures to prevent the contamination of carcasses and parts by enteric pathogens, and visible fecal material, ingesta, and milk throughout the entire slaughter and dressing operation. This cost component for establishments includes: (1) Developing and incorporating these procedures into their food safety system, (2) training, and (3) monitoring, recordkeeping, and verification. This analysis assumes 606 swine establishments will incur these costs.57 a. Costs of Developing, Composing, Training, Monitoring, Recording, and Verifying Written Sanitary Dressing Plans Under the mandatory portion of the final rule affecting all Federally inspected establishments that slaughter Costs for Developing and Composing a Written Sanitary Dressing Plan 54 BLS Occupational Employment Statistics, Occupational Employment and Wages, May 2016. 19–1021 Food Scientist and Technologist. <https:// www.bls.gov/news.release/archives/ocwage_ 03312017.pdf>. Accessed on 12/04/18. Last Modified 3/31/2017. 55 To be consistent with analyses done by the Department of Health and Human Services, this analysis accounts for fringe benefits and overhead by multiplying wages by a factor of 2. 56 Draft Market Hogs HIMP (HACCP-Bases Inspection Models Project). Draft 6/21/05. <https:// www.fsis.usda.gov/wps/wcm/connect/d6ccbad759e0-43f5-bf54-1987152ccfe8/HIMP_Market_ Hog.pdf?MOD=AJPERES.>. 57 One corporation has informed FSIS, through public comment, that all six of its swine harvest facilities have written sanitary dressing plans. As such, they were not included in this portion of the cost analysis, which reduced annual costs by roughly $87,000 as compared to the proposed rule. 58 Viator, C. et al. 2015. RTI International collected data on the cost of food safety investments for the production of meat and poultry products at VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 FSIS assumes incorporating written sanitary dressing plans into an PO 00000 Frm 00028 Fmt 4701 Sfmt 4700 establishment’s HACCP system will result in a one-time HACCP plan reassessment cost. According to RTI’s Costs of Food Safety Investments report,58 the mid-point costs of a HACCP plan reassessment for large establishments is $730, the mid-point costs for small and very small establishments is $365.59 The cost to large establishments is approximately $16,060 (22 × $730), small establishments is approximately $38,325 (105 × $365), and very small establishments is approximately $174,835 (479 × $365). The annualized costs to industry with a 3 percent discount rate for all 606 swine slaughter establishments is approximately $0.03 million, Table 9. the pre-harvest and slaughter and processing stages. This data was provided to FSIS in a final report titled ‘Costs of Food Safety Investments’ and was prepared by Catherine L. Viator, Mary K. Muth, and Jenna E. Brophy. The contract number is No. AG– 3A94–B–3–0003. The order number is AG–3A94– K–14–0056. 59 Viator, C. et al. 2015. Table 4–1. Costs of HACCP Plan Development, Validation and Reassessment per HACCP. E:\FR\FM\01OCR4.SGM 01OCR4 52327 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations TABLE 9—WRITTEN SANITARY DRESSING PLAN DEVELOPMENT [M$] Number of establishments HACCP size Large .................................................................................................................................................................... Small .................................................................................................................................................................... Very Small ........................................................................................................................................................... One-time cost 22 105 479 $0.02 0.04 0.17 One-Time Cost .................................................................................................................................................................................... 0.23 Annualized Costs, Assuming a 3% Discount Rate Over 10 Years .................................................................................................... 0.03 Annualized Costs, Assuming a 7% Discount Rate Over 10 Years .................................................................................................... 0.03 Totals Costs for Training Establishment Personnel on Executing a Written Sanitary Dressing Plan FSIS assumes training programs will be utilized to ensure that establishment personnel understand and can execute the sanitary dressing plan. This training includes a one-time initial training cost to the establishment, a recurring cost of training new hires due to separations, and the cost of conducting annual refresher training. This portion of the model is informed by the RTI Costs of Food Safety Investments report.60 As is noted in the RTI report, these costs are based on the amount of time a panel of experts recommends establishments spend on training, which may exceed the amount of time establishments spend on training. Due to data limitations, this analysis assumes the number of establishment employees conducting sanitary dressing tasks at swine establishments is equal to the number of employees conducting sanitary dressing tasks at beef slaughter establishments.61 This is likely an overestimate because unlike beef, the majority of swine are scalded, de-haired, and polished prior to opening the carcass, which decreases the need for employees to conduct sanitary dressing tasks. As seen in Table 10, costs are shared across HACCP sizes, with large establishments incurring higher costs. The rate of new hires, 29.5 percent, is derived from the BLS, 2016 Turnover Rate for Non-Durable Manufacturing Goods.62 Likewise, the retention rate for the refresher training is one minus the turnover rate. The total one-time cost to train the employees for all 606 establishments is roughly $1.00 million, while the total recurring costs is roughly $0.44 million, Table 10. The annualized costs with a 3 percent discount rate over 10 years for Sanitary Dressing task related training is $0.55 million, Table 10. TABLE 10—SANITARY DRESSING TRAINING COSTS [M$] Training costs Number of establishments HACCP size Average number of employees One-time Initial Large ................................................................................ Small ................................................................................ Very Small ........................................................................ 22 105 479 179 25 3 Recurring New hires $0.48 0.32 0.20 Refresher $0.14 0.09 0.06 $0.07 0.04 0.03 One-Time Cost .................................................................................................................................................................................... 1.00 Recurring Cost ..................................................................................................................................................................................... 0.44 Annualized Costs, Assuming a 3% Discount Rate Over 10 Years .................................................................................................... 0.55 Annualized Costs, Assuming a 7% Discount Rate Over 10 Years .................................................................................................... 0.57 Totals * jbell on DSK3GLQ082PROD with RULES4 * Note, some of the totals may not equal the sum due to rounding. 60 Viator, C. et al. 2015. Survey is at: http://www.fsis.usda.gov/wps/ wcm/connect/184a3baa-2f73-4651-8aba68124580f4e0/Pathogen_Controls_in_Beef_ Operations_Survey.pdf?MOD=AJPERES. The survey report is at: http://www.fsis.usda.gov/wps/wcm/ 61 The VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 connect/6d37a1fc-a3e1-40b6-90cc-719bdb391522/ STEC_Survey_Comments_ Summary.pdf?MOD=AJPERES. 62 Source: BLS Economic News Release Table 16. Annual total separations rates by industry and region, not seasonally adjusted. <https:// PO 00000 Frm 00029 Fmt 4701 Sfmt 4700 www.bls.gov/news.release/archives/jolts_ 03162017.htm> Accessed on 12/04/18. Last updated on 3/16/17. E:\FR\FM\01OCR4.SGM 01OCR4 52328 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations Cost of Monitoring, Recordkeeping, and Verification Associated With the Written Sanitary Dressing Plan This analysis also estimates the annual monitoring, recordkeeping and verification costs associated with maintaining sanitary dressing procedures. This analysis assumes it will take a production employee 5 minutes to monitor and 5 minutes to maintain records for the sanitary dressing procedures, for a total of 10 minutes. Establishments are required to verify the plan each day of production. In addition, this analysis assumes it will take a QC manager 15 minutes to perform a verification task and that such task will be completed each week that slaughter takes place. Combined, these tasks are estimated to cost the entire industry roughly $0.84 million annually, applying a 3 percent discount rate over 10 years, Table 11. TABLE 11—MONITORING, RECORDKEEPING AND VERIFICATION COSTS [M$] Recurring costs HACCP size Monitoring Large ................................................................................................................ Small ................................................................................................................ Very Small ....................................................................................................... Recordkeeping $0.01 0.04 0.07 $0.01 0.04 0.07 Verification Combined $0.03 0.12 0.44 $0.05 0.20 0.58 Recurring Cost ..................................................................................................................................................................................... 0.84 Annualized Costs, Assuming a 3% Discount Rate Over 10 Years .................................................................................................... 0.84 Annualized Costs, Assuming a 7% Discount Rate Over 10 Years .................................................................................................... 0.84 Totals * * Note, some of the totals may not equal the sum due to rounding. Summary Costs of Written Sanitary Dressing Procedures Table 12 provides an overview of the one-time and recurring costs associated with requiring all establishments to develop written sanitary dressing procedures. Combined, these tasks are expected to cost the industry $1.41 million annualized, assuming a 3 percent discount rate over 10 years, Table 12. TABLE 12—SUMMARY OF COSTS ASSOCIATED WITH REQUIRING WRITTEN SANITARY DRESSING PROCEDURES [M$] One-time costs Number of establishments HACCP size Large .................................................................................... Small .................................................................................... Very Small ............................................................................ Development 22 105 479 Recurring costs Initial training $0.02 0.04 0.17 $0.48 0.32 0.20 Training Monitoring, recording, validating $0.21 0.14 0.09 $0.05 0.20 0.58 One-Time Cost .................................................................................................................................................................................... 1.23 Recurring Cost ..................................................................................................................................................................................... 1.27 Annualized Costs, Assuming a 3% Discount Rate Over 10 Years .................................................................................................... 1.41 Annualized Costs, Assuming a 7% Discount Rate Over 10 Years .................................................................................................... 1.44 Totals * * Note, some of the totals may not equal the sum due to rounding. jbell on DSK3GLQ082PROD with RULES4 b. Cost of Carcass Sampling and Analysis for Microbial Organisms This section reviews the potential changes in costs associated with the alterations to microorganism testing. These costs are limited to the changes associated with removing the requirement that swine establishments test carcasses for generic E. coli and replacing it with new testing VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 requirements described above. While the final rule also removes the codified Salmonella pathogen reduction performance standards for swine, because the codified standards are already no longer in use, there are no potential costs or benefits to industry. Such changes fall under four categories: Sampling plan reassessment, transferring from prescriptive to process testing requirements, sampling rates, PO 00000 Frm 00030 Fmt 4701 Sfmt 4700 and sample recordkeeping. This analysis uses results from the RTI International Meat Industry Survey in Support of Public Health Risk-Based Inspection report 63 and Costs of Food 63 Viator, C. et al. 2015. (a) RTI International designed and conducted surveys on industry practices to control pathogens and promote food safety. The sample design, administration procedures, analysis and results were provided to FSIS in a final report titled ‘Meat Industry Survey E:\FR\FM\01OCR4.SGM 01OCR4 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations Safety Investments report.64 Each of these categories is explained in detail below. Based on industry comment on the proposed rule, this analysis excludes the 11 large swine establishments that were participating in the SIP program when data for this analysis was collected. Under SIP, these establishments currently sample at an alternative frequency and we assume that they will continue to do so. As such, these 11 SIP swine slaughter establishments are not expected to change their process control sampling and will not experience a change in associated costs. Cost of Process Control Sampling Plan Reassessment This analysis assumes establishments will incur one-time costs of conducting a process control sample plan reassessment under the final 9 CFR 310.25(a)(2)(i). The RTI Costs of Food Safety Investments report estimates the costs of reassessing a microbiological 52329 sampling plan. For large establishments, these costs include labor, consultant fees, and travel expenses, which combined range from $27,320 to $81,960, with a midpoint of $54,640 per establishment. Costs to small and very small establishments are limited to labor expenses and range from $122 to $365, with a midpoint of $243 per establishment.65 The annualized reassessment cost to industry is roughly $0.12 million, assuming a 3 percent discount rate over 10 years, Table 13. TABLE 13—COST OF PROCESS CONTROL SAMPLING PLAN REASSESSMENT [M$] Number of establishments HACCP size Large ................................................................................................................................ Small ................................................................................................................................ Very Small ....................................................................................................................... Per establishment (mid-point estimate) * 17 105 479 Total one-time costs $0.05 243 243 $0.93 0.03 0.12 One-Time Cost ................................................................................................................................................................................ 1.07 Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ................................................................................................ 0.12 Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ................................................................................................ 0.14 Totals ** jbell on DSK3GLQ082PROD with RULES4 * The values for Small and Very Small Establishments are in dollars. ** Note, some of the totals may not equal the sum due to rounding. Cost of Transferring From Prescriptive To Process Specific Microbiological Testing Requirements Prior to the final rule, regulations prescribed that each slaughter establishment test for generic E. coli.66 In addition to mandated generic E. coli testing, many establishments voluntarily conduct additional microbiological testing to verify process control. Common microbiologic tests include APC, total plate count (TPC), and total coliforms. Based on the meat slaughter survey conducted by RTI, roughly 71 percent of very small, 80 percent of small, and 100 percent of large establishments conduct microbiological testing in addition to testing for generic E. coli.67 Establishments voluntarily conducting additional testing are an indication that the generic E. coli testing is not the best means to verify process control in their respective establishments. This analysis assumes that, if permitted to choose a microbiological test to ensure process control, establishments will select the single best test that demonstrates process control at their establishment. Under these assumptions, establishments that currently test for generic E. coli and conduct at least one other type of microbiological test will stop testing for generic E. coli. As a result, the 17 large (17 × 1.00), 41 small high-volume (51 × .80), 43 small low-volume (54 × .80), 4 very small high-volume 68 (6 × .714), and 338 very small (473 × .714) establishments that currently test for generic E. coli and at least one other microbial or pathogen indicator 69 will experience a cost reduction. Given the similarity in laboratory testing costs and costs associated with switching sampling programs, this analysis assumes the remaining 158 establishments that exclusively test for generic E. coli will continue to do so. Calculating the cost reductions is a function of estimating the testing rate and testing costs. This analysis assumes all large, small, and very small highvolume,70 establishments conduct 1 test, every 1,000 carcasses, and all lowvolume establishments conduct 13 tests annually.71 To calculate testing costs, this analysis estimates the associated labor expenses, laboratory fees, and shipping costs. The mean cost to an establishment to test a single generic E. coli sample in house is $25.97.72 To have the sample tested at a contracted in Support of Public Health Risk-Based Inspection’ and was prepared by Catherine Viator, Sheri C. Cates, Shawn A. Karns, Peter Siegel, Ariana Napier, and Mary K. Muth. The contract number is No. AG– 3A94–B–13–0003. The order No. is AG–3A94–K– 13–0053. 64 Viator, C. et al. 2015. (b). 65 The report classifies establishments as either large or small. Given this data limitation, this analysis assumes very small and small establishments have similar reassessment costs. 66 9 CFR 310.25 (2018). 67 Viator, C. et al. 2015. (a) P5–42. Question 3.1. 68 Very small high-volume establishments 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. 69 Question 3.1 from the Meat Industry Survey in Support of Public Health Risk-Based Inspection Report asks ‘‘In addition to the generic E. coli testing of carcasses and Listeria testing of ready-toeat (RTE) products required by FSIS regulation, does this establishment conduct microbiological testing? ’’; 28.6% of very small, 20% of small, and 0% of large establishments responded no, meaning 71.4% of very small, 80% of small and 100% of large establishments conduct additional testing. 70 Note that the 11 large establishments participating in SIP have been excluded from this analysis because they have an alternative sampling frequency. 71 9 CFR 310.25(a)(2)(iii)(B). The current regulation (9 CFR 310.25(a)(2)(v)) defines very lowvolume swine slaughter establishments as slaughtering 20,000 head annually or fewer. For the purposes of this analysis, FSIS has labeled swine establishments that annually slaughter more than 20,000 head per year as high volume. 72 Viator, C. et al. 2015. (b) Table 5–1. VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 PO 00000 Frm 00031 Fmt 4701 Sfmt 4700 E:\FR\FM\01OCR4.SGM 01OCR4 52330 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations lab, the cost is $49.81.73 Based on survey results, this analysis assumes 79 percent of large, 28 percent of small and 5 percent of very small establishments test in house.74 For these 443 establishments, the combined reduction in testing costs of no longer being required to test for generic E. coli was estimated to reduce annual testing costs by approximately $2.69 million, assuming a 3 percent discount rate over 10 years, Table 14. TABLE 14—RECURRING COSTS (SAVINGS) FROM NO LONGER REQUIRING GENERIC E. coli TESTING [M$] Number of establishments HACCP size Large ................................................................................................................................................................ Small High-Volume .......................................................................................................................................... Small Low-Volume ........................................................................................................................................... Very Small High-Volume ................................................................................................................................. Very Small Low-Volume .................................................................................................................................. (Savings) 17 41 43 4 338 ($2.04) (0.40) (0.02) (0.01) (0.21) Recurring Cost ................................................................................................................................................................................. (2.69) Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ................................................................................................ (2.69) Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ................................................................................................ (2.69) Totals * Note, some of the totals may not equal the sum due to rounding. jbell on DSK3GLQ082PROD with RULES4 Process Control Sampling Rates The final rule requires large, small, and very small high-volume establishments to take carcass samples at pre-evisceration and post-chill (for hot-boned products carcass samples must be taken pre-evisceration and after the final wash), which will increase the number of samples taken from 1 sample per 1,000 carcasses to 2 samples per 1,000 carcasses for large, small, and very small high-volume establishments. The final rule does not require low-volume establishments to increase their sampling rates. Under the final regulations, large establishments’ annual process control sampling costs were estimated to increase by roughly $1.46 million, which is roughly $85,745 per establishment ($1.46 million/17), 75 Table 15. Small high-volume establishments’ annual process control sampling costs were estimated to increase by roughly $0.30 million, which is roughly $5,974 ($0.30 million/ 51) per establishment, Table 15. Very small high-volume establishments’ annual process control sampling costs were estimated to increase by roughly $8,890, which is roughly $1,482 ($8,890/6) per establishment, Table 15. Cost of Process Control Sample Recordkeeping This analysis takes into consideration the increase in recordkeeping costs associated with an increase in the 73 Viator, C. et al. 2015. (b) Table 5–1. C. et al. 2015. (b). 75 Values in text may differ because of rounding. 76 Values in text may differ because of rounding. 74 Viator, VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 sampling rate from 1 to 2 samples per 1,000 head. According to PHIS data, the average large non-SIP establishment slaughters approximately 3.87 million swine per year. As such, this analysis estimates that a large non-SIP establishment currently takes approximately 3,869 samples annually (3,869,276/1,000). The average small high-volume swine establishment slaughters 0.23 million swine per year and requires approximately 229 samples (228,784/1,000) annually. While the average very small high-volume establishment slaughters 51,925 swine per year and requires approximately 52 samples (51,925/1,000) annually. Assuming it takes 2.5 minutes to record the results of each sample, the average large establishment currently requires 9,673 minutes (2.5 × 3,869) per year; the average small high-volume establishment currently requires 573 minutes (2.5 × 229) per year; and the average very small high-volume establishment currently requires 130 minutes (2.5 × 52) per year. Requiring establishments to increase their sampling rates from 1 to 2 samples per 1,000 head will increase the average large non-SIP establishment’s annual number of samples to 7,738 samples annually (3,869,276/1,000 × 2), which will require approximately 19,346 minutes (2.5 × 7,738) 76 annually. The same requirement will increase a small high-volume establishment’s annual 77 BLS Occupational Employment Statistics, Occupational Employment and Wages, May 2016. 19–1021 Food Scientist and Technologist. https:// www.bls.gov/news.release/archives/ocwage_ 03312017.pdf Accessed on 12/04/18. Last Modified 3/31/2017. PO 00000 Frm 00032 Fmt 4701 Sfmt 4700 sampling to 458 (228,784/1,000 × 2), which will require approximately 1,145 minutes (2.5 × 458) annually. Likewise, a very small high-volume establishment’s annual sampling will increase to 104 (51,925/1,000 × 2), which will require approximately 260 minutes (2.5 × 104) annually. As such, the estimated additional time required for recordkeeping is approximately 9,673 minutes (19,346¥9,673) for large non-SIP establishments; 572 minutes (1,145¥573) for small high-volume establishments; and 130 minutes (260¥130) for very small high-volume establishments. Assuming a quality control technician with a compensation rate of $68.52 per hour 77 78 conducts this work, the additional costs to the average large non-SIP establishment is approximately $11,046 (9,673/60 × $68.52). Similarly, the additional cost to the average small high-volume and very small high-volume establishment is approximately $653 (572/60 × $68.52) and $148 (130/60 × $68.52, respectively). Scaling this up to all impacted establishments, the total increase in costs to all large non-SIP establishments is approximately $0.19 million ($11,046 × 17); $0.03 million ($654 × 51) for small high-volume establishments; and $888 ($148 × 6) for very small high-volume establishments, Table 15. 78 To be consistent with analyses done by the Department of Health and Human Services, this analysis accounts for benefits and overhead by multiplying wages by a factor of 2. E:\FR\FM\01OCR4.SGM 01OCR4 52331 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations The combined annualized sampling and recordkeeping cost to all large nonSIP, small, and very small high-volume establishments is roughly $1.99 million, applying a 3 percent discount rate over 10 years. Large establishments will potentially incur the majority of this cost, Table 15. TABLE 15—COSTS CHANGES ASSOCIATED WITH INCREASE SAMPLING RATES [M$] Number of establishments Large non-SIP .................................................................................. Small High-Volume .......................................................................... Very Small High-Volume (Dollars) ................................................... Costs Sampling 17 51 6 Recordkeeping $1.46 0.30 8,890 Combined * $0.19 0.03 888 $1.65 0.34 9,778 Recurring Cost ................................................................................................................................................................................. 1.99 Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ................................................................................................ 1.99 Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ................................................................................................ 1.99 Totals * Note, some of the totals may not equal the sum due to rounding. Summary of Process Control Sampling Cost Changes Overall, the changes in sampling requirements under the final rule were estimated to reduce industry wide sampling costs by about $0.57 million annualized over 10 years, applying a 3 percent discount rate, Table 16. However, only the 443 establishments that currently conduct multiple types of microbiological tests will potentially experience a reduction in cost. The remaining establishments, roughly 158 small and very small establishments, will potentially incur a portion of the one-time costs associated with plan reassessment, Table 16. Cost increases associated with testing and recordkeeping will be exclusively borne by large, small, and very small highvolume establishments. TABLE 16—SUMMARY OF CHANGES TO PROCESS CONTROL SAMPLING [M$] Cost (savings) Type of change One-time Recurring $1.07 ........................ ........................ ........................ ........................ ($2.69) 1.77 0.22 One-Time Cost .................................................................................................................................................................................... 1.07 Recurring Cost ..................................................................................................................................................................................... (0.70) Annualized Costs, Assuming a 3% Discount Rate Over 10 Years .................................................................................................... (0.57) Annualized Costs, Assuming a 7% Discount Rate Over 10 Years .................................................................................................... (0.55) Plan Reassessment ................................................................................................................................................. Converting to Process Control Sampling ................................................................................................................ Testing Costs ........................................................................................................................................................... Recordkeeping ......................................................................................................................................................... Totals * * Note, some of the totals may not equal the sum due to rounding. jbell on DSK3GLQ082PROD with RULES4 Summary of Voluntary and Mandatory Costs for Final Rule The total annualized value of all costs to industry, under the assumed five-year adoption rate as shown in Table 6, is roughly $17.83 million, assuming a 10year annualization and a 3 percent discount rate, Table 17. Large establishments that voluntarily switch VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 to the NSIS incur the majority of costs. For example, the recurring labor costs associated with the NSIS is the single largest recurring cost to industry and is mostly incurred by large establishments. It should be noted that the five HIMP pilot study establishments have already incurred these costs, suggesting for those five establishments, the benefits of the NSIS outweigh the costs. It also PO 00000 Frm 00033 Fmt 4701 Sfmt 4700 suggests that the benefits of adopting the NSIS outweigh the costs for other establishments as well. Training staff accounts for the bulk of the costs associated with written sanitary dressing procedures. Sampling costs will potentially decrease for those establishments that currently conduct microbiological tests in addition to generic E. coli. E:\FR\FM\01OCR4.SGM 01OCR4 52332 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations TABLE 17—COMBINED COSTS TO INDUSTRY [M$] Total costs Number of establishments Type of cost Voluntary: Establishment Labor ......................................................................................................... Ready to Cook .................................................................................................................. Mandatory: Written Sanitary Dressing Procedures ............................................................................. Process Control Sampling ................................................................................................ One-time Recurring 35 35 $0.84 ........................ $21.63 0.51 606 601 1.23 1.07 1.27 (0.70) Number of Establishments ** ............................................................................................................................................................... 612 One Time Cost .................................................................................................................................................................................... 3.14 Recurring Cost ..................................................................................................................................................................................... 22.72 Annualized Costs, Assuming a 3% Discount Rate Over 10 Years .................................................................................................... 17.83 Annualized Costs, Assuming a 7% Discount Rate Over 10 Years .................................................................................................... 17.23 Totals * Totals Mandatory * Number of Establishments ** ............................................................................................................................................................... 612 One-Time Cost .................................................................................................................................................................................... 2.30 Recurring Cost ..................................................................................................................................................................................... 0.58 Annualized Costs, Assuming a 3% Discount Rate Over 10 Years .................................................................................................... 0.84 Annualized Costs, Assuming a 7% Discount Rate Over 10 Years .................................................................................................... 0.88 Totals Voluntary * Number of Establishments .................................................................................................................................................................. 35 One-Time Cost .................................................................................................................................................................................... 0.84 Recurring Cost ..................................................................................................................................................................................... 22.15 Annualized Costs, Assuming a 3% Discount Rate Over 10 Years .................................................................................................... 17.0 Annualized Costs, Assuming a 7% Discount Rate Over 10 Years .................................................................................................... 16.35 * Note, some of the totals may not equal the sum due to rounding. ** Note, 612 includes all swine slaughter establishments, including the 11 SIP establishments that were excluded from the process control sampling costs and the 6 establishments that were excluded from the written sanitary dressing plans costs. H. Potential Benefits of the Final Rule jbell on DSK3GLQ082PROD with RULES4 1. Potential Benefits Associated With Public Health Switching existing FSIS inspection program personnel (IPP) activities toward more offline verification activities (e.g., sanitation performance standards, sampling, fecal inspections, and other inspection requirements) is unlikely to result in a higher prevalence of Salmonella on market hog carcasses and is estimated to result in a lower prevalence of Salmonella on market hog carcasses, which in turn may lead to fewer human illnesses. This conclusion is supported by a two-part risk assessment which compares typical FSIS market swine inspection outcomes with the outcomes observed in a small VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 subset of establishments that participated in the HIMP pilot study (referred to in the risk assessment as HIMP plants). Stage 1 of the risk assessment consists of a multiple regression analysis to identify the relationships between establishment characteristics (including HIMP status) and carcass contamination prevalence. FSIS presents two different models for estimating the potential for avoiding illnesses in the risk assessment one using only empirical data and one using additional simulated data, see Tables 13 and 14 in the risk assessment and accompanying text. The results of the modeling with simulated data, had less uncertainty around the estimated change in illnesses—are not used in support of the final rule. The modeling PO 00000 Frm 00034 Fmt 4701 Sfmt 4700 without simulated data is carried through in this section. As a result, the uncertainty around estimated illnesses avoided is greater; however, the most likely estimated illnesses avoided are not affected. Stage 2 of the risk assessment consists of multiple scenario models in which combinations of plausible changes to inspection procedures are inserted into equations created using the coefficients computed in Stage 1. These scenarios produce estimates of changes in carcass contamination prevalence under the inspection procedures of NSIS. Changes in estimated numbers of Salmonella illness are estimated based on a proportional relationship between carcass contamination prevalence and illnesses that has been published in the E:\FR\FM\01OCR4.SGM 01OCR4 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations peer-reviewed literature.79 80 This relationship was also validated internally in the risk assessment, with an analysis of variance (ANOVA) test indicating that carcasses slaughtered in establishments with relatively low prevalence of Salmonella did not show significantly different contamination load (measured by enumeration of Salmonella colony-forming units per gram) when compared with establishments with relatively high prevalence of Salmonella. In other words, the proportion of contaminated carcasses is more predictive of Salmonella illnesses than the contamination load of each contaminated carcass; thus, if the proportion of carcasses with no detectable Salmonella contamination increases with implementation of the NSIS, illnesses caused by consumers’ exposure to these carcasses were estimated to decrease proportionally. As with any risk assessment, FSIS’s risk assessment relies on a number of assumptions. FSIS assumed that the differences between the process of slaughtering hogs and slaughtering poultry do not alter the relationship between the presence of Salmonella contamination post-slaughter and human illness. 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. 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 jbell on DSK3GLQ082PROD with RULES4 79 Williams M.S., Ebel, E.D., Vose, D. 2011. Framework for Microbial Food-Safety Risk Assessments Amenable to Bayesian Modeling. Risk Analysis 31(4):548–565. 80 Ebel, E.E., et al. 2012. Simplified framework for predicting changes in public health from performance standards applied in slaughter establishments. Food Control 28(2): pp. 250 257. VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 carcasses and chicken parts.81 These analyses indicate that the prevalence of Salmonella contamination on downstream products (e.g., parts) often exceeds that for the prevalence of Salmonella contamination in upstream products (e.g., carcasses). The higher prevalence is logical given that samples of downstream products contain primals from multiple carcasses, increasing the likelihood of a single sample being contaminated. The market hog Salmonella illness risk model estimates that the prevalence of Salmonella detected in carcasses may decline on average from an initial prevalence of 0.9407% to a final prevalence of 0.9066% if the 35 identified establishments adopt the new inspection system. This decrease in prevalence should correspond to an average decrease in illnesses due to market hog product consumption by an average of 2,533 annual cases.82 More specifically, CDC applies 14 empirical, population-adjusted, and Pert uncertainty distributions multiplicatively modeled as Monte Carlo distributions with repeated sampling and Bayesian characteristics to the data collected at their surveillance sites. CDC states that the illness estimates are robust but likely underestimates due to extrapolation from surveillance and outbreak data with underreporting not captured in the CDC uncertainty estimates based ultimately on laboratory confirmed cases. CDC’s modeling approach used to estimate total uncertainty of illnesses is designed to capture multiple sources of uncertainty that were not explicitly modeled, that is, the uncertainty in CDC illness estimates captures components of consumer behavior, cross contamination and Salmonella 81 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. 82 The relationship between carcass contamination prevalence and human illnesses modeled as in Williams et al., 2010, Estimating changes in public health following implementation of hazard analysis and critical control point in the United States broiler slaughter industry, Foodborne Pathogens and Disease, 9 and Ebel et al., 2012, Simplified framework for predicting changes in public health from performance standards applied in slaughter establishments, Food Control, 28. PO 00000 Frm 00035 Fmt 4701 Sfmt 4700 52333 inactivation and growth between production and consumption.83 The uncertainty surrounding illness estimates is the largest contributor to overall uncertainty in the NSIS risk model. The total uncertainty in the case rate is estimated to be bounded at the 10th and 90th percentiles by a potential increase of 1,719 and a potential decrease of 6,685 cases, respectively. The total case uncertainty distribution is dependent on the uncertainty in the change in Salmonella prevalence in market hogs. The prevalence estimates are modeled with data variability and robust uncertainty components taken from sampling data and model parameter estimates. Additional, unquantified uncertainty includes the possibility that differences between HIMP plants and non-HIMP plants that adopt NSIS not accounted for in the risk assessment could affect Salmonella prevalence. A number of potential differences, however, are taken into account in the risk assessment. The variability and uncertainty in the market hog proportion of illnesses is modeled from FSIS market hog slaughter data and Bayesian uncertainty. As demonstrated in the 2010–2011 Market Hog Baseline Study, the market hog slaughter process resulted in 2,390,482 carcasses produced per year and a weighted Salmonella contamination prevalence rate of 1.66%; the 10th percentile estimate for this value is 2,218,169 carcasses and the 90th percentile estimate is 2,561,973 carcasses. This uncertainty in the carcass prevalence rate in market hogs according to the peer reviewed prevalence model corresponds to the overall uncertainty in consumer Salmonella cases of illnesses from market hogs with an average of 69,857 cases and 10th and 90th percentiles of 40,778 and 104,333 cases respectively, under traditional inspection. With adoption of the new inspection system, the average number of cases is likely to decrease to 67,324. 83 CDC’s surveillance and outbreak attribution data are available in Scallan, E., et al. 2011. Foodborne Illness Acquired in the United States— Major Pathogens. Emerging Infectious Diseases 17(1): 7–15. E:\FR\FM\01OCR4.SGM 01OCR4 52334 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations The market hog risk assessment estimates that if the 35 establishments expected to convert to the NSIS over 5 years do so, the number of human illnesses attributed to products derived from market hogs could reduce by an average of 2,533 Salmonella illnesses. The combined robust model estimate of quantified uncertainty in the case rate based on CDC Salmonella illness and FSIS market hog contamination data is estimated to be bounded at the 10th and 90th percentiles by an increase of 1,719 and a decrease of 6,685 cases, respectively. It is worth noting, however, that there is an approximately 80% likelihood of a decrease in illnesses.84 The ERS estimates of the annual per case cost of foodborne illnesses for Salmonella range from roughly $321 to $5,820, with a mean of roughly $3,682.85 These estimates factor in the costs of physician office, emergency room, and outpatient clinic visits, as well as hospitalizations, productivity loss, and deaths. Assuming approximately 2,533 averted cases of Salmonella, potential savings range from roughly $0.81 million to $14.74 million, with a midpoint of $9.33 million, Table 18. Health costs would increase by roughly $6.33 million if cases increased by 1,719, which corresponds to the 10th percentile, and each case cost $3,682, Table 18. Alternatively, health costs would decrease by roughly $24.62 million if 6,685 cases were averted, which corresponds to the 90th percentile, and each case cost $3,682, Table 18. Using the midpoint estimate of $9.33 million cost decrease and applying a five-year adoption rate, the annualized value is approximately $7.09 million, at a 3 percent discount rate, Table 18. These estimated benefits may underestimate total benefits because they do not include pain and suffering costs. They may also overestimate benefits and cost savings given the uncertainty between the number of illnesses and the number of carcasses with detectable Salmonella. TABLE 18—POTENTIAL BENEFITS FROM AVERTED CASES OF SALMONELLA Cost per illness * Change in illnesses by scenario Percentile Low Mid High $321 $3,682 $5,820 Scenario Costs, $M 10th .................................................................................................................. Mean ................................................................................................................ 90th .................................................................................................................. 1,719 (2,533) (6,685) $0.55 (0.81) (2.15) $6.33 (9.33) (24.62) $10.01 (14.74) (38.91) Recurring Cost ..................................................................................................................................................................................... 6.33 Annualized Costs, Assuming a 3% Discount Rate Over 10 Years .................................................................................................... 4.81 Annualized Costs, Assuming a 7% Discount Rate Over 10 Years .................................................................................................... 4.62 Comparison of Mean Recurring Costs (M$) Low Mid Recurring Cost ..................................................................................................................................................................................... (9.33) Annualized Costs, Assuming a 3% Discount Rate Over 10 Years .................................................................................................... (7.09) Annualized Costs, Assuming a 7% Discount Rate Over 10 Years .................................................................................................... (6.81) High Recurring Cost ..................................................................................................................................................................................... (24.62) Annualized Costs, Assuming a 3% Discount Rate Over 10 Years .................................................................................................... (18.71) Annualized Costs, Assuming a 7% Discount Rate Over 10 Years .................................................................................................... ($17.97) jbell on DSK3GLQ082PROD with RULES4 * Source: USDA ERS, 2014, Cost Estimates of foodborne illnesses. http://www.ers.usda.gov/data-products/cost-estimates-of-foodborne-illnesses.aspx#48446 Accessed on 9/9/2011. Last updated on 11/12/2014. Note, some of the totals may not equal the sum due to rounding. 84 The primary conclusion for the purposes of this regulatory change, however, is that 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 VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 carcasses, which in turn may lead to fewer human illnesses. As such, public health benefits are characterized as ‘‘potential’’ rather than ‘‘expected’’ benefits. PO 00000 Frm 00036 Fmt 4701 Sfmt 4700 85 USDA ERS, 2014, Cost Estimates of foodborne illnesses. http://www.ers.usda.gov/data-products/ cost-estimates-of-foodborne-illnesses.aspx#48446 Accessed on 9/9/2011. Last Updated on 11/12/2014. E:\FR\FM\01OCR4.SGM 01OCR4 52335 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations 2. Other Benefits Associated With Modernizing Existing Regulations The final rule will potentially reduce the regulatory burden on establishments by shifting from prescriptive to performance-based regulation. Based on the Evaluation of HACCP Inspection Models Project (HIMP) for Market Hogs Report, the five HIMP establishments’ average line speed was approximately 12.49 percent faster than comparable establishments.86 This increase in line speed is synonymous with an increase in industrial efficiency. To quantify the benefit associated with this efficiency gain, this analysis used the North American Meat Institutes’ (NAMI’s) average pork packer margins for 2013– 2017, which was reported to be $15.20 87 per head in NAMI’s 2017 Meat and Poultry Facts.88 The pork packer margin is the price the packer receives less the cost of the hog and production costs, making it an estimate for accounting profits. However, economic profit may be more precisely associated with producer surplus. Economic profit is equal to the establishment’s revenues minus its implicit and explicit costs. Implicit costs are costs establishments do not spend money on, such as opportunity costs, while explicit costs are costs establishments spend money on, such as labor or hogs. Accounting profits can be larger than economic profits because they exclude some implicit costs. FSIS requested, but did not receive, comment on refining this estimate so as to distinguish between accounting profit and economic profit. By using accounting profits to estimate producer surplus, this analysis multiplied the change in quantity produced by half the per head margin, which is $7.60 ($15.20/2). This approach assumes that marginal costs increases as a function of quantity produced and that the marginal cost curve is linear, in which case the profit margin reaches zero for the last unit produced. Assuming establishments increase their production by 12.49 percent and that this increased production has an average packer margin of $7.60 per head, an average large establishment’s surplus could increase by approximately $3.78 million, while an average small high-volume establishment’s surplus could increase by $0.34 million, all else being equal. Combined, such an increase in efficiency at all 35 establishments will increase producer surplus by roughly $87.64 million 89 (22 × $3.78 million + 13 × $0.34 million), which has an annualized benefit of roughly $66.93 million, assuming a 3 percent discount rate over 10 years, Table 19. This estimate takes into consideration the assumed five-year adoption rate. However, this increase in surplus may be an overestimate given that an increase in line speeds may change market hog prices, establishment production costs, retail prices, and export volumes. Additionally, this analysis does not account for a change in consumer surplus, which will be conditional on how an increase in line speed affects retail prices. The Agency sought, but did not receive, comment on the extent to which such an increase in line speeds will affect market hog prices, establishment hours of production, consumer prices, and export volumes. TABLE 19—INDUSTRIAL EFFICIENCY, (BENEFITS) [M$] Change in producer surplus Number of establishments Type of establishment Per establishment Large .............................................................................................................................. Small .............................................................................................................................. Combined * ..................................................................................................................... 22 13 35 Combined ($3.78) (0.34) .................................. ($83.26) (4.38) (87.64) Recurring Cost ..................................................................................................................................................................................... (87.64) Annualized Costs, Assuming a 3% Discount Rate Over 10 Years .................................................................................................... (66.93) Annualized Costs, Assuming a 7% Discount Rate Over 10 Years .................................................................................................... (64.32) Totals * jbell on DSK3GLQ082PROD with RULES4 * Note, some of the totals may not equal the sum due to rounding. 86 USDA FSIS Evaluations—HACCP Inspection Models Project (HIMP) for Market Hogs https:// www.fsis.usda.gov/wps/portal/fsis/topics/ regulatory-compliance/haccp/haccp-basedinspection-models-project/evaluations+himpAccessedon1/6/2017. Last updated on 11/14/ 2014. VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 87 Note that the increase in benefits as compared to the proposed rule is due to updating the margin used from NAMI’s 2015 Meat and Poultry Facts to NAMI’s 2017 Meat and Poultry Facts. The proposed rule used a five-year average of $4.10 (2010–2014) per head, with a low of a $2.85 (2012) per head loss to a $11.49 (2010) per head gain. While the Final PO 00000 Frm 00037 Fmt 4701 Sfmt 4700 Rule uses a five-year average of $15.20 (2013–2017) per head, with a low of a $4.50 (2013) per head gain to a $25.26 (2017) per head gain. 88 Nalivka, J.S., The 2017 Meat and Poultry Facts, NAMI August 2018. 89 Note, some of the totals may not equal the sum due to rounding. E:\FR\FM\01OCR4.SGM 01OCR4 52336 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations The five HIMP establishments have demonstrated that establishments operating under the NSIS are able to increase their compliance with sanitation SOPs and HACCP regulations, lower their level of nonfood safety defects, achieve equivalent or better Salmonella verification testing rates, and lower the level of violative chemical residues.90 The five establishments that participated in the HIMP pilot study account for 15 percent of total swine production. Additionally, the NSIS increases the Agency’s ability to conduct more process and product verification and to increase monitoring of humane handling procedures, which is expected to improve animal welfare. FSIS inspectors devoted approximately 5.33 hours per shift to verifying humane handling activities for the Humane Activity Tracking System, HATS, categories in HIMP market hog establishments compared to approximately 4.29 hours per shift in the 21 non-HIMP market hog comparison establishments.91 Under the NSIS, establishments sort, remove, and identify swine unfit for slaughter before FSIS ante-mortem inspection. More FSIS resources can be devoted to offline inspection activities because initial sorting and tagging functions are performed by establishment personnel. This change will provide Agency personnel with more time to conduct offline inspection activities. I. Potential Budgetary Impacts on the Agency Under the final rule, FSIS will shift Agency resources from online to offline activities. This analysis estimates how such a shift will reduce labor expenses jbell on DSK3GLQ082PROD with RULES4 90 USDA FSIS Evaluations—HACCP Inspection Models Project (HIMP) for Market Hogs https:// www.fsis.usda.gov/wps/portal/fsis/topics/ regulatory-compliance/haccp/haccp-basedinspection-models-project/evaluations+himpAccessedon1/6/2017. Last updated on 11/14/ 2014. 91 USDA FSIS Evaluations—HACCP Inspection Models Project (HIMP) for Market Hogs https:// www.fsis.usda.gov/wps/portal/fsis/topics/ regulatory-compliance/haccp/haccp-basedinspection-models-project/evaluations+himpAccessedon1/6/2017. Last updated on 11/14/ 2014. VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 by approximately $6.67 million annually, Table 20. However, Agency personnel at NSIS establishments will require additional training, the annualized cost of which is estimated to be approximately $0.30 million. Both annualized estimates apply a 3 percent discount rate over 10 years and takes into consideration the assumed five-year adoption period. The Agency will also update PHIS to allow establishments to enter information on animals removed from the slaughter process. This modernization process will likely cost FSIS approximately $300,000 but will be paid for using existing Agency funds. Details of these costs are provided below. 1. Agency Staffing The following section discusses the impact on the Agency’s budget due to reassignment of the inspection staff. As discussed in section F of this document, under traditional inspection, a single slaughter line at a large establishment requires up to 11 FTEs, while a small market hog establishment requires up to 2 FTEs. Under NSIS, a single slaughter line at a large establishment will potentially require 6 FTEs, while a small market hog establishment will potentially to require 3 FTEs. Under NSIS, large establishments with 2 slaughter lines will potentially require 10 FTEs,92 while a small market hog establishment with 2 slaughter lines will potentially require 4 FTEs. This analysis considers likely staffing changes at the 22 large and 13 small establishments which will potentially convert to NSIS over a course of five years. Combined, these establishments operate 46 shifts and 55 lines.93 This analysis uses PHIS data provided by the Office of Field Operations (OFO) to calculate the number of FTEs assigned to each slaughter line. The FSIS Office of the Chief Financial Officer (OCFO) provided the wage and benefit data for 92 The difference in staffing between large establishments with 1 and 2 lines is because the Agency does not anticipate duplicating offline FTEs per line. 93 The 22 large establishments operate 41 slaughter lines during 32 shifts, while the 13 small establishments operate 14 lines during 14 shifts, source PHIS. PO 00000 Frm 00038 Fmt 4701 Sfmt 4700 each of these positions. This data was used to model the staffing changes in terms of both full- time positions and monetary value. Based on this data, to conduct traditional inspection, the Agency requires a combined 365 (334 at large and 31 at small establishments) FTE food or consumer safety inspectors at an annual cost of approximately $30.43 million, Table 20. If all 22 large non-HIMP and 13 small high-volume market hog only establishments convert to the NSIS, the Agency will require 218 (187 at large and 31 at small establishments) FTE food or consumer safety inspectors. This number was arrived at by assuming that under NSIS each of the 41 lines at the large establishments will have up to 3 FTEs assigned to them and each of the 32 shifts at the large establishments will have up 2 FTEs assigned to them ((41 lines × 3 FTEs) + (32 shifts × 2 FTEs) = 187 FTEs). Likewise, under NSIS, the 13 small establishments will each require between 2–3 FTEs, based on configuration, for a total of 31 FTEs. These staffing levels are based on FSIS’s experience at HIMP establishments. The combined labor costs for NSIS is approximately $21.70 million, Table 20. This cost estimate includes estimated grade increases associated with converting to the NSIS. As is shown in Table 20, if all 22 large establishments convert to NSIS, this analysis estimates a net decrease of 147 (334¥187) FTEs required for slaughter line inspection. The NSIS inspection program at these large establishments has a remuneration value of just over $18.58 million. A similar analysis of the 13 small highvolume establishments reveals no net change in the number of FTEs. However, because the NSIS requires all inspectors to be CSIs, many of the FTEs will likely be promoted from a FI to a CSI. Overall, if all 35 establishments converted to NSIS, the Agency will require 147 fewer FTEs for swine slaughter inspection, with potential annual decrease in costs of roughly $8.73 million, which is equal to roughly $6.67 million a year, assuming a 3 percent discount rate and the assumed five-year adoption period, Table 20. E:\FR\FM\01OCR4.SGM 01OCR4 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations 52337 TABLE 20—POTENTIAL CHANGES IN AGENCY STAFFING [M$] Traditional Type Number positions NSIS Labor costs Number positions Increases (reductions) Labor costs Number positions Labor costs Large ........................................................ Small ........................................................ 334 31 $27.56 $2.87 187 31 $18.58 $3.12 (147) 0 ($8.98) 0.25 Total .................................................. 365 $30.43 218 $21.70 (147) (8.73) Recurring Cost ..................................................................................................................................................................................... (8.73) Annualized Costs, Assuming a 3% Discount Rate Over 10 Years .................................................................................................... (6.67) Annualized Costs, Assuming a 7% Discount Rate Over 10 Years .................................................................................................... (6.42) Totals Since 2008, the Agency has annually lost, through attrition, 270 food inspectors on average. See Table 21 for details. The Agency plans to utilize all personnel made available as a result of conversion to NSIS to fill these vacant positions. TABLE 21—ANNUAL TURNOVER OF FOOD INSPECTORS Fiscal year 2008 2009 2010 2011 2012 2013 2014 2015 Number of positions ...................................... ...................................... ...................................... ...................................... ...................................... ...................................... ...................................... ...................................... 307 264 231 268 266 246 273 305 small establishments, Table 22. The associated one-time cost of such training includes labor and travel expenses associated with the employees receiving Number of Fiscal year positions training, as well as temporary replacement labor costs required to Average ................................ 270 fulfill the work that would have been completed by the employees receiving Source: OFO. training. Based on the HIMP pilot study, 2. Agency Training this analysis assumes NSIS methods training will take 3 days and a. Three Day NSIS Methods Course replacement labor will be equivalent to If all 22 large and 13 small market hog GS–13 step 5. Under these assumptions, establishments convert to NSIS over the the total one-time cost of NSIS training course of five years, as set forth in Table is approximately $0.64 million ($0.56 6, the Agency estimated training 266 million for all large establishments and personnel (218 CSIs and 48 PHVs), with $0.08 million for all small pay grades ranging from GS–8 to GS–13, establishments), Table 22. This one-time on NSIS methods. The majority of these cost equals approximately $0.07 million personnel, 228, are associated with 22 if it were annualized over 10 years large establishments, while the under a 3 percent discount rate, Table remaining 38 are associated with 13 22. TABLE 21—ANNUAL TURNOVER OF FOOD INSPECTORS—Continued TABLE 22—THREE DAY NSIS TRAINING COURSE [M$] Cost of trainee Number of inspectors requiring training Type of establishment Large .................................................................................... Small .................................................................................... Replacement labor Costs of wages and benefits for trainees 228 38 Number of replacement inspectors required $0.21 0.03 228 38 Costs of wages and benefits for replacements Combined costs $0.34 0.06 $0.56 0.08 One-Time Cost .................................................................................................................................................................................... 0.64 Annualized Costs, Assuming a 3% Discount Rate Over 10 Years .................................................................................................... 0.07 Annualized Costs, Assuming a 7% Discount Rate Over 10 Years .................................................................................................... 0.07 jbell on DSK3GLQ082PROD with RULES4 Totals * * Note, some of the totals may not equal the sum due to rounding. VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 PO 00000 Frm 00039 Fmt 4701 Sfmt 4700 E:\FR\FM\01OCR4.SGM 01OCR4 52338 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations b. Fill an Increase Need for Consumer Safety Inspectors Under the final rule, slaughter line inspectors at a NSIS establishment will work both on and off the slaughter line. As such, every inspection position will fall under the CSI position classification. To fill the increase in demand for CSIs, the Agency plans to train existing FIs. Training includes a four-week meat inspector course titled Inspection Methods (IM) and a one-day computer familiarization course. If all 22 large establishments convert to NSIS, the Agency will need an additional 82 CSIs. Likewise, if all 13 small market hog establishments convert, the Agency will need an additional 16 CSIs. Converting a FI into a CSI may result in a grade increase, the cost of which has been included in the Agency Staffing section above. The combined one-time cost for converting FIs into CSIs is roughly $2.16 million, Table 23. Nearly half of this cost stems from the need for replacement labor. Again, under the projected five-year adoption rate, as set forth in Table 6, and annualized over 10 years under a 3 percent discount rate, the cost for converting FIs to CSIs is approximately $0.23 million, Table 23. TABLE 23—COST OF CONVERTING A FOOD INSPECTOR INTO A CONSUMER SAFETY INSPECTOR [M$] Labor Travel, M&IE, and lodging Training component Trainee Four Week IM Course ..................................................................................... One Day Computer Training ............................................................................ Replacement $0.52 0.03 $0.98 0.05 Combined costs $0.59 ........................ $2.09 0.07 One-Time Cost .................................................................................................................................................................................... 2.16 Annualized Costs, Assuming a 3% Discount Rate Over 10 Years .................................................................................................... 0.23 Annualized Costs, Assuming a 7% Discount Rate Over 10 Years .................................................................................................... 0.25 Totals * * Note, some of the totals may not equal the sum due to rounding. Combined Estimated Budgetary Impacts The Agency’s budget will potentially be impacted both by changes to personnel and training requirements. First, on average, there will be fewer Agency inspection personnel per slaughter line operating under NSIS. If all 22 large and 13 small establishments convert to NSIS over the course of five years, the Agency will require approximately 147 fewer FTEs to inspect the 55 94 slaughter lines operating at these establishments. The annual remuneration value of these 147 positions is roughly $8.73 million, Table 24. Second, the Agency will need to train approximately 266 personnel on NSIS methods at a one-time cost of approximately $0.64 million, Table 24. Third, the Agency plans to meet the increase in demand for CSIs by converting existing FIs into CSIs. The one-time cost of doing so is approximately $2.16 million, Table 24. The annualized value of the combined changes to the Agency’s budget is a net reduction of roughly $6.38 million, over 10 years assuming a 3 percent discount rate, Table 24. TABLE 24—COMBINED CHANGES TO FSIS’S BUDGET [M$] Total costs One-time Recurring ........................ $0.64 2.16 ($8.73) ........................ ........................ One-Time Cost .................................................................................................................................................................................... 2.80 Recurring Cost ..................................................................................................................................................................................... (8.73) Annualized Costs, Assuming a 3% Discount Rate Over 10 Years .................................................................................................... (6.38) Annualized Costs, Assuming a 7% Discount Rate Over 10 Years .................................................................................................... (6.09) Changes to Agency Staffing .................................................................................................................................... Three Day NSIS Training ........................................................................................................................................ Converting Food Inspectors into Consumer Safety Inspectors .............................................................................. jbell on DSK3GLQ082PROD with RULES4 Totals J. Net Benefits Assuming all high-volume large and small exclusively market hog establishments convert to NSIS (5 94 Source: HIMP, 22 large, and 13 small highvolume), the rule is anticipated to have a net benefit of approximately $62.56 million a year, annualized over 10 years assuming a 3 percent discount rate, Table 25. The majority of the costs will be incurred by the 35 non-HIMP establishments that will potentially voluntarily switch to the NSIS in the form of increased labor needs. PHIS. VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 PO 00000 Frm 00040 Fmt 4701 Sfmt 4700 E:\FR\FM\01OCR4.SGM 01OCR4 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations 52339 TABLE 25—NET COSTS AND (BENEFITS) [M$] Number of establishments Costs to Industry ...................................................................................................................... Voluntary * ................................................................................................................................ Mandatory ................................................................................................................................ One-time Recurring $3.14 0.84 2.30 ** 40 612 $22.72 22.15 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 were not estimated to incur any cost 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 $3,682. **** Note, some of the totals may not equal the sum due to rounding. Given the lack of data with which to make cost-benefit comparisons across the industry, Table 26 provides a range of possible adoption scenarios and their corresponding costs and benefits. Under scenario A, only the 5 HIMP establishments adopt the NSIS. Because these 5 establishments are already operating under NSIS practices, there will not be any additional voluntary costs or benefits associated with these 5 establishments adopting the NSIS. However, 606 establishments will incur costs associated with the final rule’s mandatory components. As such, scenario A has a net cost. Scenario B assesses the net cost and benefits of just 6 establishments adopting the NSIS (5 HIMP and 1 large). This scenario reveals that the rule is net beneficial if just 1 large establishment adopts the NSIS in addition to the 5 HIMP establishments. Scenarios C, D, and E measure the net costs and benefits of 50, 75, and 100 percent of the 35 non-HIMP establishments converting to the NSIS, respectively. Each of these scenarios are net beneficial. TABLE 26—QUANTIFIED COST AND (BENEFITS) OF VARIOUS ADOPTION RATES [M$] ∧ Number to adopt * A B C D E ................................. ................................. ................................. ................................. ................................. 5 6 23 32 40 Costs (Benefits) Net Mandatory @ $0.84 0.84 0.84 0.84 0.84 NSIS Health $0.0 0.86 8.34 13.08 17.0 $0.0 (0.27) (3.59) (5.52) (7.09) Line speeds Agency budget $0.0 (3.78) (33.34) (51.51) (66.93) $0.0 (0.38) (3.14) (4.88) (6.38) $0.84 (2.73) (30.90) (47.99) (62.56) * These numbers include the 5 HIMP establishments. However, because these establishments are already conducting NSIS practices, they did not contribute to quantified NSIS costs, health benefits, or the impacts to the Agency’s budget. @These costs are incurred by all 612 swine establishments. ∧ Annualized Assuming a 3% Discount Rate Over 10 Years * Note, some of the totals may not equal the sum due to rounding. jbell on DSK3GLQ082PROD with RULES4 K. Alternatives VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 PO 00000 Frm 00041 Fmt 4701 Sfmt 4700 E:\FR\FM\01OCR4.SGM 01OCR4 52340 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations Table 27: Alternative Policy Options Benefits Costs 1. In comparison to the baseline, potential $0.57M in Process Control Sampling cost B. Mandatory Portion of the Final Rule Only jbell on DSK3GLQ082PROD with RULES4 1. Potentially more than $7.09M in averted illnesses. BILLING CODE 3410–DM–C A—Taking No Action (Baseline) FSIS considered maintaining the current inspection system for all 612 VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 1. In comparison to the baseline, potential $1.41M in Other Industry Costs. 1. Potential $25.9M Increase in Industry Labor swine slaughter establishments. The Agency rejected this alternative because it would forgo the benefits provided by the NSIS. These benefits include the establishment’s ability to innovate and PO 00000 Frm 00042 Fmt 4701 Net Sfmt 4700 Costs of $0.84M Benefits of $47.59M develop process controls which increase foodborne hazard detection and more efficiently use all their resources. Taking no action would also forgo potential industrial efficiency increases. E:\FR\FM\01OCR4.SGM 01OCR4 ER01OC19.000</GPH> Alternatives Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations Further, no action would result in the Agency continuing to dedicate resources to food quality issues, at the expense of increasing offline activities benefitting food safety. Last, taking no action would also forgo potential health benefits identified under the final rule. jbell on DSK3GLQ082PROD with RULES4 B—The Mandatory Portion of the Final Rule FSIS considered limiting the final rule to only include new requirements that affect all swine slaughter establishments. Under such a scenario, quantified benefits are limited to an estimated $0.57 million reduction in process control sampling costs. This cost reduction will potentially be off-set by a $1.41 million increase in other industry costs associated with requiring written sanitary dressing plans. In comparison to the baseline, this scenario has a net cost of roughly $0.84 million. Additionally, under such a scenario, the Agency’s inspection staff would not be reassigned, and the Agency would continue to require the same number of inspectors. As such, the Agency’s labor costs would not decrease by the estimated $6.67 million. However, because FIs would not be converted into CSIs nor will inspectors require additional training, the Agency would not incur the corresponding $0.30 million in training costs ($0.07 for NSIS training plus $0.23 in CSI training). As mentioned earlier, simultaneously increasing unscheduled and scheduled inspection procedures and decreasing scheduled but not performed procedures accrues most of the public health benefits. The unscheduled and scheduled tasks are currently not performed as a result of lack of offline personnel. In comparison to the final rule, this alternative would eliminate most of the public health benefits associated with the rule, which are estimated at $7.09 million annually. Additionally, line speed restrictions would remain in place, leading to an estimated loss of over $36.14 million in industrial efficiency gains. FSIS has rejected this alternative in light of its estimated net cost as compared to the baseline as well as the decrease in net benefits as compared to the final rule. C—The Final Rule Applying a 3 percent discount rate over 10 years the costs associated with the final rule includes $16.61 million in additional industry labor costs, $1.80 million in other industry costs including costs associated with meeting ready to cook standards and written sanitary dressing plans, as well as $0.30 million in Agency training costs. The quantified health benefits of the final VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 rule are limited to reductions in Salmonella illnesses and have an estimated value of $7.09 million, assuming a 3 percent discount rate. Allowing establishments to set line speeds so long as they maintain process control will potentially increase their efficiency by $66.93 million, assuming a 3 percent discount rate. The final rule could potentially reduce industry costs associated with process control sampling by roughly $0.57 million, assuming a 3 percent discount rate. Additionally, the final rule could potentially reduce the Agency’s labor costs by roughly $6.67 million, assuming a 3 percent discount rate. In comparison to the baseline, the final rule has an estimated net benefit of $62.56 million, assuming a 3 percent discount rate over 10 years, and as such, the Agency recommends the final rule. D—Requiring All Federally Inspected Establishments Adopt the New Swine Inspection System FSIS considered requiring all federally inspected swine slaughter establishments to convert to NSIS. This would expand NSIS from the 5 large HIMP, 22 large and 13 small highvolume non-HIMP establishments expected to convert under the final rule to include 572 additional establishments. This expansion would include low-volume establishments that slaughter all types of swine as well as other establishments that slaughter a mix of species. In comparison to the baseline, the benefits of this alternative potentially include more than $7.09 million in averted illnesses, a $66.93 million increase in industrial efficiency, $0.57 million in industrial savings associated with process control sampling requirements, assuming a 3 percent discount rate over 10 years. While compared to the baseline, this alternative reduces Agency labor costs by $2.72 million, assuming a 3 percent discount rate over 10 years. However, this alternative’s Agency labor costs savings are less than the final rule’s Agency labor costs savings because this alternative would result in additional promotions and training in small and very small establishments. The production at these 572 additional establishments represents less than 8 percent of total production and, as such, is not expected to return substantial reductions in contamination prevalence or illnesses and falls outside of the current risk assessment. In particular, the uncertainty around measurement and model parameters that is already included in the health benefit calculations for the final rule likely PO 00000 Frm 00043 Fmt 4701 Sfmt 4700 52341 produce wide enough estimates that the impact of adopting the NSIS in all establishments would have an effect within the uncertainty bounds. The increase in industrial efficiency remains similar to that of the final rule because these additional establishments are generally less automated and maintain slower line speeds to address higher rates of quality defects associated with non-market hogs. In comparison to the baseline, the potential costs associated with this alternative include a $25.90 million increase in industrial labor, a $3.14 million increase in other industry costs, which include costs associated with RTC standards and written sanitary dressing plans, as well as roughly $0.68 million in Agency training costs. In comparison to the final rule, the additional increases in costs to industry are substantially higher and predominately fall on small and very small business. While this alternative has a net benefit of $47.59 million, assuming a 3 percent discount rate over 10 years, the Agency rejects it because its net benefit is less than the final rule. IV. Regulatory Flexibility Act Assessment The FSIS Administrator has made a determination that this final rule will not have a significant economic impact on a substantial number of small entities in the United States, as defined by the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). FSIS used an establishment’s HACCP processing size, which applies to an individual establishment, as a proxy for business size. HACCP processing sizes are the following: large establishments have 500 or more employees; small establishments have between 10 and 499 employees; very small establishments have fewer than 10 employees or annual sales of less than $2.5 million. Section III provides additional details on costs incurred by small businesses. The final rule’s mandatory requirements will affect approximately 584 small entities—105 small and 479 very small. First, the mandatory requirements include that all small and very small establishments create written sanitary dressing plans with cost components of development of the plan, training of employees, and recordkeeping, at an annualized cost of $1,869 per establishment, applying a 3 percent discount rate over 10 years. Second, the mandatory changes to process control sampling requirements could potentially decrease small establishments’ sampling costs by roughly $984 per establishment annually, applying a 3 percent discount E:\FR\FM\01OCR4.SGM 01OCR4 52342 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations rate over 10 years. In addition to this sampling cost reduction, the Agency will allow small and very small lowvolume establishments to modify their sampling plans to collect samples less frequently once they have collected 13 consecutive weekly samples and can demonstrate that they are not exceeding their upper control limit and that they are effectively maintaining process control. FSIS is also allowing establishments to develop sampling plans that are more tailored to their specific operation, and thus more effective in monitoring their specific process control as compared to the current generic E. coli criteria. Therefore, the final rule’s mandatory requirements could potentially increase small establishments’ costs by roughly $885 ($1,869¥$984 = $885) per establishment annually, an amount that will potentially have little effect on small entities. To put this in perspective, the average small and very small establishment slaughters over 21,000 swine annually. Using the American Meat Institute’s average pork packer dollars per head margins for 2013–2017, the average small and very small establishment’s marginal revenue is $332 thousand (21,858 (heads slaughtered) × $15.20 (average margin per head)). The final rule also provides small and very small establishments with additional time to comply with the new requirements in 9 CFR 310.18(c) and (d). Additionally, the optional NSIS portion of the rule could potentially provide an overall cost savings for the 13 small high-volume establishments of roughly $288,731 per establishment that adopts the NSIS. This estimate takes into consideration the increase in labor cost ($42,025 per establishment), cost associated with meeting RTC standards ($6,300 per establishments) and cost savings from increased industrial efficiency ($337,056 per establishment). See section III for additional details. jbell on DSK3GLQ082PROD with RULES4 V. Executive Order 13771 Consistent with E.O. 13771 (82 FR 9339, February 3, 2017), FSIS estimates that this final rule will yield cost savings. Assuming a 7 percent discount rate, a perpetual time horizon, and a starting year of 2019, the final rule is estimated to yield approximately $51.91 million (2016$) in annual cost savings, not including potential health benefits. Therefore, this rule is an E.O. 13771 deregulatory action. VI. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), the Office of Information and Regulatory Affairs VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 designated this rule as not a ‘‘major rule,’’ as defined by 5 U.S.C. 804(2). How To File a Complaint of Discrimination VII. E-Government Act To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed on-line at http:// www.ocio.usda.gov/sites/default/files/ docs/2012/Complain_combined_6_8_ 12.pdf, or write a letter signed by you or your authorized representative. Send your completed complaint form or letter to USDA by mail, fax, or email: Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW, Washington, DC 20250–9410. Fax: (202) 690–7442. Email: program.intake@usda.gov. Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA’s TARGET Center at (202) 720–2600 (voice and TDD). FSIS and USDA are committed to achieving the purposes of the EGovernment Act (44 U.S.C. 3601, et seq.) by, among other things, promoting the use of the internet and other information technologies and providing increased opportunities for citizen access to Government information and services, and for other purposes. VIII. Executive Order 12988, Civil Justice Reform This rule has been reviewed under E.O. 12988, Civil Justice Reform. Under this rule: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) no administrative proceedings will be required before parties may file suit in court challenging this rule. IX. Executive Order 13175 This rule has been reviewed in accordance with the requirements of E.O. 13175, Consultation and Coordination with Indian Tribal Governments. E.O. 13175 requires Federal agencies to consult and coordinate with Indian tribes on a government-to-government basis on policies that have tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. The USDA’s Office of Tribal Relations (OTR) has assessed the impact of this rule on Indian tribes and determined that this rule has minimal tribal implications. If an Indian tribe requests consultation, FSIS will work with the OTR to ensure meaningful consultation is provided. X. USDA Nondiscrimination Statement No agency, officer, or employee of the USDA must, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/ parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA. PO 00000 Frm 00044 Fmt 4701 Sfmt 4700 XI. Environmental Impact Each USDA agency is required to comply with 7 CFR part 1b of the Departmental regulations, which supplements the National Environmental Policy Act regulations published by the Council on Environmental Quality. Under these regulations, actions of certain USDA agencies and agency units are categorically excluded from the preparation of an EA or an EIS unless the agency head determines that an action may have a significant environmental effect (7 CFR 1b.4 (b)). FSIS is among the agencies categorically excluded from the preparation of an EA or EIS (7 CFR 1b.4 (b)(6)). Establishments that operate under NSIS will be able to slaughter and process swine more efficiently than is possible under current regulations, leading to a reduction in production costs. FSIS expects that consumer demand for pork products will determine the number of swine slaughtered rather than production costs. Because of the efficiencies in the NSIS, the price of pork products may decrease. The predicted price reduction could lead to a slight increase in demand for pork products. With the slight increase in pork product sales, some establishments may choose to increase the number of swine slaughtered, which could result in an increase in the number of condemned carcasses and parts that must be disposed of. However, because the anticipated change in price and sales is very small, especially in comparison to changes in price and sales in response to other market forces, the Agency has determined that the change in the E:\FR\FM\01OCR4.SGM 01OCR4 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations number of swine slaughtered, as well as the number of condemned carcasses and parts to be disposed of, will be very small and thus will not have a significant individual or cumulative effect on the human environment. Therefore, this regulatory action is appropriately subject to the categorical exclusion from the preparation of an EA or EIS provided under 7 CFR 1b.4(b)(6) of the USDA regulations. XII. Paperwork Reduction Act In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection and recordkeeping requirements included in this final rule have been submitted by the Agency to OMB for approval which has not yet been received. FSIS will collect no information associated with this rule until the information collection is approved by OMB. Title: Swine Slaughter Inspection. Type of Collection: New. Abstract: FSIS updated the proposed rule’s information collection assessment to reflect the changes made in the final rule in response to public comments and to better align it with the final cost estimates in section III. FSIS is also requiring a new information collection burden but has reduced the total annual burden estimate by 52,729.04 hours. The changes to the final burden estimates incorporate the following factors: • FSIS is requiring a new information collection burden; specifically, the Agency is requiring market hog slaughter establishments operating under NSIS to maintain records to document the total number of animals and carcasses sorted and removed per day and the reasons for their removal. • The proposed mandatory preoperational environmental sampling was removed from the final rule. Therefore, these time estimates were removed from the final burden estimates. • Establishments operating under SIP conduct process control sampling at an alternative frequency. Therefore, these 11 establishments have been removed from the final burden estimates. • The final burden estimates only include the time to record the sample results for the new process control sampling requirements. • The final burden estimates were updated so that the establishment and time estimates align with the final cost analysis in section III. New Information Collection in This Final Rule FSIS is requiring a new regulation that will create a new information collection burden, in that it will require market hog slaughter establishments operating under NSIS to maintain Estimated number of respondents Respondents Large establishments .......... Small high-volume establishments. jbell on DSK3GLQ082PROD with RULES4 Total Recordkeeping Burden for sorting and removing. 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 estimates this new requirement will take establishments operating under NSIS, 5 minutes per shift regardless of whether establishments complete the form or submit the information electronically. This is a new recordkeeping requirement that FSIS has submitted to OMB for approval. Estimated Annual Recordkeeping Burden for Maintaining Records to Document the Total Number of Animals and Carcasses Sorted and Removed per Day and the Reasons for Their Removal Respondents: Official market hog slaughter establishments that operate under NSIS. Estimated maximum number of respondents: 40. Estimated Average Annual Number of Responses per Respondent: Large establishments 352; small high-volume establishments 290. Estimated Maximum Total Potential Annual Responses: 13,282. Estimated Total Annual Recordkeeping Burden: 1,107 hours. Total annual responses Time per response in minutes Total annual burden hours Animals and carcasses sorted and removed and their reasons. Animals and carcasses sorted and removed and their reasons. 27 352 9,504 5 792 13 290 3,770 5 314 ............................................. 40 332 13,274 5 1,106 Under this final rule, establishments also will have to 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 under 9 CFR part 314. The requirement that swine slaughter establishments have written procedures in their HACCP systems is already covered under an approved information collection system, Pathogen Reduction/ Hazard Analysis and Critical Control Point Systems (OMB control number VerDate Sep<11>2014 Average annual number of responses per respondent 52343 19:06 Sep 30, 2019 Jkt 250001 0583–0103). Therefore, this requirement of this final rule will create no new burden on establishments. Copies of this information collection assessment can be obtained from Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW, Room 6065, South Building, Washington, DC 20250; (202)720–5627. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance PO 00000 Frm 00045 Fmt 4701 Sfmt 4700 of FSIS’s functions, including whether the information will have practical utility; (b) the accuracy of FSIS’s estimate of the burden of the proposed collection of information, including the validity of the method and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information, including through the use of appropriate automated, electronic, mechanical, or other technological E:\FR\FM\01OCR4.SGM 01OCR4 52344 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations collection techniques, or other forms of information technology. Comments on the proposed information collection may be sent to both FSIS, at the addresses provided above, and the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20253. To be most effective, comments should be sent within 60 days of the publication date of this final rule. Information Collections That Were Included in the Proposed Rule Under this final rule, establishments operating under NSIS are required to (1) identify animals or carcasses that establishment personnel have sorted and removed for disposal before FSIS inspection with a unique tag, tattoo, or similar device, and to develop, implement, (2) maintain records to document the total number of animals and carcasses sorted and removed per day and the reasons for their removal, and (3) maintain records documenting that products resulting from their slaughter operations meet the new definition of RTC pork product. Furthermore, each establishment operating under the NSIS will also need to submit, on an annual basis, an attestation to the management member of the local FSIS circuit safety committee stating that it maintains a program to monitor and document any work-related conditions of establishment workers. In addition, each official swine slaughter establishment, regardless of the inspection system under which they operate, will need to maintain, as part of its HACCP system, written procedures for preventing, throughout the entire slaughter and dressing operation, contamination of carcasses and parts by enteric pathogens, and visible fecal material, ingesta, and milk. 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 mentioned above, the requirement that swine slaughter establishments have written procedures in their HACCP systems is already covered under an approved information collection system. Therefore, this requirement of this final rule will create no new burden on establishments. The requirement that swine slaughter establishments monitor their systems through microbial testing and recordkeeping will create a new information collection burden. For each Respondents jbell on DSK3GLQ082PROD with RULES4 Average annual number of responses per respondent Estimated number of respondents sample on which a microbiological test is conducted, there is a ‘‘response’’ for the establishment to record the sample result. Under the final rule, large, small and very small high-volume establishments will test and record microbiological results for enteric pathogens, for carcass samples taken at both pre-evisceration and post-chill (for hot-boned products, carcass samples will be collected pre-evisceration and after the final wash), at a frequency of once per 1,000 carcasses; and small and very small low-volume establishments, 13 times a year. The small and very small low-volume establishments do not experience an increase in sampling under the final rule. Estimated Annual Recordkeeping Burden: Swine Slaughter Inspection. Respondents: Official high-volume swine establishments. Estimated Number of Respondents: 74 (17 large, 51 small high-volume, and 6 very small high-volume). Estimated Average Annual Number of Responses (samples) per Respondent: Large establishments 3,869; small highvolume establishments 229; and very small high-volume establishments 52. Estimated Total Annual Responses: 77,764. Estimated Total Annual Recordkeeping Burden: 3,240 hours. Total annual responses Time per response in minutes Total annual burden hours Large establishments. Small high-volume establishments. Very small highvolume establishments. Microbial testing data recordkeeping ... 17 3,869 65,773 2.5 2,741 Microbial testing data recordkeeping ... 51 229 11,679 2.5 487 Microbial testing data recordkeeping ... 6 52 312 2.5 13 Total Recordkeeping Burden for process control. ............................................................... 74 1,051 77,764 2.5 3,240 FSIS is also requiring that market hog slaughter establishments operating under NSIS submit on an annual basis, an attestation to the management member of the local FSIS circuit safety committee stating that it maintains a program to monitor and document any work-related conditions of establishment workers. VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 Estimated Annual Reporting Burden for Submitting an Annual Attestation on Work-Related Conditions to the FSIS Circuit. Safety Committee: Swine Slaughter Inspection. Respondents: Official market hog slaughter establishments that operate under NSIS. Estimated maximum number of respondents: 40. PO 00000 Frm 00046 Fmt 4701 Sfmt 4700 Estimated Average Annual Number of Responses per Respondent: Large establishments 1; small high-volume establishments 1. Estimated Maximum Total Potential Annual Responses: 40. Estimated Total Annual Recordkeeping Burden: 1.33 hours. E:\FR\FM\01OCR4.SGM 01OCR4 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations Estimated number of respondents Respondents Large establishments .......... Small high-volume establishments. Total Reporting Burden Average annual number of responses per respondent Total annual burden hours 27 1 27 2 .90 13 1 13 2 .43 ............................................. 40 1 40 2 1.33 information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls, export [With the recordkeeping burden for maintaining records to document the total number of information, regulations, directives, and animals and carcasses sorted and removed notices. Customers can add or delete per day and the reasons for their removal] subscriptions themselves and have the option to password protect their Total Number Respondents 84 accounts. Average Annual Number Responses per Respondent .. Total Annual Responses ...... Average Hours per Response ............................... Total Annual Burden Hours .. 1,084.33 91,084 0.05 Final Regulatory Amendments List of Subjects 9 CFR Part 301 Meat inspection. 4,347.33 9 CFR Part 309 SUMMARY OF BURDEN SWINE SLAUGHTER INSPECTION [Without the recordkeeping burden for maintaining records to document the total number of animals and carcasses sorted and removed per day and the reasons for their removal] jbell on DSK3GLQ082PROD with RULES4 Time per response in minutes Attestation on Work-Related Conditions. Attestation on Work-Related Conditions. SUMMARY OF BURDEN SWINE SLAUGHTER INSPECTION Total Number Respondents Average Annual Number Responses per Respondent .. Total Annual Responses ...... Average Hours per Response ............................... 926.24 77,804 Total Annual Burden Hours .. 3,241.33 84 19:06 Sep 30, 2019 Animal diseases, Meat inspection, Reporting and recordkeeping requirements. 9 CFR Part 310 Animal diseases, Meat inspection. For the reasons stated in the preamble, FSIS is amending 9 CFR chapter III as follows: PART 301—TERMINOLOGY; ADULTERATION AND MISBRANDING 0.04 STANDARDS XIII. Additional Public Notification Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS web page located at: http:// www.fsis.usda.gov/federal-register. FSIS will also announce and provide a link to it through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Constituent Update is available on the FSIS web page. Through the web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and VerDate Sep<11>2014 Total annual responses 52345 Jkt 250001 1. The authority citation for part 301 is revised to read as follows: ■ Authority: 7 U.S.C. 138–138i, 450, 1901– 1906; 21 U.S.C. 601–695; 7 CFR 2.7, 2.18, 2.53. 2. Amend § 301.2 by adding the definition of ‘‘Ready-to-cook (RTC) pork product’’ in alphabetical order to read as follows: ■ § 301.2 Definitions. * * * * * Ready-to-cook (RTC) pork product. 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. * * * * * PART 309—ANTE–MORTEM INSPECTION 3. The authority citation for part 309 continues to read as follows: ■ PO 00000 Frm 00047 Fmt 4701 Sfmt 4700 Authority: 21 U.S.C. 601–695; 7 CFR 2.18, 2.53. ■ 4. Add § 309.19 to read as follows: § 309.19 Market hog segregation under the new swine slaughter inspection system. (a) The establishment must conduct market hog sorting activities before the animals are presented for ante-mortem inspection. Market hogs exhibiting signs of moribundity, central nervous system disorders, or pyrexia must be disposed of according to paragraph (c) of this section. (b) The establishment must develop, implement, and maintain written procedures to ensure that market hogs exhibiting signs of moribundity, central nervous system disorders, or pyrexia do not enter the official establishment to be slaughtered. The establishment must incorporate these procedures into its HACCP plan, or sanitation SOPs, or other prerequisite programs. (c) The establishment must identify livestock that establishment employees have sorted and removed from slaughter with a unique tag, tattoo, or similar device. The establishment must develop, implement, and maintain written procedures to ensure that the animals sorted and removed from slaughter do not enter the human food supply and are disposed of according to 9 CFR part 314. (d) The establishment must maintain records to document the number of animals disposed of per day because they were removed from slaughter by establishment sorters before antemortem inspection by FSIS inspectors and the reasons that the animals were removed. These records are subject to review and evaluation by FSIS personnel. (e) The establishment must immediately notify FSIS inspectors if the establishment has reason to believe that market hogs may have a notifiable animal disease. Notifiable animal diseases are designated by World Animal Health Organization. E:\FR\FM\01OCR4.SGM 01OCR4 52346 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations PART 310—POST-MORTEM INSPECTION 5. The authority citation for part 310 continues to read as follows: ■ Authority: 21 U.S.C. 601–695; 7 CFR 2.18, 2.53. 6. Amend § 310.1 by revising paragraph (b)(3) to read as follows: ■ § 310.1 Extent and time of post-mortem inspection; post-mortem inspection staffing standards. * * * * * (b) * * * (3) Swine inspection. There are two systems of post-mortem inspection: The New Swine Slaughter Inspection System (NSIS), which may be used for market hogs, and the traditional inspection system, which may be used for all swine. (i) The NSIS may be used for market hogs if the official establishment requests to use it and meets or agrees to meet the requirements in 9 CFR 309.19 and § 310.26. The Administrator may permit establishments that slaughter classes of swine other than market hogs to use NSIS under a waiver from the provisions in 9 CFR 309.19 and § 310.26 as provided by 9 CFR 303.1(h). The Administrator also may permit establishments that slaughter both market hogs and other classes of swine to slaughter the market hogs under NSIS and slaughter the other classes of swine under traditional inspection. (ii) Traditional inspection shall be used for swine when NSIS is not used. The following inspection staffing standards are applicable to swine slaughter configurations operating under traditional inspection when NSIS is not used. The inspection standards for all slaughter lines are based upon the observation rather than palpation, at the viscera inspection station, of the spleen, liver, heart, lungs, and mediastinal lymph nodes. In addition, for one- and two-inspector lines under traditional inspection, the standards are based upon the distance walked (in feet) by the inspector between work stations; and for three or more inspector slaughter lines, upon the use of a mirror, as described in § 307.2(m)(6) of this chapter, at the carcass inspection station. Although not required in a oneor two-inspector slaughter configuration, except in certain cases as determined by the inspection service, if a mirror is used, it must comply with the requirements of § 307.2(m)(6). TABLE 1 TO PARAGRAPH (B)(3)—ONE INSPECTOR—STAFFING STANDARDS FOR SWINE Maximum inspection rates (head per hour) Market hogs (heads attached or detached) Distance walked 1 in feet is— Without mirror 0 to 5 ................................................................................................................ 6 to 10 .............................................................................................................. 11 to 15 ............................................................................................................ 16 to 20 ............................................................................................................ 21 to 35 ............................................................................................................ 26 to 30 ............................................................................................................ 31 to 35 ............................................................................................................ 36 to 40 ............................................................................................................ 41 to 45 ............................................................................................................ 46 to 50 ............................................................................................................ 51 to 55 ............................................................................................................ 56 to 60 ............................................................................................................ 61 to 65 ............................................................................................................ 66 to 70 ............................................................................................................ 71 to 75 ............................................................................................................ 76 to 80 ............................................................................................................ 81 to 85 ............................................................................................................ 86 to 90 ............................................................................................................ 91 to 95 ............................................................................................................ 96 to 100 .......................................................................................................... Sows and boars (heads detached) With mirror 140 134 129 124 120 116 112 108 105 101 98 96 93 90 88 86 84 82 80 78 Without mirror 150 144 137 132 127 122 118 114 110 107 103 100 97 95 92 89 87 85 83 81 With mirror 131 126 122 117 113 110 106 103 100 97 94 91 89 87 85 82 80 79 77 75 143 137 132 127 122 118 114 110 106 103 100 97 94 92 89 87 85 83 81 79 1 Distance walked is the total distance that the inspector will have to walk between work stations during one inspection cycle (e.g., between viscera, carcass, head, and wash-basin). TABLE 2 TO PARAGRAPH (B)(3)—TWO INSPECTORS—STAFFING STANDARDS FOR MARKET HOGS Maximum inspection rates (head per hour with heads attached or detached) Distance walked 1 in feet by inspector B is— Line configuration Carcass,2 head viscera 3 Viscera,2 head carcass 3 Head,2 viscera carcass 3 151–253 151–239 151–226 151–214 151–204 151–271 151–255 151–240 151–227 151–215 151–296 151–277 151–260 151–244 151–231 jbell on DSK3GLQ082PROD with RULES4 Without Mirror 0 to 5 ............................................................................................................................................ 6 to 10 .......................................................................................................................................... 11 to 15 ........................................................................................................................................ 16 to 20 ........................................................................................................................................ 21 to 25 ........................................................................................................................................ VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 PO 00000 Frm 00048 Fmt 4701 Sfmt 4700 E:\FR\FM\01OCR4.SGM 01OCR4 52347 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations TABLE 2 TO PARAGRAPH (B)(3)—TWO INSPECTORS—STAFFING STANDARDS FOR MARKET HOGS—Continued Maximum inspection rates (head per hour with heads attached or detached) Distance walked 1 in feet by inspector B is— Line configuration Carcass,2 head viscera 3 Viscera,2 head carcass 3 Head,2 viscera carcass 3 151–253 151–239 151–226 151–214 151–204 151–303 151–283 151–265 151–249 151–235 151–318 151–304 151–289 151–270 151–254 With Mirror 0 to 5 ............................................................................................................................................ 6 to 10 .......................................................................................................................................... 11 to 15 ........................................................................................................................................ 16 to 20 ........................................................................................................................................ 21 to 25 ........................................................................................................................................ 1Distance walked is the total distance that Inspector B will have to walk between work stations during one inspection cycle (e.g., between viscera, carcass, and washbasin). 2Inspector A. 3Inspector B. Note 1 to Table 2 to paragraph (b)(3): In multiple-inspector plants, the inspectors must rotate between all inspection positions during each shift to equalize the workload. TABLE 3 TO PARAGRAPH (B)(3)—TWO INSPECTORS—STAFFING STANDARDS FOR SOWS AND BOARS Maximum inspection rates (head per hour) Line Configuration Distance walked 1 in feet by inspector B is— Carcass,2 head viscera,3 heads detached Viscera,2 head carcass,3 heads detached Head,2 viscera carcass,3 heads detached Head,2 viscera carcass,3 heads attached 144–248 144–235 144–222 144–211 144–201 144–254 144–240 144–227 144–215 144–205 144–267 144–253 144–239 144–226 144–214 144–267 144–253 144–239 144–226 144–214 144–248 144–235 144–222 144–211 144–201 144–292 144–273 144–256 144–241 144–228 144–305 144–291 144–272 144–255 144–240 144–292 144–280 144–268 144–255 144–240 Without Mirror 0 to 5 ................................................................................................................ 6 to 10 .............................................................................................................. 11 to 15 ............................................................................................................ 16 to 20 ............................................................................................................ 21 to 25 ............................................................................................................ With Mirror 0 to 5 ................................................................................................................ 6 to 10 .............................................................................................................. 11 to 15 ............................................................................................................ 16 to 20 ............................................................................................................ 21 to 25 ............................................................................................................ 1Distance walked is the total distance that Inspector B will have to walk between work stations during one inspection cycle (e.g., between viscera, carcass, and washbasin). 2Inspector A. 3Inspector B. Note 1 to table 3 to Paragraph (b)(3): In multiple-inspector plants, the inspectors must rotate between all inspection positions during each shift to equalize the workload. TABLE 4 TO PARAGRAPH (B)(3)—THREE INSPECTORS OR MORE—STAFFING STANDARDS FOR SWINE Number of inspectors by station jbell on DSK3GLQ082PROD with RULES4 Maximum inspection rates (head per hour with heads attached) Head Market hogs: 319 to 506 ........................................................................................................ 507 to 540 ........................................................................................................ 541 to 859 ........................................................................................................ 860 to 1,022 ..................................................................................................... 1,023 to 1,106 .................................................................................................. Sows and boars: 306 to 439 ........................................................................................................ 306 to 462 1 ...................................................................................................... 440 to 475 ........................................................................................................ 476 to 752 ........................................................................................................ 753 to 895 ........................................................................................................ VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 PO 00000 Frm 00049 Fmt 4701 Sfmt 4700 Viscera Carcass Total 1 1 2 2 3 1 2 2 3 3 1 1 1 1 1 3 4 5 6 7 1 1 2 2 3 1 1 1 2 2 1 1 1 1 1 3 3 4 5 6 E:\FR\FM\01OCR4.SGM 01OCR4 52348 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations TABLE 4 TO PARAGRAPH (B)(3)—THREE INSPECTORS OR MORE—STAFFING STANDARDS FOR SWINE—Continued Number of inspectors by station Maximum inspection rates (head per hour with heads attached) Head 896 to 964 ........................................................................................................ Viscera 3 Carcass 3 Total 1 7 1This rate applies if the heads of sows and boars are detached from the carcasses at the time of inspection. Note 1 to table 4 to paragraph (b)(3): In multiple-inspector plants, the inspectors must rotate between all inspection positions during each shift to equalize the workload. 7. Amend § 310.18 by adding paragraphs (c) and (d) to read as follows: ■ § 310.18 Contamination of carcasses, organs, or other parts. jbell on DSK3GLQ082PROD with RULES4 * * * * * (c) Official swine slaughter establishments must develop, implement, and maintain written procedures to prevent contamination of carcasses and parts by enteric pathogens, and visible fecal material, ingesta, and milk contamination throughout the entire slaughter and dressing operation. Establishments must incorporate these procedures into their HACCP plans, or sanitation SOPs, or other prerequisite programs. These procedures must include sampling and analysis for microbial organisms in accordance with the sampling location and frequency requirements in paragraphs (c)(1) and (2) of this section to monitor their ability to maintain process control. (1) Sampling locations. Official swine slaughter establishments, except for very low-volume establishments, must collect and analyze carcass samples for microbial organisms at the preevisceration and post-chill points in the process. Establishments that slaughter more than one type of livestock must test the type of livestock slaughtered in the greatest number. Establishments that bone their products before chilling (i.e., hot-boned products) must collect and analyze samples at the pre-evisceration point in the process and after the final wash instead of at post-chill. Very lowvolume establishments must collect and analyze samples for microbial organisms at the post-chill point in the process. All swine establishments must sponge or excise tissue from the ham, belly, and jowl areas. (i) Very low-volume establishments annually slaughter no more than 20,000 swine, or a combination of swine and other livestock not exceeding 6,000 cattle and 20,000 total of all livestock. (ii) [Reserved] (2) Sampling frequency. Establishments, except for very lowvolume establishments as defined in paragraph (c)(1)(i) of this section, must collect and analyze samples at a frequency proportional to the VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 establishment’s volume of production at the following rates: (i) Establishments, except for very low-volume establishments as defined in paragraph (c)(1)(i) of this section, must collect and analyze samples at a frequency of once per 1,000 carcasses, but a minimum of once during each week of operation. (ii) Very low-volume establishments as defined in paragraph (c)(1)(i) of this section must collect and analyze samples at least once during each week of operation starting June 1 of every year. If, after consecutively collecting 13 weekly samples, very low-volume establishments can demonstrate that they are effectively maintaining process control, they may modify their sampling plans. (iii) Establishments must maintain accurate records of all test results and retain these records as provided in paragraph (d) of this section. (d) Official swine slaughter establishments must maintain daily records sufficient to document the implementation and monitoring of the procedures required under this section. Records required by this section may be maintained on computers if the establishment implements appropriate controls to ensure the integrity of the electronic data. Records required by this section must be maintained for at least one year and must be accessible to FSIS. § 310.25 [Amended] 8. Amend § 310.25 as follows: a. Remove paragraph (a)(2)(ii)(C); b. Remove the undesignated sentence following paragraph (a)(2)(iii)(A); ■ c. Remove ‘‘20,000 swine,’’ in paragraph (a)(2)(v)(A); ■ d. In paragraph (a)(5): ■ i. Redesignate Table 1 as Table 1 to paragraph (a)(5); and ■ ii. In newly redesignated Table 1 to paragraph (a)(5), remove the entry for ‘‘swine’’; ■ e. In paragraph (b)(1): ■ i. Remove ‘‘in Table 2’’ and add ‘‘in Table 1 to this paragraph’’ in its place; ■ ii. Redesignate Table 2 as Table 1 to paragraph (b)(1); and ■ iii. In newly redesignated Table 1 to paragraph (b)(1), remove the entries for ■ ■ ■ PO 00000 Frm 00050 Fmt 4701 Sfmt 4700 ‘‘Hogs’’ and ‘‘fresh pork sausages’’ and footnote (b). ■ 9. Add § 310.26 to read as follows: § 310.26 Establishment responsibilities under the new swine slaughter inspection system. (a) Facilities. The establishment must comply with the facilities requirements in 9 CFR part 307. The establishment must provide a mirror at the carcass inspection station in accordance with 9 CFR 307.2(m)(6). (b) Carcass sorting and disposition. The establishment must conduct carcass sorting activities and identify any condemnable conditions or defects before carcasses are presented to online inspectors. Establishment sorters must incise mandibular lymph nodes and palpate the viscera to detect the presence of animal diseases as part of their sorting activities. The establishment must develop, implement, and maintain written procedures to ensure that market hog carcasses adulterated with septicemia, toxemia, pyemia, or cysticercosis are properly removed before the point of post-mortem inspection of carcasses. The establishment must incorporate these procedures into its HACCP plan, or sanitation SOPs, or other prerequisite program. These procedures must cover the establishment sorting activities required under this section. (c) Line speed limits. The line speed limits in § 310.1 do not apply to the establishment, provided it is able to maintain effective process control and prevent contamination of carcasses and parts by enteric pathogens and visible fecal material, ingesta, and milk. Establishments operating under the NSIS must reduce their line speed as directed by the Inspector-in-Charge (IIC). The IIC is authorized to direct an establishment to operate at a reduced line speed when in their judgment a carcass-by-carcass inspection cannot be adequately performed within the time available due to the manner in which the carcasses are presented to the online inspector, the health conditions of a particular herd, or factors that may indicate a loss of process control. (d) Records. (1) The establishment must maintain records to document that E:\FR\FM\01OCR4.SGM 01OCR4 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations the products resulting from its slaughter operation meet the definition of Readyto-cook pork product in § 301.2. These records are subject to review and evaluation by FSIS personnel. (2) The establishment must maintain records to document the number of carcasses disposed of per day by establishment sorters before FSIS postmortem inspection and the reasons that the carcasses were disposed of. These records are subject to review and evaluation by FSIS personnel. ■ 10. Add § 310.27 to read as follows: § 310.27 Attestation requirements. jbell on DSK3GLQ082PROD with RULES4 Each establishment that participates in the NSIS must submit on an annual basis an attestation to the management member of the local FSIS circuit safety committee stating that it maintains a VerDate Sep<11>2014 19:06 Sep 30, 2019 Jkt 250001 program to monitor and document any work-related conditions of establishment workers, and that the program includes the following elements: (a) Policies to encourage early reporting of symptoms of injuries and illnesses, and assurance that it has no policies or programs in place that would discourage the reporting of injuries and illnesses. (b) Notification to employees of the nature and early symptoms of occupational illnesses and injuries, in a manner and language that workers can understand, including by posting in a conspicuous place or places where notices to employees are customarily posted, a copy of the FSIS/OSHA poster encouraging reporting and describing reportable signs and symptoms. PO 00000 Frm 00051 Fmt 4701 Sfmt 9990 52349 (c) Monitoring, on a regular and routine basis, injury and illness logs, as well as nurse or medical office logs, workers’ compensation data, and any other injury or illness information available. ■ 11. Add § 310.28 to read as follows: § 310.28 Severability. Should a court of competent jurisdiction hold any provision of § 310.27 to be invalid, such action will not affect any other provision of 9 CFR part 309 or this part. Done in Washington, DC. Carmen M. Rottenberg, Administrator. [FR Doc. 2019–20245 Filed 9–30–19; 8:45 am] BILLING CODE 3410–DM–P E:\FR\FM\01OCR4.SGM 01OCR4

Agencies

[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Rules and Regulations]
[Pages 52300-52349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20245]



[[Page 52299]]

Vol. 84

Tuesday,

No. 190

October 1, 2019

Part IV





Department of Agriculture





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Food and Safety and Inspection Service





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9 CFR Parts 301, 309, and 31





Modernization of Swine Slaughter Inspection; Final Rule

Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / 
Rules and Regulations

[[Page 52300]]


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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.

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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

[[Page 52301]]

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.

[[Page 52302]]



                                        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;

[[Page 52303]]

     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.
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    \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.
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    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.
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    \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).
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    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

[[Page 52304]]

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.
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    \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

[[Page 52305]]

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\
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    \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,

[[Page 52306]]

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.
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    \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.
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    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\
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    \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.
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    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.
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    \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.
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    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

[[Page 52307]]

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

[[Page 52308]]

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

[[Page 52309]]

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

[[Page 52310]]

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.

[[Page 52311]]

    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

[[Page 52312]]

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

[[Page 52313]]

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

[[Page 52314]]

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.

[[Page 52315]]

     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

[[Page 52316]]

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 operation meet the definition of RTC pork 
product.
    If FSIS online inspectors believe that the presentation of 
persistent unattended trim or processing defects indicates a lack of 
process control, they will notify the PHV. The PHV may then tell an 
offline inspector to conduct a directed PHIS Swine RTC task. FSIS 
offline inspectors will follow the same method and apply the same 
criteria that the establishment uses to check that they are meeting the 
RTC standard. FSIS will issue an NR for 9 CFR 310.26(d)(1) if the 
results exceed the criteria set by the establishment or if the 
establishment did not take the necessary corrective actions to restore 
process control when the evaluation criteria was exceeded.
    If the PHV determines that the presentation of persistent 
unattended trim or processing defects indicates a loss of process 
control that affects the online inspectors' ability to adequately 
conduct a carcass-by-carcass inspection, the PHV will direct the 
establishment to reduce its line speeds. The PHV will then issue an NR 
citing 9 CFR 310.26(d)(1).
    FSIS inspectors will use PHIS to link all NRs that are issued for 
the failure to meet the RTC pork product standard and associated 
documentation requirements. If establishment management is unwilling or 
unable to take the necessary steps to re-establish control of its 
process to meet RTC regulatory requirements, FSIS inspectors will 
discuss the issue with their supervisor and the DO. The DO will notify 
the establishment in writing that repeated NRs may lead the Agency to 
take a regulatory control action (9 CFR 500.2).
    In the rare case that FSIS online inspectors identify a carcass so 
affected with non-food safety defects (e.g., malignant lymphoma, 
icterus, or uremia) that the entire carcass must be condemned, they 
will stop the line for carcass condemnation unless the establishment 
provides a rail-out loop to rail carcasses offline for reexamination 
and condemnation.

G. Implementation

    Comment: One member of the pork industry supported the NSIS 
implementation strategy suggested in the proposed rule. However, the 
pork producer requested more information on whether two shift 
operations must convert both shifts to NSIS at the same time. The same 
commenter also requested more information on what would happen if an 
establishment that converted to NSIS decided it wants to move back to 
traditional inspection.
    A trade association noted that FSIS's implementation plan for NPIS 
was phased in with close coordination with DOs and establishments. The 
commenter stated that FSIS should follow a similar implementation plan 
for NSIS, with an initial notification period for establishments that 
want to adopt NSIS and an algorithm to

[[Page 52317]]

determine transition order. This commenter also suggested a phased-in 
approach for the mandatory provisions for all swine establishments 
based on establishment size.
    The same trade association stated that establishments should submit 
for approval unique transition plans to the DO when providing 
notification that they intend to adopt NSIS. The trade association 
suggested that FSIS identify and provide acceptable examples of 
transition plan elements. According to the commenter, pre-approved 
elements should include transitioning single inspection stations in 
succession, one shift at a time, one inspection focus area (i.e., head 
inspection) at a time, RTC monitoring before transitioning inspection 
activities, and others.
    Consumer advocacy organizations stated that only establishments 
that have their HACCP plans approved by FSIS should be allowed to 
implement NSIS. The commenters suggested that FSIS should review every 
establishment's HACCP plans to determine if their tailored 
microbiological testing programs are valid before allowing them to 
convert to NSIS.
    Response: All market hog establishments will initially have six 
months to notify their DO of their intent to operate under NSIS. 
Establishments that do not notify their DO of their intent to 
transition during this time will be deemed to have chosen to continue 
to operate under traditional inspection. Market hog establishments that 
decide that they would like to convert to NSIS after the initial 
notification date may notify their DO of their intent at any time after 
that date. The Agency will implement NSIS in the additional 
establishments that intend to convert on a schedule consistent with the 
availability of Agency resources and establishment readiness. The 
Agency intends to implement NSIS in all market hog establishments that 
choose to operate under this new inspection system, regardless of when 
the establishment notifies FSIS of its intent to transition to NSIS. 
However, the initial implementation wave will only include those 
establishments that submit their intent to convert to NSIS within the 
initial notification period.
    Because there are fewer market hog establishments than poultry 
establishments, the Agency does not think it will be necessary to use 
an algorithm to determine transition order. FSIS also does not think it 
is necessary to require establishments to develop formal transition 
plans. Establishments will need to transition all shifts and inspection 
stations to NSIS at one time. However, FSIS DOs will work with 
establishments to ensure a smooth transition from traditional 
inspection to NSIS. And, if necessary, FSIS DOs will work with 
establishments to ensure a smooth transition from NSIS back to 
traditional inspection.
    FSIS does not think it is necessary to review HACCP plans before 
establishments convert to NSIS. FSIS already has inspection tasks in 
place to verify that establishments are properly implementing their 
HACCP systems in accordance with 9 CFR part 417.
    The Agency is establishing separate applicability dates for large, 
small, and very small establishments to comply with 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). The 
applicability dates will provide additional time for small and very 
small establishments to comply with these provisions.

H. Environmental Assessment

    Comments: Comments from an animal welfare advocacy organization and 
an environmental advocacy organization stated that before FSIS can 
finalize the proposed rule, the Agency must prepare an Environmental 
Impact Statement (EIS), as required under the National Environmental 
Policy Act (NEPA; 42 U.S.C. 4321 et seq.) because, according to these 
commenters, allowing market hog slaughter establishments to increase 
line speeds will result in significant environmental impacts. The 
commenters stated that faster line speeds would mean more hogs 
slaughtered per shift. According to the commenters, more hogs 
slaughtered would mean more waste and more water use. The commenters 
asserted that these are all significant environmental impacts, with 
both individual and cumulative effects at the local, state, and 
national levels. The commenters also stated that FSIS cannot claim the 
categorical exclusion from the preparation of an Environmental 
Assessment (EA) or an EIS under 7 CFR part 1b of the USDA regulations.
    Response: FSIS maintains that this rulemaking is categorically 
excluded from NEPA requirements. Federal agencies may identify classes 
of actions that normally do not require the preparation of either an EA 
or EIS because such actions do not have a significant effect on the 
human environment, either individually or cumulatively (40 CFR 
1507.3(b)(2)). Such classes of actions are ``categorically excluded'' 
from NEPA requirements (40 CFR 1508.4). Under 7 CFR 1b.4, all FSIS 
actions, including inspection functions, are categorically excluded 
from preparation of an EA or EIS unless the Agency head determines that 
a particular action may have a significant environmental effect. 
Accordingly, FSIS is not required to prepare an EA or EIS unless it 
anticipates that this rule may have a significant environmental effect.
    The Agency does not anticipate that its decision to revoke maximum 
line speeds for establishments that operate under NSIS will have 
individual or cumulative effects on the environment. As FSIS explained 
in the proposed rule, expected sales of pork products to consumers will 
determine the total number of hogs that an establishment slaughters, 
not the maximum line speed under which it operates. The Agency has no 
authority to determine an establishment's production levels. An 
establishment may decide to increase production hours to slaughter more 
hogs in response to market demand, regardless of its maximum line 
speed. Revoking maximum line speeds allow establishments to slaughter 
hogs more efficiently but will not directly affect consumer demand for 
the establishment's pork products. In some instances, an establishment 
operating under NSIS may be able to reduce its hours of operation while 
maintaining production at a rate necessary to meet market demand for 
its meat products. Thus, revoking line speeds is not expected to 
determine the number of hogs slaughtered or result in more waste or 
more water use, as suggested by the commenters.
    In addition, all slaughter establishments, regardless of line 
speed, are required to meet all local, State, and Federal environmental 
requirements.
Sampling
    Comments: Comments from consumer advocacy organizations and public 
health organizations supported FSIS's decision to require 
establishments to develop written procedures to prevent and mitigate 
microbial contamination of carcasses throughout the entire slaughter 
and dressing operations and incorporate the intervention strategies 
into their HACCP systems. These same commenters stated that sampling at 
pre-evisceration and post-chill will make it easier for establishments 
to see if their process control system is working. According to the 
commenters, microbial testing at the end of the process encourages 
industry to focus primarily on post-slaughter interventions, while the 
new approach encourages them to focus on prevention and mitigation of

[[Page 52318]]

microbial contamination throughout the slaughter process.
    Response: FSIS agrees that requiring establishments to keep written 
records to document the implementation and monitoring of their process 
control procedures is a positive step forward for public health. This 
ongoing documentation will allow both the establishment and FSIS to 
identify specific points in the production process where a lack of 
process control may have resulted in product contamination or 
insanitary conditions. This will allow the establishment to take the 
necessary corrective actions to prevent further product contamination.
    Comments: Comments from members of industry stated that FSIS should 
revise the proposed rule to remove sampling schemes based on 
establishment size. According to the commenters, basing sampling 
frequency on the size of the establishment is not supportable from a 
statistical sampling point of view. The commenters suggested that FSIS 
propose a minimum sampling frequency for all establishments based on 
the number of head slaughtered, over a certain time period.
    Response: FSIS changed its proposed sampling frequency to remove 
the exception for very small establishments. Under this final rule, 
very small establishments will need to sample carcasses at pre-
evisceration and post-chill (for hot-boned product, carcasses sampled 
at pre-evisceration and after the final wash) at a frequency of one per 
1,000 carcasses. However, FSIS has decided to keep the exception for 
very low-volume establishments. This change makes the sampling 
requirements for swine slaughter establishments more consistent with 
the sampling requirements for poultry slaughter establishments. 
Additionally, if FSIS adopted a sample frequency of one per 1,000 
carcasses for very low-volume establishments, many of these 
establishments would not have to sample at all.
    Comment: Several consumer advocacy organizations and one public 
health organization objected to FSIS's proposal to allow establishments 
to develop their own sampling and testing protocols and to use 
alternate sampling locations and frequencies. These same commenters 
argued that it would be too difficult for FSIS inspectors to verify 
sampling plans that use alternate sampling locations and frequencies. 
Two consumer advocacy organizations argued that FSIS's Salmonella 
performance standards remain a core element of HACCP and should not be 
eliminated under the proposed rule. One consumer advocacy organization 
argued that FSIS must not move forward with proposed inspection changes 
without maintaining a pathogen-specific performance standard. The 
commenter argued that modernized, HACCP-based inspection cannot 
function adequately without such a performance standard. The commenter 
further stated that uniform microbial testing is necessary to evaluate 
the impact of FSIS's planned inspection changes, as the Agency will not 
be able to verify trends in pathogen rates caused by the inspection 
changes without an effective national testing program.
    One consumer advocacy organization argued that FSIS should maintain 
the current generic E. coli testing standard. Although the commenter 
did not oppose substitution of another indicator organism for generic 
E. coli, they argued that FSIS must ensure that any newly permitted 
testing program is evidence-based and equal or superior to the prior 
generic E. coli standard for fecal contamination detection. The 
commenter recommended that FSIS require establishments who seek to use 
an alternative testing program to the generic E. coli standard to apply 
for a regulatory waiver, which would allow for pre-implementation 
Agency review.
    Response: The purpose of the new sampling requirement is to ensure 
that establishments monitor and evaluate the effectiveness of their 
procedures to prevent contamination of carcasses by enteric pathogens, 
and visible fecal material, ingesta, and milk on an ongoing basis. It 
is not intended to generate data to compare establishment performance 
across the industry.
    However, FSIS has determined that it may be too difficult for 
inspectors to review and verify sampling plans that use alternate 
sampling frequencies and locations. As a result, FSIS is withdrawing 
the proposal to allow establishments to use alternate sampling 
frequencies and locations. Establishments that still wish to use 
alternate sampling frequencies and locations may submit a SIP waiver 
request to FSIS for review.\24\ As is noted above, FSIS will provide 
information about waiver criteria in a future Federal Register 
document.
---------------------------------------------------------------------------

    \24\ See FSIS Compliance Guideline Procedures for New Technology 
Notifications and Protocols available at https://www.fsis.usda.gov/wps/wcm/connect/c64d8f3b-56aa-49c9-91f3-daf0caaba6bd/New-Technology-Protocols-042015.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

    As FSIS explained in the proposed rule, FSIS discontinued its 
Salmonella verification sampling program for market hogs (carcasses) in 
2011 to make better use of its resources. Because verifying the 
codified performance standards for market hogs was not a good use of 
Agency resources, and the standards have not been used since 2011, FSIS 
is removing the carcass Salmonella performance standards for market 
hogs. With that said, FSIS is currently testing pork cuts and 
comminuted pork products for Salmonella and expects to decide in 2019 
whether to develop new pathogen performance standards for these 
products or take other actions to address Salmonella in these 
products.\25\ FSIS pathogen test results for pork products are posted 
quarterly on the FSIS website: https://www.fsis.usda.gov/wps/wcm/connect/df529ce7-575a-43e7-9219-48be29c80fa5/Sampling-Project-Results-Data.xlsx?MOD=AJPERES.
---------------------------------------------------------------------------

    \25\ See U.S. Govt. Accountability Office, GAO-18-272, Food 
Safety: USDA Should Take Further Action to Reduce Pathogens in Meat 
and Poultry Products (March 2018). https://www.gao.gov/assets/700/690709.pdf.
---------------------------------------------------------------------------

    Establishments may continue to sample for generic E. coli. FSIS 
considers the requirements under the former regulations for generic E. 
coli to be a scientifically validated ``safe harbor'' for monitoring 
process control, specifically for fecal contamination. FSIS previously 
granted waivers under the SIP to the generic E. coli testing 
regulations for establishments that want to test for other indicator 
organisms. Establishments operating under these waivers have 
demonstrated that they are able to effectively maintain process control 
based on their SIP sampling data.
    Comments: Several members of industry, trade associations, and a 
State Department of Agriculture objected to the proposed pre-
operational environmental sampling requirements. One HIMP establishment 
stated that environmental sampling would be an expensive change with 
little value. The commenter argued that current HIMP establishments 
have not been required to conduct environmental sampling beyond those 
tests that may also meet the Sanitation SOP requirements, and these 
establishments have shown consistent or better performance controlling 
for Salmonella.
    A few public health organizations stated that requiring facilities 
to monitor and assess food contact surfaces for enteric pathogens is a 
reasonable measure given that recent investigations of Salmonella 
foodborne illness outbreaks revealed food contact surfaces to be 
contaminated with the outbreak strain. The commenters stated that 
requiring pre-operational environmental sampling should help ensure 
that

[[Page 52319]]

surfaces are sanitary and free of enteric pathogens.
    Response: This final rule 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. In response to concerns 
about the regulatory burden, FSIS has decided to withdraw this part of 
the proposal until it considers options and timing for gathering more 
data on enteric pathogen contamination in the pre-operational 
environment. FSIS agrees that current HIMP establishments have shown 
consistent performance controlling for Salmonella.
    Comments: Several members of industry, industry trade associations, 
and private individuals objected to certain content in the sampling 
guide. These commenters argued that the language in the sampling guide 
is prescriptive in both tone and language and implies mandatory 
requirements. The commenters stated that the sampling guide includes 
unhelpful and problematic sampling methods, techniques, and analysis, 
as these depend on individual establishments' sampling programs. For 
example, several commenters argued that, absent codified standards, 
Table 4 in the sampling guide would be a de facto performance standard, 
contrary to the objectives in the proposed rule. The commenters stated 
that the sampling guide should be revised to promote sampling programs 
tailored to each establishment. One industry commenter further argued 
that the word ``compliance'' should be removed from the document title 
to be consistent with recent changes to other FSIS guidance documents 
and because the document provides best practice recommendations and not 
regulatory requirements.
    Response: FSIS guidance documents are intended to provide best 
practices and, in some cases, safe harbors based on the most current 
science available to Agency stakeholders to help them comply with 
regulatory requirements, and when applicable, meet performance 
standards. The sampling guide explains that FSIS considers the 
requirements under the former regulations for generic E. coli to be a 
scientifically validated ``safe harbor'' for monitoring process control 
for very low-volume establishments. The sampling guide also includes 
recommendations to assist small and very small establishments to meet 
regulatory requirements, and recommendations to develop a custom 
approach that are not dependent on establishments' available resources. 
For example, the sampling guide provides baseline information for those 
establishments that may need a starting place from which to calculate 
their own control limits. However, control limits change over time as 
establishment-specific data is collected and analyzed. FSIS has removed 
Table 4 and replaced it with a new table (Table 2) to provide better 
guidance for establishments that may want to use data from the 2010-
2011 market hog baseline survey as an initial starting point from which 
to set their upper control limits. Therefore, the information provided 
in the document is not a performance standard.
    In response to the comments, FSIS has revised the sampling guide 
to, in part, further clarify the purpose of the document, which is to 
assist small and very small establishments to comply with the new 
microbial organism sampling requirements that apply to all swine 
slaughter establishments under this final rule. The sampling guide has 
also been revised to include additional information on the intended use 
of provided methods, techniques, and analyses; and to remove the word 
``compliance'' from the document title and clarify that the document 
does not constitute regulatory requirements. Additionally, the Agency 
moved the example control charts from the sampling guide from the 
sampling guide to Appendix 2 of the guideline and clarified how 
establishments can use control charts. The Agency did not recommend a 
specific control chart format. Finally, the Agency removed all 
references to pre-operational environmental sampling. The updated 
sampling guide is available at https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index.
    Comments: Several commenters objected to certain information 
provided in the sampling guide related to indicator organism sampling 
and testing. One industry commenter stated that both the proposed rule 
and the sampling guide, as written, could mandate a shift from 
analyzing market hog carcasses for enteric pathogens of concern, such 
as Salmonella, to monitoring a surrogate, such as Aerobic Plate Count 
(APC). The commenter argued that this process control approach is too 
singular, and FSIS should clarify in the sampling guide that 
establishments will maintain the flexibility to select for one or more 
indicator organisms. In addition, several commenters argued that FSIS 
should revise the sampling guide to remove sampling schemes based on 
establishment size. They stated that, from a statistical sampling 
viewpoint, establishing sampling frequency based on the size of the 
establishment is not supportable. These commenters also stated that 
generic E. coli testing should not remain a ``safe harbor,'' even for 
small and very small establishments, because no scientific correlation 
exists between microorganism presence/growth and facility size. 
Finally, one industry commenter noted that the sampling guide does not 
summarize all known control points for Salmonella, as the document 
claims it does.
    Response: The sampling guide provides flexibility and monitoring 
options for establishments, and it makes clear that establishments may 
select one or more indicator organisms to monitor.
    To address the comment about the singular process control approach, 
the sampling guide provides a link to the December 2013 FSIS guideline 
for controlling Salmonella in market hogs, which describes potential 
control points for Salmonella in the pre- and post-harvest production 
process. The potential control points described in that 2013 guideline 
may or may not be applicable to a specific establishment's process.
    Comments: Several commenters expressed concerns with information 
provided in reference and example charts throughout the sampling guide. 
One member of the pork industry and one trade association representing 
the pork industry argued that establishments should not compare process 
control results to a nationwide geometric mean displayed in one chart. 
The commenters argued that market hog data is an inappropriate basis 
for developing upper control limits, as it is not applicable to all 
swine establishments. Further, they stated that these data from 2011 
are outdated. One commenter stated that ``under NSIS'' should be 
removed from one table column heading, as the information would apply 
to all swine establishments.
    Response: FSIS revised the sampling guide to remove the table that 
provided averages that represented the 80th percentile limits for each 
indicator organism included in FSIS's 2010-2011 market hog baseline 
survey. The Agency also removed the ``under NSIS'' language from the 
table that provides information for all swine establishments
    In cases where an establishment does not have the resources or 
capacity to initially develop its own statistical control limits or 
analytical procedures, an establishment can utilize the aggregated data 
from the FSIS Nationwide Market Hog Microbiological Baseline Survey. 
The 2010-2011 baseline survey provides a wealth of microbiological data 
specific to swine

[[Page 52320]]

carcass sampling; these data are meant to provide a starting point for 
an establishment to develop its own control limit parameters over time. 
During the survey, FSIS collected two carcass samples at pre-
evisceration and post chill.
    Comment: One member of the pork industry and one trade association 
representing the pork industry recommended that FSIS remove from the 
sampling guide information related to finished product standard (FPS) 
waivers, as the subject is unrelated to the sampling guide.
    Response: FSIS has removed the FPS waiver information from the 
sampling guideline.

I. Economic Assessment

    Comment: One company that owns a HIMP establishment said that the 
cost of additional employees has been their most significant cost from 
the HIMP pilot study, and that they have had to hire and train up to 11 
employees per shift to staff and maintain the inspection process.
    Response: FSIS incorporated information from this comment into 
section III.G.1.a by revising the upper bound estimate from 10 
employees to 11 in the description of additional establishment workers 
likely to be required by establishments that adopt the NSIS.
    Comment: One industry commenter estimated that a full-time 
position, per slaughter shift, would be required to collect, record, 
and analyze data required to verify that an establishment's products 
meet the definition of RTC.
    Response: While establishments are free to design their own process 
control monitoring systems, FSIS finds the estimated time and labor 
requirement provided in this comment to be inconsistent with FSIS's 
observations of HIMP establishments verifying OCP performance 
standards. FSIS explained in the proposed rule that pork carcasses that 
meet the HIMP OCP performance standards would meet the RTC pork product 
definition. Large swine establishments can verify OCP performance 
standards by taking 24 carcass samples per shift, requiring roughly one 
hour to collect, record, and analyze the data.
    Comments: Several comments from members of the pork industry stated 
that they own establishments that operate under SIP waivers and conduct 
process control sampling at alternate frequencies.
    Response: FSIS incorporated the information from these comments 
into section III.G.2.b of the final rule and used it to revise the cost 
estimate associated with changes to requirements for microbial organism 
process control sampling and analysis. This revision caused a slight 
decrease in potential industry savings. Under the SIP, 11 large swine 
establishments currently sample at an alternative frequency and the 
Agency assumes that these establishments will continue to do so when 
the applicability dates for this final rule arrive. As such, these 
establishments are not expected to change their process control 
sampling and will not experience a change in associated costs.
    Comment: One member of the pork industry claimed that process 
control sampling requirements would increase cost.
    Response: As is detailed in section III.G.2.b of the final rule, 
overall, the changes in process control sampling requirements were 
estimated to reduce industry wide sampling costs by about $0.57 million 
annualized over 10 years, applying a three percent discount rate.
    Comment: One member of the pork industry reported that all six of 
their company's facilities have written sanitary dressing plans.
    Response: FSIS incorporated information from this comment into 
section III.G.2.a of the final rule to reduce the cost estimate 
associated with developing, composing, training, monitoring, recording, 
and verifying written sanitary dressing plans to reflect that six 
establishments already have written sanitary dressing plans.
    Comment: One company stated that many small and very small 
establishments are unlikely to adopt the NSIS due to the program's 
costs.
    Response: FSIS agrees that many small and very small establishments 
are unlikely to adopt the NSIS. The Agency's cost benefit analysis 
assumes that very small establishments that exclusively slaughter 
market hogs do not have a high enough production volume to justify 
incurring the costs of converting to the NSIS.
    Comment: One company participating in HIMP stated that it invested 
in capital expenditure projects to add or relocate inspection stations 
and reconfigure lines.
    Response: The NSIS may require a minor capital improvement if the 
establishment does not already provide a mirror at the carcass 
inspection station. All the large high-volume establishments are 
already required to provide mirrors under existing regulations. 
Providing a mirror is a minor potential cost for a limited number of 
establishments.\26\ If an establishment believes that additional 
capital expenditures will result in a benefit, they may voluntarily 
reconfigure or update their facilities to fully capture all the 
potential production efficiencies offered through participation in 
NSIS. Examples of such changes include line reconfiguration, which can 
cost between $10,000 and $250,000 and the creation of an inspection 
station, which can cost between $5,000 and $6,000. Establishments may 
reduce these costs by coordinating these facility updates with 
previously planned establishment renovations.
---------------------------------------------------------------------------

    \26\ The cost was estimated to be very small because all 22 
large high-volume establishments and potentially several of the 13 
small high-volume establishments are already required to provide 
mirrors. As such, any new expense would be negligible compared to 
the industry costs included in the cost-benefit analysis.
---------------------------------------------------------------------------

    Comment: A few consumer advocacy organizations claimed that the 
Agency's cost benefit analysis understated training costs because the 
industry has a high turnover rate, necessitating that training take 
place more frequently than once per year.
    Response: FSIS used BLS' industry turnover rate for non-durable 
manufactured goods to estimate annual training costs. Section III.G.1.a 
of the final rule provides additional details on how the cost benefit 
analysis estimates industry's training costs, which includes training 
new employees given the industry's turnover rate.
    Comments: Several commenters stated that the Agency's guidance 
documents will likely need to be translated into additional languages. 
One commenter claimed that industry would be forced to hire translators 
to translate the Agency's guidance documents, the cost of which was not 
included in the cost benefit analysis.
    Response: The Agency plans to make translated guidance documents 
publicly available as the need arises at no cost to industry. The cost 
of translating these documents is already within the Agency's budget. 
As such, the cost is not expected to increase the Agency's budgetary 
needs and is therefore not included in the rule's cost analysis.

III. Executive Orders (E.O.s) 12866 and 13563

    E.O.s 12866 and 13563 direct agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, distributive impacts,

[[Page 52321]]

and equity). E.O. 13563 emphasizes the importance of quantifying both 
costs and benefits, of reducing costs, of harmonizing rules, and of 
promoting flexibility. This final rule has been designated a 
``significant'' regulatory action under section 3(f) of E.O. 12866. 
Accordingly, the rule has been reviewed by the OMB under E.O. 12866.

A. Updates to the Regulatory Impact Analysis (RIA)

    FSIS updated the proposed rule's RIA to reflect the changes made in 
the final rule in response to public comments. The changes to the costs 
and benefits sections incorporate the following factors:
     The Agency removed the mandatory pre-operational 
environmental sampling requirement.
     Establishments currently operating under SIP waivers 
conduct process control sampling at an alternative frequency and the 
Agency assumes that they will continue to do so when the applicability 
dates for this final rule arrive. Therefore, these establishments have 
been removed from the cost estimate associated with changes to 
requirements for microbial organism process control sampling and 
analysis.
     Additional information from the risk assessment that more 
transparently demonstrates the potential uncertainty, is now reflected 
in the cost-benefit analysis. However, the anticipated net benefit did 
not change.
     One company reported that all 6 of its establishments 
already have written sanitary dressing plans. As such, the annual cost 
estimate associated with developing, composing, training, monitoring, 
recording, and verifying written sanitary dressing plans has been 
revised down by approximately $87,000.
     The highest number of establishment employees to be hired 
to meet the needs of NSIS has been revised up to 11, based on an 
industry comment.
     The per head margin has been updated to rely on the North 
American Meat Institute's (NAMI's) 2017 Meat and Poultry Facts.\27\
---------------------------------------------------------------------------

    \27\ Nalivka, J.S., The 2017 Meat and Poultry Facts, NAMI August 
2018.
---------------------------------------------------------------------------

B. Need for the Rule

    The swine slaughter industry in the United States has evolved since 
Congress enacted the Wholesome Meat Act in 1967. Many of today's 
producers have invested in farm to table quality and food safety 
controls that effectively address health risks and consumer quality 
issues.\28\ For these producers, the prescriptive nature of some FSIS 
regulations inhibits efficient production and the adoption of improved 
production methods and restricts their ability to adopt new 
technologies. Further, at large and high-volume establishments that 
exclusively slaughter market hogs, the current regulations that require 
FSIS to focus on non-food safety issues prevent FSIS from efficiently 
allocating resources, which inhibits food safety improvements and 
humane handling hazard prevention. Therefore, while traditional 
inspection is generally sufficient for low-volume establishments and 
for establishments that slaughter classes of swine other than market 
hogs, a modernized swine slaughter inspection system is needed, one 
that is less prescriptive, creates incentives for establishments to 
develop and invest in advancements in food safety and quality controls 
and procedures, and allows FSIS to improve inspection methods.
---------------------------------------------------------------------------

    \28\ Key, Nigel and William McBride. 2007. The Changing 
Economics of U.S. Hog Production. USDA Economic Research Service 
(ERS.). Report No. 52.
---------------------------------------------------------------------------

Baseline

C. Overview of the Market

    U.S. pork production has increased at a moderate pace as seen in 
Table 2. Much of the additional growth in domestic production has been 
used to satisfy increasing export demands, which increased 43 percent 
between 2009 and 2018.\29\ According to the Food and Agricultural 
Organization (FAO), pork is consistently ranked as the top meat in per-
capita consumption worldwide \30\ and is ranked third in the United 
States.\31\
---------------------------------------------------------------------------

    \29\ Livestock and Meat Domestic Data, All supply and 
disappearance, Historical, WASDE Pork-Full. USDA ERS Livestock and 
Meat Domestic Data. <https://www.ers.usda.gov/data-products/
livestock-meat-domestic-data/livestock-meat-domestic-data/
#All%20meat%20statistics> accessed on 6/12/2019. Last updated on 5/
29/19.
    \30\ FAO Livestock commodities. <http://www.fao .org/docrep/005/
y4252e/y4252e05b.htm> Accessed on 11/29/16.
    \31\ Livestock and Meat Domestic Data, All supply and 
disappearance, Historical. USDA ERS Livestock and Meat Domestic 
Data. <https://www.ers.usda .gov/data-products/livestock-meat-
domestic-data/livestock-meat-domestic-data/#All%20meat%20 
statistics> accessed on 6/12/2019. Last updated on 5/29/19.

                                      Table 2--U.S. Pork Supply and Demand
                                        [Carcass weight, million pounds]
----------------------------------------------------------------------------------------------------------------
                                                                                            Consumption
              Year                     U.S.           Imports         Exports    -------------------------------
                                    production                                       Domestic      Per capita *
----------------------------------------------------------------------------------------------------------------
2009............................          22,999             834           4,094          19,869              65
2010............................          22,437             859           4,223          19,077              62
2011............................          22,758             803           5,196          18,382              59
2012............................          23,253             802           5,379          18,607              59
2013............................          23,187             880           4,986          19,104              60
2014............................          22,843           1,011           5,092          18,836              59
2015............................          24,501           1,116           5,010          20,592              64
2016............................          24,941           1,091           5,239          20,892              65
2017............................          25,584           1,116           5,632          21,034              65
2018............................          26,315           1,042           5,870          21,497              66
----------------------------------------------------------------------------------------------------------------
* Measured in carcass weight, pounds.
Source: Livestock and Meat Domestic Data, All supply and disappearance, Historical, WASDE Pork-Full. USDA ERS
  Livestock and Meat Domestic Data. <https://www.ers.usda.gov/data-products/livestock-meat-domestic-data/
  livestock-meat-domestic-data/#All%20meat%20statistics> accessed on 6/12/2019. Last updated on 5/29/19.

    In 2016, there were approximately 612 swine slaughter 
establishments under Federal inspection, Table 3.\32\ Combined, these 
establishments process roughly 118 million hogs annually. FSIS divides 
swine into the following

[[Page 52322]]

production categories for data collection purposes: Roaster swine, 
market hog, sow, and boar/stag. Today, the majority (97%) of the pork 
products available in the market are derived from market hogs.\33\
---------------------------------------------------------------------------

    \32\ USDA, FSIS, Public Health Information System (PHIS).
    \33\ Source: PHIS.

                         Table 3--Number of Swine Slaughter Establishments by Size, 2016
----------------------------------------------------------------------------------------------------------------
                                                                  Total swine    Total market
           HACCP  processing size                 Number of        slaughter     hog slaughter   Percent market
                                               establishments    (head count)    (head count)          hog
----------------------------------------------------------------------------------------------------------------
Large.......................................                28     105,678,519     105,321,950             99.66
Small.......................................               105      11,862,341       8,497,891             71.64
Very Small *................................               479         903,009         625,863             69.31
                                             -------------------------------------------------------------------
    Total...................................               612     118,443,869     114,445,704             96.62
----------------------------------------------------------------------------------------------------------------
Source: Public Health Information System (PHIS).
* Two establishments classified as N/A were included in the category total for Very Small establishments.

    As shown below in Table 4, many establishments now exclusively 
slaughter market hogs, a species sub class which, because of 
technological and animal management improvements, such as improved 
genetics, nutrition, and medical services, generally presents fewer 
food safety and quality issues.\34\
---------------------------------------------------------------------------

    \34\ Key, Nigel and William McBride. 2007. The Changing 
Economics of U.S. Hog Production. USDA ERS. Report No. 52.
---------------------------------------------------------------------------

D. Overview of the Final Rule's NSIS

    Several of the final rule's provisions apply to only those 
establishments that choose to participate in the optional NSIS. Meeting 
these provisions will likely increase an establishment's labor and 
training costs. Only market hog slaughter establishments are eligible 
to participate in the NSIS. Due to the economic constraints, FSIS 
expects that only large and small high-volume establishments that 
exclusively slaughter market hogs will choose to participate in the 
optional NSIS. In 2016,\35\ there were 40 high-volume establishments 
that exclusively slaughtered market hogs: 27 \36\ large \37\ (5 HIMP + 
22 non-HIMP) \38\ and 13 small establishments, Table 4. These 
establishments account for 93 percent of total swine slaughter 
annually, Table 4. Given their large share of the market and the 
ability to slaughter a sufficient number of market hogs to justify the 
likely costs associated with the NSIS, these 40 market hog 
establishments are expected to choose to implement the optional NSIS. 
Therefore, this analysis calculates the costs and benefits associated 
with the NSIS provisions for these 40 market hog establishments. 
However, because the 5 HIMP establishments already meet NSIS 
requirements, they are not expected to incur any additional new costs 
nor contribute to any increase in quantified benefits associated with 
adopting the NSIS.
---------------------------------------------------------------------------

    \35\ Establishment level data from 2016 was used in both the 
Preliminary Regulatory Impact Analysis (RIA) and the Final RIA.
    \36\ In 2016 there was 1 large establishment that did not 
exclusively slaughter market hogs. As such, this analysis assumed 
they would not choose to participate in the optional NSIS and were 
excluded from the relevant sections in the analysis.
    \37\ HACCP size: Very Small Establishment = Less than 10 
employees or less than $2.5 million in annual sales; Small 
Establishment = 10-499 employees; Large Establishment = 500 or more 
employees.
    \38\ In 2016, there was 1 large establishment that did not 
exclusively slaughter market hogs.

                      Table 4--Head Count Distribution Across Types of Establishments, 2016
----------------------------------------------------------------------------------------------------------------
                                                                                    Total swine     Percent of
        Type of establishment                 HACCP size            Number of        slaughter      total head
                                                                 establishments    (head count)        count
----------------------------------------------------------------------------------------------------------------
High-Volume Market Hog Only..........  Large--HIMP............                 5      17,517,254           14.79
                                       Large--Non-HIMP........                22      87,746,770           74.08
                                       Small..................                13       4,617,680            3.90
Low-Volume Market Hog Only...........  Very Small.............                71          32,360            0.03
Mix of Species and Swine Sub Classes.  Large/Small............                93       7,659,156            6.47
                                       Very Small.............               408         870,649            0.74
                                                               -------------------------------------------------
    Grand Totals.....................  .......................               612     118,443,869  ..............
----------------------------------------------------------------------------------------------------------------
* HACCP sizes were combined so as to not reveal proprietary information.
Source: PHIS.

E. Overview of the Final Rule's Mandatory Components

    All swine slaughter establishments will need to comply with the two 
mandatory provisions of the final rule discussed below.
1. Written Sanitary Dressing Plans
    FSIS is amending 9 CFR 310.18 to require swine slaughter 
establishments to develop, implement, and maintain as part of their 
HACCP systems, written procedures to ensure that no visible fecal 
material, ingesta, or milk is present by the point of FSIS post-mortem 
inspection of swine carcasses. This requirement will address a weakness 
of the current traditional inspection system, which is that 
verification checks performed at the end of the slaughter and chilling 
process encourage industry to focus its activities on post-process 
interventions to reduce contamination rather than prevention throughout 
the slaughter process. Prevention throughout the slaughter process is 
preferred because it promotes containing contamination close to its 
origin, which reduces cross contamination of multiple carcasses. The 
existing regulations require that establishments prevent swine 
carcasses contaminated with visible fecal material

[[Page 52323]]

from entering the cooler. While preventing swine carcasses contaminated 
with visible fecal material from entering the cooler is an important 
safeguard for reducing the prevalence of pathogens on swine carcasses, 
this result generally cannot be effectively accomplished unless 
establishments implement appropriate measures to prevent contamination 
from occurring throughout the slaughter and dressing operation and 
implement process control procedures for preventive measures. Requiring 
establishments to keep daily written records to document the 
implementation and monitoring of their process control procedures is a 
positive step forward for public health. This ongoing documentation 
allows both the establishment and FSIS to identify specific points in 
the production process where a lack of process control may have 
resulted in product contamination or insanitary conditions. In 
addition, it will allow the establishment to implement corrective 
actions that could include the addition of preventive control measures 
to prevent recurrence of similar product contamination events or 
insanitary conditions.
    Based on public comment, the final rule assumes all but six 
establishments will need to develop written sanitary dressing plans.
2. Process Control Sampling and Analysis for Microbial Organisms
    Under this final rule, instead of following a prescribed 
microbiological testing program, each establishment will be responsible 
for developing and implementing its own microbiological sampling plan. 
Each establishment, except very low-volume establishments, is required 
to include carcass sampling at pre-evisceration and 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 hot-
boned products, carcass sampling at pre-evisceration and after the 
final wash.
    The microbiological standards prior to the final rule prescribed 
that all establishments monitor process control by sampling for generic 
E. coli. High-volume establishments were required to take one sample 
per 1,000 carcasses or request an alternative frequency. Very low-
volume establishments were required to take 1 sample per week of 
operation up to 13 times a year. Several commenters from industry 
reported that each of their establishments operating under SIP conduct 
process control sampling at an alternative frequency. In addition, an 
industry survey found that many establishments elect to perform other 
microbiological tests in addition to testing for generic E. coli.\39\
---------------------------------------------------------------------------

    \39\ Viator, C. et al. 2015. Meat Industry Survey in Support of 
Public Health Risk-Based Inspection. P5-42. Question 3.1.
---------------------------------------------------------------------------

F. Overview of the Impact of the Final Rule on the Agency

    This analysis, in part, takes into consideration potential impacts 
to the Agency's budget. FSIS's budget is expected to be impacted by 
changes in staffing and training requirements for those establishments 
that choose to operate under the NSIS. Under traditional inspection, 
each slaughter line requires up to 11 full-time positions. Generally, 
these positions include both a supervisory and non-supervisory Public 
Health Veterinarian, (PHV) (OPM Veterinary Medical Science Series, 
0701); a supervisory and non-supervisory consumer safety inspector, 
(CSI) (OPM Consumer Safety Inspection Series, 1862); and up to 7 Food 
Inspectors, (FI) (OPM Food Inspection Series, 1863). There are 
currently 418 full-time equivalent units (FTE) assigned to slaughter 
inspection at the 22 large non-HIMP (27 large--5 HIMP) and 13 small 
swine slaughter establishments expected to convert to the NSIS, Table 
5. When these establishments convert to the NSIS, Agency personnel will 
require NSIS training. Additionally, the number of Agency personnel 
required to inspect the slaughter process will likely be reduced. See 
Agency Staffing section for details.

       Table 5--Current FSIS Slaughter Line Positions at Non-HIMP
          Establishments That Slaughter Exclusively Market Hogs
------------------------------------------------------------------------
                                                             Number of
                      OPM job code                           positions
------------------------------------------------------------------------
1862 (CSI)..............................................             120
1863 (FI)...............................................             245
0701 (PHV)..............................................              53
                                                         ---------------
  Total.................................................             418
------------------------------------------------------------------------
Source: PHIS.

G. Potential Costs of the Final Rule

1. Costs Associated With the NSIS Components of the Rule
    This analysis estimates the costs associated with the final rule's 
NSIS components. The 35 establishments that the Agency assumes will 
adopt the NSIS portion of the rule have similar characteristics to the 
5 HIMP establishments, such as volume and sub species slaughtered. 
Given the successful participation of the 5 HIMP establishments in the 
pilot program and industry's continued interest in increasing the 
number of establishments participating in the HIMP pilot study, the 
potential benefits from adopting NSIS are expected to outweigh the 
potential costs. This analysis assumes that very small establishments 
that exclusively slaughter market hogs do not have a high enough 
production volume to justify incurring the costs of converting to the 
NSIS. While the 5 HIMP establishments are expected to adopt the NSIS, 
they have already implemented the changes associated with the NSIS by 
their participation in the HIMP pilot study and are not expected to 
incur any new or additional expenses. As such, they are not included in 
the group of establishments expected to incur an increase in costs 
associated with NSIS. The following analysis also excludes further 
consideration of the costs of submitting an attestation of work-related 
conditions due to its small estimated cost.\40\ Costs examined 
generally fall under three categories: Labor, capital expenses, and 
developing written procedures.
---------------------------------------------------------------------------

    \40\ It was estimated that submitting such an attestation would 
require a Quality Control Technician with a labor compensation rate 
of $68.52 per hour, 2 minutes per year. Combined, submitting an 
annual attestation would cost all 27 large and 13 small 
establishments likely to adopt the NSIS approximately $91.36 
annually (2 minutes * $68.52 per hour * 40).
---------------------------------------------------------------------------

    In the following sections, this analysis presents the costs and 
benefits generated over a range of assumptions with respect to how much 
of the industry chooses to adopt the NSIS within five years. As was 
done with the NPIS, this analysis assumes a 5-year adoption period with 
roughly consistent annual adoption rates. These estimates are scaled 
for an illustrative calculation and assume that 35 of the 40 
establishments that are likely to adopt the NSIS will incur additional 
costs associated with adoption. Using this illustrative calculation was 
supported by one public comment, which suggested that adoption timing 
and rate are difficult to estimate without a final rule. As is stated 
above, the 5 HIMP establishments are not expected to incur any 
additional costs associated with adopting the NSIS and are therefore 
excluded when calculating potential costs of the NSIS components of 
this final rule.

[[Page 52324]]



                                           Table 6--NSIS Adoption Rate
----------------------------------------------------------------------------------------------------------------
                                                                  Total number of establishments
                                                                              adopted                 Percent
                              Year                               --------------------------------     adopted
                                                                       Large           Small
----------------------------------------------------------------------------------------------------------------
1...............................................................               4               2              17
2...............................................................               8               4              34
3...............................................................              12               7              54
4...............................................................              17              10              77
5...............................................................              22              13             100
----------------------------------------------------------------------------------------------------------------

a. Costs of Additional Establishment Workers
    This analysis expects establishments operating under the NSIS to 
experience an increase in labor costs. Under the NSIS, establishments 
will be required to dedicate labor to sort and remove unfit animals 
before ante-mortem inspection; trim and identify defects, such as 
dressing defects, contamination, and pathology defects, on carcasses 
and parts before post-mortem inspection; 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 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; maintain records to 
document the total number of animals and carcasses sorted and removed 
per day and the reasons for their removal; while conducting sorting 
activities, notify Agency inspectors if they suspect that an animal or 
carcass has a reportable or foreign animal disease; and maintain 
records documenting that products resulting from their slaughter 
operations meet the new definition of RTC pork product. Based on 
observations \41\ of HIMP establishments and a comment from 
industry,\42\ this increase in work is expected to require an increase 
in labor demand ranging from 6-11 additional workers per line per shift 
at large establishments. This analysis assumes each large establishment 
that converts to the NSIS will require 9 additional workers per line 
per shift. Due to data limitations, this analysis assumes small 
establishments that convert to the NSIS will require 1 additional 
worker per line per shift. Costs associated with this labor fall into 3 
categories: Wages and benefits, training, and continuing education.
---------------------------------------------------------------------------

    \41\ Observations were obtained through a survey conducted, in 
February 2016, through the Salmonella Initiative Program and 
conversations with industry at a meeting, which took place in 
February 2016, with the North American Meat Institute.
    \42\ One corporation reported in a comment to the proposed rule 
that they hired and trained up to 11 employees per shift.
---------------------------------------------------------------------------

Establishment Labor Wage Increases
    Many of the 22 large and 13 small non-HIMP market hog 
establishments that are assumed to adopt the NSIS operate multiple 
lines and shifts. Taking these multiple lines and shifts into 
consideration, the number of industry positions is estimated to 
increase by 383 if all high-volume establishments that have a history 
of exclusively slaughtering market hogs, adopt NSIS. The majority of 
these, 369, are attributable to the large establishments (41 (number of 
lines) x 9),\43\ Table 7. The remaining 14 positions are attributable 
to the small establishments (14 (number of lines) x 1),\44\ Table 7. 
According to the BLS, the estimated hourly wage for a Slaughterer and 
Meat Packer occupation (``production employee'') is $13.00.\45\ A 
benefits and overhead factor of two was then used to estimate the total 
labor costs. The total hourly labor costs to industry for a production 
employee including benefits and overhead, is $26.00 per hour ($13.00 x 
2 \46\). Based on data obtained through PHIS, the average large 
establishment slaughters swine 269 days annually. Assuming workers work 
8-hour shifts, the total annual remuneration cost to these 22 large 
establishments is approximately $20.65 million, (369 x $26.00 x 269 x 
8), Table 7. The average small establishment slaughters 244 days 
annually. Again, assuming workers work 8-hour shifts, the total annual 
remuneration cost to these 13 small establishments is approximately 
$0.71 million, (14 x $26.00 x 244 x 8), Table 7. These cost estimates 
take into consideration the fact that some establishments operate 
multiple lines and multiple shifts.
---------------------------------------------------------------------------

    \43\ Source: PHIS.
    \44\ Source: PHIS.
    \45\ BLS Occupational Employment Statistics, Occupational 
Employment and Wages, May 2016. 51-3023 Slaughterers and Meat 
Packers https://www.bls.gov/news.release/archives/ocwage_03312017.pdf Accessed on 12/04/18. Last modified 3/31/17.
    \46\ To be consistent with analyses done by the Department of 
Health and Human Services, this analysis accounts for fringe 
benefits and overhead by multiplying wages by a factor of 2.
---------------------------------------------------------------------------

Costs for Training Online Sorters and Carcass-Inspection Helpers
    Establishments are expected to incur costs associated with 
initially training employees to fill online sorter and carcass-
inspection helper positions, annual replacement training, and 
continuing education training. This analysis assumes the cost to train 
online sorters and carcass-inspection helpers are similar to the costs 
of training production employees in HACCP, which range from $274 to 
$823 with a midpoint average of $549 per new employee.\47\ To ensure a 
conservative estimate and account for employee rotation patterns as 
well as leave, FSIS assumes that establishments will train 4 employees 
for each new position. Under these assumptions, large establishments 
will need to train approximately 1,476 (369 x 4) employees, while small 
establishments will need to train approximately 56 (14 x 4) employees. 
The cost of this training ranges from $419,768 to $1,260,836, with a 
midpoint estimate of $0.84 million (1,532 x $549), Table 7.
---------------------------------------------------------------------------

    \47\ Viator, C. et al. 2015. Costs of Food Safety Investments. 
Table 4-4. Training Costs for Management and Production Employees.
---------------------------------------------------------------------------

    To account for estimated turnover of establishment employees, FSIS 
projects that establishments will have to train approximately 452 
(1,532 x 0.295) replacement employees annually, 435 at the large and 17 
at the small establishments.\48\ The additional annual training cost 
for new employees was estimated to also be similar to the costs of 
HACCP training. Therefore, FSIS estimates the combined annual training 
costs due to turnover to be approximately $0.25 million (452 x

[[Page 52325]]

$549), with large establishments accounting for approximately $0.24 
million (435 x $549) and small establishments accounting for 
approximately $9,333 (17 x $549), Table 7.
---------------------------------------------------------------------------

    \48\ This estimate was rounded up. This analysis uses the 
industry turnover rate for non-durable manufactured goods to 
estimate separations. Source: BLS Economic News Release Table 16. 
Annual total separations rates by industry and region, not 
seasonally adjusted. https://www.bls.gov/news.release/archives/jolts_03162017.htm Accessed on 12/04/18. Last updated on 3/16/17.
---------------------------------------------------------------------------

    FSIS assumes that 1,080 (1,532 x 0.705) retained employees, 1,041 
at the large and 39 at the small establishments, will require annual 
continuing education. This analysis assumes annual continuing education 
costs to be similar to annual HACCP refresher training costs, which 
range from $12 to $36 per employee, with a mid-point of $24.\49\ Using 
the mid-point value, this analysis estimates the combined average 
recurring cost for continuing education is $25,920 (1,080 x $24), with 
large establishments accounting for approximately $24,984 (1,041 x $24) 
and small establishments accounting for approximately $936 (39 x 24).
---------------------------------------------------------------------------

    \49\ Viator, C. et al. 2015. Costs of Food Safety Investments. 
Table 4-4. Training Costs for Management and Production Employees.
---------------------------------------------------------------------------

    Under the assumed adoption rate as set forth in Table 6, annualized 
wages and training cost to industry for staffing additional online 
personnel is approximately $16.61 million, applying a 3 percent 
discount rate \50\ over 10 years, Table 7. The majority of this cost is 
attributed to wages and benefits, Table 7.
---------------------------------------------------------------------------

    \50\ As is explained in Circular A-4, a discount factor should 
be used to adjust the estimated benefits and costs for differences 
in timing. For regulatory analysis, net benefit estimates should be 
provided using a 3 percent and 7 percent discount rate. Source: 
Circular A-4, OMB, September 17, 2003, https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf.

                                       Table 7--Establishment Labor Costs
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                                                     Number of                       Recurring
       Type of establishment               Type of expense           personnel    One-time  cost       cost
----------------------------------------------------------------------------------------------------------------
Large..............................  Wages......................             369  ..............          $20.65
                                     Initial Training...........           1,476           $0.81  ..............
                                     Training Due to Labor                   435  ..............            0.24
                                      Turnover.
                                     Continuing Education.......           1,041  ..............            0.02
----------------------------------------------------------------------------------------------------------------
Small..............................  Wages......................              14  ..............            0.71
                                     Initial Training...........              56            0.03  ..............
                                     Training Due to Labor                    17  ..............           0.009
                                      Turnover.
                                     Continuing Education.......              39  ..............           0.001
----------------------------------------------------------------------------------------------------------------
                                                     Totals
----------------------------------------------------------------------------------------------------------------
One-Time........................................................................................            0.84
----------------------------------------------------------------------------------------------------------------
Recurring Cost..................................................................................           21.63
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.....................................           16.61
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.....................................           15.97
----------------------------------------------------------------------------------------------------------------

b. Costs of Capital Improvements
    The NSIS may require a minor capital improvement if the 
establishment does not already provide a mirror at the carcass 
inspection station. All the large high-volume establishments are 
already required to provide mirrors under existing regulations. The 
following analysis excludes further consideration of the costs of 
requiring a mirror due to its minor potential cost for a limited number 
of establishments.\51\ If an establishment believes that additional 
capital expenditures will result in a benefit, they may voluntarily 
reconfigure or update their facilities to fully capture all the 
potential production efficiencies offered through participation in the 
NSIS. Examples of such changes include line reconfiguration, which can 
cost between $10,000 to $250,000 \52\ and the creation of an inspection 
station, which can cost between $5,000 and $6,000.\53\ Establishments 
may reduce these costs by coordinating these facility updates with 
previously planned establishment renovations.
---------------------------------------------------------------------------

    \51\ The cost was estimated to be very small because all 22 
large high-volume establishments and potentially several of the 13 
small high-volume establishments are already required to provide 
mirrors. As such, any new expense would be negligible compared to 
the industry costs included in the analysis.
    \52\ In a May 2004 study, ERS estimated the cost of compliance 
per establishment with the PR/HACCP rule. Capital expenditures in 
Hog Slaughter establishments were estimated to be $251,800.
    Ollinger, Moore, Chandran (2004). Meat and Poultry 
Establishments' Food Safety Investments. USDA, Economic Research 
Service.
    \53\ Modernization of Poultry Slaughter Inspection; Final Rule, 
79 FR 49566 (2014).
---------------------------------------------------------------------------

c. Costs of Developing Ante-Mortem Written Procedures
    Under the final rule, establishments operating under the NSIS are 
required to develop and maintain in their HACCP systems (HACCP plans, 
sanitation SOPs, or other prerequisite programs) written procedures for 
the segregation, identification, and disposition of animals suspected 
of having one of the condemnable generalized diseases or conditions 
listed in 9 CFR 309. This analysis assumes establishments will 
coordinate this work and costs with the development of 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, a mandatory 
component of the final rule. Details of these costs can be found in the 
sanitary dressing costs section III.G.2.a.
d. Costs Associated With Ready-to-Cook Pork Standards
    Under the final rule, establishments operating under the NSIS are 
required to collect, record, and analyze documentation to demonstrate 
that the products resulting from their slaughter operation meet the 
definition of RTC pork products. This analysis estimates the labor 
costs to collect, record and analyze such documentation under two 
assumptions. First, FSIS assumes that establishments will assign the 
task to a quality control (QC) technician, with an hourly compensation 
rate, which

[[Page 52326]]

includes wages, benefits, and overhead, of $68.52.54 55 
Second, FSIS assumes that this work will take 1 hour at a large 
establishment and \1/2\ hour at a small establishment per day. As is 
explained in the Draft Market Hogs HIMP paper, \56\ large swine 
establishments can verify they meet OCP performance standards by taking 
24 unit samples, requiring roughly 1 hour to collect, record, and 
analyze the data. Based on information obtained through PHIS, the 
average large swine establishment operates 269 days per year. This 
equates to an annual cost of approximately $18,432 (269 x 1 x $68.52), 
or approximately $0.41 million for all 22 non-HIMP establishments 
($18,432 x 22). Similarly, the cost to an average small establishment, 
which based on data obtained through PHIS operates 244 days a year, is 
approximately $8,359 (244 x 0.5 x $68.52), or approximately $0.11 
million for all 13 small establishments ($8,359 x 13). Combined, under 
the assumed adoption rate as set forth in Table 6, these costs are 
expected to increase NSIS establishments' annual labor costs by 
approximately $0.39 million, applying a 3 percent discount rate over 10 
years, Table 8.
---------------------------------------------------------------------------

    \54\ BLS Occupational Employment Statistics, Occupational 
Employment and Wages, May 2016. 19-1021 Food Scientist and 
Technologist. <https://www.bls.gov/news.release/archives/ocwage_03312017.pdf>. Accessed on 12/04/18. Last Modified 3/31/2017.
    \55\ To be consistent with analyses done by the Department of 
Health and Human Services, this analysis accounts for fringe 
benefits and overhead by multiplying wages by a factor of 2.
    \56\ Draft Market Hogs HIMP (HACCP-Bases Inspection Models 
Project). Draft 6/21/05. <https://www.fsis.usda.gov/wps/wcm/connect/d6ccbad7-59e0-43f5-bf54-1987152ccfe8/HIMP_Market_Hog.pdf?MOD=AJPERES.>.

                                        Table 8--Cost of RTC Requirements
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                                                                                     Recurring
                     Type of market hog only establishment                          Number of    ---------------
                                                                                 establishments        Labor
----------------------------------------------------------------------------------------------------------------
Large.........................................................................                22           $0.41
Small.........................................................................                13            0.11
----------------------------------------------------------------------------------------------------------------
                                                    Totals *
----------------------------------------------------------------------------------------------------------------
Recurring Cost..................................................................................            0.51
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.....................................            0.39
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.....................................            0.38
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.

2. Costs Associated With Requirements for All Swine Slaughter 
Establishments
    The mandatory costs of the final rule will apply to all 612 swine 
slaughter establishments and begin on the effective date for these 
requirements. These costs are associated with (a) written procedures to 
prevent visible fecal material, ingesta, and milk contamination; and 
(b) sampling and analysis for microbial organisms to monitor process 
control for enteric pathogens.
a. Costs of Developing, Composing, Training, Monitoring, Recording, and 
Verifying Written Sanitary Dressing Plans
    Under the mandatory portion of the final rule affecting all 
Federally inspected establishments that slaughter swine, FSIS is 
requiring that all official swine slaughter establishments develop, 
implement, and maintain in their HACCP systems written procedures to 
prevent the contamination of carcasses and parts by enteric pathogens, 
and visible fecal material, ingesta, and milk throughout the entire 
slaughter and dressing operation. This cost component for 
establishments includes: (1) Developing and incorporating these 
procedures into their food safety system, (2) training, and (3) 
monitoring, recordkeeping, and verification. This analysis assumes 606 
swine establishments will incur these costs.\57\
---------------------------------------------------------------------------

    \57\ One corporation has informed FSIS, through public comment, 
that all six of its swine harvest facilities have written sanitary 
dressing plans. As such, they were not included in this portion of 
the cost analysis, which reduced annual costs by roughly $87,000 as 
compared to the proposed rule.
---------------------------------------------------------------------------

Costs for Developing and Composing a Written Sanitary Dressing Plan
    FSIS assumes incorporating written sanitary dressing plans into an 
establishment's HACCP system will result in a one-time HACCP plan 
reassessment cost. According to RTI's Costs of Food Safety Investments 
report,\58\ the mid-point costs of a HACCP plan reassessment for large 
establishments is $730, the mid-point costs for small and very small 
establishments is $365.\59\ The cost to large establishments is 
approximately $16,060 (22 x $730), small establishments is 
approximately $38,325 (105 x $365), and very small establishments is 
approximately $174,835 (479 x $365). The annualized costs to industry 
with a 3 percent discount rate for all 606 swine slaughter 
establishments is approximately $0.03 million, Table 9.
---------------------------------------------------------------------------

    \58\ Viator, C. et al. 2015. RTI International collected data on 
the cost of food safety investments for the production of meat and 
poultry products at the pre-harvest and slaughter and processing 
stages. This data was provided to FSIS in a final report titled 
`Costs of Food Safety Investments' and was prepared by Catherine L. 
Viator, Mary K. Muth, and Jenna E. Brophy. The contract number is 
No. AG-3A94-B-3-0003. The order number is AG-3A94-K-14-0056.
    \59\ Viator, C. et al. 2015. Table 4-1. Costs of HACCP Plan 
Development, Validation and Reassessment per HACCP.

[[Page 52327]]



           Table 9--Written Sanitary Dressing Plan Development
                                  [M$]
------------------------------------------------------------------------
                                            Number of
              HACCP size                 establishments    One-time cost
------------------------------------------------------------------------
Large.................................                22           $0.02
Small.................................               105            0.04
Very Small............................               479            0.17
------------------------------------------------------------------------
                                 Totals
------------------------------------------------------------------------
One-Time Cost...........................................            0.23
------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10               0.03
 Years..................................................
------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10               0.03
 Years..................................................
------------------------------------------------------------------------

Costs for Training Establishment Personnel on Executing a Written 
Sanitary Dressing Plan
    FSIS assumes training programs will be utilized to ensure that 
establishment personnel understand and can execute the sanitary 
dressing plan. This training includes a one-time initial training cost 
to the establishment, a recurring cost of training new hires due to 
separations, and the cost of conducting annual refresher training. This 
portion of the model is informed by the RTI Costs of Food Safety 
Investments report.\60\ As is noted in the RTI report, these costs are 
based on the amount of time a panel of experts recommends 
establishments spend on training, which may exceed the amount of time 
establishments spend on training. Due to data limitations, this 
analysis assumes the number of establishment employees conducting 
sanitary dressing tasks at swine establishments is equal to the number 
of employees conducting sanitary dressing tasks at beef slaughter 
establishments.\61\ This is likely an overestimate because unlike beef, 
the majority of swine are scalded, de-haired, and polished prior to 
opening the carcass, which decreases the need for employees to conduct 
sanitary dressing tasks.
---------------------------------------------------------------------------

    \60\ Viator, C. et al. 2015.
    \61\ The Survey is at: http://www.fsis.usda.gov/wps/wcm/connect/184a3baa-2f73-4651-8aba-68124580f4e0/Pathogen_Controls_in_Beef_Operations_Survey.pdf?MOD=AJPERES. The 
survey report is at: http://www.fsis.usda.gov/wps/wcm/connect/6d37a1fc-a3e1-40b6-90cc-719bdb391522/STEC_Survey_Comments_Summary.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

    As seen in Table 10, costs are shared across HACCP sizes, with 
large establishments incurring higher costs. The rate of new hires, 
29.5 percent, is derived from the BLS, 2016 Turnover Rate for Non-
Durable Manufacturing Goods.\62\ Likewise, the retention rate for the 
refresher training is one minus the turnover rate. The total one-time 
cost to train the employees for all 606 establishments is roughly $1.00 
million, while the total recurring costs is roughly $0.44 million, 
Table 10. The annualized costs with a 3 percent discount rate over 10 
years for Sanitary Dressing task related training is $0.55 million, 
Table 10.
---------------------------------------------------------------------------

    \62\ Source: BLS Economic News Release Table 16. Annual total 
separations rates by industry and region, not seasonally adjusted. 
<https://www.bls.gov/news.release/archives/jolts_03162017.htm> 
Accessed on 12/04/18. Last updated on 3/16/17.

                                   Table 10--Sanitary Dressing Training Costs
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                                                                  Training costs
                                                      Average    -----------------------------------------------
          HACCP size                Number of       number  of       One-time                Recurring
                                 establishments      employees   -----------------------------------------------
                                                                      Initial        New hires       Refresher
----------------------------------------------------------------------------------------------------------------
Large.........................                22             179           $0.48           $0.14           $0.07
Small.........................               105              25            0.32            0.09            0.04
Very Small....................               479               3            0.20            0.06            0.03
----------------------------------------------------------------------------------------------------------------
                                                    Totals *
----------------------------------------------------------------------------------------------------------------
One-Time Cost...................................................................................            1.00
----------------------------------------------------------------------------------------------------------------
Recurring Cost..................................................................................            0.44
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.....................................            0.55
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.....................................            0.57
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.


[[Page 52328]]

Cost of Monitoring, Recordkeeping, and Verification Associated With the 
Written Sanitary Dressing Plan
    This analysis also estimates the annual monitoring, recordkeeping 
and verification costs associated with maintaining sanitary dressing 
procedures. This analysis assumes it will take a production employee 5 
minutes to monitor and 5 minutes to maintain records for the sanitary 
dressing procedures, for a total of 10 minutes. Establishments are 
required to verify the plan each day of production. In addition, this 
analysis assumes it will take a QC manager 15 minutes to perform a 
verification task and that such task will be completed each week that 
slaughter takes place. Combined, these tasks are estimated to cost the 
entire industry roughly $0.84 million annually, applying a 3 percent 
discount rate over 10 years, Table 11.

                           Table 11--Monitoring, Recordkeeping and Verification Costs
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                                 Recurring costs
-----------------------------------------------------------------------------------------------------------------
                   HACCP size                       Monitoring     Recordkeeping   Verification      Combined
----------------------------------------------------------------------------------------------------------------
Large...........................................           $0.01           $0.01           $0.03           $0.05
Small...........................................            0.04            0.04            0.12            0.20
Very Small......................................            0.07            0.07            0.44            0.58
----------------------------------------------------------------------------------------------------------------
                                                    Totals *
----------------------------------------------------------------------------------------------------------------
Recurring Cost..................................................................................            0.84
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.....................................            0.84
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.....................................            0.84
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.

Summary Costs of Written Sanitary Dressing Procedures
    Table 12 provides an overview of the one-time and recurring costs 
associated with requiring all establishments to develop written 
sanitary dressing procedures. Combined, these tasks are expected to 
cost the industry $1.41 million annualized, assuming a 3 percent 
discount rate over 10 years, Table 12.

            Table 12--Summary of Costs Associated With Requiring Written Sanitary Dressing Procedures
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                                          One-time costs                  Recurring costs
                                                 ---------------------------------------------------------------
           HACCP size                Number of                                                      Monitoring,
                                  establishments    Development       Initial        Training       recording,
                                                                     training                       validating
----------------------------------------------------------------------------------------------------------------
Large...........................              22           $0.02           $0.48           $0.21           $0.05
Small...........................             105            0.04            0.32            0.14            0.20
Very Small......................             479            0.17            0.20            0.09            0.58
----------------------------------------------------------------------------------------------------------------
                                                    Totals *
----------------------------------------------------------------------------------------------------------------
One-Time Cost...................................................................................            1.23
----------------------------------------------------------------------------------------------------------------
Recurring Cost..................................................................................            1.27
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.....................................            1.41
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.....................................            1.44
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.

b. Cost of Carcass Sampling and Analysis for Microbial Organisms
    This section reviews the potential changes in costs associated with 
the alterations to microorganism testing. These costs are limited to 
the changes associated with removing the requirement that swine 
establishments test carcasses for generic E. coli and replacing it with 
new testing requirements described above. While the final rule also 
removes the codified Salmonella pathogen reduction performance 
standards for swine, because the codified standards are already no 
longer in use, there are no potential costs or benefits to industry. 
Such changes fall under four categories: Sampling plan reassessment, 
transferring from prescriptive to process testing requirements, 
sampling rates, and sample recordkeeping. This analysis uses results 
from the RTI International Meat Industry Survey in Support of Public 
Health Risk-Based Inspection report \63\ and Costs of Food

[[Page 52329]]

Safety Investments report.\64\ Each of these categories is explained in 
detail below. Based on industry comment on the proposed rule, this 
analysis excludes the 11 large swine establishments that were 
participating in the SIP program when data for this analysis was 
collected. Under SIP, these establishments currently sample at an 
alternative frequency and we assume that they will continue to do so. 
As such, these 11 SIP swine slaughter establishments are not expected 
to change their process control sampling and will not experience a 
change in associated costs.
---------------------------------------------------------------------------

    \63\ Viator, C. et al. 2015. (a) RTI International designed and 
conducted surveys on industry practices to control pathogens and 
promote food safety. The sample design, administration procedures, 
analysis and results were provided to FSIS in a final report titled 
`Meat Industry Survey in Support of Public Health Risk-Based 
Inspection' and was prepared by Catherine Viator, Sheri C. Cates, 
Shawn A. Karns, Peter Siegel, Ariana Napier, and Mary K. Muth. The 
contract number is No. AG-3A94-B-13-0003. The order No. is AG-3A94-
K-13-0053.
    \64\ Viator, C. et al. 2015. (b).
---------------------------------------------------------------------------

Cost of Process Control Sampling Plan Reassessment
    This analysis assumes establishments will incur one-time costs of 
conducting a process control sample plan reassessment under the final 9 
CFR 310.25(a)(2)(i). The RTI Costs of Food Safety Investments report 
estimates the costs of reassessing a microbiological sampling plan. For 
large establishments, these costs include labor, consultant fees, and 
travel expenses, which combined range from $27,320 to $81,960, with a 
midpoint of $54,640 per establishment. Costs to small and very small 
establishments are limited to labor expenses and range from $122 to 
$365, with a midpoint of $243 per establishment.\65\ The annualized 
reassessment cost to industry is roughly $0.12 million, assuming a 3 
percent discount rate over 10 years, Table 13.
---------------------------------------------------------------------------

    \65\ The report classifies establishments as either large or 
small. Given this data limitation, this analysis assumes very small 
and small establishments have similar reassessment costs.

                          Table 13--Cost of Process Control Sampling Plan Reassessment
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                                                                     Per
                                                                Number of       establishment    Total one-time
                        HACCP size                           establishments      (mid-point           costs
                                                                                 estimate) *
----------------------------------------------------------------------------------------------------------------
Large.....................................................                17             $0.05             $0.93
Small.....................................................               105               243              0.03
Very Small................................................               479               243              0.12
----------------------------------------------------------------------------------------------------------------
                                                    Totals **
----------------------------------------------------------------------------------------------------------------
One-Time Cost.................................................................................              1.07
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years...................................              0.12
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years...................................              0.14
----------------------------------------------------------------------------------------------------------------
* The values for Small and Very Small Establishments are in dollars.
** Note, some of the totals may not equal the sum due to rounding.

Cost of Transferring From Prescriptive To Process Specific 
Microbiological Testing Requirements
    Prior to the final rule, regulations prescribed that each slaughter 
establishment test for generic E. coli.\66\ In addition to mandated 
generic E. coli testing, many establishments voluntarily conduct 
additional microbiological testing to verify process control. Common 
microbiologic tests include APC, total plate count (TPC), and total 
coliforms. Based on the meat slaughter survey conducted by RTI, roughly 
71 percent of very small, 80 percent of small, and 100 percent of large 
establishments conduct microbiological testing in addition to testing 
for generic E. coli.\67\ Establishments voluntarily conducting 
additional testing are an indication that the generic E. coli testing 
is not the best means to verify process control in their respective 
establishments.
---------------------------------------------------------------------------

    \66\ 9 CFR 310.25 (2018).
    \67\ Viator, C. et al. 2015. (a) P5-42. Question 3.1.
---------------------------------------------------------------------------

    This analysis assumes that, if permitted to choose a 
microbiological test to ensure process control, establishments will 
select the single best test that demonstrates process control at their 
establishment. Under these assumptions, establishments that currently 
test for generic E. coli and conduct at least one other type of 
microbiological test will stop testing for generic E. coli. As a 
result, the 17 large (17 x 1.00), 41 small high-volume (51 x .80), 43 
small low-volume (54 x .80), 4 very small high-volume \68\ (6 x .714), 
and 338 very small (473 x .714) establishments that currently test for 
generic E. coli and at least one other microbial or pathogen indicator 
\69\ will experience a cost reduction. Given the similarity in 
laboratory testing costs and costs associated with switching sampling 
programs, this analysis assumes the remaining 158 establishments that 
exclusively test for generic E. coli will continue to do so.
---------------------------------------------------------------------------

    \68\ Very small high-volume establishments 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.
    \69\ Question 3.1 from the Meat Industry Survey in Support of 
Public Health Risk-Based Inspection Report asks ``In addition to the 
generic E. coli testing of carcasses and Listeria testing of ready-
to-eat (RTE) products required by FSIS regulation, does this 
establishment conduct microbiological testing? ''; 28.6% of very 
small, 20% of small, and 0% of large establishments responded no, 
meaning 71.4% of very small, 80% of small and 100% of large 
establishments conduct additional testing.
---------------------------------------------------------------------------

    Calculating the cost reductions is a function of estimating the 
testing rate and testing costs. This analysis assumes all large, small, 
and very small high-volume,\70\ establishments conduct 1 test, every 
1,000 carcasses, and all low-volume establishments conduct 13 tests 
annually.\71\ To calculate testing costs, this analysis estimates the 
associated labor expenses, laboratory fees, and shipping costs. The 
mean cost to an establishment to test a single generic E. coli sample 
in house is $25.97.\72\ To have the sample tested at a contracted

[[Page 52330]]

lab, the cost is $49.81.\73\ Based on survey results, this analysis 
assumes 79 percent of large, 28 percent of small and 5 percent of very 
small establishments test in house.\74\ For these 443 establishments, 
the combined reduction in testing costs of no longer being required to 
test for generic E. coli was estimated to reduce annual testing costs 
by approximately $2.69 million, assuming a 3 percent discount rate over 
10 years, Table 14.
---------------------------------------------------------------------------

    \70\ Note that the 11 large establishments participating in SIP 
have been excluded from this analysis because they have an 
alternative sampling frequency.
    \71\ 9 CFR 310.25(a)(2)(iii)(B). The current regulation (9 CFR 
310.25(a)(2)(v)) defines very low-volume swine slaughter 
establishments as slaughtering 20,000 head annually or fewer. For 
the purposes of this analysis, FSIS has labeled swine establishments 
that annually slaughter more than 20,000 head per year as high 
volume.
    \72\ Viator, C. et al. 2015. (b) Table 5-1.
    \73\ Viator, C. et al. 2015. (b) Table 5-1.
    \74\ Viator, C. et al. 2015. (b).
    \75\ Values in text may differ because of rounding.
    \76\ Values in text may differ because of rounding.
    \77\ BLS Occupational Employment Statistics, Occupational 
Employment and Wages, May 2016. 19-1021 Food Scientist and 
Technologist. https://www.bls.gov/news.release/archives/ocwage_03312017.pdf Accessed on 12/04/18. Last Modified 3/31/2017.
    \78\ To be consistent with analyses done by the Department of 
Health and Human Services, this analysis accounts for benefits and 
overhead by multiplying wages by a factor of 2.

 Table 14--Recurring Costs (Savings) From No Longer Requiring Generic E.
                              coli Testing
                                   [M$]
------------------------------------------------------------------------
                                          Number of
             HACCP size                establishments       (Savings)
------------------------------------------------------------------------
Large...............................                17           ($2.04)
Small High-Volume...................                41            (0.40)
Small Low-Volume....................                43            (0.02)
Very Small High-Volume..............                 4            (0.01)
Very Small Low-Volume...............               338            (0.21)
------------------------------------------------------------------------
                                 Totals
------------------------------------------------------------------------
Recurring Cost........................................            (2.69)
------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10             (2.69)
 Years................................................
------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10             (2.69)
 Years................................................
------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.

Process Control Sampling Rates
    The final rule requires large, small, and very small high-volume 
establishments to take carcass samples at pre-evisceration and post-
chill (for hot-boned products carcass samples must be taken pre-
evisceration and after the final wash), which will increase the number 
of samples taken from 1 sample per 1,000 carcasses to 2 samples per 
1,000 carcasses for large, small, and very small high-volume 
establishments. The final rule does not require low-volume 
establishments to increase their sampling rates. Under the final 
regulations, large establishments' annual process control sampling 
costs were estimated to increase by roughly $1.46 million, which is 
roughly $85,745 per establishment ($1.46 million/17), \75\ Table 15. 
Small high-volume establishments' annual process control sampling costs 
were estimated to increase by roughly $0.30 million, which is roughly 
$5,974 ($0.30 million/51) per establishment, Table 15. Very small high-
volume establishments' annual process control sampling costs were 
estimated to increase by roughly $8,890, which is roughly $1,482 
($8,890/6) per establishment, Table 15.
Cost of Process Control Sample Recordkeeping
    This analysis takes into consideration the increase in 
recordkeeping costs associated with an increase in the sampling rate 
from 1 to 2 samples per 1,000 head. According to PHIS data, the average 
large non-SIP establishment slaughters approximately 3.87 million swine 
per year. As such, this analysis estimates that a large non-SIP 
establishment currently takes approximately 3,869 samples annually 
(3,869,276/1,000). The average small high-volume swine establishment 
slaughters 0.23 million swine per year and requires approximately 229 
samples (228,784/1,000) annually. While the average very small high-
volume establishment slaughters 51,925 swine per year and requires 
approximately 52 samples (51,925/1,000) annually. Assuming it takes 2.5 
minutes to record the results of each sample, the average large 
establishment currently requires 9,673 minutes (2.5 x 3,869) per year; 
the average small high-volume establishment currently requires 573 
minutes (2.5 x 229) per year; and the average very small high-volume 
establishment currently requires 130 minutes (2.5 x 52) per year. 
Requiring establishments to increase their sampling rates from 1 to 2 
samples per 1,000 head will increase the average large non-SIP 
establishment's annual number of samples to 7,738 samples annually 
(3,869,276/1,000 x 2), which will require approximately 19,346 minutes 
(2.5 x 7,738) \76\ annually. The same requirement will increase a small 
high-volume establishment's annual sampling to 458 (228,784/1,000 x 2), 
which will require approximately 1,145 minutes (2.5 x 458) annually. 
Likewise, a very small high-volume establishment's annual sampling will 
increase to 104 (51,925/1,000 x 2), which will require approximately 
260 minutes (2.5 x 104) annually. As such, the estimated additional 
time required for recordkeeping is approximately 9,673 minutes (19,346-
9,673) for large non-SIP establishments; 572 minutes (1,145-573) for 
small high-volume establishments; and 130 minutes (260-130) for very 
small high-volume establishments. Assuming a quality control technician 
with a compensation rate of $68.52 per hour 77 78 conducts 
this work, the additional costs to the average large non-SIP 
establishment is approximately $11,046 (9,673/60 x $68.52). Similarly, 
the additional cost to the average small high-volume and very small 
high-volume establishment is approximately $653 (572/60 x $68.52) and 
$148 (130/60 x $68.52, respectively). Scaling this up to all impacted 
establishments, the total increase in costs to all large non-SIP 
establishments is approximately $0.19 million ($11,046 x 17); $0.03 
million ($654 x 51) for small high-volume establishments; and $888 
($148 x 6) for very small high-volume establishments, Table 15.

[[Page 52331]]

    The combined annualized sampling and recordkeeping cost to all 
large non-SIP, small, and very small high-volume establishments is 
roughly $1.99 million, applying a 3 percent discount rate over 10 
years. Large establishments will potentially incur the majority of this 
cost, Table 15.

                         Table 15--Costs Changes Associated With Increase Sampling Rates
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                                                                    Costs
                                              Number of    -----------------------------------------------------
                                           establishments       Sampling        Recordkeeping      Combined *
----------------------------------------------------------------------------------------------------------------
Large non-SIP...........................                17             $1.46             $0.19             $1.65
Small High-Volume.......................                51              0.30              0.03              0.34
Very Small High-Volume (Dollars)........                 6             8,890               888             9,778
----------------------------------------------------------------------------------------------------------------
                                                     Totals
----------------------------------------------------------------------------------------------------------------
Recurring Cost................................................................................              1.99
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years...................................              1.99
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years...................................              1.99
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.

Summary of Process Control Sampling Cost Changes
    Overall, the changes in sampling requirements under the final rule 
were estimated to reduce industry wide sampling costs by about $0.57 
million annualized over 10 years, applying a 3 percent discount rate, 
Table 16. However, only the 443 establishments that currently conduct 
multiple types of microbiological tests will potentially experience a 
reduction in cost. The remaining establishments, roughly 158 small and 
very small establishments, will potentially incur a portion of the one-
time costs associated with plan reassessment, Table 16. Cost increases 
associated with testing and recordkeeping will be exclusively borne by 
large, small, and very small high-volume establishments.

        Table 16--Summary of Changes to Process Control Sampling
                                  [M$]
------------------------------------------------------------------------
                                                  Cost  (savings)
             Type of change              -------------------------------
                                             One-time        Recurring
------------------------------------------------------------------------
Plan Reassessment.......................           $1.07  ..............
Converting to Process Control Sampling..  ..............         ($2.69)
Testing Costs...........................  ..............            1.77
Recordkeeping...........................  ..............            0.22
------------------------------------------------------------------------
                                Totals *
------------------------------------------------------------------------
One-Time Cost...........................................            1.07
------------------------------------------------------------------------
Recurring Cost..........................................          (0.70)
------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10             (0.57)
 Years..................................................
------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10             (0.55)
 Years..................................................
------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.

Summary of Voluntary and Mandatory Costs for Final Rule
    The total annualized value of all costs to industry, under the 
assumed five-year adoption rate as shown in Table 6, is roughly $17.83 
million, assuming a 10-year annualization and a 3 percent discount 
rate, Table 17. Large establishments that voluntarily switch to the 
NSIS incur the majority of costs. For example, the recurring labor 
costs associated with the NSIS is the single largest recurring cost to 
industry and is mostly incurred by large establishments. It should be 
noted that the five HIMP pilot study establishments have already 
incurred these costs, suggesting for those five establishments, the 
benefits of the NSIS outweigh the costs. It also suggests that the 
benefits of adopting the NSIS outweigh the costs for other 
establishments as well. Training staff accounts for the bulk of the 
costs associated with written sanitary dressing procedures. Sampling 
costs will potentially decrease for those establishments that currently 
conduct microbiological tests in addition to generic E. coli.

[[Page 52332]]



                                      Table 17--Combined Costs to Industry
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                                                                            Total costs
                         Type of cost                               Number of    -------------------------------
                                                                 establishments      One-time        Recurring
----------------------------------------------------------------------------------------------------------------
Voluntary:
    Establishment Labor.......................................                35           $0.84          $21.63
    Ready to Cook.............................................                35  ..............            0.51
Mandatory:
    Written Sanitary Dressing Procedures......................               606            1.23            1.27
    Process Control Sampling..................................               601            1.07          (0.70)
----------------------------------------------------------------------------------------------------------------
                                                    Totals *
----------------------------------------------------------------------------------------------------------------
Number of Establishments **.....................................................................             612
----------------------------------------------------------------------------------------------------------------
One Time Cost...................................................................................            3.14
----------------------------------------------------------------------------------------------------------------
Recurring Cost..................................................................................           22.72
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.....................................           17.83
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.....................................           17.23
----------------------------------------------------------------------------------------------------------------
                                               Totals Mandatory *
----------------------------------------------------------------------------------------------------------------
Number of Establishments **.....................................................................             612
----------------------------------------------------------------------------------------------------------------
One-Time Cost...................................................................................            2.30
----------------------------------------------------------------------------------------------------------------
Recurring Cost..................................................................................            0.58
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.....................................            0.84
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.....................................            0.88
----------------------------------------------------------------------------------------------------------------
                                               Totals Voluntary *
----------------------------------------------------------------------------------------------------------------
Number of Establishments........................................................................              35
----------------------------------------------------------------------------------------------------------------
One-Time Cost...................................................................................            0.84
----------------------------------------------------------------------------------------------------------------
Recurring Cost..................................................................................           22.15
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.....................................            17.0
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.....................................           16.35
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.
** Note, 612 includes all swine slaughter establishments, including the 11 SIP establishments that were excluded
  from the process control sampling costs and the 6 establishments that were excluded from the written sanitary
  dressing plans costs.

H. Potential Benefits of the Final Rule

1. Potential Benefits Associated With Public Health
    Switching existing FSIS inspection program personnel (IPP) 
activities toward more offline verification activities (e.g., 
sanitation performance standards, sampling, fecal inspections, and 
other inspection requirements) is unlikely to result in a higher 
prevalence of Salmonella on market hog carcasses and is estimated to 
result in a lower prevalence of Salmonella on market hog carcasses, 
which in turn may lead to fewer human illnesses. This conclusion is 
supported by a two-part risk assessment which compares typical FSIS 
market swine inspection outcomes with the outcomes observed in a small 
subset of establishments that participated in the HIMP pilot study 
(referred to in the risk assessment as HIMP plants).
    Stage 1 of the risk assessment consists of a multiple regression 
analysis to identify the relationships between establishment 
characteristics (including HIMP status) and carcass contamination 
prevalence. FSIS presents two different models for estimating the 
potential for avoiding illnesses in the risk assessment one using only 
empirical data and one using additional simulated data, see Tables 13 
and 14 in the risk assessment and accompanying text. The results of the 
modeling with simulated data, had less uncertainty around the estimated 
change in illnesses--are not used in support of the final rule. The 
modeling without simulated data is carried through in this section. As 
a result, the uncertainty around estimated illnesses avoided is 
greater; however, the most likely estimated illnesses avoided are not 
affected. Stage 2 of the risk assessment consists of multiple scenario 
models in which combinations of plausible changes to inspection 
procedures are inserted into equations created using the coefficients 
computed in Stage 1. These scenarios produce estimates of changes in 
carcass contamination prevalence under the inspection procedures of 
NSIS.
    Changes in estimated numbers of Salmonella illness are estimated 
based on a proportional relationship between carcass contamination 
prevalence and illnesses that has been published in the

[[Page 52333]]

peer-reviewed literature.79 80 This relationship was also 
validated internally in the risk assessment, with an analysis of 
variance (ANOVA) test indicating that carcasses slaughtered in 
establishments with relatively low prevalence of Salmonella did not 
show significantly different contamination load (measured by 
enumeration of Salmonella colony-forming units per gram) when compared 
with establishments with relatively high prevalence of Salmonella. In 
other words, the proportion of contaminated carcasses is more 
predictive of Salmonella illnesses than the contamination load of each 
contaminated carcass; thus, if the proportion of carcasses with no 
detectable Salmonella contamination increases with implementation of 
the NSIS, illnesses caused by consumers' exposure to these carcasses 
were estimated to decrease proportionally.
---------------------------------------------------------------------------

    \79\ Williams M.S., Ebel, E.D., Vose, D. 2011. Framework for 
Microbial Food-Safety Risk Assessments Amenable to Bayesian 
Modeling. Risk Analysis 31(4):548-565.
    \80\ Ebel, E.E., et al. 2012. Simplified framework for 
predicting changes in public health from performance standards 
applied in slaughter establishments. Food Control 28(2): pp. 250 
257.
---------------------------------------------------------------------------

    As with any risk assessment, FSIS's risk assessment relies on a 
number of assumptions. FSIS assumed that the differences between the 
process of slaughtering hogs and slaughtering poultry do not alter the 
relationship between the presence of Salmonella contamination post-
slaughter and human illness.
    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. 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.\81\ These analyses indicate that the 
prevalence of Salmonella contamination on downstream products (e.g., 
parts) often exceeds that for the prevalence of Salmonella 
contamination in upstream products (e.g., carcasses). The higher 
prevalence is logical given that samples of downstream products contain 
primals from multiple carcasses, increasing the likelihood of a single 
sample being contaminated.
---------------------------------------------------------------------------

    \81\ 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 market hog Salmonella illness risk model estimates that the 
prevalence of Salmonella detected in carcasses may decline on average 
from an initial prevalence of 0.9407% to a final prevalence of 0.9066% 
if the 35 identified establishments adopt the new inspection system. 
This decrease in prevalence should correspond to an average decrease in 
illnesses due to market hog product consumption by an average of 2,533 
annual cases.\82\
---------------------------------------------------------------------------

    \82\ The relationship between carcass contamination prevalence 
and human illnesses modeled as in Williams et al., 2010, Estimating 
changes in public health following implementation of hazard analysis 
and critical control point in the United States broiler slaughter 
industry, Foodborne Pathogens and Disease, 9 and Ebel et al., 2012, 
Simplified framework for predicting changes in public health from 
performance standards applied in slaughter establishments, Food 
Control, 28.
---------------------------------------------------------------------------

    More specifically, CDC applies 14 empirical, population-adjusted, 
and Pert uncertainty distributions multiplicatively modeled as Monte 
Carlo distributions with repeated sampling and Bayesian characteristics 
to the data collected at their surveillance sites. CDC states that the 
illness estimates are robust but likely underestimates due to 
extrapolation from surveillance and outbreak data with underreporting 
not captured in the CDC uncertainty estimates based ultimately on 
laboratory confirmed cases. CDC's modeling approach used to estimate 
total uncertainty of illnesses is designed to capture multiple sources 
of uncertainty that were not explicitly modeled, that is, the 
uncertainty in CDC illness estimates captures components of consumer 
behavior, cross contamination and Salmonella inactivation and growth 
between production and consumption.\83\ The uncertainty surrounding 
illness estimates is the largest contributor to overall uncertainty in 
the NSIS risk model. The total uncertainty in the case rate is 
estimated to be bounded at the 10th and 90th percentiles by a potential 
increase of 1,719 and a potential decrease of 6,685 cases, 
respectively. The total case uncertainty distribution is dependent on 
the uncertainty in the change in Salmonella prevalence in market hogs.
---------------------------------------------------------------------------

    \83\ CDC's surveillance and outbreak attribution data are 
available in Scallan, E., et al. 2011. Foodborne Illness Acquired in 
the United States--Major Pathogens. Emerging Infectious Diseases 
17(1): 7-15.
---------------------------------------------------------------------------

    The prevalence estimates are modeled with data variability and 
robust uncertainty components taken from sampling data and model 
parameter estimates. Additional, unquantified uncertainty includes the 
possibility that differences between HIMP plants and non-HIMP plants 
that adopt NSIS not accounted for in the risk assessment could affect 
Salmonella prevalence. A number of potential differences, however, are 
taken into account in the risk assessment. The variability and 
uncertainty in the market hog proportion of illnesses is modeled from 
FSIS market hog slaughter data and Bayesian uncertainty. As 
demonstrated in the 2010-2011 Market Hog Baseline Study, the market hog 
slaughter process resulted in 2,390,482 carcasses produced per year and 
a weighted Salmonella contamination prevalence rate of 1.66%; the 10th 
percentile estimate for this value is 2,218,169 carcasses and the 90th 
percentile estimate is 2,561,973 carcasses. This uncertainty in the 
carcass prevalence rate in market hogs according to the peer reviewed 
prevalence model corresponds to the overall uncertainty in consumer 
Salmonella cases of illnesses from market hogs with an average of 
69,857 cases and 10th and 90th percentiles of 40,778 and 104,333 cases 
respectively, under traditional inspection. With adoption of the new 
inspection system, the average number of cases is likely to decrease to 
67,324.

[[Page 52334]]

    The market hog risk assessment estimates that if the 35 
establishments expected to convert to the NSIS over 5 years do so, the 
number of human illnesses attributed to products derived from market 
hogs could reduce by an average of 2,533 Salmonella illnesses. The 
combined robust model estimate of quantified uncertainty in the case 
rate based on CDC Salmonella illness and FSIS market hog contamination 
data is estimated to be bounded at the 10th and 90th percentiles by an 
increase of 1,719 and a decrease of 6,685 cases, respectively. It is 
worth noting, however, that there is an approximately 80% likelihood of 
a decrease in illnesses.\84\ The ERS estimates of the annual per case 
cost of foodborne illnesses for Salmonella range from roughly $321 to 
$5,820, with a mean of roughly $3,682.\85\ These estimates factor in 
the costs of physician office, emergency room, and outpatient clinic 
visits, as well as hospitalizations, productivity loss, and deaths. 
Assuming approximately 2,533 averted cases of Salmonella, potential 
savings range from roughly $0.81 million to $14.74 million, with a 
midpoint of $9.33 million, Table 18. Health costs would increase by 
roughly $6.33 million if cases increased by 1,719, which corresponds to 
the 10th percentile, and each case cost $3,682, Table 18. 
Alternatively, health costs would decrease by roughly $24.62 million if 
6,685 cases were averted, which corresponds to the 90th percentile, and 
each case cost $3,682, Table 18. Using the midpoint estimate of $9.33 
million cost decrease and applying a five-year adoption rate, the 
annualized value is approximately $7.09 million, at a 3 percent 
discount rate, Table 18. These estimated benefits may underestimate 
total benefits because they do not include pain and suffering costs. 
They may also overestimate benefits and cost savings given the 
uncertainty between the number of illnesses and the number of carcasses 
with detectable Salmonella.
---------------------------------------------------------------------------

    \84\ The primary conclusion for the purposes of this regulatory 
change, however, is that 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. As such, public health 
benefits are characterized as ``potential'' rather than ``expected'' 
benefits.
    \85\ USDA ERS, 2014, Cost Estimates of foodborne illnesses. 
http://www.ers.usda.gov/data-products/cost-estimates-of-foodborne-illnesses.aspx#48446 Accessed on 9/9/2011. Last Updated on 11/12/
2014.

                          Table 18--Potential Benefits From Averted Cases of Salmonella
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per illness *
                                                     Change in   -----------------------------------------------
                   Percentile                      illnesses by         Low             Mid            High
                                                     scenario    -----------------------------------------------
                                                                       $321           $3,682          $5,820
----------------------------------------------------------------------------------------------------------------
                                                                                Scenario Costs, $M
----------------------------------------------------------------------------------------------------------------
10th............................................           1,719           $0.55           $6.33          $10.01
Mean............................................         (2,533)          (0.81)          (9.33)         (14.74)
90th............................................         (6,685)          (2.15)         (24.62)         (38.91)
----------------------------------------------------------------------------------------------------------------
                                     Comparison of Mean Recurring Costs (M$)
----------------------------------------------------------------------------------------------------------------
                                                       Low
----------------------------------------------------------------------------------------------------------------
Recurring Cost..................................................................................            6.33
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.....................................            4.81
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.....................................            4.62
----------------------------------------------------------------------------------------------------------------
                                                       Mid
----------------------------------------------------------------------------------------------------------------
Recurring Cost..................................................................................          (9.33)
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.....................................          (7.09)
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.....................................          (6.81)
----------------------------------------------------------------------------------------------------------------
                                                      High
----------------------------------------------------------------------------------------------------------------
Recurring Cost..................................................................................         (24.62)
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.....................................         (18.71)
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.....................................        ($17.97)
----------------------------------------------------------------------------------------------------------------
* Source: USDA ERS, 2014, Cost Estimates of foodborne illnesses. http://www.ers.usda.gov/data-products/cost-estimates-of-foodborne-illnesses.aspx#48446 Accessed on 9/9/2011. Last updated on 11/12/2014.
Note, some of the totals may not equal the sum due to rounding.


[[Page 52335]]

2. Other Benefits Associated With Modernizing Existing Regulations
    The final rule will potentially reduce the regulatory burden on 
establishments by shifting from prescriptive to performance-based 
regulation. Based on the Evaluation of HACCP Inspection Models Project 
(HIMP) for Market Hogs Report, the five HIMP establishments' average 
line speed was approximately 12.49 percent faster than comparable 
establishments.\86\ This increase in line speed is synonymous with an 
increase in industrial efficiency. To quantify the benefit associated 
with this efficiency gain, this analysis used the North American Meat 
Institutes' (NAMI's) average pork packer margins for 2013-2017, which 
was reported to be $15.20 \87\ per head in NAMI's 2017 Meat and Poultry 
Facts.\88\ The pork packer margin is the price the packer receives less 
the cost of the hog and production costs, making it an estimate for 
accounting profits. However, economic profit may be more precisely 
associated with producer surplus. Economic profit is equal to the 
establishment's revenues minus its implicit and explicit costs. 
Implicit costs are costs establishments do not spend money on, such as 
opportunity costs, while explicit costs are costs establishments spend 
money on, such as labor or hogs. Accounting profits can be larger than 
economic profits because they exclude some implicit costs. FSIS 
requested, but did not receive, comment on refining this estimate so as 
to distinguish between accounting profit and economic profit.
---------------------------------------------------------------------------

    \86\ USDA FSIS Evaluations--HACCP Inspection Models Project 
(HIMP) for Market Hogs https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/haccp/haccp-based-inspection-models-project/evaluations-+himpAccessedon1/6/2017. Last updated on 11/14/
2014.
    \87\ Note that the increase in benefits as compared to the 
proposed rule is due to updating the margin used from NAMI's 2015 
Meat and Poultry Facts to NAMI's 2017 Meat and Poultry Facts. The 
proposed rule used a five-year average of $4.10 (2010-2014) per 
head, with a low of a $2.85 (2012) per head loss to a $11.49 (2010) 
per head gain. While the Final Rule uses a five-year average of 
$15.20 (2013-2017) per head, with a low of a $4.50 (2013) per head 
gain to a $25.26 (2017) per head gain.
    \88\ Nalivka, J.S., The 2017 Meat and Poultry Facts, NAMI August 
2018.
---------------------------------------------------------------------------

    By using accounting profits to estimate producer surplus, this 
analysis multiplied the change in quantity produced by half the per 
head margin, which is $7.60 ($15.20/2). This approach assumes that 
marginal costs increases as a function of quantity produced and that 
the marginal cost curve is linear, in which case the profit margin 
reaches zero for the last unit produced.
    Assuming establishments increase their production by 12.49 percent 
and that this increased production has an average packer margin of 
$7.60 per head, an average large establishment's surplus could increase 
by approximately $3.78 million, while an average small high-volume 
establishment's surplus could increase by $0.34 million, all else being 
equal. Combined, such an increase in efficiency at all 35 
establishments will increase producer surplus by roughly $87.64 million 
\89\ (22 x $3.78 million + 13 x $0.34 million), which has an annualized 
benefit of roughly $66.93 million, assuming a 3 percent discount rate 
over 10 years, Table 19. This estimate takes into consideration the 
assumed five-year adoption rate. However, this increase in surplus may 
be an overestimate given that an increase in line speeds may change 
market hog prices, establishment production costs, retail prices, and 
export volumes. Additionally, this analysis does not account for a 
change in consumer surplus, which will be conditional on how an 
increase in line speed affects retail prices. The Agency sought, but 
did not receive, comment on the extent to which such an increase in 
line speeds will affect market hog prices, establishment hours of 
production, consumer prices, and export volumes.
---------------------------------------------------------------------------

    \89\ Note, some of the totals may not equal the sum due to 
rounding.

                                   Table 19--Industrial Efficiency, (Benefits)
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                                                                 Change in producer  surplus
                  Type of establishment                        Number of    ------------------------------------
                                                            establishments    Per establishment      Combined
----------------------------------------------------------------------------------------------------------------
Large....................................................                22              ($3.78)        ($83.26)
Small....................................................                13               (0.34)          (4.38)
Combined *...............................................                35  ...................         (87.64)
----------------------------------------------------------------------------------------------------------------
                                                    Totals *
----------------------------------------------------------------------------------------------------------------
Recurring Cost..................................................................................         (87.64)
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.....................................         (66.93)
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.....................................         (64.32)
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.


[[Page 52336]]

    The five HIMP establishments have demonstrated that establishments 
operating under the NSIS are able to increase their compliance with 
sanitation SOPs and HACCP regulations, lower their level of non-food 
safety defects, achieve equivalent or better Salmonella verification 
testing rates, and lower the level of violative chemical residues.\90\ 
The five establishments that participated in the HIMP pilot study 
account for 15 percent of total swine production.
---------------------------------------------------------------------------

    \90\ USDA FSIS Evaluations--HACCP Inspection Models Project 
(HIMP) for Market Hogs https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/haccp/haccp-based-inspection-models-project/evaluations-+himpAccessedon1/6/2017. Last updated on 11/14/
2014.
---------------------------------------------------------------------------

    Additionally, the NSIS increases the Agency's ability to conduct 
more process and product verification and to increase monitoring of 
humane handling procedures, which is expected to improve animal 
welfare. FSIS inspectors devoted approximately 5.33 hours per shift to 
verifying humane handling activities for the Humane Activity Tracking 
System, HATS, categories in HIMP market hog establishments compared to 
approximately 4.29 hours per shift in the 21 non-HIMP market hog 
comparison establishments.\91\ Under the NSIS, establishments sort, 
remove, and identify swine unfit for slaughter before FSIS ante-mortem 
inspection. More FSIS resources can be devoted to offline inspection 
activities because initial sorting and tagging functions are performed 
by establishment personnel. This change will provide Agency personnel 
with more time to conduct offline inspection activities.
---------------------------------------------------------------------------

    \91\ USDA FSIS Evaluations--HACCP Inspection Models Project 
(HIMP) for Market Hogs https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/haccp/haccp-based-inspection-models-project/evaluations-+himpAccessedon1/6/2017. Last updated on 11/14/
2014.
---------------------------------------------------------------------------

I. Potential Budgetary Impacts on the Agency

    Under the final rule, FSIS will shift Agency resources from online 
to offline activities. This analysis estimates how such a shift will 
reduce labor expenses by approximately $6.67 million annually, Table 
20. However, Agency personnel at NSIS establishments will require 
additional training, the annualized cost of which is estimated to be 
approximately $0.30 million. Both annualized estimates apply a 3 
percent discount rate over 10 years and takes into consideration the 
assumed five-year adoption period. The Agency will also update PHIS to 
allow establishments to enter information on animals removed from the 
slaughter process. This modernization process will likely cost FSIS 
approximately $300,000 but will be paid for using existing Agency 
funds. Details of these costs are provided below.
1. Agency Staffing
    The following section discusses the impact on the Agency's budget 
due to reassignment of the inspection staff. As discussed in section F 
of this document, under traditional inspection, a single slaughter line 
at a large establishment requires up to 11 FTEs, while a small market 
hog establishment requires up to 2 FTEs. Under NSIS, a single slaughter 
line at a large establishment will potentially require 6 FTEs, while a 
small market hog establishment will potentially to require 3 FTEs. 
Under NSIS, large establishments with 2 slaughter lines will 
potentially require 10 FTEs,\92\ while a small market hog establishment 
with 2 slaughter lines will potentially require 4 FTEs.
---------------------------------------------------------------------------

    \92\ The difference in staffing between large establishments 
with 1 and 2 lines is because the Agency does not anticipate 
duplicating offline FTEs per line.
---------------------------------------------------------------------------

    This analysis considers likely staffing changes at the 22 large and 
13 small establishments which will potentially convert to NSIS over a 
course of five years. Combined, these establishments operate 46 shifts 
and 55 lines.\93\ This analysis uses PHIS data provided by the Office 
of Field Operations (OFO) to calculate the number of FTEs assigned to 
each slaughter line. The FSIS Office of the Chief Financial Officer 
(OCFO) provided the wage and benefit data for each of these positions. 
This data was used to model the staffing changes in terms of both full- 
time positions and monetary value. Based on this data, to conduct 
traditional inspection, the Agency requires a combined 365 (334 at 
large and 31 at small establishments) FTE food or consumer safety 
inspectors at an annual cost of approximately $30.43 million, Table 20. 
If all 22 large non-HIMP and 13 small high-volume market hog only 
establishments convert to the NSIS, the Agency will require 218 (187 at 
large and 31 at small establishments) FTE food or consumer safety 
inspectors. This number was arrived at by assuming that under NSIS each 
of the 41 lines at the large establishments will have up to 3 FTEs 
assigned to them and each of the 32 shifts at the large establishments 
will have up 2 FTEs assigned to them ((41 lines x 3 FTEs) + (32 shifts 
x 2 FTEs) = 187 FTEs). Likewise, under NSIS, the 13 small 
establishments will each require between 2-3 FTEs, based on 
configuration, for a total of 31 FTEs. These staffing levels are based 
on FSIS's experience at HIMP establishments. The combined labor costs 
for NSIS is approximately $21.70 million, Table 20. This cost estimate 
includes estimated grade increases associated with converting to the 
NSIS. As is shown in Table 20, if all 22 large establishments convert 
to NSIS, this analysis estimates a net decrease of 147 (334-187) FTEs 
required for slaughter line inspection. The NSIS inspection program at 
these large establishments has a remuneration value of just over $18.58 
million. A similar analysis of the 13 small high-volume establishments 
reveals no net change in the number of FTEs. However, because the NSIS 
requires all inspectors to be CSIs, many of the FTEs will likely be 
promoted from a FI to a CSI. Overall, if all 35 establishments 
converted to NSIS, the Agency will require 147 fewer FTEs for swine 
slaughter inspection, with potential annual decrease in costs of 
roughly $8.73 million, which is equal to roughly $6.67 million a year, 
assuming a 3 percent discount rate and the assumed five-year adoption 
period, Table 20.
---------------------------------------------------------------------------

    \93\ The 22 large establishments operate 41 slaughter lines 
during 32 shifts, while the 13 small establishments operate 14 lines 
during 14 shifts, source PHIS.

[[Page 52337]]



                                                     Table 20--Potential Changes in Agency Staffing
                                                                          [M$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Traditional                        NSIS                   Increases (reductions)
                                                         -----------------------------------------------------------------------------------------------
                          Type                                Number                          Number                          Number
                                                             positions     Labor  costs      positions     Labor  costs      positions     Labor  costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large...................................................             334          $27.56             187          $18.58           (147)         ($8.98)
Small...................................................              31           $2.87              31           $3.12               0            0.25
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total...............................................             365          $30.43             218          $21.70           (147)          (8.73)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Totals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recurring Cost..........................................................................................................................          (8.73)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.............................................................................          (6.67)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.............................................................................          (6.42)
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Since 2008, the Agency has annually lost, through attrition, 270 
food inspectors on average. See Table 21 for details. The Agency plans 
to utilize all personnel made available as a result of conversion to 
NSIS to fill these vacant positions.

              Table 21--Annual Turnover of Food Inspectors
------------------------------------------------------------------------
                                                             Number of
                       Fiscal year                           positions
------------------------------------------------------------------------
2008....................................................             307
2009....................................................             264
2010....................................................             231
2011....................................................             268
2012....................................................             266
2013....................................................             246
2014....................................................             273
2015....................................................             305
Average.................................................             270
------------------------------------------------------------------------
Source: OFO.

2. Agency Training
a. Three Day NSIS Methods Course
    If all 22 large and 13 small market hog establishments convert to 
NSIS over the course of five years, as set forth in Table 6, the Agency 
estimated training 266 personnel (218 CSIs and 48 PHVs), with pay 
grades ranging from GS-8 to GS-13, on NSIS methods. The majority of 
these personnel, 228, are associated with 22 large establishments, 
while the remaining 38 are associated with 13 small establishments, 
Table 22. The associated one-time cost of such training includes labor 
and travel expenses associated with the employees receiving training, 
as well as temporary replacement labor costs required to fulfill the 
work that would have been completed by the employees receiving 
training. Based on the HIMP pilot study, this analysis assumes NSIS 
methods training will take 3 days and replacement labor will be 
equivalent to GS-13 step 5. Under these assumptions, the total one-time 
cost of NSIS training is approximately $0.64 million ($0.56 million for 
all large establishments and $0.08 million for all small 
establishments), Table 22. This one-time cost equals approximately 
$0.07 million if it were annualized over 10 years under a 3 percent 
discount rate, Table 22.

                                    Table 22--Three Day NSIS Training Course
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                          Cost of trainee                Replacement labor
                                 ----------------------------------------------------------------
                                     Number of       Costs of        Number of       Costs of
      Type of establishment         inspectors       wages and      replacement      wages and    Combined costs
                                     requiring     benefits for     inspectors     benefits for
                                     training        trainees        required      replacements
----------------------------------------------------------------------------------------------------------------
Large...........................             228           $0.21             228           $0.34           $0.56
Small...........................              38            0.03              38            0.06            0.08
----------------------------------------------------------------------------------------------------------------
                                                    Totals *
----------------------------------------------------------------------------------------------------------------
One-Time Cost...................................................................................            0.64
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.....................................            0.07
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.....................................            0.07
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.


[[Page 52338]]

b. Fill an Increase Need for Consumer Safety Inspectors
    Under the final rule, slaughter line inspectors at a NSIS 
establishment will work both on and off the slaughter line. As such, 
every inspection position will fall under the CSI position 
classification. To fill the increase in demand for CSIs, the Agency 
plans to train existing FIs. Training includes a four-week meat 
inspector course titled Inspection Methods (IM) and a one-day computer 
familiarization course. If all 22 large establishments convert to NSIS, 
the Agency will need an additional 82 CSIs. Likewise, if all 13 small 
market hog establishments convert, the Agency will need an additional 
16 CSIs. Converting a FI into a CSI may result in a grade increase, the 
cost of which has been included in the Agency Staffing section above. 
The combined one-time cost for converting FIs into CSIs is roughly 
$2.16 million, Table 23. Nearly half of this cost stems from the need 
for replacement labor. Again, under the projected five-year adoption 
rate, as set forth in Table 6, and annualized over 10 years under a 3 
percent discount rate, the cost for converting FIs to CSIs is 
approximately $0.23 million, Table 23.

                 Table 23--Cost of Converting a Food Inspector Into a Consumer Safety Inspector
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                                               Labor
               Training component                -------------------------------- Travel,  M&IE,     Combined
                                                      Trainee       Replacement    and  lodging        costs
----------------------------------------------------------------------------------------------------------------
Four Week IM Course.............................           $0.52           $0.98           $0.59           $2.09
One Day Computer Training.......................            0.03            0.05  ..............            0.07
----------------------------------------------------------------------------------------------------------------
                                                    Totals *
----------------------------------------------------------------------------------------------------------------
One-Time Cost...................................................................................            2.16
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.....................................            0.23
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.....................................            0.25
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.

Combined Estimated Budgetary Impacts
    The Agency's budget will potentially be impacted both by changes to 
personnel and training requirements. First, on average, there will be 
fewer Agency inspection personnel per slaughter line operating under 
NSIS. If all 22 large and 13 small establishments convert to NSIS over 
the course of five years, the Agency will require approximately 147 
fewer FTEs to inspect the 55 \94\ slaughter lines operating at these 
establishments. The annual remuneration value of these 147 positions is 
roughly $8.73 million, Table 24. Second, the Agency will need to train 
approximately 266 personnel on NSIS methods at a one-time cost of 
approximately $0.64 million, Table 24. Third, the Agency plans to meet 
the increase in demand for CSIs by converting existing FIs into CSIs. 
The one-time cost of doing so is approximately $2.16 million, Table 24. 
The annualized value of the combined changes to the Agency's budget is 
a net reduction of roughly $6.38 million, over 10 years assuming a 3 
percent discount rate, Table 24.
---------------------------------------------------------------------------

    \94\ Source: PHIS.

               Table 24--Combined Changes to FSIS's Budget
                                  [M$]
------------------------------------------------------------------------
                                                    Total costs
                                         -------------------------------
                                             One-time        Recurring
------------------------------------------------------------------------
Changes to Agency Staffing..............  ..............         ($8.73)
Three Day NSIS Training.................           $0.64  ..............
Converting Food Inspectors into Consumer            2.16  ..............
 Safety Inspectors......................
------------------------------------------------------------------------
                                 Totals
------------------------------------------------------------------------
One-Time Cost...........................................            2.80
------------------------------------------------------------------------
Recurring Cost..........................................          (8.73)
------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10             (6.38)
 Years..................................................
------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10             (6.09)
 Years..................................................
------------------------------------------------------------------------

J. Net Benefits

    Assuming all high-volume large and small exclusively market hog 
establishments convert to NSIS (5 HIMP, 22 large, and 13 small high-
volume), the rule is anticipated to have a net benefit of approximately 
$62.56 million a year, annualized over 10 years assuming a 3 percent 
discount rate, Table 25. The majority of the costs will be incurred by 
the 35 non-HIMP establishments that will potentially voluntarily switch 
to the NSIS in the form of increased labor needs.

[[Page 52339]]



                                       Table 25--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 were not estimated to incur any cost 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.

    Given the lack of data with which to make cost-benefit comparisons 
across the industry, Table 26 provides a range of possible adoption 
scenarios and their corresponding costs and benefits. Under scenario A, 
only the 5 HIMP establishments adopt the NSIS. Because these 5 
establishments are already operating under NSIS practices, there will 
not be any additional voluntary costs or benefits associated with these 
5 establishments adopting the NSIS. However, 606 establishments will 
incur costs associated with the final rule's mandatory components. As 
such, scenario A has a net cost. Scenario B assesses the net cost and 
benefits of just 6 establishments adopting the NSIS (5 HIMP and 1 
large). This scenario reveals that the rule is net beneficial if just 1 
large establishment adopts the NSIS in addition to the 5 HIMP 
establishments. Scenarios C, D, and E measure the net costs and 
benefits of 50, 75, and 100 percent of the 35 non-HIMP establishments 
converting to the NSIS, respectively. Each of these scenarios are net 
beneficial.

                                           Table 26--Quantified Cost and (Benefits) of Various Adoption Rates
                                                                     [M$] [supcaret]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Costs                                 (Benefits)
                                            Number to   ---------------------------------------------------------------------------------
                                             adopt *       Mandatory @                                                                          Net
                                                                              NSIS           Health        Line speeds    Agency budget
--------------------------------------------------------------------------------------------------------------------------------------------------------
A......................................               5           $0.84            $0.0            $0.0            $0.0             $0.0           $0.84
B......................................               6            0.84            0.86          (0.27)          (3.78)           (0.38)          (2.73)
C......................................              23            0.84            8.34          (3.59)         (33.34)           (3.14)         (30.90)
D......................................              32            0.84           13.08          (5.52)         (51.51)           (4.88)         (47.99)
E......................................              40            0.84            17.0          (7.09)         (66.93)           (6.38)         (62.56)
--------------------------------------------------------------------------------------------------------------------------------------------------------
* These numbers include the 5 HIMP establishments. However, because these establishments are already conducting NSIS practices, they did not contribute
  to quantified NSIS costs, health benefits, or the impacts to the Agency's budget.
@These costs are incurred by all 612 swine establishments.
[supcaret] Annualized Assuming a 3% Discount Rate Over 10 Years
* Note, some of the totals may not equal the sum due to rounding.

K. Alternatives

[[Page 52340]]

[GRAPHIC] [TIFF OMITTED] TR01OC19.000

BILLING CODE 3410-DM-C

A--Taking No Action (Baseline)

    FSIS considered maintaining the current inspection system for all 
612 swine slaughter establishments. The Agency rejected this 
alternative because it would forgo the benefits provided by the NSIS. 
These benefits include the establishment's ability to innovate and 
develop process controls which increase foodborne hazard detection and 
more efficiently use all their resources. Taking no action would also 
forgo potential industrial efficiency increases.

[[Page 52341]]

Further, no action would result in the Agency continuing to dedicate 
resources to food quality issues, at the expense of increasing offline 
activities benefitting food safety. Last, taking no action would also 
forgo potential health benefits identified under the final rule.

B--The Mandatory Portion of the Final Rule

    FSIS considered limiting the final rule to only include new 
requirements that affect all swine slaughter establishments. Under such 
a scenario, quantified benefits are limited to an estimated $0.57 
million reduction in process control sampling costs. This cost 
reduction will potentially be off-set by a $1.41 million increase in 
other industry costs associated with requiring written sanitary 
dressing plans. In comparison to the baseline, this scenario has a net 
cost of roughly $0.84 million. Additionally, under such a scenario, the 
Agency's inspection staff would not be reassigned, and the Agency would 
continue to require the same number of inspectors. As such, the 
Agency's labor costs would not decrease by the estimated $6.67 million. 
However, because FIs would not be converted into CSIs nor will 
inspectors require additional training, the Agency would not incur the 
corresponding $0.30 million in training costs ($0.07 for NSIS training 
plus $0.23 in CSI training). As mentioned earlier, simultaneously 
increasing unscheduled and scheduled inspection procedures and 
decreasing scheduled but not performed procedures accrues most of the 
public health benefits. The unscheduled and scheduled tasks are 
currently not performed as a result of lack of offline personnel. In 
comparison to the final rule, this alternative would eliminate most of 
the public health benefits associated with the rule, which are 
estimated at $7.09 million annually. Additionally, line speed 
restrictions would remain in place, leading to an estimated loss of 
over $36.14 million in industrial efficiency gains. FSIS has rejected 
this alternative in light of its estimated net cost as compared to the 
baseline as well as the decrease in net benefits as compared to the 
final rule.

C--The Final Rule

    Applying a 3 percent discount rate over 10 years the costs 
associated with the final rule includes $16.61 million in additional 
industry labor costs, $1.80 million in other industry costs including 
costs associated with meeting ready to cook standards and written 
sanitary dressing plans, as well as $0.30 million in Agency training 
costs. The quantified health benefits of the final rule are limited to 
reductions in Salmonella illnesses and have an estimated value of $7.09 
million, assuming a 3 percent discount rate. Allowing establishments to 
set line speeds so long as they maintain process control will 
potentially increase their efficiency by $66.93 million, assuming a 3 
percent discount rate. The final rule could potentially reduce industry 
costs associated with process control sampling by roughly $0.57 
million, assuming a 3 percent discount rate. Additionally, the final 
rule could potentially reduce the Agency's labor costs by roughly $6.67 
million, assuming a 3 percent discount rate. In comparison to the 
baseline, the final rule has an estimated net benefit of $62.56 
million, assuming a 3 percent discount rate over 10 years, and as such, 
the Agency recommends the final rule.

D--Requiring All Federally Inspected Establishments Adopt the New Swine 
Inspection System

    FSIS considered requiring all federally inspected swine slaughter 
establishments to convert to NSIS. This would expand NSIS from the 5 
large HIMP, 22 large and 13 small high-volume non-HIMP establishments 
expected to convert under the final rule to include 572 additional 
establishments. This expansion would include low-volume establishments 
that slaughter all types of swine as well as other establishments that 
slaughter a mix of species.
    In comparison to the baseline, the benefits of this alternative 
potentially include more than $7.09 million in averted illnesses, a 
$66.93 million increase in industrial efficiency, $0.57 million in 
industrial savings associated with process control sampling 
requirements, assuming a 3 percent discount rate over 10 years. While 
compared to the baseline, this alternative reduces Agency labor costs 
by $2.72 million, assuming a 3 percent discount rate over 10 years. 
However, this alternative's Agency labor costs savings are less than 
the final rule's Agency labor costs savings because this alternative 
would result in additional promotions and training in small and very 
small establishments. The production at these 572 additional 
establishments represents less than 8 percent of total production and, 
as such, is not expected to return substantial reductions in 
contamination prevalence or illnesses and falls outside of the current 
risk assessment. In particular, the uncertainty around measurement and 
model parameters that is already included in the health benefit 
calculations for the final rule likely produce wide enough estimates 
that the impact of adopting the NSIS in all establishments would have 
an effect within the uncertainty bounds. The increase in industrial 
efficiency remains similar to that of the final rule because these 
additional establishments are generally less automated and maintain 
slower line speeds to address higher rates of quality defects 
associated with non-market hogs.
    In comparison to the baseline, the potential costs associated with 
this alternative include a $25.90 million increase in industrial labor, 
a $3.14 million increase in other industry costs, which include costs 
associated with RTC standards and written sanitary dressing plans, as 
well as roughly $0.68 million in Agency training costs. In comparison 
to the final rule, the additional increases in costs to industry are 
substantially higher and predominately fall on small and very small 
business. While this alternative has a net benefit of $47.59 million, 
assuming a 3 percent discount rate over 10 years, the Agency rejects it 
because its net benefit is less than the final rule.

IV. Regulatory Flexibility Act Assessment

    The FSIS Administrator has made a determination that this final 
rule will not have a significant economic impact on a substantial 
number of small entities in the United States, as defined by the 
Regulatory Flexibility Act (5 U.S.C. 601 et seq.). FSIS used an 
establishment's HACCP processing size, which applies to an individual 
establishment, as a proxy for business size. HACCP processing sizes are 
the following: large establishments have 500 or more employees; small 
establishments have between 10 and 499 employees; very small 
establishments have fewer than 10 employees or annual sales of less 
than $2.5 million. Section III provides additional details on costs 
incurred by small businesses.
    The final rule's mandatory requirements will affect approximately 
584 small entities--105 small and 479 very small. First, the mandatory 
requirements include that all small and very small establishments 
create written sanitary dressing plans with cost components of 
development of the plan, training of employees, and recordkeeping, at 
an annualized cost of $1,869 per establishment, applying a 3 percent 
discount rate over 10 years. Second, the mandatory changes to process 
control sampling requirements could potentially decrease small 
establishments' sampling costs by roughly $984 per establishment 
annually, applying a 3 percent discount

[[Page 52342]]

rate over 10 years. In addition to this sampling cost reduction, the 
Agency will allow small and very small low-volume establishments to 
modify their sampling plans to collect samples less frequently once 
they have collected 13 consecutive weekly samples and can demonstrate 
that they are not exceeding their upper control limit and that they are 
effectively maintaining process control. FSIS is also allowing 
establishments to develop sampling plans that are more tailored to 
their specific operation, and thus more effective in monitoring their 
specific process control as compared to the current generic E. coli 
criteria. Therefore, the final rule's mandatory requirements could 
potentially increase small establishments' costs by roughly $885 
($1,869-$984 = $885) per establishment annually, an amount that will 
potentially have little effect on small entities. To put this in 
perspective, the average small and very small establishment slaughters 
over 21,000 swine annually. Using the American Meat Institute's average 
pork packer dollars per head margins for 2013-2017, the average small 
and very small establishment's marginal revenue is $332 thousand 
(21,858 (heads slaughtered) x $15.20 (average margin per head)). The 
final rule also provides small and very small establishments with 
additional time to comply with the new requirements in 9 CFR 310.18(c) 
and (d). Additionally, the optional NSIS portion of the rule could 
potentially provide an overall cost savings for the 13 small high-
volume establishments of roughly $288,731 per establishment that adopts 
the NSIS. This estimate takes into consideration the increase in labor 
cost ($42,025 per establishment), cost associated with meeting RTC 
standards ($6,300 per establishments) and cost savings from increased 
industrial efficiency ($337,056 per establishment). See section III for 
additional details.

V. Executive Order 13771

    Consistent with E.O. 13771 (82 FR 9339, February 3, 2017), FSIS 
estimates that this final rule will yield cost savings. Assuming a 7 
percent discount rate, a perpetual time horizon, and a starting year of 
2019, the final rule is estimated to yield approximately $51.91 million 
(2016$) in annual cost savings, not including potential health 
benefits. Therefore, this rule is an E.O. 13771 deregulatory action.

VI. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the Office of Information and Regulatory Affairs designated this rule 
as not a ``major rule,'' as defined by 5 U.S.C. 804(2).

VII. E-Government Act

    FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things, 
promoting the use of the internet and other information technologies 
and providing increased opportunities for citizen access to Government 
information and services, and for other purposes.

VIII. Executive Order 12988, Civil Justice Reform

    This rule has been reviewed under E.O. 12988, Civil Justice Reform. 
Under this rule: (1) All State and local laws and regulations that are 
inconsistent with this rule will be preempted; (2) no retroactive 
effect will be given to this rule; and (3) no administrative 
proceedings will be required before parties may file suit in court 
challenging this rule.

IX. Executive Order 13175

    This rule has been reviewed in accordance with the requirements of 
E.O. 13175, Consultation and Coordination with Indian Tribal 
Governments. E.O. 13175 requires Federal agencies to consult and 
coordinate with Indian tribes on a government-to-government basis on 
policies that have tribal implications, including regulations, 
legislative comments or proposed legislation, and other policy 
statements or actions that have substantial direct effects on one or 
more Indian tribes, on the relationship between the Federal Government 
and Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes.
    The USDA's Office of Tribal Relations (OTR) has assessed the impact 
of this rule on Indian tribes and determined that this rule has minimal 
tribal implications. If an Indian tribe requests consultation, FSIS 
will work with the OTR to ensure meaningful consultation is provided.

X. USDA Nondiscrimination Statement

    No agency, officer, or employee of the USDA must, on the grounds of 
race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed on-line at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.
    Fax: (202) 690-7442.
    Email: [email protected].
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

XI. Environmental Impact

    Each USDA agency is required to comply with 7 CFR part 1b of the 
Departmental regulations, which supplements the National Environmental 
Policy Act regulations published by the Council on Environmental 
Quality. Under these regulations, actions of certain USDA agencies and 
agency units are categorically excluded from the preparation of an EA 
or an EIS unless the agency head determines that an action may have a 
significant environmental effect (7 CFR 1b.4 (b)). FSIS is among the 
agencies categorically excluded from the preparation of an EA or EIS (7 
CFR 1b.4 (b)(6)).
    Establishments that operate under NSIS will be able to slaughter 
and process swine more efficiently than is possible under current 
regulations, leading to a reduction in production costs. FSIS expects 
that consumer demand for pork products will determine the number of 
swine slaughtered rather than production costs. Because of the 
efficiencies in the NSIS, the price of pork products may decrease. The 
predicted price reduction could lead to a slight increase in demand for 
pork products. With the slight increase in pork product sales, some 
establishments may choose to increase the number of swine slaughtered, 
which could result in an increase in the number of condemned carcasses 
and parts that must be disposed of. However, because the anticipated 
change in price and sales is very small, especially in comparison to 
changes in price and sales in response to other market forces, the 
Agency has determined that the change in the

[[Page 52343]]

number of swine slaughtered, as well as the number of condemned 
carcasses and parts to be disposed of, will be very small and thus will 
not have a significant individual or cumulative effect on the human 
environment. Therefore, this regulatory action is appropriately subject 
to the categorical exclusion from the preparation of an EA or EIS 
provided under 7 CFR 1b.4(b)(6) of the USDA regulations.

XII. Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection and 
recordkeeping requirements included in this final rule have been 
submitted by the Agency to OMB for approval which has not yet been 
received. FSIS will collect no information associated with this rule 
until the information collection is approved by OMB.
    Title: Swine Slaughter Inspection.
    Type of Collection: New.
    Abstract: FSIS updated the proposed rule's information collection 
assessment to reflect the changes made in the final rule in response to 
public comments and to better align it with the final cost estimates in 
section III. FSIS is also requiring a new information collection burden 
but has reduced the total annual burden estimate by 52,729.04 hours. 
The changes to the final burden estimates incorporate the following 
factors:
     FSIS is requiring a new information collection burden; 
specifically, the Agency is requiring market hog slaughter 
establishments operating under NSIS to maintain records to document the 
total number of animals and carcasses sorted and removed per day and 
the reasons for their removal.
     The proposed mandatory pre-operational environmental 
sampling was removed from the final rule. Therefore, these time 
estimates were removed from the final burden estimates.
     Establishments operating under SIP conduct process control 
sampling at an alternative frequency. Therefore, these 11 
establishments have been removed from the final burden estimates.
     The final burden estimates only include the time to record 
the sample results for the new process control sampling requirements.
     The final burden estimates were updated so that the 
establishment and time estimates align with the final cost analysis in 
section III.

New Information Collection in This Final Rule

    FSIS is requiring a new regulation that will create a new 
information collection burden, in that it will require market hog 
slaughter establishments operating under NSIS 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 estimates this new 
requirement will take establishments operating under NSIS, 5 minutes 
per shift regardless of whether establishments complete the form or 
submit the information electronically. This is a new recordkeeping 
requirement that FSIS has submitted to OMB for approval.
Estimated Annual Recordkeeping Burden for Maintaining Records to 
Document the Total Number of Animals and Carcasses Sorted and Removed 
per Day and the Reasons for Their Removal
    Respondents: Official market hog slaughter establishments that 
operate under NSIS.
    Estimated maximum number of respondents: 40.
    Estimated Average Annual Number of Responses per Respondent: Large 
establishments 352; small high-volume establishments 290.
    Estimated Maximum Total Potential Annual Responses: 13,282.
    Estimated Total Annual Recordkeeping Burden: 1,107 hours.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                              Average
                                                                             Estimated     annual number                     Time per
                Respondents                                                  number of     of responses    Total annual    response  in    Total annual
                                                                            respondents         per          responses        minutes      burden hours
                                                                                            respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large establishments......................  Animals and carcasses sorted              27             352           9,504               5             792
                                             and removed and their
                                             reasons.
Small high-volume establishments..........  Animals and carcasses sorted              13             290           3,770               5             314
                                             and removed and their
                                             reasons.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total Recordkeeping Burden for sorting  ............................              40             332          13,274               5           1,106
     and removing.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Under this final rule, establishments also will have to 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 under 9 CFR part 314. The requirement that 
swine slaughter establishments have written procedures in their HACCP 
systems is already covered under an approved information collection 
system, Pathogen Reduction/Hazard Analysis and Critical Control Point 
Systems (OMB control number 0583-0103). Therefore, this requirement of 
this final rule will create no new burden on establishments.
    Copies of this information collection assessment can be obtained 
from Gina Kouba, Office of Policy and Program Development, Food Safety 
and Inspection Service, USDA, 1400 Independence Avenue SW, Room 6065, 
South Building, Washington, DC 20250; (202)720-5627.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of FSIS's 
functions, including whether the information will have practical 
utility; (b) the accuracy of FSIS's estimate of the burden of the 
proposed collection of information, including the validity of the 
method and assumptions used; (c) ways to enhance the quality, utility, 
and clarity of the information to be collected; and (d) ways to 
minimize the burden of the collection of information, including through 
the use of appropriate automated, electronic, mechanical, or other 
technological

[[Page 52344]]

collection techniques, or other forms of information technology.
    Comments on the proposed information collection may be sent to both 
FSIS, at the addresses provided above, and the Desk Officer for 
Agriculture, Office of Information and Regulatory Affairs, Office of 
Management and Budget, Washington, DC 20253. To be most effective, 
comments should be sent within 60 days of the publication date of this 
final rule.

Information Collections That Were Included in the Proposed Rule

    Under this final rule, establishments operating under NSIS are 
required to (1) identify animals or carcasses that establishment 
personnel have sorted and removed for disposal before FSIS inspection 
with a unique tag, tattoo, or similar device, and to develop, 
implement, (2) maintain records to document the total number of animals 
and carcasses sorted and removed per day and the reasons for their 
removal, and (3) maintain records documenting that products resulting 
from their slaughter operations meet the new definition of RTC pork 
product. Furthermore, each establishment operating under the NSIS will 
also need to submit, on an annual basis, an attestation to the 
management member of the local FSIS circuit safety committee stating 
that it maintains a program to monitor and document any work-related 
conditions of establishment workers.
    In addition, each official swine slaughter establishment, 
regardless of the inspection system under which they operate, will need 
to maintain, as part of its HACCP system, written procedures for 
preventing, throughout the entire slaughter and dressing operation, 
contamination of carcasses and parts by enteric pathogens, and visible 
fecal material, ingesta, and milk. 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 mentioned above, the requirement that swine slaughter 
establishments have written procedures in their HACCP systems is 
already covered under an approved information collection system. 
Therefore, this requirement of this final rule will create no new 
burden on establishments.
    The requirement that swine slaughter establishments monitor their 
systems through microbial testing and recordkeeping will create a new 
information collection burden. For each sample on which a 
microbiological test is conducted, there is a ``response'' for the 
establishment to record the sample result. Under the final rule, large, 
small and very small high-volume establishments will test and record 
microbiological results for enteric pathogens, for carcass samples 
taken at both pre-evisceration and post-chill (for hot-boned products, 
carcass samples will be collected pre-evisceration and after the final 
wash), at a frequency of once per 1,000 carcasses; and small and very 
small low-volume establishments, 13 times a year. The small and very 
small low-volume establishments do not experience an increase in 
sampling under the final rule.
    Estimated Annual Recordkeeping Burden: Swine Slaughter Inspection.
    Respondents: Official high-volume swine establishments.
    Estimated Number of Respondents: 74 (17 large, 51 small high-
volume, and 6 very small high-volume).
    Estimated Average Annual Number of Responses (samples) per 
Respondent: Large establishments 3,869; small high-volume 
establishments 229; and very small high-volume establishments 52.
    Estimated Total Annual Responses: 77,764.
    Estimated Total Annual Recordkeeping Burden: 3,240 hours.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          Average annual
                                                                             Estimated       number of     Total annual      Time per      Total annual
                Respondents                                                  number of     responses per     responses      response in    burden hours
                                                                            respondents     respondent                        minutes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large establishments......................  Microbial testing data                    17           3,869          65,773             2.5           2,741
                                             recordkeeping.
Small high-volume establishments..........  Microbial testing data                    51             229          11,679             2.5             487
                                             recordkeeping.
Very small high-volume establishments.....  Microbial testing data                     6              52             312             2.5              13
                                             recordkeeping.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total Recordkeeping Burden for process      ............................              74           1,051          77,764             2.5           3,240
 control.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    FSIS is also requiring that market hog slaughter establishments 
operating under NSIS submit on an annual basis, an attestation to the 
management member of the local FSIS circuit safety committee stating 
that it maintains a program to monitor and document any work-related 
conditions of establishment workers.
    Estimated Annual Reporting Burden for Submitting an Annual 
Attestation on Work-Related Conditions to the FSIS Circuit. Safety 
Committee: Swine Slaughter Inspection.
    Respondents: Official market hog slaughter establishments that 
operate under NSIS.
    Estimated maximum number of respondents: 40.
    Estimated Average Annual Number of Responses per Respondent: Large 
establishments 1; small high-volume establishments 1.
    Estimated Maximum Total Potential Annual Responses: 40.
    Estimated Total Annual Recordkeeping Burden: 1.33 hours.

[[Page 52345]]



--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                              Average
                                                                             Estimated     annual number                     Time per
                Respondents                                                  number of     of  responses   Total annual     response in    Total annual
                                                                            respondents         per          responses        minutes      burden hours
                                                                                            respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large establishments......................  Attestation on Work-Related               27               1              27               2             .90
                                             Conditions.
Small high-volume establishments..........  Attestation on Work-Related               13               1              13               2             .43
                                             Conditions.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total Reporting Burden................  ............................              40               1              40               2            1.33
--------------------------------------------------------------------------------------------------------------------------------------------------------


              SUMMARY OF BURDEN Swine Slaughter Inspection
 [With the recordkeeping burden for maintaining records to document the
total number of animals and carcasses sorted and removed per day and the
                       reasons for their removal]
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Total Number Respondents................................              84
Average Annual Number Responses per Respondent..........        1,084.33
Total Annual Responses..................................          91,084
Average Hours per Response..............................            0.05
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total Annual Burden Hours...............................        4,347.33
------------------------------------------------------------------------


              SUMMARY OF BURDEN Swine Slaughter Inspection
  [Without the recordkeeping burden for maintaining records to document
the total number of animals and carcasses sorted and removed per day and
                     the reasons for their removal]
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Total Number Respondents................................              84
Average Annual Number Responses per Respondent..........          926.24
Total Annual Responses..................................          77,804
Average Hours per Response..............................            0.04
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total Annual Burden Hours...............................        3,241.33
------------------------------------------------------------------------

XIII. Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS web page located at: 
http://www.fsis.usda.gov/federal-register.
    FSIS will also announce and provide a link to it through the FSIS 
Constituent Update, which is used to provide information regarding FSIS 
policies, procedures, regulations, Federal Register notices, FSIS 
public meetings, and other types of information that could affect or 
would be of interest to our constituents and stakeholders. The 
Constituent Update is available on the FSIS web page. Through the web 
page, FSIS is able to provide information to a much broader, more 
diverse audience. In addition, FSIS offers an email subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls, export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves and have the option to password protect 
their accounts.

Final Regulatory Amendments

List of Subjects

9 CFR Part 301

    Meat inspection.

9 CFR Part 309

    Animal diseases, Meat inspection, Reporting and recordkeeping 
requirements.

9 CFR Part 310

    Animal diseases, Meat inspection.

    For the reasons stated in the preamble, FSIS is amending 9 CFR 
chapter III as follows:

PART 301--TERMINOLOGY; ADULTERATION AND MISBRANDING STANDARDS

0
1. The authority citation for part 301 is revised to read as follows:

    Authority:  7 U.S.C. 138-138i, 450, 1901-1906; 21 U.S.C. 601-
695; 7 CFR 2.7, 2.18, 2.53.


0
2. Amend Sec.  301.2 by adding the definition of ``Ready-to-cook (RTC) 
pork product'' in alphabetical order to read as follows:


Sec.  301.2  Definitions.

* * * * *
    Ready-to-cook (RTC) pork product. 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.
* * * * *

PART 309--ANTE-MORTEM INSPECTION

0
3. The authority citation for part 309 continues to read as follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.


0
4. Add Sec.  309.19 to read as follows:


Sec.  309.19  Market hog segregation under the new swine slaughter 
inspection system.

    (a) The establishment must conduct market hog sorting activities 
before the animals are presented for ante-mortem inspection. Market 
hogs exhibiting signs of moribundity, central nervous system disorders, 
or pyrexia must be disposed of according to paragraph (c) of this 
section.
    (b) The establishment must develop, implement, and maintain written 
procedures to ensure that market hogs exhibiting signs of moribundity, 
central nervous system disorders, or pyrexia do not enter the official 
establishment to be slaughtered. The establishment must incorporate 
these procedures into its HACCP plan, or sanitation SOPs, or other 
prerequisite programs.
    (c) The establishment must identify livestock that establishment 
employees have sorted and removed from slaughter with a unique tag, 
tattoo, or similar device. The establishment must develop, implement, 
and maintain written procedures to ensure that the animals sorted and 
removed from slaughter do not enter the human food supply and are 
disposed of according to 9 CFR part 314.
    (d) The establishment must maintain records to document the number 
of animals disposed of per day because they were removed from slaughter 
by establishment sorters before ante-mortem inspection by FSIS 
inspectors and the reasons that the animals were removed. These records 
are subject to review and evaluation by FSIS personnel.
    (e) The establishment must immediately notify FSIS inspectors if 
the establishment has reason to believe that market hogs may have a 
notifiable animal disease. Notifiable animal diseases are designated by 
World Animal Health Organization.

[[Page 52346]]

PART 310--POST-MORTEM INSPECTION

0
5. The authority citation for part 310 continues to read as follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.


0
6. Amend Sec.  310.1 by revising paragraph (b)(3) to read as follows:


Sec.  310.1  Extent and time of post-mortem inspection; post-mortem 
inspection staffing standards.

* * * * *
    (b) * * *
    (3) Swine inspection. There are two systems of post-mortem 
inspection: The New Swine Slaughter Inspection System (NSIS), which may 
be used for market hogs, and the traditional inspection system, which 
may be used for all swine.
    (i) The NSIS may be used for market hogs if the official 
establishment requests to use it and meets or agrees to meet the 
requirements in 9 CFR 309.19 and Sec.  310.26. The Administrator may 
permit establishments that slaughter classes of swine other than market 
hogs to use NSIS under a waiver from the provisions in 9 CFR 309.19 and 
Sec.  310.26 as provided by 9 CFR 303.1(h). The Administrator also may 
permit establishments that slaughter both market hogs and other classes 
of swine to slaughter the market hogs under NSIS and slaughter the 
other classes of swine under traditional inspection.
    (ii) Traditional inspection shall be used for swine when NSIS is 
not used. The following inspection staffing standards are applicable to 
swine slaughter configurations operating under traditional inspection 
when NSIS is not used. The inspection standards for all slaughter lines 
are based upon the observation rather than palpation, at the viscera 
inspection station, of the spleen, liver, heart, lungs, and mediastinal 
lymph nodes. In addition, for one- and two-inspector lines under 
traditional inspection, the standards are based upon the distance 
walked (in feet) by the inspector between work stations; and for three 
or more inspector slaughter lines, upon the use of a mirror, as 
described in Sec.  307.2(m)(6) of this chapter, at the carcass 
inspection station. Although not required in a one- or two-inspector 
slaughter configuration, except in certain cases as determined by the 
inspection service, if a mirror is used, it must comply with the 
requirements of Sec.  307.2(m)(6).

                    Table 1 to Paragraph (b)(3)--One Inspector--Staffing Standards for Swine
----------------------------------------------------------------------------------------------------------------
                                                             Maximum inspection rates (head per hour)
                                                 ---------------------------------------------------------------
                                                   Market hogs  (heads attached       Sows and boars  (heads
        Distance walked \1\ in feet is--                   or detached)                      detached)
                                                 ---------------------------------------------------------------
                                                  Without mirror    With mirror   Without mirror    With mirror
----------------------------------------------------------------------------------------------------------------
0 to 5..........................................             140             150             131             143
6 to 10.........................................             134             144             126             137
11 to 15........................................             129             137             122             132
16 to 20........................................             124             132             117             127
21 to 35........................................             120             127             113             122
26 to 30........................................             116             122             110             118
31 to 35........................................             112             118             106             114
36 to 40........................................             108             114             103             110
41 to 45........................................             105             110             100             106
46 to 50........................................             101             107              97             103
51 to 55........................................              98             103              94             100
56 to 60........................................              96             100              91              97
61 to 65........................................              93              97              89              94
66 to 70........................................              90              95              87              92
71 to 75........................................              88              92              85              89
76 to 80........................................              86              89              82              87
81 to 85........................................              84              87              80              85
86 to 90........................................              82              85              79              83
91 to 95........................................              80              83              77              81
96 to 100.......................................              78              81              75              79
----------------------------------------------------------------------------------------------------------------
\1\ Distance walked is the total distance that the inspector will have to walk between work stations during one
  inspection cycle (e.g., between viscera, carcass, head, and wash-basin).


                 Table 2 to Paragraph (b)(3)--Two Inspectors--Staffing Standards for Market Hogs
----------------------------------------------------------------------------------------------------------------
                                                                   Maximum inspection rates  (head per hour with
                                                                            heads attached or detached)
                                                                 -----------------------------------------------
                                                                                Line configuration
         Distance walked \1\ in feet by inspector B is--         -----------------------------------------------
                                                                    Carcass,\2\     Viscera,\2\      Head,\2\
                                                                   head viscera    head carcass       viscera
                                                                        \3\             \3\         carcass \3\
----------------------------------------------------------------------------------------------------------------
                                                 Without Mirror
----------------------------------------------------------------------------------------------------------------
0 to 5..........................................................         151-253         151-271         151-296
6 to 10.........................................................         151-239         151-255         151-277
11 to 15........................................................         151-226         151-240         151-260
16 to 20........................................................         151-214         151-227         151-244
21 to 25........................................................         151-204         151-215         151-231
----------------------------------------------------------------------------------------------------------------

[[Page 52347]]

 
                                                   With Mirror
----------------------------------------------------------------------------------------------------------------
0 to 5..........................................................         151-253         151-303         151-318
6 to 10.........................................................         151-239         151-283         151-304
11 to 15........................................................         151-226         151-265         151-289
16 to 20........................................................         151-214         151-249         151-270
21 to 25........................................................         151-204         151-235         151-254
----------------------------------------------------------------------------------------------------------------
\1\Distance walked is the total distance that Inspector B will have to walk between work stations during one
  inspection cycle (e.g., between viscera, carcass, and washbasin).
\2\Inspector A.
\3\Inspector B.
Note 1 to Table 2 to paragraph (b)(3): In multiple-inspector plants, the inspectors must rotate between all
  inspection positions during each shift to equalize the workload.


               Table 3 to Paragraph (b)(3)--Two Inspectors--Staffing Standards for Sows and Boars
----------------------------------------------------------------------------------------------------------------
                                                             Maximum inspection rates  (head per hour)
                                                 ---------------------------------------------------------------
                                                                        Line Configuration
                                                 ---------------------------------------------------------------
 Distance walked \1\ in feet by inspector B is--    Carcass,\2\     Viscera,\2\      Head,\2\        Head,\2\
                                                       head            head           viscera         viscera
                                                    viscera,\3\     carcass,\3\     carcass,\3\     carcass,\3\
                                                  heads detached  heads detached  heads detached  heads attached
----------------------------------------------------------------------------------------------------------------
                                                 Without Mirror
----------------------------------------------------------------------------------------------------------------
0 to 5..........................................         144-248         144-254         144-267         144-267
6 to 10.........................................         144-235         144-240         144-253         144-253
11 to 15........................................         144-222         144-227         144-239         144-239
16 to 20........................................         144-211         144-215         144-226         144-226
21 to 25........................................         144-201         144-205         144-214         144-214
----------------------------------------------------------------------------------------------------------------
                                                   With Mirror
----------------------------------------------------------------------------------------------------------------
0 to 5..........................................         144-248         144-292         144-305         144-292
6 to 10.........................................         144-235         144-273         144-291         144-280
11 to 15........................................         144-222         144-256         144-272         144-268
16 to 20........................................         144-211         144-241         144-255         144-255
21 to 25........................................         144-201         144-228         144-240         144-240
----------------------------------------------------------------------------------------------------------------
\1\Distance walked is the total distance that Inspector B will have to walk between work stations during one
  inspection cycle (e.g., between viscera, carcass, and washbasin).
\2\Inspector A.
\3\Inspector B.
Note 1 to table 3 to Paragraph (b)(3): In multiple-inspector plants, the inspectors must rotate between all
  inspection positions during each shift to equalize the workload.


               Table 4 to paragraph (b)(3)--Three Inspectors or More--Staffing Standards for Swine
----------------------------------------------------------------------------------------------------------------
                                                                  Number of inspectors by station
  Maximum inspection rates  (head per hour with  ---------------------------------------------------------------
                 heads attached)                       Head           Viscera         Carcass          Total
----------------------------------------------------------------------------------------------------------------
Market hogs:
319 to 506......................................               1               1               1               3
507 to 540......................................               1               2               1               4
541 to 859......................................               2               2               1               5
860 to 1,022....................................               2               3               1               6
1,023 to 1,106..................................               3               3               1               7
Sows and boars:
306 to 439......................................               1               1               1               3
306 to 462 \1\..................................               1               1               1               3
440 to 475......................................               2               1               1               4
476 to 752......................................               2               2               1               5
753 to 895......................................               3               2               1               6

[[Page 52348]]

 
896 to 964......................................               3               3               1               7
----------------------------------------------------------------------------------------------------------------
\1\This rate applies if the heads of sows and boars are detached from the carcasses at the time of inspection.
Note 1 to table 4 to paragraph (b)(3): In multiple-inspector plants, the inspectors must rotate between all
  inspection positions during each shift to equalize the workload.


0
7. Amend Sec.  310.18 by adding paragraphs (c) and (d) to read as 
follows:


Sec.  310.18  Contamination of carcasses, organs, or other parts.

* * * * *
    (c) Official swine slaughter establishments must develop, 
implement, and maintain written procedures to prevent contamination of 
carcasses and parts by enteric pathogens, and visible fecal material, 
ingesta, and milk contamination throughout the entire slaughter and 
dressing operation. Establishments must incorporate these procedures 
into their HACCP plans, or sanitation SOPs, or other prerequisite 
programs. These procedures must include sampling and analysis for 
microbial organisms in accordance with the sampling location and 
frequency requirements in paragraphs (c)(1) and (2) of this section to 
monitor their ability to maintain process control.
    (1) Sampling locations. Official swine slaughter establishments, 
except for very low-volume establishments, must collect and analyze 
carcass samples for microbial organisms at the pre-evisceration and 
post-chill points in the process. Establishments that slaughter more 
than one type of livestock must test the type of livestock slaughtered 
in the greatest number. Establishments that bone their products before 
chilling (i.e., hot-boned products) must collect and analyze samples at 
the pre-evisceration point in the process and after the final wash 
instead of at post-chill. Very low-volume establishments must collect 
and analyze samples for microbial organisms at the post-chill point in 
the process. All swine establishments must sponge or excise tissue from 
the ham, belly, and jowl areas.
    (i) Very low-volume establishments annually slaughter no more than 
20,000 swine, or a combination of swine and other livestock not 
exceeding 6,000 cattle and 20,000 total of all livestock.
    (ii) [Reserved]
    (2) Sampling frequency. Establishments, except for very low-volume 
establishments as defined in paragraph (c)(1)(i) of this section, must 
collect and analyze samples at a frequency proportional to the 
establishment's volume of production at the following rates:
    (i) Establishments, except for very low-volume establishments as 
defined in paragraph (c)(1)(i) of this section, must collect and 
analyze samples at a frequency of once per 1,000 carcasses, but a 
minimum of once during each week of operation.
    (ii) Very low-volume establishments as defined in paragraph 
(c)(1)(i) of this section must collect and analyze samples at least 
once during each week of operation starting June 1 of every year. If, 
after consecutively collecting 13 weekly samples, very low-volume 
establishments can demonstrate that they are effectively maintaining 
process control, they may modify their sampling plans.
    (iii) Establishments must maintain accurate records of all test 
results and retain these records as provided in paragraph (d) of this 
section.
    (d) Official swine slaughter establishments must maintain daily 
records sufficient to document the implementation and monitoring of the 
procedures required under this section. Records required by this 
section may be maintained on computers if the establishment implements 
appropriate controls to ensure the integrity of the electronic data. 
Records required by this section must be maintained for at least one 
year and must be accessible to FSIS.


Sec.  310.25  [Amended]

0
8. Amend Sec.  310.25 as follows:
0
a. Remove paragraph (a)(2)(ii)(C);
0
b. Remove the undesignated sentence following paragraph (a)(2)(iii)(A);
0
c. Remove ``20,000 swine,'' in paragraph (a)(2)(v)(A);
0
d. In paragraph (a)(5):
0
i. Redesignate Table 1 as Table 1 to paragraph (a)(5); and
0
ii. In newly redesignated Table 1 to paragraph (a)(5), remove the entry 
for ``swine'';
0
e. In paragraph (b)(1):
0
i. Remove ``in Table 2'' and add ``in Table 1 to this paragraph'' in 
its place;
0
ii. Redesignate Table 2 as Table 1 to paragraph (b)(1); and
0
iii. In newly redesignated Table 1 to paragraph (b)(1), remove the 
entries for ``Hogs'' and ``fresh pork sausages'' and footnote (b).

0
9. Add Sec.  310.26 to read as follows:


Sec.  310.26  Establishment responsibilities under the new swine 
slaughter inspection system.

    (a) Facilities. The establishment must comply with the facilities 
requirements in 9 CFR part 307. The establishment must provide a mirror 
at the carcass inspection station in accordance with 9 CFR 307.2(m)(6).
    (b) Carcass sorting and disposition. The establishment must conduct 
carcass sorting activities and identify any condemnable conditions or 
defects before carcasses are presented to online inspectors. 
Establishment sorters must incise mandibular lymph nodes and palpate 
the viscera to detect the presence of animal diseases as part of their 
sorting activities. The establishment must develop, implement, and 
maintain written procedures to ensure that market hog carcasses 
adulterated with septicemia, toxemia, pyemia, or cysticercosis are 
properly removed before the point of post-mortem inspection of 
carcasses. The establishment must incorporate these procedures into its 
HACCP plan, or sanitation SOPs, or other prerequisite program. These 
procedures must cover the establishment sorting activities required 
under this section.
    (c) Line speed limits. The line speed limits in Sec.  310.1 do not 
apply to the establishment, provided it is able to maintain effective 
process control and prevent contamination of carcasses and parts by 
enteric pathogens and visible fecal material, ingesta, and milk. 
Establishments operating under the NSIS must reduce their line speed as 
directed by the Inspector-in-Charge (IIC). The IIC is authorized to 
direct an establishment to operate at a reduced line speed when in 
their judgment a carcass-by-carcass inspection cannot be adequately 
performed within the time available due to the manner in which the 
carcasses are presented to the online inspector, the health conditions 
of a particular herd, or factors that may indicate a loss of process 
control.
    (d) Records. (1) The establishment must maintain records to 
document that

[[Page 52349]]

the products resulting from its slaughter operation meet the definition 
of Ready-to-cook pork product in Sec.  301.2. These records are subject 
to review and evaluation by FSIS personnel.
    (2) The establishment must maintain records to document the number 
of carcasses disposed of per day by establishment sorters before FSIS 
post-mortem inspection and the reasons that the carcasses were disposed 
of. These records are subject to review and evaluation by FSIS 
personnel.

0
10. Add Sec.  310.27 to read as follows:


Sec.  310.27  Attestation requirements.

    Each establishment that participates in the NSIS must submit on an 
annual basis an attestation to the management member of the local FSIS 
circuit safety committee stating that it maintains a program to monitor 
and document any work-related conditions of establishment workers, and 
that the program includes the following elements:
    (a) Policies to encourage early reporting of symptoms of injuries 
and illnesses, and assurance that it has no policies or programs in 
place that would discourage the reporting of injuries and illnesses.
    (b) Notification to employees of the nature and early symptoms of 
occupational illnesses and injuries, in a manner and language that 
workers can understand, including by posting in a conspicuous place or 
places where notices to employees are customarily posted, a copy of the 
FSIS/OSHA poster encouraging reporting and describing reportable signs 
and symptoms.
    (c) Monitoring, on a regular and routine basis, injury and illness 
logs, as well as nurse or medical office logs, workers' compensation 
data, and any other injury or illness information available.

0
11. Add Sec.  310.28 to read as follows:


Sec.  310.28  Severability.

    Should a court of competent jurisdiction hold any provision of 
Sec.  310.27 to be invalid, such action will not affect any other 
provision of 9 CFR part 309 or this part.

    Done in Washington, DC.
Carmen M. Rottenberg,
Administrator.
[FR Doc. 2019-20245 Filed 9-30-19; 8:45 am]
BILLING CODE 3410-DM-P