Modernization of Swine Slaughter Inspection, 4780-4823 [2018-01256]

Download as PDF 4780 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules 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 Food Safety and Inspection Service, USDA. ACTION: Proposed rule. AGENCY: The Food Safety and Inspection Service (FSIS) is proposing to amend the Federal meat inspection regulations to establish a new inspection system for market hog slaughter establishments that has been demonstrated to provide public health protection at least equivalent to the existing inspection system. Market hog slaughter establishments that do not choose to operate under the new swine inspection system may continue to operate under their existing inspection system. The Agency is also proposing several changes to the regulations that would affect all establishments that slaughter any swine, regardless of the inspection system under which they operate or the age, size, or class of swine. These proposed changes would allow all swine slaughter establishments to develop sampling plans that are more tailored to their specific operations, and thus be more effective in monitoring their specific process control. These proposed changes also would ensure that before the start of slaughter operations, food-contact surfaces are sanitary and free of enteric pathogens. DATES: Comments must be received on or before April 2, 2018. ADDRESSES: FSIS invites interested persons to submit comments on this rule. Comments may be submitted by one of the following methods: • Federal eRulemaking Portal: This website provides the ability to type short comments directly into the comment field on this web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for submitting comments. • Mail, including CD–ROMs, etc.: Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, Patriots Plaza 3, 1400 Independence Avenue SW, Mailstop 3782, Room 8–163A, Washington, DC 20250–3700. • Hand- or courier-delivered submittals: Deliver to Patriots Plaza 3, srobinson on DSK9F5VC42PROD with PROPOSALS2 SUMMARY: VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 355 E Street SW, Room 8–163A, Washington, DC 20250–3700. Instructions: All items submitted by mail or electronic mail must include the Agency name and docket number FSIS– 2016–0017. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to http:// www.regulations.gov. Docket: For access to background documents or comments received, go to the FSIS Docket Room at Patriots Plaza 3, 355 E Street SW, Room 8–164, Washington, DC 20250–3700, between 8:00 a.m. and 4:30 p.m., Monday through Friday. FOR FURTHER INFORMATION CONTACT: Roberta Wagner, Assistant Administrator, Office of Policy and Program Development; Telephone: (202) 205–0495. SUPPLEMENTARY INFORMATION: Executive Summary FSIS began experimenting with new approaches to slaughter inspection based on Hazard Analysis and Critical Control Point Systems (HACCP) principles shortly after publishing the Pathogen Reduction/HACCP rule in 1996. In 1997, the Agency developed the HACCP-Based Inspection Models Project (HIMP) study to determine whether applying new Government slaughter inspection procedures, along with new plant responsibilities, could promote innovation and provide at least the same food safety and consumer protection. FSIS initiated the HIMP study in 20 young chicken, five young turkey, and five market hog establishments on a waiver basis. In 2014, the Agency amended the poultry products inspection regulations to establish a new optional inspection system for young chicken and all turkey slaughter establishments informed by the Agency’s experiences under HIMP (79 FR 49566, August 21, 2014). The New Poultry Inspection System (NPIS) was designed to facilitate pathogen reduction in poultry products, improve the effectiveness of poultry slaughter inspection, make better use of the Agency’s resources, and remove unnecessary regulatory obstacles to innovation. The risk model employed to assess the potential impact of the NPIS modeled scenarios involving an increase in targeted inspection activities (specifically unscheduled offline inspection activities). The results of this model, constructed on the assumption that the number of offline procedures performed in poultry establishments under the NPIS would increase PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 proportionally to the number observed in HIMP establishments, suggested that implementing the NPIS would likely result in public health benefits, in the form of fewer poultry-associated foodborne Salmonella illnesses per year. Consistent with the underlying assumptions of the model, it is reasonable to conclude that inspection systems in which Agency resources are used to continue core online inspection activities while enhancing the frequency and focus of unscheduled offline activities directly related to food safety, such as HIMP and the NPIS, would likely result in a lower prevalence of carcasses contaminated with Salmonella, which in turn would likely lead to fewer human illnesses. In addition to establishing the NPIS for young chickens and turkeys, FSIS also amended the poultry products inspection regulations that apply to all establishments that slaughter poultry other than ratites. The new requirements ensure that all poultry slaughter establishments implement appropriate measures in their HACCP plans, sanitation standard operating procedures (sanitation SOPs), or other prerequisite programs (hereafter referred to as their ‘‘HACCP systems’’) to prevent contamination of carcasses and parts by enteric pathogens and visible fecal material throughout the entire slaughter operation, and ensure that both FSIS and establishments have the documentation they need to verify the effectiveness of these measures on an ongoing basis. FSIS is now proposing to amend the Federal meat inspection regulations to establish a new optional inspection system for market hog slaughter establishments, the New Swine Slaughter Inspection System (NSIS), informed by the Agency’s experiences under HIMP. FSIS is proposing this new inspection system to facilitate pathogen reduction in pork products; improve compliance with the HMSA; improve the effectiveness of market hog slaughter inspection; make better use of the Agency’s resources; and remove unnecessary regulatory obstacles to innovation by revoking maximum line speeds and allowing establishments flexibility to reconfigure evisceration lines. If establishment personnel sorted and removed unfit animals before antemortem inspection and trimmed and identified defects on carcasses and parts before post-mortem inspection by FSIS inspectors, FSIS inspectors would be presented with healthier animals and carcasses that have fewer defects to inspect, which would allow inspectors to conduct a more efficient and effective inspection of each animal and each E:\FR\FM\01FEP2.SGM 01FEP2 srobinson on DSK9F5VC42PROD with PROPOSALS2 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules carcass. Such a system would allow FSIS inspectors to conduct a more efficient inspection. As a result, FSIS could assign fewer inspectors to online inspection, freeing up Agency resources to conduct more offline inspection activities that FSIS has determined are more effective in ensuring food safety, such as verifying compliance with sanitation, HACCP, and humane handling requirements. Key elements of the proposed NSIS include: (1) Requiring establishment personnel to sort and remove unfit animals before ante-mortem inspection by FSIS and to trim and identify defects on carcasses and parts before postmortem inspection by FSIS; (2) requiring establishment personnel to identify animals or carcasses that they have sorted and removed for disposal before FSIS inspection with a unique tag, tattoo, or similar device and immediately denature all major portions of the carcass on-site, and maintain records to document the total number of animals and carcasses sorted and removed per day; (3) requiring establishment personnel to immediately notify FSIS inspectors if they suspect an animal or carcass with a reportable or foreign animal disease (e.g., African swine fever, classical swine fever, or Nipah virus encephalitis) while conducting sorting activities; (4) shifting Agency resources to conduct more offline inspection activities that are more effective in ensuring food safety, which would allow for up to two offline verification inspectors per line per shift and would reduce the number of online inspectors to a maximum of three per line per shift; (5) requiring establishments to maintain records documenting that products resulting from their slaughter operations meet the new proposed definition of Ready-tocook (RTC) pork product, which would be defined as any slaughtered pork product free from bile, hair, scurf, dirt, hooves, toe nails, claws, bruises, edema, scabs, skin lesions, icterus, foreign material, and odor which is suitable for cooking without need of further processing; and (6) revoking maximum line speeds and authorizing establishments to determine their own line speeds based on their ability to maintain process control for preventing fecal contamination and meeting microbial performance measures during the slaughter operation. FSIS projects that the new system is unlikely to result in a higher prevalence of Salmonella on market hog carcasses and may even result in a lower prevalence of Salmonella on market hog carcasses, which in turn may lead to fewer human VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 illnesses. In addition, the new system should improve animal welfare and compliance with the Humane Methods of Slaughter Act (HMSA) because more FSIS resources will be available to verify humane handling as an offline activity. Under the proposed rule, market hog slaughter establishments that do not choose to operate under the NSIS may continue to operate under their existing inspection system (hereafter referred to as ‘‘traditional inspection’’). As mentioned above, NSIS provides public health protection at least equivalent to traditional inspection. FSIS recognizes that some establishments may not be prepared to make the investment in facilities and labor needed to convert to NSIS. In addition, many small, very low volume establishments slaughter more than one type of livestock species and the facilities updates need to convert to the proposed NSIS may not accommodate the slaughter of livestock other than market hogs. Therefore, FSIS is proposing to give establishments the flexibility to operate under the system that is best suited to their operations. FSIS is also proposing several changes that would affect all establishments that slaughter swine, regardless of the inspection system under which they operate. FSIS is proposing to require that all official swine slaughter establishments develop, implement, and maintain in their HACCP systems written procedures to prevent the contamination of carcasses and parts by enteric pathogens, fecal material, ingesta, and milk throughout the entire slaughter and dressing operation. These procedures must include sampling and analysis for microbial organisms to monitor process control for enteric pathogens, as well as written procedures to prevent visible fecal material, ingesta, and milk contamination. FSIS is proposing to prescribe a minimum frequency with which establishments would be required to collect two samples, one at preevisceration and one at post-chill (i.e., the point in the slaughter process after the carcass has chilled in the cooler and after all slaughter interventions are completed), or, for very small and very low volume establishments, a single post-chill sample. FSIS considers the microbial load of hog carcasses at preevisceration to be a valuable source of data about how well an establishment is taking into account the sanitary condition of live hogs coming to slaughter and the processing steps (i.e., washing, dehairing) they implement to reduce the external contamination of the carcass prior to evisceration. FSIS also considers the microbial characteristics PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 4781 of hog carcasses post-chill (after all processing steps have taken place) to be a valuable source of data about how well an establishment is minimizing contamination during chilling as well as the overall effectiveness of all process control interventions the establishment has chosen to apply throughout its production process. Because most establishments apply one or more interventions between the preevisceration and post-chill sampling points to help control microbiological hazards, FSIS would expect that a reduction in microbiological contamination between these two sampling points to be an indication of the effectiveness of those controls. Under the proposed rule, establishments, except for very small and very low volume establishments, would be required to collect preevisceration and post chill samples at a frequency of once per 1,000 carcasses. Very small and very low volume establishments would be required to collect at least one sample during each week of operation each year. If, after consecutively collecting 13 weekly samples, very small and very low volume establishments can demonstrate that they are effectively maintaining process control, they can modify their sampling plans to collect samples less frequently. FSIS is proposing to allow very small and very low volume establishments to collect and analyze samples for microbial organisms at the post-chill point in the process only because these establishments typically are less automated and run at slower line speeds than larger establishments. The lower level of automation and the slower line speeds require less complicated measures for maintaining and monitoring process control on an ongoing basis. These proposed frequencies reflect the frequencies prescribed under the existing regulations for generic Escherichia coli (E. coli) testing. FSIS is proposing to remove the current requirement that swine establishments test carcasses for generic E. coli to monitor process control and to remove the codified Salmonella pathogen reduction performance standards for swine and replace them with the new testing requirements described above. The new testing requirements would allow establishments to develop sampling plans that are more tailored to the specific establishment, and thus more effective in monitoring their specific process control than the current generic E. coli criteria. FSIS is proposing to allow establishments to substitute alternative sampling locations if they are able to E:\FR\FM\01FEP2.SGM 01FEP2 4782 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules demonstrate that the alternative sampling locations are able to provide a definite improvement in monitoring process control than at pre-evisceration and post-chill. FSIS interprets ‘‘definite improvement’’ to mean any improvement of equipment, substances, methods, processes, or procedures affecting the slaughter of livestock and poultry or processing of meat, poultry, or egg products. FSIS is also proposing to allow establishments to substitute alternative sampling frequencies if they are able to demonstrate that the alternative is an integral part of the establishments’ verification procedures for their HACCP plans and are able to provide a definite improvement in monitoring process control than at the prescribed frequency. FSIS is requesting comments on the proposed sampling requirements, particularly the incremental value (from both a processimprovement and public health standpoint) of pre-evisceration sampling over what is provided by post-chill sampling. Finally, FSIS is proposing to require that all official swine slaughter establishments develop, implement, and maintain in their HACCP systems written procedures to prevent contamination of the pre-operational environment by enteric pathogens. The pre-operational environment comprises food contact surfaces, reuse water, and equipment, including knives, in edible food production departments before slaughter operations begin. These procedures would need to include sampling and analysis of food-contact surfaces in the pre-operational environment for microbial organisms to ensure that the surfaces are sanitary and free of enteric pathogens. The sampling frequency would need to be adequate to monitor the establishment’s ability to maintain sanitary conditions in the pre- operational environment. Please see the draft compliance guide for additional information about implementation of this provision. FSIS is proposing this requirement as a direct result of a recent outbreak of foodborne illness associated with a hog slaughter establishment where food contact surfaces were found to be contaminated with the outbreak strain. FSIS is requesting comments on this proposed sampling requirement and the extent to which interventions in the pre-operational environment are needed to ensure food safety. In Table 1 below, FSIS presents the estimated costs and benefits of the proposed rule. Later portions of the regulatory impact analysis section contain explanation of the assumptions, alternative adoption scenarios, and a discussion of the uncertainty surrounding the net benefits associated with how much of the industry would choose to adopt NSIS. TABLE 1—NET COSTS AND (BENEFITS) [M$] Number of establishments One-time ........................ ** 40 612 ........................ ........................ ........................ $3.88 0.84 3.03 ........................ ........................ 2.80 $22.65 22.17 0.48 (9.33) (47.33) (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 ...................................................................................... $6.68 (42.75) (31.77) (30.40) Costs To Industry ........................................................................................................................ Voluntary * ............................................................................................................................. Mandatory ............................................................................................................................. Potential Health Benefits *** ........................................................................................................ Industrial Efficiency ...................................................................................................................... Impacts to Agency’s Budget ........................................................................................................ Recurring * Further explanation and details on the NSIS adoption rate are provided in section G. Expected Cost of the Proposed Rule, Table 6: NSIS Adoption Rate and section J. Net Benefits, Table 28: Quantified Cost and (Benefits) of Various Adoption Rates. ** Note, this includes 5 HIMP establishments, which are not expected to incur any costs or benefits associated with the NSIS. *** Further explanation and details on the range of health benefits have been provided in section H. Expected Benefits Associated With Public Health, Table 20: Health Benefits from Averted Cases of Salmonella. The value of health benefits ranges from $0.19 million to $18.97 million, with a mean of $9.33 million. srobinson on DSK9F5VC42PROD with PROPOSALS2 Statutory Authority FSIS inspects and regulates the production of meat and meat food products prepared for distribution in commerce under the authority of the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.). The FMIA provides that the Secretary shall cause to be made by inspectors an examination and inspection of all amenable species before they enter into any establishment in which they are to be slaughtered and the meat and meat food products thereof are to be used in commerce (21 U.S.C. 603(a)). All amenable species found to show symptoms of disease are to be set apart and slaughtered separately; the carcasses of such animals are to be subject to a careful inspection (21 U.S.C. VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 603(a)). The FMIA requires that the livestock be slaughtered and handled in connection with slaughter in a manner that is consistent with the HMSA (21 U.S.C. 603(b)). Under the HMSA, the handling of livestock in connection with slaughter must be carried out only by humane methods (7 U.S.C. 1902). The FMIA also requires inspectors to conduct a post-mortem examination and inspection, and any necessary reinspection, of carcasses and parts of amenable species prepared for human food (21 U.S.C. 604). The FMIA requires that all carcasses and parts found to be adulterated be condemned (21 U.S.C. 604). Under the FMIA, a meat or meat food product is adulterated, among other circumstances, if it bears or PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 contains any poisonous or deleterious substance that may render it injurious to health; it is unhealthful, unwholesome, or otherwise unfit for human consumption; it was prepared, packaged, or held under insanitary conditions whereby it may have been rendered injurious to health; or if damage or inferiority has been concealed in any manner (21 U.S.C. 601(m)(1), (3), (4), and (8)). Finally, 21 U.S.C. 621 provides that the Secretary shall make such rules and regulations as are necessary for the efficient execution of the provisions of the FMIA. FSIS regulations and inspection programs are designed to verify that livestock are handled and slaughtered humanely, and that meat and meat food products are E:\FR\FM\01FEP2.SGM 01FEP2 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules unadulterated, wholesome, and properly marked, labeled, and packaged. srobinson on DSK9F5VC42PROD with PROPOSALS2 Table of Contents of Proposed Rule Discussion I. Background A. Traditional Market Hog Slaughter Inspection Under Existing Regulations 1. Description of the Inspection System Under Existing Regulations 2. Need for Modernization B. Regulations for Microbiological Testing Under Traditional Inspection 1. Generic E. Coli Criteria for Measuring Process Control 2. Salmonella Pathogen Reduction/HACCP Performance Standards C. Waivers of Regulatory Requirements 1. Waivers to Test New Technology 2. Salmonella Initiative Program Waivers II. Consideration of Need for a New Swine Slaughter Inspection System A. Early Development of the Inspection Models Program B. Existing HACCP-Based Inspection Models Program C. U.S. General Accountability Office (GAO) and the USDA’s Office of the Inspector General (OIG) Reports on HIMP D. Analysis of HIMP 1. FSIS Evaluation of HIMP a. Overview of the HIMP Report b. Verification by Offline Inspectors of the Establishment Executing Its HIMP Process Control Plan Under Which Establishment Employees Sort Acceptable and Unacceptable Carcasses and Parts c. Verification of the Establishment Executing Its HACCP System Under 9 CFR Parts 416 and 417 d. Verification of the Outcomes of the Establishment Process Control Plan, Both Organoleptic and Microbiologic e. Conclusion of HIMP Report f. Verification of Humane Handling E. Public Health Benefits Projected From Allocating More Inspection Resources to Food Safety-Related Inspection Activities 1. Market Hog Risk Assessment 2. Model 3. Conclusions of the Market Hog Risk Assessment III. Proposed NSIS A. Live Market Hog Sorting by Establishment Personnel B. Post-Mortem Carcass Sorting by Establishment Employees and Online Carcass Inspection C. Offline Verification Inspection D. RTC Pork Product E. Line Speeds Under NSIS IV. Other Proposed Changes That Affect All Swine Slaughter Establishments A. Procedures To Address Enteric Pathogens, Fecal Material, Ingesta, and Milk Contamination as Hazards Reasonably Likely to Occur V. Implementation VI. Executive Orders 12866 and 13563 A. Request for Comments Summary B. Need for the Rule C. Overview of the Market D. Overview of the Proposed Rule’s NSIS VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 E. Overview of the Proposed Rule’s Mandatory Components F. Overview of the Proposed Rule’s Agency Impact G. Expected Cost of the Proposed Rule 1. Costs Associated With the NSIS Components of the Rule a. Costs of Additional Establishment Workers b. Costs of Capital Improvements: Line Configuration and Inspection Stations c. Costs of Developing Ante-Mortem Written Procedures d. Ready-to-Cook Standards 2. Costs Associated With the Mandatory Components of the Rule a. Costs of Developing, Composing, Training, Monitoring, Recording, and Verifying Written Sanitary Dressing Plans b. Process Control Sampling and Analysis for Microbial Organisms c. Environmental Sampling H. Expected Benefits of the Proposed Rule 1. Expected Benefits Associated With Public Health 2. Other Benefits Associated With Modernizing Existing Regulations I. Expected Budgetary Impacts 1. Agency Staffing 2. Agency Training J. Net Benefits K. Alternatives VII. Regulatory Flexibility Act Assessment VIII. E-Government Act IX. Executive Order 12988, Civil Justice Reform X. Executive Order 13175 XI. USDA Nondiscrimination Statement XII. Environmental Impact XIII. Paperwork Reduction Act XIV. Additional Public Notification XV. Proposed Regulatory Amendments I. Background A. Traditional Market Hog Slaughter Inspection Under Existing Regulations 1. Description of the Inspection System Under Existing Regulations Under the existing regulations for traditional inspection, FSIS antemortem inspectors examine all market hogs for visible signs of condemnable diseases or conditions while they are at rest and in motion (see 9 CFR part 309). FSIS ante-mortem inspectors direct establishment personnel to set apart animals showing signs of condemnable diseases or conditions into separate ‘‘U.S. Suspect’’ pens for further examination by the FSIS Public Health Veterinarian (PHV). The FSIS PHV determines whether the animals shall be identified as ‘‘U.S. Condemned’’ and disposed of in accordance with 9 CFR 309.13 (9 CFR 309.2). Most establishments under traditional inspection that slaughter only market hogs voluntarily segregate animals that show signs of diseases or conditions from healthy animals before the Agency performs ante-mortem inspection (see PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 4783 FSIS Directive 6100.1, Ante-mortem Livestock Inspection available at http:// www.fsis.usda.gov/wps/wcm/connect/ 2b2e7adc-961e-4b1d-b5937dc5a0263504/6100.1.pdf ?MOD=AJPERES). Market hog establishment personnel segregate animals that appear to be normal and healthy from abnormal or unhealthy animals that appear to have condemnable diseases or conditions (e.g., animals exhibiting signs of neurologic conditions, pyrexia, or severe lameness) into ‘‘subject’’ pens, where they are subject to additional FSIS inspection. FSIS requires these establishments to document their segregation procedures in their HACCP plans or prerequisite programs. FSIS inspectors examine all animals found by the establishment to be normal at rest, and five to ten percent of those animals in motion. If any animals exhibit signs of condemnable conditions, FSIS inspectors direct establishment employees to move the animals to the ‘‘U.S. Suspect’’ pens for final disposition by the FSIS PHV. The FSIS PHV examines all animals in the ‘‘subject’’ pens, and directs establishment employees to move animals to ‘‘U.S. Suspect’’ pens for final disposition. FSIS inspectors observe establishment employees performing segregation procedures at least once per month. Because establishment employees are responsible for identifying and removing market hogs that are not fit for slaughter before FSIS ante-mortem inspection, FSIS inspectors are presented with healthier animals that are more likely to pass inspection. Therefore, under the voluntary segregation procedures, FSIS inspectors are able to conduct a more efficient and effective ante-mortem inspection to determine whether each animal is fit for slaughter. During post-mortem inspection at all market hog slaughter establishments, FSIS online inspectors inspect the head, viscera, and carcass of each animal for localized defects and direct establishment employees to remove the defects through trimming (9 CFR 310.1(b)(3)). FSIS online inspectors perform manual incisions, palpations, and other organoleptic inspections (i.e., using sight, smell, and touch) to detect signs of disease or contamination. In large establishments, up to seven online inspectors are assigned per line per shift to cover inspection stations for the head, viscera, and carcass at fixed points along the slaughter and evisceration line. In small or very small establishments, one inspector may perform all of the post-mortem E:\FR\FM\01FEP2.SGM 01FEP2 srobinson on DSK9F5VC42PROD with PROPOSALS2 4784 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules inspection procedures on each animal. FSIS online inspectors identify and retain carcasses and parts with visible animal diseases and conditions. The FSIS PHV thoroughly examines retained carcasses and parts to determine whether they should be condemned; establishment personnel then dispose of condemned carcasses under FSIS supervision in accordance with 9 CFR part 314. Under the existing regulations for traditional inspection, establishments conduct no post-mortem carcass sorting to identify which carcasses and parts appear eligible to bear the mark of inspection, which carcasses and parts contain removable defects correctable through trimming, and which carcasses and parts should be submitted to FSIS for condemnation because of generalized diseases or conditions. These sorting functions are conducted by establishment personnel under HIMP. Rather, the existing regulations for traditional inspection require establishments to assign competent assistants to take such actions as directed by FSIS online inspectors after the inspectors have conducted the initial sorting activities (see 9 CFR 307.2(g)). Therefore, under the existing regulations for traditional inspection, establishments rely on FSIS online inspectors to effectively control and direct their processing. Moreover, because FSIS online inspectors are responsible for identifying unacceptable carcasses and parts, it takes online inspectors more time to conduct a carcass-by-carcass inspection than would be necessary if establishments sorted carcasses and parts, trimmed dressing defects and contamination that do not impact the FSIS inspectors’ ability to assess the fitness of the carcass or part, and identified pathology defects, before the carcasses and parts were inspected. More FSIS resources also could be devoted to offline inspection activities if initial sorting and tagging functions were performed by establishment personnel. Under the existing regulations, only FSIS inspectors may direct the application and removal of ‘‘U.S. Condemned’’ tags from animals and carcasses condemned by FSIS inspectors on ante-mortem and postmortem inspection (9 CFR 309.13 and 310.5). The tag must remain on the carcass until it goes into the tank, or the carcass is otherwise disposed of in accordance with 9 CFR part 314. Establishments are required to denature condemned carcasses and parts if they do not have tanking facilities and the carcasses and parts are to be rendered or otherwise disposed of off-site (see 9 CFR VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 314.3). FSIS inspectors enter the number on each ‘‘U.S. Condemned’’ tag into the Public Health Information System (PHIS). Under the existing regulations, most ‘‘U.S. Condemned’’ tags are applied during ante-mortem inspection to animals that arrive dead. Because FSIS inspectors are responsible for removing all of the ‘‘U.S. Condemned’’ tags and documenting each ‘‘U.S. Condemned’’ tag number into PHIS, it takes inspectors more time to complete ante-mortem and postmortem inspections than it would if establishments sorted and removed these animals before FSIS inspection and maintained records that could be verified by FSIS, as appropriate, and reported their daily totals to FSIS inspectors. In addition to the post-mortem inspection activities conducted by online inspectors, offline inspectors conduct additional food safety related activities such as verifying that establishments’ processing meets their HACCP critical limits and verifying whether sanitation SOPs are effective. 2. Need for Modernization Modernization of market hog slaughter inspection is necessary because traditional inspection was developed before FSIS issued its HACCP regulations, and before the Agency began targeting its resources to address public health risks associated with foodborne pathogens. Traditional inspection obscures the proper roles of industry and inspection personnel by assigning to FSIS inspectors responsibility for sorting acceptable animals from unacceptable animals, finding carcass defects, identifying production control problems for the establishment, and verifying corrective actions in addition to determining whether the carcasses meet regulatory requirements. Additionally, traditional inspection requires FSIS to allocate significant inspection personnel resources towards online inspection activities in large and high volume market hog establishments to detect quality defects and conditions that present minimal food safety risks, thus limiting the resources available for offline inspection activities such as verifying the effectiveness of HACCP plans and sanitation SOPs. FSIS has concluded, based on the Agency’s analysis of the market hog HIMP pilot (discussed in more detail below), conducting more offline activities will be more effective in ensuring food safety and humane handling verification tasks. Traditional inspection requires inspectors to conduct time-intensive ante-mortem and post-mortem sorting PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 activities. This necessitates FSIS to allocate significant personnel resources to conduct activities that are more appropriately the responsibility of the establishment. As a result, traditional inspection limits line speeds, even if establishments can demonstrate that they are able to produce safe, unadulterated, wholesome products at more efficient rates. It also limits large and high volume market hog slaughter establishments’ incentive to improve their processing methods and to develop more efficient slaughter and dressing technologies. For example, under traditional inspection, the maximum line speed authorized for slaughter lines with one or two inspectors is partially based upon the distance walked (in feet) by the inspector between work stations to conduct the sorting activities mentioned above (see 9 CFR 310.1(b)(3)). For slaughter lines with three or more inspectors, line speeds may also depend on whether FSIS online inspectors observe the back of the carcasses by looking in a mirror or whether they must turn the carcass to observe the back of the carcass (see 9 CFR 310.1(b)(3)). The maximum line speed under the existing regulations for market hogs is 1,106 head per hour (hph) with seven online inspectors. Establishments determine their line speeds based on their equipment, size and condition of the animals, and their ability to maintain process control when operating at a given line speed. Additionally, traditional inspection restricts establishments’ ability to reconfigure and consolidate lines if they determine that they need more space to conduct other activities in their facilities. For example, establishments slaughtering 1,025 market hogs per hour must configure their evisceration lines to accommodate three online head inspectors, three online viscera inspectors, and one online carcass inspector. The regulations require that establishments provide an inspection station consisting of five feet of unobstructed line space for each head or carcass inspector and, for viscera table kills, eight feet for each viscera inspector on the inspector’s side of the table (9 CFR 307.2 (m)(1)). As a result, the current regulations for traditional inspection prevent large and high volume market hog slaughter establishments from consolidating inspection stations or otherwise reconfiguring their evisceration lines in order to make room for more innovative, automated equipment such as head dropping equipment, bung equipment (which separates digestive and urinary organs from pelvic attachments), E:\FR\FM\01FEP2.SGM 01FEP2 srobinson on DSK9F5VC42PROD with PROPOSALS2 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules eviscerating equipment, and back saws. Traditional inspection is generally sufficient for low volume establishments and for establishments that slaughter classes of swine other than market hogs because these establishments typically are less automated and run at slower line speeds than larger establishments. Additionally, traditional inspection was developed when visually detectable animal diseases such as pneumonias, erysipelas, hog cholera, cystercercosis, parasites, and arthritis were more prevalent and considered to be more of a concern than they are today. The line speed limits prescribed under traditional inspection reflect the Agency’s previous focus on the detection of visible defects and animal diseases and do not give establishments the flexibility to address these conditions before presenting the carcasses and parts to FSIS inspectors. Traditional inspection focuses substantial FSIS resources on detecting visible trim and dressing defects that are not directly related to food safety, particularly in light of what is now known about the role microbial contamination plays in causing foodborne human illness. The traditional inspection model needs to be updated in light of the significant advances that have been made in the control or eradication of many animal diseases that were more prevalent and were considered to present a greater concern when the existing inspection systems were designed, particularly in generally healthy classes of animals such as market hogs. Moreover, the analysis in FSIS’s ‘‘Assessment of the Potential Change in Human Health Risk Associated with Modernizing Inspection of Market Hog Slaughter Establishments’’ (hereafter referred to as the market hog risk assessment) conducted by FSIS suggests a statistically significant correlation between increased scheduled and unscheduled offline inspection procedures and a reduction in the prevalence of Salmonella in market hog establishments. Projecting out illness reductions based on reduction in Salmonella prevalence in 35 plants results in wide uncertainty, but the model confidently estimates that the level of protection from Salmonella illnesses would be at least as good as the current system. Based on these results, the redeployment of Agency resources dedicated to online inspection under the traditional inspection system to unscheduled offline activities, such as increased HACCP and sanitation SOP verification, has the potential to contribute to improved food safety VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 resulting from a lower prevalence of carcasses contaminated with Salmonella, which may in turn lead to fewer human illnesses. While prevalence of Salmonella measured in FSIS’s market hog baseline study is low, Salmonella is a pathogen of public health concern for pork products, and the data available are adequate to estimate the potential changes in prevalence with changes in FSIS’s swine inspection system. B. Regulations for Microbiological Testing Under Traditional Inspection 1. Generic E. Coli Criteria for Measuring Process Control The existing regulations require that official swine slaughter establishments conduct regular testing for generic E. coli at the end of the chilling process or after the final wash as a means to verify process control (9 CFR 310.25(a)(1)). These regulations prescribe requirements for collecting the samples, obtaining analytical results, and maintaining records of such results (9 CFR 310.25(a)(2), (3), and (4)). They also include criteria for evaluating an establishment’s generic E. coli testing results (9 CFR 310.25(a)(5)). The regulations provide that generic E. coli testing results that do not meet the criteria described in the regulations indicate that the establishment may not be maintaining process controls sufficient to prevent fecal contamination (9 CFR 310.25(a)(6)). If an establishment is not meeting the E. coli test results criteria, the regulations state that FSIS will take further action as appropriate to ensure that all applicable provisions of the law are being met (9 CFR 310.25(a)(6)). In 2014, FSIS rescinded the regulations that required that poultry establishments test carcasses for generic E. coli to monitor for process control (79 FR 49565, August 21, 2014). The final regulations replaced the generic E. coli regulations with new testing requirements that allow establishments to develop sampling plans that are more tailored to the specific establishment, and thus are more effective in monitoring their specific process control than the former generic E. coli criteria. The Agency concluded that the use of generic E. coli as an indicator for process control may not be as useful in certain poultry slaughter operations as originally thought. Therefore, FSIS made the change to allow poultry establishments to use other more relevant indicators of process control. The Agency is aware that most swine slaughter establishments currently conduct additional sampling for micro- PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 4785 organisms other than generic E. coli (e.g., Salmonella spp. and aerobic plate count bacteria (APC)) because they have found these organisms to be more relevant indicators of their process control. Therefore, FSIS is proposing to remove the generic E. coli sampling requirements for swine slaughter establishments to give establishments more flexibility in monitoring their process control and to make the Federal meat inspection regulations more consistent with the Federal poultry products inspection regulations. FSIS is proposing that all swine slaughter establishments collect and analyze carcass samples for microbiological analysis at the pre-evisceration and post-chill points in the process. The discussion of the proposed testing requirements is set out later in this document. 2. Salmonella Pathogen Reduction/ HACCP Performance Standards In addition to generic E. coli criteria, the existing regulations contain Salmonella pathogen reduction performance standards for market hogs (9 CFR 310.25(b)). The codified performance standards are based on the prevalence of Salmonella found by two nationwide microbiological baseline surveys conducted from April 1995 to March 1996 and from June 1997 to May 1998. The regulations provide for FSIS to collect and analyze unannounced Salmonella samples sets in swine slaughter establishments to detect whether these establishments are meeting the pathogen reduction performance standards (9 CFR 310.25(b)(2)). The performance standards set a maximum number of Salmonella-positive samples allowable per sample set and are defined on a product class basis so that an establishment operating at the baseline level would have an 80 percent chance of meeting the standard. Establishments are required to take corrective actions when FSIS determines that they are not meeting the performance standards (9 CFR 310.25(b)(3)(i) and (ii)). Under the regulations, an establishment’s failure to take the corrective actions necessary to comply with the Salmonella performance standards, or an establishment’s failure to meet the standards on the third consecutive series of FSIS-conducted tests for that product, constitutes a failure to maintain sanitary conditions and to maintain an adequate HACCP plan (9 CFR 310.25(b)(3)(iii)). The regulations provide that such failure will cause FSIS to suspend inspection services (9 CFR 310.25(b)(3)(iii)). However, the Agency’s ability to E:\FR\FM\01FEP2.SGM 01FEP2 srobinson on DSK9F5VC42PROD with PROPOSALS2 4786 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules directly enforce the pathogen reduction performance standards has been limited since 2001, after a ruling by the U.S. Court of Appeals for the Fifth Circuit in Supreme Beef Processors, Inc. v. USDA. In that case, the court enjoined FSIS from suspending inspection services against a meat grinding operation for failure to meet the Salmonella performance standards. Since that time, FSIS has used Salmonella failures as a basis to conduct an in-depth evaluation of the establishment’s HACCP systems, including its HACCP plan and sanitation SOPs. From August 2010 to August 2011, FSIS conducted a third market hog baseline survey to estimate the national prevalence of Salmonella in market hogs (The Nationwide Microbiological Baseline Data Collection Program: Market Hogs Survey August 2010–2011 available at http://www.fsis.usda.gov/ wps/wcm/connect/d5c7c1d6-09b5-4dcc93ae-f3e67ff045bb/Baseline_Data_ Market_Hogs_2010-2011.pdf?MOD= AJPERES). The third market hog baseline survey included 253 establishments that produce approximately 99.9 percent of market hogs slaughtered in the United States. For the third baseline survey, FSIS collected samples in 152 random establishments from market hog carcasses at two points in the slaughter process: Pre-evisceration and post-chill. The Salmonella percent positive rate at pre-evisceration was 69.64 percent, but at post-chill it was reduced to 2.70 percent. The third baseline survey’s percent positive rate at post-chill was significantly lower than the rates found in the two earlier surveys mentioned above, which reported Salmonella percent positive rates of 8.7 percent and 6.9 percent, respectively. Based on the data from the third baseline survey, FSIS estimated prevalence of Salmonella in market hogs was 1.66 percent with a 95 percent confidence interval between 0.82 percent and 2.51 percent. Because the estimated prevalence of Salmonella was low, and FSIS did not find enough pathogen positives to justify the resources needed (e.g., time and supplies) to conduct carcass swabbing, the Agency determined that this type of sampling was not an effective use of resources for verifying process control. As a result, FSIS did not develop new Salmonella performance standards for market hogs. Rather, in September 2011, FSIS discontinued its Salmonella verification sampling program for market hogs to make better use of its resources. Therefore, FSIS is proposing to eliminate the pathogen performance standards for market hogs in 9 CFR VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 310.25(b) because verifying the codified standards was not a good use of Agency resources and the standards have not been used since 2011. Instead, FSIS has decided to focus on its resources on sampling raw pork parts for pathogens of public health concern, as well as for indicator organisms. FSIS is currently addressing Salmonella through the Salmonella Initiative Program (SIP) described below. In addition, FSIS has published a compliance guideline to help official establishments control and reduce the spread of Salmonella in hog slaughter facilities (79 FR 633, January 6, 2014). The guidance is available on the FSIS web page at: http://www.fsis.usda.gov/ wps/portal/fsis/topics/regulatorycompliance/compliance-guides-index. The guidance provides information on best practices that may be applied at a hog slaughter facility to prevent, eliminate, or reduce levels of Salmonella on hogs at all stages of slaughter and dressing. Importantly, FSIS has identified microbial performance measures, as guidance, at the pre-evisceration and post chill points. Moreover, FSIS is currently conducting exploratory sampling of raw pork products for pathogens of public health concern, as well as for indicator organisms (80 FR 12618). A summary of the Phase I positive sampling results collected from May 2015 to November 2015 are as follows: 16.7 percent Salmonella, 1 percent Campylobacter, 4.5 percent Methicillin-Resistant Staphylococcus aureus (MRSA), 1 percent Toxoplasma gondii, 1.5 percent Yersinia enterocolitica, 0 percent E. coli O157:H7, and 5 percent non-O157 shiga toxin-producing E. coli (non-O157 STEC). FSIS has posted more detailed sampling results on its website at https://www.fsis.usda.gov/wps/wcm/ connect/68f5f6f2-9863-41a5-a5c425cc6470c09f/Sampling-Project-ResultsData.pdf?MOD=AJPERES. The Agency may develop pathogen reduction performance standards for pork parts at a later date. In 2019, the Agency will use this data to determine whether standards or additional policies (e.g., training, guidance to industry, or instructions to field personnel) are needed to address Salmonella in pork products. C. Waivers of Regulatory Requirements 1. Waivers To Test New Technology The regulations in 9 CFR 303.2(h) and 381.3(b) provide for the Administrator to waive for limited periods any provisions of the regulations to permit experimentation so that new PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 procedures, equipment, or processing techniques may be tested to facilitate definite improvements. Under these regulations, FSIS may only grant waivers from the provisions in the regulations that are not in conflict with the purposes or provisions of the FMIA or PPIA (9 CFR 303.1(h) and 381.3(b)). FSIS decides whether to grant requests for waivers based on proposals and documentation submitted by establishments to demonstrate that the use of a new technology is scientifically sound; that it will facilitate definite improvements; and that issuing the waiver will not conflict with the provisions of the FMIA or PPIA.1 If FSIS determines that the information submitted by an establishment supports the requested waiver, the Agency will waive the appropriate provisions in the regulation for a limited period of time to allow the establishment to conduct an in-plant trial. The purpose of the inplant trial is to gather data on the effects of the use of the new technology. FSIS reviews the data that is developed in the trial to determine whether they establish that the purpose of the waiver is being met. 2. Salmonella Initiative Program Waivers Under SIP, the Agency grants meat and poultry slaughter establishments waivers of regulatory requirements on condition that they will conduct regular microbial testing and share the resulting data with FSIS. The Agency described preliminary details of SIP in a January 28, 2008, Federal Register notice (73 FR 4767–4774) and announced its final terms and conditions in the July 13, 2011, Federal Register notice (76 FR 41186). SIP benefits public health in that it encourages slaughter establishments to conduct testing for microbial pathogens, which is a key feature of effective process control, and to respond to testing results by taking steps when necessary to regain process control. In addition, SIP enables FSIS to use establishment data to inform Agency policy aimed at enhancing public health protection. SIP establishments test for Salmonella, Campylobacter (if applicable), and generic E. coli or other indicator organisms and share all sample results with FSIS. Establishments that had been operating under regulatory waivers before FSIS implemented the SIP were required to participate in SIP or forfeit their waivers. The list of establishments 1 For Agency New Technology waiver procedures, see http://www.fsis.usda.gov/wps/portal/fsis/topics/ regulatory-compliance/New-Technologies. E:\FR\FM\01FEP2.SGM 01FEP2 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules participating in SIP is available on FSIS’s website at https://www.fsis. usda.gov/wps/wcm/connect/188bf58345c9-4837-9205-37e0eb1ba243/Waiver_ Table.pdf?MOD=AJPERES. To date the regulations waived for swine slaughter establishments under SIP include: 9 CFR 310.1(b)(3)— line speed; 9 CFR 310.25(a)— generic E. coli testing 2; 9 CFR 310.25(b)—Salmonella performance standards; 9 CFR 310.18(a)— contamination of organs; 9 CFR 310.11—cleaning and hair removal; and 9 CFR 310.14—handling of bruised parts. All swine slaughter establishments operating under SIP waivers will continue to operate under waivers and will continue to conduct testing under SIP if their waivers are not addressed in the final rule resulting from this proposal. If their waivers are addressed in the final rule resulting from this proposal, their waivers will end. srobinson on DSK9F5VC42PROD with PROPOSALS2 II. Consideration of Need for a New Swine Slaughter Inspection System A. Early Development of the Inspection Models Program In 1996, FSIS published its Pathogen Reduction/HACCP (PR/HACCP) final rule as the first step of a comprehensive initiative to target the Agency’s resources to address the public health risks associated with foodborne pathogens, which cannot be detected by organoleptic inspection (61 FR 38868, July 25, 1996). Under FSIS’s PR/HACCP regulations, establishments are required to develop and implement a system of preventive controls to ensure that their products are safe. This approach gives establishments more flexibility to determine how they can best meet the Agency’s regulatory requirements. FSIS verifies the adequacy and effectiveness of establishments’ HACCP systems. In 1997, in order to improve food safety and the effectiveness of inspection systems, reduce the risk of foodborne illness in the United States, remove unnecessary regulatory obstacles to innovation, and make better use of the Agency’s resources, FSIS announced, in a Federal Register notice, that the Agency would be developing a new HIMP study (62 FR 31553, June 10, 1997). During the HIMP study, FSIS would design and test various new inspection models in a series of trials in volunteer meat and poultry slaughter establishments. Under the initial HIMP inspection models approach, establishment 2 Some establishments continue to sample for generic e. coli to monitor their process control. The SIP waivers allow these establishments to use alternative sampling locations and frequencies. VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 personnel were responsible for sorting and removing animals unfit for slaughter and identifying and removing abnormal carcasses and parts, and FSIS inspection personnel performed inspection activities that focused on the areas of greatest risk in the hog slaughter inspection system in each establishment. In 1998, the American Federation of Government Employees, several FSIS inspectors, and a public interest organization filed suit to enjoin FSIS from implementing the HIMP model. The plaintiffs alleged that HIMP violated the requirement in the FMIA that government inspectors conduct a post-mortem inspection of each carcass. Specifically, the FMIA provides that the Secretary shall cause to be made by inspectors a post-mortem inspection of the carcasses and parts thereof of all amenable species to be prepared at any slaughtering, meat-canning, salting, packing, rendering, or similar establishment (21 U.S.C. 604). The district court upheld HIMP, finding that the word ‘‘inspection’’, as used in the statute, does not necessarily mandate a direct, physical examination of each carcass by an FSIS inspector, and that the model program was a rational policy judgment within the discretion afforded to the Secretary. The plaintiffs appealed, and the Court of Appeals for the District of Columbia Circuit reversed the district court’s decision. The Court of Appeals found that the FMIA requires Federal inspectors—rather than plant employees—to make the decision whether each carcass is adulterated within the meaning of the statute (AFGE v. Glickman, 215 F.3d 7, 11 (D.C. Circ. 2000)). The case was remanded to the district court for further proceedings. In response to the Court of Appeals’ opinion, FSIS modified HIMP to position up to three 3 online inspectors at fixed locations along the slaughter lines: In the area where the carcass and head were separated; where the carcass and viscera were separated; and at the pre-wash carcass verification location. These inspectors were responsible for examining the head, viscera, and carcass of each hog. The modified models project also included FSIS offline inspectors who were responsible for conducting HACCP and sanitation system verification activities and for 3 FSIS is able to assign fewer than three online inspectors if the physical configuration of the slaughter line allows one inspector to inspect both the head and viscera or the viscera and carcass. For example, in one establishment, the chain that carries the carcass is adjacent to the viscera pans, which enables one inspector to examine both the carcass and viscera. PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 4787 closely examining a sample of carcasses for food safety defects to ensure that the establishment’s process was under control and that adulterated carcasses and parts were not getting past the establishment sorters. On remand, the district court found that HIMP, as modified, complied with both the applicable statutory provisions and the opinion issued by the Court of Appeals. The plaintiffs again appealed to the Court of Appeals for the D.C. Circuit. The plaintiffs argued that the modified inspection procedures were not in compliance with the Court of Appeals’ prior opinion because FSIS had delegated some inspection duties to plant employees who were responsible for sorting defective carcasses and making preliminary decisions regarding adulteration. The Court of Appeals rejected this argument, finding that the FMIA does not prohibit plant employees from paring down the overall number of carcasses by sorting and removing carcasses before they reach the Federal inspector (AFGE v. Veneman, 284 F.3d 125, 131 (D.C. Cir. 2002)). The Court held that the modified inspection model program satisfied the FMIA because it required Federal inspectors to personally examine all hog carcasses, heads, and viscera, as required by 21 U.S.C. 604. The plaintiffs also argued that the line speeds allowed in the HIMP plants were too fast to allow Federal inspectors to make a critical appraisal of each carcass. The Court found that FSIS’s decision to allow higher line speeds was reasonable in light of the fact that establishment employees are required to sort carcasses and parts and identify defects prior to Federal inspection, resulting in fewer adulterated carcasses and parts being presented for Federal inspection. The Court also noted that although the FMIA delineates what must be inspected and by whom, it does not define exactly what constitutes an inspection. The court concluded that HIMP, as modified, reflected a reasonable design of an inspection system by the agency charged with responsibility for administering the FMIA and that it would rely on the Agency’s experience and informed judgment in evaluating the validity of the system under the law. Under these circumstances, the Court of Appeals upheld HIMP, as modified. B. Existing HACCP-Based Inspection Models Program The revised HIMP study was initiated in five market hog slaughter establishments on a waiver basis. Similar to the voluntary segregation procedures described above in establishments that slaughter only E:\FR\FM\01FEP2.SGM 01FEP2 srobinson on DSK9F5VC42PROD with PROPOSALS2 4788 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules market hogs under traditional inspection, establishment personnel sort animals before they are presented to FSIS ante-mortem inspectors under HIMP. Establishment personnel sort animals that appear to be healthy into ‘‘Normal’’ pens and animals that appear to have condemnable diseases or conditions into ‘‘Subject’’ pens. Establishment personnel remove and dispose of dead and moribund animals and animals suspected of having central nervous system disorders (CNS) or pyrexia. Under HIMP, FSIS inspectors examine all animals found by the establishment to be normal at rest, and five to ten percent of those animals in motion. If any animals exhibit signs of condemnable conditions, FSIS inspectors direct establishment employees to move the animals to the ‘‘U.S. Suspect’’ pens for final disposition by the FSIS PHV. FSIS PHVs examine all animals in the establishment’s ‘‘Subject’’ pens, and direct establishment employees to move animals to ‘‘U.S. Suspect’’ pens for final disposition by the FSIS PHV. The FSIS PHV determines if any animals must be identified as ‘‘U.S. Condemned’’ and disposed of in accordance with 9 CFR 309.13 (9 CFR 309.2). While establishment personnel sort and remove animals unfit for slaughter, only FSIS inspectors have the authority to condemn an animal. FSIS inspectors observe establishment employees performing sorting procedures at least twice per shift under HIMP compared to at least once per month under the voluntary segregation procedures permitted under traditional inspection of market hogs. Under HIMP, post-mortem inspection is conducted by up to three online inspectors who visually inspect the head, viscera, and carcass of each hog at fixed locations on the evisceration line. Before FSIS online inspection, establishment personnel sort carcasses and parts and trim dressing defects and contamination (e.g., hair, bruises, feces, ingesta, and milk). Establishment employees also mark with ink localized pathology defects intended for removal under FSIS supervision (e.g. localized nephritis and localized arthritis) and carcasses and parts intended for disposal under FSIS supervision (e.g., carcasses and parts with malignant lymphoma). Online inspection is conducted much more efficiently and effectively under HIMP than under traditional inspection because establishment personnel have already sorted carcasses and parts, trimmed dressing defects and contamination, and identified pathology defects on the VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 carcasses, thereby correcting most removable defects, before the FSIS online inspectors perform their carcassby-carcass inspection. Under HIMP, offline inspection consists of system verification activities through which FSIS continuously monitors and evaluates establishment process control. FSIS conducts more offline, food safety related verification inspection activities under HIMP than under traditional inspection. Some examples of food safety related verification inspection activities include: HACCP, sanitation SOP, and other prerequisite program verification procedures, including 24 carcass verification checks per shift specifically for generalized diseases and conditions and for contamination (compared to 11 carcass verification checks per shift under traditional inspection). FSIS also conducts more offline humane handling verification tasks under HIMP than under traditional inspection. FSIS has concluded that the HIMP model has a number of benefits, such as focusing FSIS inspection personnel on the areas of greatest risk in the hog slaughter system and providing an incentive to establishments to improve and innovate, while ensuring effective online inspection. C. U.S. General Accountability Office (GAO) and the USDA’s Office of the Inspector General (OIG) Reports on HIMP In 2013, the U.S. General Accountability Office (GAO) and the USDA’s Office of the Inspector General (OIG) evaluated FSIS’s HIMP pilot study and issued findings and recommendations.4 5 GAO identified strengths in the pilot study, including that of giving plants responsibility and flexibility for ensuring food safety and quality and allowing FSIS inspectors to focus more on food safety activities. However, GAO also identified what it believed to be data gaps in the HIMP pilot study. GAO recommended that FSIS collect and analyze information to determine if the HIMP pilot study is meeting its purpose, and FSIS agreed with the recommendation. The OIG report also included recommendations related to HIMP procedures. According to the OIG, FSIS did not adequately oversee the HIMP program because the Agency did not 4 GAO, 2013. More Disclosure and Data Needed to Clarify Impact of Changes to Poultry and Hog Inspections, http://www.gao.gov/assets/660/ 657144.pdf. 5 OIG, 2013. Food Safety and Inspection Service— Inspection and Enforcement Activities at Swine Slaughter Plants, https://www.usda.gov/oig/ webdocs/24601-0001-41.pdf. PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 evaluate whether the program resulted in a measurable improvement of the inspection process; allowed one HIMP plant to forgo the standard FSIS policy to manually inspect viscera; and did not have formal agreements with the HIMP plants. In response to OIG, FSIS agreed to complete an evaluation of HIMP market hog establishments. D. Analysis of HIMP 1. FSIS Evaluation of HIMP In 2014, in response to the GAO and OIG reports, FSIS conducted a comprehensive analysis of data collected from the operation of HIMP in market hog establishments and prepared a written report (the ‘‘Hog HIMP Report’’) that presents a thorough evaluation of the models tested. Based on this evaluation, FSIS concluded that market hog slaughter establishments participating in HIMP were performing as well as comparable large non-HIMP market hog establishments and meeting FSIS requirements for operating under waivers through the HIMP project. A summary of the Hog HIMP Report is provided below. The full Hog HIMP Report is available on the FSIS website at: http://www.fsis.usda.gov/wps/wcm/ connect/f7be3e74-552f-4239-ac4c59a024fd0ec2/Evaluation-HIMP-MarketHogs.pdf?MOD=AJPERES. Before implementation of the HIMP project, an independent consulting firm, Research Triangle Institute (RTI) collected baseline organoleptic and microbiological data in the five market hog slaughter establishments that volunteered to participate in the HIMP program. These data reflect the performance of the establishments under traditional inspection and provided the basis to establish HIMP performance standards for food safety defects and non-food safety ‘‘Other Consumer Protection’’ (OCP) defects. FSIS established three categories of food safety related performance standards under HIMP for these conditions: ‘‘FS–1’’ addresses infectious conditions (e.g., septicemia, toxemia, pyemia, and cysticercosis); ‘‘FS–2’’ addresses contamination from fecal material, ingesta, and milk; and ‘‘FS–3’’ addresses certain conditions identified at ante-mortem (e.g. moribund, pyretic, and neurologic conditions). FSIS has a zero tolerance policy for food safety conditions identified as FS–1, FS–2, and FS–3 to protect consumers from conditions that may be harmful. Therefore, the HIMP performance standard for food safety defects was set at zero. FSIS established the performance standard for non-food safety OCP E:\FR\FM\01FEP2.SGM 01FEP2 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules srobinson on DSK9F5VC42PROD with PROPOSALS2 defects based on the performance level of the establishment representing the 75th percentile for each category of OCP defects (i.e., slightly below the fourth of the five baseline results for each category). FSIS established three categories of OCP performance standards for various types of trim and dressing defects that primarily affect the quality of products: ‘‘OCP–1’’ addresses carcass pathology defects (e.g., arthritis, emaciation, and erysipelas) and was set at 4.1 percent of carcasses, ‘‘OCP–2’’ addresses visceral pathology defects (e.g., cystic kidneys, enteritis, and nephritis) and was set at 7.2 percent of carcasses, and ‘‘OCP–3’’ addresses miscellaneous defects such as bile, bruises, and skin lesions and was set at 20.5 percent of carcasses. The HIMP performance standards were finalized in November 2000 (see 65 FR 65828, November 2, 2000). To participate in the program, establishments operating under HIMP are required to maintain process control plans to meet the performance standards for food safety and non-food safety OCP defects. The HIMP performance standards are a measure for comparing the performance of establishments operating under the HIMP inspection system with performance when operating under the current non-HIMP, traditional inspection system. a. Overview of the HIMP Report The Hog HIMP Report describes FSIS’s microbiological and inspection findings in the five market hog slaughter establishments participating in HIMP and compares them with 21 non-HIMP establishments of comparable production volume, line speed, and days of operation. The evaluation is based on establishment performance results for calendar years CY2006 through CY2010, and CY2012 through CY2013. Establishment performance results from CY2006 to CY2010 are based on data from the previously used Performance Based Inspection System (PBIS) database and results from CY2012 to CY2013 are based on data from the new Public Health Information System (PHIS) database. FSIS began transitioning establishments from PBIS to the PHIS in April 2011. The period April 2011 to December 2011 was a transitional period during which the inspection results for some establishments were recorded under PBIS, while others were recorded under PHIS. The data under the two systems are not completely compatible because inspection task codes and noncompliance records (NRs) were recorded differently in PHIS than in PBIS. For this reason, the transitional VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 period CY2011 is not included in the Hog HIMP Report, and the analysis of CY2006 through CY2010 data is separate from the CY2012 through CY2013 data. Across HIMP and non-HIMP establishments, analyses compared the number of offline inspection procedures, the rates of health-related regulatory non-compliances, Salmonella positive rates, and violative chemical residue rates. FSIS evaluated offline inspection procedures to determine whether comparable levels of inspection are being performed in HIMP establishments compared to non-HIMP establishments. The Hog HIMP Report found that establishments participating in HIMP performed as well as comparable large non-HIMP establishments and met the Agency’s requirements for participating in the HIMP project. b. Verification by Offline Inspectors of the Establishment Executing Its HIMP Process Control Plan Under Which Establishment Employees Sort Acceptable and Unacceptable Carcasses and Parts The Hog HIMP Report found that the rate of ante- and post-mortem sorting by HIMP establishment personnel was comparable to the rate of ante- and postmortem condemnation by FSIS inspectors at non-HIMP market hog establishments (3.0 per 1,000 hogs compared to 2.7 per 1,000 hogs, respectively). The Hog HIMP Report also found that FSIS inspectors in HIMP establishments performed more offline inspection activities than in non-HIMP establishments to verify that the establishments are executing their HIMP slaughter process control plans. In CY2010, FSIS inspectors performed an average of 2,061 offline verification inspections per HIMP market hog establishment compared to an average of 1,482 offline verification inspection procedures per non-HIMP establishment. Accordingly, FSIS inspectors performed 1.4 times more offline verification inspection procedures in HIMP market hog establishments than in non-HIMP market hog establishments. In CY2013, FSIS inspectors performed an average of 19,180 Public Health Regulation (PHR) 6 verification tasks per HIMP market hog 6 PHRs consists of regulations and specific provisions of regulations that have higher rates of noncompliance three months before a pathogen positive or enforcement action. The inclusion of provisions of regulations in the PHR list allows FSIS to focus on specific health related provisions of regulations that may be most informative for prioritizing Food Safety Assessments (FSAs). FSAs are in-depth evaluations of an establishment’s food safety system. FSAs can be routine or for cause. PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 4789 establishment compared to an average of 14,099 PHR verification tasks per nonHIMP establishment. Thus, FSIS inspectors performed 1.4 times more of the offline inspection verifications of mandatory regulations in HIMP market hog establishments than in non-HIMP market hog establishments. The HIMP Report concluded that this increased level of offline inspection activities provides increased assurance that HIMP establishments are maintaining OCP and food safety defects at levels that are to or less than the levels in non-HIMP establishments. c. Verification of the Establishment Executing Its HACCP System Under 9 CFR Parts 416 and 417 The sanitation SOP regulations in 9 CFR 416 and the HACCP regulations in 9 CFR 417 are among the regulations most strongly related to public health. The Hog HIMP Report found that in CY2010, FSIS inspectors performed 1.5 times more offline sanitation SOP and HACCP inspection verifications of public health-related regulations in HIMP than non-HIMP market hog comparison establishments. In CY2012 and CY2013, FSIS inspectors performed 1.1 times more offline sanitation SOP and HACCP inspection verifications of public health-related regulations in HIMP than non-HIMP market hog comparison establishments. The regression analysis of historical data that was included in FSIS’s ‘‘Risk Assessment for Guiding Public HealthBased Poultry Slaughter Inspection,’’ which was used to inform the final rule ‘‘Modernization of Poultry Slaughter Inspection’’ (79 FR 49565), showed a statistically significant correlation between unscheduled offline inspection procedures and reduction in the prevalence of Salmonella and Campylobacter positive samples. Based on these modeling results, FSIS thought it was reasonable to conclude that the redeployment of Agency resources to unscheduled offline activities was likely to contribute to improved food safety resulting from a lower prevalence of carcasses contaminated with Salmonella and Campylobacter, which in turn could lead to fewer human illnesses. Depending on how reallocation of inspection activities was implemented, it was likely that changes in off-line inspection could have resulted in a decrease in the numbers of positive microbial samples in FSIS-regulated young chicken and young turkey establishments. Specifically, the scenario that only increased unscheduled inspection procedures performed much better than the scenario that did not target specific E:\FR\FM\01FEP2.SGM 01FEP2 4790 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules srobinson on DSK9F5VC42PROD with PROPOSALS2 types of procedures, and the results suggest a reasonable degree of confidence that the discriminate scenario would do no harm. That poultry slaughter risk assessment is available on FSIS’s website at http:// www.fsis.usda.gov/wps/portal/fsis/ topics/regulatory-compliance/haccp/ haccp-based-inspection-models-project/ himp-study-plans-resources/poultryslaughter-inspection. The risk model and model results are also posted online as a technical support document for the risk assessment on the FSIS website. The market hog risk assessment uses a similar approach and model as the poultry slaughter risk assessment and estimates the reduction in illnesses likely to result from the reallocation of inspectors contemplated by this proposed rule. The market hog risk assessment is discussed in more detail below. d. Verification of the Outcomes of the Establishment Process Control Plan, Both Organoleptic and Microbiologic To assess the microbiological outcomes of HIMP establishments’ process control plans, the Hog HIMP Report analyzed data from FSIS’s Salmonella verification program. For the years CY2006–CY2009, the differences in Salmonella positive rates between HIMP market hog establishments and non-HIMP comparison establishments were not statistically significant for any of the years. The Hog HIMP Report also analyzed data from FSIS’s Salmonella baseline study on market hog slaughter establishments, conducted from August 2010 to August 2011. The Salmonella positive rates in HIMP market hog establishments were not statistically significantly different from those in the subset of 21 non-HIMP comparison establishments. This is probably the result of the small sample size relative to the low Salmonella positive rate. However, in the August 2010 to August 2011 baseline study the Salmonella positive rates in HIMP market hog establishments were statistically significantly lower than those in all 147 non-HIMP market hog establishments (which included the subset of 21 nonHIMP comparison establishments, as well as all other non-HIMP market hog establishments) (0.65 percent versus 3.05 percent). The Hog HIMP Report also analyzed data from FSIS’s residue sampling program for chemical contaminants including approved and unapproved veterinary drugs, pesticides, and environmental compounds. FSIS conducts directed sampling scheduled by FSIS Headquarters and inspector- VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 generated sampling when the FSIS PHV suspects that an animal may have a violative level of chemical residue. The Hog HIMP Report found no differences in the number of scheduled directed samples collected in the HIMP market hog establishments and those in the non-HIMP market hog comparison establishments. However, the Hog HIMP Report found that FSIS offline inspectors at the HIMP market hog establishments were able to collect 2.7 times more inspector-generated residue samples than inspectors at the nonHIMP market hog comparison establishments for CY2009–2010, and 1.7 times more for CY2012–2013 because the inspectors had more time to conduct offline activities. Data from FSIS’s residue sampling program showed that from CY2006 to CY2010, the number of samples that tested positive for violative levels of chemical residues in HIMP market hog establishments were not statistically significantly different from those in the non-HIMP market hog comparison establishments (zero versus six (0.057 percent of samples)). However, from CY2012 to CY2013, the amount of samples that tested positive for violative levels of chemical residues in HIMP market hog establishments was statistically significantly lower than non-HIMP market hog comparison establishments (nine violative levels (0.15 percent of samples) versus 115 (0.76 percent of samples). The Hog HIMP Report explained that this difference could suggest that the HIMP market hog establishments are exercising active control of potential chemical hazards in their products, and that this approach may result from better control over contract grower relationships by the five HIMP market hog establishments. e. Conclusion of HIMP Report The Hog HIMP Report concluded that HIMP market hog establishments are receiving more offline food safety related inspection verification checks than the non-HIMP market hog comparison establishments, and that the HIMP inspection system, which provides for increased offline inspection activities that are directly related to food safety, results in greater compliance with sanitation and HACCP regulations (9 CFR parts 416 and 417); carcasses with equivalent or lower levels of Salmonella contamination; and carcasses with lower levels of violative chemical residues. f. Verification of Humane Handling FSIS inspectors verify that establishments comply with the HMSA PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 by performing Humane Activities Tracking System (HATS) tasks that are divided into nine categories. The HATS tasks provide FSIS with data on the time that FSIS inspectors spend verifying whether (1) establishments adapt their facilities to inclement weather; (2) humanely handle livestock during truck unloading; (3) provide water and feed to livestock in holding pens; (4) humanely handle livestock during ante-mortem inspection; (5) humanely handle ‘‘U.S. Suspect’’ and disabled livestock; (6) move livestock without excessive prodding or the use of sharp objects after ante-mortem inspection; (7) prevent livestock from slipping and falling; (8) effectively administer stunning methods that produce unconsciousness in the animals; and (9) ensure that animals do not regain consciousness throughout the shackling, sticking, and bleeding process. FSIS inspectors enter the hours devoted to verifying humane handling activities for the HATS categories. The data is entered into PHIS in one-quarter hour increments (e.g., .25, .5, .75, 1.0). The Hog HIMP Report did not address compliance with the HMSA, but FSIS reviewed HATS task data in PHIS from January 2013 through September 2015 and compared the number of offline humane handling activities performed in five HIMP market hog establishments and the same 21 comparable large nonHIMP market hog establishments that FSIS used in the Hog HIMP Report. The Agency found that FSIS inspectors spent more time verifying that specific humane handling and slaughter requirements were met in HIMP market hog establishments than in non-HIMP market hog establishments. FSIS inspectors devoted approximately 5.33 hours per shift to verifying humane handling activities for the HATS categories in HIMP market hog establishments compared to approximately 4.29 hours per shift in the 21 non-HIMP market hog comparison establishments. FSIS also compared the rate of humane handling NRs issued in HIMP market hog establishments and non-HIMP market hog establishments. FSIS inspectors documented fewer humane handling NRs in HIMP market hog establishments than in non-HIMP market hog establishments. From January 2013 through September 2015, FSIS recorded 11 humane handling NRs in five HIMP market hog establishments and 117 NRs in the 21 non-HIMP market hog comparison establishments. It should be noted that none of the 11 NRs recorded in the HIMP establishments documented market hogs being forced to E:\FR\FM\01FEP2.SGM 01FEP2 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules move faster than normal walking speeds to keep up with faster evisceration line speeds. The data demonstrate that HIMP establishments have higher compliance with humane handling regulations than non-HIMP establishments, and that increased offline inspection may improve compliance with the HMSA. E. Public Health Benefits Projected From Allocating More Inspection Resources to Food Safety-Related Inspection Activities srobinson on DSK9F5VC42PROD with PROPOSALS2 1. Market Hog Risk Assessment FSIS completed a quantitative risk assessment to determine how performing a greater number of offline inspection procedures in market hog slaughter establishments might affect the number of human illnesses from Salmonella. These offline inspection procedures primarily involve activities that FSIS inspection personnel perform to verify the effectiveness of establishment sanitary operations and other food safety-related activities. The Hog HIMP Report, discussed above, found that FSIS inspectors performed more offline inspections to verify compliance with sanitation SOP and HACCP regulations in HIMP establishments than they do in nonHIMP establishments. The risk assessment is available for viewing by the public in the FSIS docket room and on the FSIS website at: http:// www.fsis.usda.gov/regulations_&_ policies/Proposed_Rules/index.asp. FSIS developed the market hog risk assessment to help the Agency inform its judgement about the potential impact of changes to FSIS’s swine inspection system on risks to public health associated with pork products. To give the Agency the information it needed, the market hog risk assessment focused on three risk management questions: (1) What predicted effects will various models for increasing the number of offline inspection tasks in non-HIMP establishments have on human salmonellosis rates? (2) Where can inspectors be relocated to have the most impact toward reducing Salmonella prevalence and corresponding human illness? (3) What is the magnitude of uncertainty about the predicted prevalence of pathogens and corresponding illness effects? 2. Model FSIS developed a risk assessment model for exploring the potential relationships between current variations in inspection personnel assignments and prevalence of Salmonella on hog carcasses, and estimating the VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 subsequent possible reductions in human illnesses attributable to that pathogen. FSIS paired inspection data with Salmonella prevalence data for the same establishments and timeframes. As explained above, FSIS based this risk assessment model on the model for the risk assessment that FSIS used to inform the final rule ‘‘Modernization of Poultry Slaughter Inspection’’ (79 FR 49565). FSIS employed a stochastic simulation model using multi-variable logistic regressions to identify correlations between (1) the numbers of offline food-safety inspection procedures, both scheduled and unscheduled, along with the numbers of non-compliances and scheduled-butnot-completed procedures, and (2) contamination of hog carcasses with Salmonella.7 The correlations were used to predict the potential effect that devoting more resources to those offline procedures might have on human illness attributable to the consumption of pork products. Stochastic simulations were used to account for statistical uncertainty in the estimates relating inspection procedures in an establishment to detection of Salmonella in samples from hog carcasses. Illness estimates were based on data from the Centers for Disease Control and Prevention (CDC), and uncertainty distributions were used to account for the variability in annual Salmonella illnesses and statistical uncertainty about the relationship between the pathogen prevalence levels at the establishments and the corresponding annual number of illnesses that could be attributed to the pathogens. 3. Conclusions of the Market Hog Risk Assessment The regression analysis of historical data included in the market hog risk assessment showed a statistically significant correlation between (1) increased scheduled and unscheduled offline procedures and decreased scheduled but not performed procedures and (2) reduction in the prevalence of Salmonella positive samples. Based on these results, the redeployment of Agency resources to scheduled and unscheduled offline activities, along with a reduction in scheduled but not performed 7 Scheduled procedures are assigned to inspectors at an establishment by PBIS or PHIS. Unscheduled procedures are performed according to inspector needs at an establishment and may include verification checks for fecal, ingesta, and milk, or they may be a response to unforeseen hazards or unsanitary conditions arising from sanitation SOP failures, or the need to verify corrective actions taken under the establishment’s HACCP plan. PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 4791 procedures, is likely to contribute to food safety resulting from a lower prevalence of carcasses contaminated with Salmonella, which in turn we expect to lead to fewer human illnesses. In answer to the first risk-management question, the market hog risk assessment results suggest that, depending on how reallocation of inspection activities is implemented, it is likely that changes in offline inspection would not result in an increase in the prevalence of Salmonella in hog carcasses, and could even result in a decrease in the prevalence of Salmonella in hog carcasses. Specifically, the scenario that simultaneously increases unscheduled and scheduled inspection procedures and decreases scheduled but not performed procedures performs better than scenarios that target the three specific types of procedures one at a time. Under the scenario where all types of procedures are targeted for increase, with resulting decrease in scheduled but not performed procedures and decrease in instances of observed and reported establishment non-compliance, the model estimates an average decrease of 2,533 Salmonella-related illnesses per year attributable to pork products. FSIS assumes that 65,869 expected annual Salmonella illnesses are attributed to consumption of pork products. Thus, a reduction of 2,533 expected Salmonella illnesses annually, would reflect a 3.8 percent reduction in Salmonella illnesses attributable to pork products. Responding to the second question, modeling and scenario analysis results suggest that increasing scheduled and unscheduled procedures and decreasing scheduled but not performed procedures would be most effective in reducing pathogen occurrence on carcasses because of consistency in the decision variable parameter’s effect across all models. However, each category of offline procedures relates to an individual decrease in Salmonella contaminated carcasses which if any one of the three categories or a combination of categories of offline procedures were implemented still would result in decreased contamination, but less than if the scenario combining all three decision variables was adopted. In answer to the third riskmanagement question, on the uncertainty of the results for pathogen prevalence and illness reductions, FSIS’s modeling approach includes the inherent uncertainty about the relationship between the frequency of inspection activities and pathogen prevalence, about the actual change in future inspection activities that would E:\FR\FM\01FEP2.SGM 01FEP2 4792 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules likely be observed, and about the representativeness of the rates of human Salmonella illnesses attributable to pork products. srobinson on DSK9F5VC42PROD with PROPOSALS2 III. Proposed NSIS FSIS is proposing to create a new swine slaughter inspection system, the NSIS, informed by the Agency’s experiences under HIMP and NPIS. All establishments that slaughter market hogs would be permitted to operate under the proposed NSIS. Establishments that slaughter classes of swine other than market hogs would be permitted to operate under NSIS under a waiver through the SIP. FSIS would consider the data collected in swine slaughter establishments operating under a SIP waiver to determine whether to expand NSIS to other classes of swine. Establishments that slaughter market hogs and other classes of swine, and that do not want to slaughter other classes of swine under NSIS under a waiver through the SIP, would be permitted to slaughter market hogs under NSIS and to slaughter the other classes of swine under traditional inspection. FSIS would staff such establishments to NSIS and would not add additional staff for traditional inspection; therefore, establishments would need to operate traditional inspection under slower line speeds than they are currently operating to accommodate for the reduced number of inspectors. FSIS seeks comment on the impact of staffing at establishments that slaughter market hogs and other classes of swine and how it will impact their decision to participate in NSIS. A. Live Market Hog Sorting by Establishment Personnel Under the proposed NSIS, establishment personnel would be required to sort market hogs and remove for disposal animals unfit for slaughter before they are presented to FSIS PHVs for inspection and final disposition. Establishment personnel would sort animals that appear to be healthy into ‘‘Normal’’ pens and animals that appear to have diseases or abnormal conditions into ‘‘Subject’’ pens. Establishment personnel may also sort and remove animals with localized conditions (e.g., animals with arthritis or abscesses) or animals that do not meet establishment specifications (e.g., hogs that are the wrong size or underweight) to be diverted to another official establishment for slaughter. Establishment personnel would remove and properly dispose of dead and moribund animals and animals suspected of having CNS conditions or pyrexia. Under the proposed NSIS, FSIS VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 inspectors would inspect all animals found by the establishment to be normal at rest, and five to ten percent of those animals in motion. If any animals exhibit signs of condemnable conditions, FSIS inspectors would direct establishment employees to move the animals to the ‘‘U.S. Suspect’’ pens for final disposition by the FSIS PHV. The FSIS PHV would inspect all animals in the ‘‘Subject’’ and ‘‘U.S. Suspect’’ pens and render a final disposition decision. FSIS inspectors would observe establishment employees performing sorting procedures at least twice per shift. During this time, FSIS inspectors would verify that animals that are intended to be disposed of are humanely euthanized and that animals that are intended to be diverted to another official establishment are eligible for transport. FSIS inspectors also would conduct HACCP verification tasks in PHIS at least twice per shift to verify that establishments meet the regulatory requirements found in 9 CFR 417 for implementation, monitoring, recordkeeping, prerequisite programs (when applicable), and corrective actions. Under the proposed rule, if any market hogs become non-ambulatory disabled after ante-mortem inspection, establishments would be required to move them to the ‘‘Subject’’ pens for reinspection by FSIS PHVs. All sorting would be a function of the establishment’s HACCP plan or prerequisite program. Because establishments operating under the proposed NSIS would be required to sort and remove market hogs that are unfit for slaughter before FSIS antemortem inspection, FSIS is proposing that establishments under the proposed NSIS address, as part of their HACCP system, procedures for sorting animals showing signs of diseases or abnormalities from healthy animals. These procedures must cover establishment sorting activities for dead and moribund swine and swine suspected of having CNS conditions or pyrexia. FSIS also is proposing to require that establishments immediately notify FSIS inspectors in the rare circumstance that they suspect animals of having notifiable or foreign animal diseases during sorting activities. For example, establishments may suspect that market hogs have notifiable or foreign animal diseases if they observe animals with abnormal lesions or behavior, or an abnormal change in the amount of animals that arrive to the establishment dead. Notifiable diseases are those that are designated by the World Animal Health Organization (Office PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 International des Epizooties or OIE). The list of notifiable diseases includes anthrax, cysticercosis, scabies, bovine tuberculosis, myiasis (screwworm), and vesicular diseases. Of these diseases, anthrax, cysticercosis, and bovine tuberculosis are transmissible to humans. The complete list is available on OIE’s website at http://www.oie.int/ en/animal-health-in-the-world/oielisted-diseases-2016/. FSIS would report any animal disease issues to the USDA Animal and Plant Health Inspection Service (APHIS). Under the proposed NSIS, FSIS would maintain its zero tolerance for market hogs exhibiting signs of moribundity, CNS conditions, and pyrexia. Market hogs exhibiting signs of these generalized diseases or conditions, if not sorted and removed by the establishment before ante-mortem inspection, would be condemned by FSIS PHVs, as under the existing regulations (9 CFR 309.3). FSIS PHVs would issue an NR for every animal exhibiting signs of moribundity, CNS conditions, or pyrexia found by the FSIS inspector after the establishment sorting step is completed. Additionally, under the proposed NSIS, FSIS would maintain its zero tolerance for violative levels of chemical residues. Establishments would be required to address chemical hazards through their HACCP program including preventing animals with violative levels of chemical residues from being presented for slaughter. FSIS inspectors would continue to select animals at post-mortem and perform chemical residue sample collection and testing procedures in accordance with FSIS Directive 10,800.1, Residue Sampling, Testing and Other Verification Procedures under the National Residue Program for Meat and Poultry Products (available on FSIS’s website at http:// www.fsis.usda.gov/wps/wcm/connect/ 147066f0-564c-4590-b36f-97ffc5ab9797/ 10800.1.pdf?MOD=AJPERES). Under the proposed NSIS, establishment personnel would be required to identify carcasses of market hogs sorted and removed by establishment employees before FSIS inspection and intended for disposal and destruction with a unique tag, tattoo, or similar device. Establishment personnel also would be required to immediately denature all carcasses and parts removed as unacceptable by plant sorters on-site, even if establishments have tanking facilities, to ensure that the carcasses and parts are properly disposed of and never enter commerce. Under the proposed NSIS, establishment personnel would be required to maintain records to E:\FR\FM\01FEP2.SGM 01FEP2 srobinson on DSK9F5VC42PROD with PROPOSALS2 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules document the number of animals and carcasses and parts sorted and removed by establishment personnel per day. These records and procedures would be subject to daily review by FSIS inspectors. Under NSIS, FSIS inspectors would document in PHIS the total number of animals that the establishment employees have sorted and removed per day. Under the proposed rule, FSIS would still direct the application and removal of ‘‘U.S. Condemned’’ tags to animals condemned during ante-mortem inspection. FSIS would also continue to enter each and every ‘‘U.S. Condemned’’ tag into PHIS. However, FSIS inspectors should be able to complete these tasks faster because they would be presented animals that have been sorted by establishment employees and are thus more likely to pass ante-mortem inspection and not have condemnable conditions. In addition to the total number of animals sorted and removed by establishment personnel per day before FSIS ante-mortem and post-mortem inspection, FSIS is requesting comments on whether or not the Agency should require establishments under NSIS to specify in their records the reason that the animals were removed from slaughter, including animals sorted and removed because they were dead on arrival or suspected of having CNS conditions, pneumonia, pyrexia, septicemia, erysipelas, or tuberculosis (e.g., 20 sorted and removed; 10 pneumonia, 10 dead on arrival) and how this information should be collected. Under traditional inspection, FSIS inspectors record similar condemnation information into PHIS for APHIS’ swine slaughter condemnation monitoring system; however, this information is not being collected under HIMP. APHIS Veterinary Services (VS) uses this type of data to monitor changes in the rate or count of swine condemnations by swine type (market, roaster, sow, and boar) and by selected condemnation categories (e.g., central nervous system disorders, dead on arrival, pneumonia, pyrexia, septicemia, erysipelas, and tuberculosis). APHIS conducts weekly monitoring to compare baseline (expected) condemnation counts by condemnation category to current weekly counts to identify noteworthy increases (signals) in condemnations in near-real time. APHIS produces a weekly report, and shares it with the National Pork Board to identify any noteworthy increases in condemnations which could indicate the emergence of disease and may warrant further investigation. FSIS and VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 APHIS recognize that ‘‘presumptive diagnoses’’ by establishment personnel under the NSIS may not be as accurate as condemnation information entered by an FSIS PHV under traditional inspection. However, FSIS and APHIS believe that the self-reported information may still be useful and significant in monitoring disease conditions in the United States. B. Post-Mortem Carcass Sorting by Establishment Employees and Online Carcass Inspection Under the proposed NSIS, establishment personnel would be required to sort carcasses and parts and trim dressing defects and contamination (e.g., hair, bruises, feces, ingesta, and milk) before the carcasses and parts are presented to an FSIS online inspector for post-mortem inspection. Establishment personnel also would be required to mark with ink, or otherwise identify, localized pathological defects intended for removal under FSIS supervision (e.g. localized nephritis and localized arthritis) and carcasses and parts intended for disposal under FSIS supervision (e.g., carcasses and parts with malignant lymphoma). Under the proposed NSIS, the head, and viscera of each hog must be handled in a way as to identify them with the rest of the carcass and as being derived from the particular animal involved, until FSIS’s post-mortem inspection of the carcass and parts thereof have been complete. FSIS would not complete an inspection of the carcass if the head or viscera were missing before the final rail, unless the head or viscera were properly disposed of under FSIS supervision. Consistent with traditional inspection, only FSIS inspectors would be authorized to condemn carcasses and parts. Carcasses and parts contaminated with fecal material, ingesta, or milk or that exhibit signs of septicemia, toxemia, pyemia, or cysticercosis during post-mortem examination are likely to contain infectious agents, such as bacteria, virus, richettsia, fungus, protozoa, or helminth organisms, which can be transmitted to humans. For this reason, they present a food safety risk if they are permitted to enter the cooler. Therefore, FSIS is proposing that establishments under the new system address, as part of their HACCP systems, procedures for ensuring that carcasses and parts contaminated with fecal material, ingesta, or milk or affected by septicemia, toxemia, pyemia, or cysticercosis are trimmed or identified by the establishment before they are presented to the FSIS carcass inspector and disposed of under FSIS supervision. These procedures must cover PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 4793 establishment sorting activities for these conditions. Under this proposal, FSIS would maintain its zero tolerance for carcasses and parts contaminated by fecal material, ingesta, or milk, or affected by septicemia, toxemia, pyemia, or cysticercosis. If FSIS online inspectors discover a carcass contaminated by fecal material, ingesta, or milk, they would stop the line for carcass reexamination and trimming by the establishment unless the establishment elected to provide a rail-out loop to rail contaminated carcasses offline for reexamination, trimming, and positioning back on the line for reinspection, consistent with the existing regulations (9 CFR 310.17 and 310.18) and FSIS Directive 6420.2, Verification of Procedures for Controlling Fecal Material, Ingesta, and Milk in Slaughter Operations (available on FSIS’s website at http://www.fsis. usda.gov/wps/wcm/connect/478aca7637c5-4dc3-9925-1556402d8daf/PHIS_ 6420.2.pdf?MOD=AJPERES). An NR would be issued by the FSIS offline inspector at or after the final rail for every carcass contaminated by fecal material, ingesta, or milk. FSIS online inspectors would also stop the line if they discover carcasses exhibiting septicemia, toxemia, pyemia, or cysticercosis, as under the existing regulations (9 CFR 311.16 and 311.17). The carcasses would be retained for FSIS PHV disposition. An NR would be issued by the PHV for every carcass affected by septicemia, toxemia, pyemia, or cysticercosis that reaches the online carcass inspection station. Moreover, because establishments would be required to address these food safety hazards in their HACCP systems, the Agency continuously would assess the effectiveness of an establishment’s procedures for ensuring that carcasses are prevented from becoming contaminated with fecal material, ingesta, or milk, and that carcasses affected by septicemia, toxemia, pyemia, or cysticercosis do not reach the final FSIS inspection station. FSIS is not proposing to prescribe specific sorter training or certification to give establishments operating under the NSIS the flexibility to select the training program that would best assist them to meet the requirements of this proposed rule. However, the Agency has developed a draft guidance document to assist establishments in training their sorters should this rule become final. The draft guidance is based on the training that FSIS provides to online inspection personnel that are responsible for identifying these nonfood safety defects on carcasses and E:\FR\FM\01FEP2.SGM 01FEP2 srobinson on DSK9F5VC42PROD with PROPOSALS2 4794 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules parts under traditional inspection. FSIS has posted this draft compliance guide on its web page (http://www.fsis.usda. gov/wps/portal/fsis/topics/regulatorycompliance/compliance-guides-index) and is requesting comments on the guidance. FSIS believes that training of sorters is important to ensure that they are able to properly perform their duties. Proper training is necessary if sorters are to make accurate decisions on how to address animal disease conditions and trim and dressing defects. Under the proposed NSIS, if sorters do not make these decisions correctly, FSIS inspection personnel would take appropriate action such as stopping the line, issuing NRs, and directing the establishment to reduce the line speed. FSIS would thereby ensure that the establishment is able to maintain process control as evidenced by preventing fecal contamination and meeting microbial performance measures, that the establishment sorters are able to successfully perform their duties, and that the FSIS online inspectors are able to conduct a proper food safety inspection. Establishments that operate under the proposed NSIS would have greater flexibility over their production process. For example, establishments operating under the proposed NSIS would have the flexibility to reconfigure lines if they decided to change the way that the head, viscera, and carcasses are presented to FSIS inspectors to improve ergonomics and process control and to maintain optimum line speed. FSIS would still inspect the head, viscera, and carcass of each animal. However, under the proposed NSIS, establishments may reconfigure their lines so that they present a ready-toinspect head, viscera, and carcass for FSIS post-mortem inspection in one location or separately in two or three locations. FSIS would assign one to three inspectors to conduct online inspection activities, depending on need and line configuration. These inspectors would also rotate to conduct offline inspection activities. FSIS would assign one online inspector only if the Agency had the data and experience (including processes and procedures) to ensure that one inspector is able to conduct all online post-mortem inspection activities. Under the proposed NSIS, all establishments with fewer than three inspection stations would be required to provide a mirror at the carcass inspection station in accordance with 9 CFR 307.2 (m)(6) so that the inspector standing at the inspection station can readily view the back of the carcass for evidence that could impact food safety. VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 Under NSIS, as under HIMP, establishment sorters would be required to incise mandibular lymph nodes and palpate the viscera to detect the presence of animal diseases (e.g., Mycobacterium Avium) as part of their sorting activities before FSIS postmortem inspection. FSIS is requesting comments on whether or not the Agency should allow establishments that operate under the proposed NSIS to use discretion when deciding, on a lot-bylot basis, whether or not to incise mandibular lymph nodes and palpate the viscera to detect the presence of animal diseases (e.g., M. Avium) if they submit documentation to FSIS supporting that the presence of M. Avium is not likely to occur, such as records documenting their on-farm controls. In the last 10–15 years, industry led initiatives like the Pork Quality Assurance Plus certification program (http://www.pork.org/pqa-pluscertification) and the Common Industry Audit (http://www.pork.org/commonindustry-audit) have improved biosecurity practices which not only reduce disease spread but also address risk factors for M. Avium such as exposure to birds.8 9 Because on-farm practices have improved, the prevalence of M. Avium in U.S. swine is very low. After reviewing PHIS condemnation data from 21 large market hog establishments from 2012 through 2015, FSIS found that only 0.9 percent of all condemnations are due to M. Avium. The animal disease M. Avium does not present a food safety concern, and can be detected visually by inspectors. Moreover, Denmark and the Netherlands already conduct alternative post-mortem visual inspections and allow establishments to use discretion when determining, on a lot-by-lot basis, whether or not to incise lymph nodes and palpate the viscera. Under the FMIA and the regulations that implement it, meat and meat products imported into the United States must be produced under standards for safety, wholesomeness, and labeling accuracy that are equivalent to those of the United States (21 U.S.C. 620). FSIS has 8 United States Department of Agriculture, Animal and Plant Health Inspection Service. (2008). National Animal Health Monitoring System Swine 2006, Part IV: Changes in the U.S. Pork Industry, 1990–2006. Retrieved from https:// www.aphis.usda.gov/animal_health/nahms/swine/ downloads/swine2006/Swine2006_dr_PartIV.pdf. 9 United States Department of Agriculture, Animal and Plant Health Inspection Service. (2015). National Animal Health Monitoring System Swine 2012, Part 1: Baseline Reference of Swine Health and Management in the United States, 2012. Retrieved from https://www.aphis.usda.gov/ animal_health/nahms/swine/downloads/ swine2012/Swine2012_dr_PartI.pdf. PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 reviewed Denmark’s and the Netherlands’ market hog slaughter inspection systems and found them to be equivalent to the United States’ market hog slaughter inspection system. FSIS determined that visual postmortem inspection will still allow veterinary inspectors to palpate and incise lymph nodes and organs (as occurs in traditional inspection) at their discretion. Each herd of hogs that arrives at establishments to be slaughtered is accompanied by historical ‘‘Supply-Chain Information,’’ which consists of paperwork that documents the health status and history of each herd, complete traceback information, as well as details about the originating farm (e.g., history of disease, use of medications, and on-farm practices that contribute to maintenance of the herd’s health.) FSIS concluded that this documentation, as well as any ante-mortem inspection observances, will be sufficient to inform the veterinary inspector’s decision whether or not to perform visual inspection or traditional inspection. Importantly, because lymphatic tissue may be contaminated with pathogens, not incising the lymphatic tissue may reduce contamination of food contact surfaces and other carcasses. FSIS also is proposing to require establishment personnel to maintain records to document the number of carcasses and parts disposed of by establishment personnel per day as part of their sorting activities. The records would not need to include the number of carcasses condemned by FSIS. These records would be subject to review by FSIS inspectors. Under NSIS, FSIS inspectors would document in PHIS the total number of carcasses and parts sorted and disposed of by plant employees per day. FSIS inspectors would continue to enter dispositions for each and every carcass condemned by FSIS into PHIS. C. Offline Verification Inspection In addition to the online inspectors performing carcass inspection, FSIS is proposing that up to two inspectors be assigned for each evisceration line per shift to conduct offline verification activities in establishments operating under the proposed NSIS. Inspectors conducting offline inspection activities would rotate with the inspectors conducting online inspection activities. FSIS is also proposing to assign one PHV to make carcass and parts dispositions. As in HIMP, offline inspectors under the new inspection system would conduct food safety related inspection activities and would continuously E:\FR\FM\01FEP2.SGM 01FEP2 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules srobinson on DSK9F5VC42PROD with PROPOSALS2 monitor and evaluate establishment process control. Offline inspectors would conduct inspection activities including HACCP, sanitation SOP, and other prerequisite program verification procedures; verification checks for septicemia, toxemia, pyemia, cysticercosis, fecal material, ingesta, or milk contamination; checks to verify and ensure that sanitary dressing requirements are being met; and antemortem inspection. Under this proposed rule, offline inspectors would also conduct more humane handling verification tasks than are conducted under traditional inspection. The offline verification inspectors would work with the Inspector-In-Charge (IIC) to ensure that food safety related or non-foodsafety related conditions do not impair the online carcass inspectors’ ability to conduct the inspection of each head, viscera, and carcass or would notify the IIC whenever circumstances indicate a loss of process control. When circumstances indicate a loss of process control, the IIC will be authorized to require that the establishment slow the evisceration line speed. D. RTC Pork Product As discussed above, under HIMP, OCP standards are non-food safety standards concerned primarily with diseases of no public health significance and carcass processing defects. Data collected from market hog establishments operating under HIMP show that from CY 2012 through 2013, HIMP establishments maintained OCP defect levels that average about half the corresponding OCP performance standards derived from the performance of non-HIMP establishments. Thus, the data show that establishments operating under the HIMP system do exceptionally well in controlling OCP defects. Accordingly, FSIS is not proposing OCP requirements as a condition for establishments to participate in the proposed NSIS. Under this proposal, establishments operating under NSIS would be allowed to implement the process controls that they have determined will best allow them to produce an RTC pork product that is wholesome and not adulterated. The new proposed definition of RTC pork product is any slaughtered pork product free from bile, hair, scurf, dirt, hooves, toe nails, claws, bruises, edema, scabs, skin lesions, icterus, foreign material, and odor which is suitable for cooking without need of further processing. Under the proposed NSIS, establishments would have the flexibility to design and implement measures to address OCP defects that VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 are best suited to their operations. They would also be responsible for determining the type of records that will best document that they are meeting the RTC pork product definition. The records would be subject to review and evaluation by FSIS inspectors. For their record reviews, FSIS inspectors would verify that establishments operating under the proposed NSIS have written criteria for determining whether carcasses meet the RTC definition and that they are documenting that the pork products resulting from their slaughter operations meet these criteria before packaging or further processing that would conceal a defect. Records that would meet the proposed requirements include: • The records system that the establishment uses to document that it is producing RTC pork. For example, an establishment may use statistical process control charts, HACCP records, or other documentation. • The points in the operation where the establishment monitors carcasses to determine whether they meet the RTC definition and records the results of its monitoring activities. For example, an establishment may conduct monitoring and record the results at a preevisceration and a post-chill station. • The frequency with which the establishment conducts monitoring activities. The records should specify how often the establishment monitors carcasses per line per shift. For example, an establishment may conduct and document its monitoring activities at least every two hours per line per shift at the pre-evisceration location and at least twice per shift per line for postchill location. • The definitions of the OCP nonconformances or processing and trim defects for which the establishment is monitoring. For example, the establishment may be monitoring carcasses for processing and trim nonconformances as specified for trim and processing OCP defects specified under the HIMP OCP performance standards, or defects as defined in a published study or a study that the establishment conducted itself. If the establishment references a study, it should give a brief description of the study and have the supporting information on file. • The criteria that the establishment would use to determine that the products resulting from its slaughter operation meet the RTC definition. For example, an establishment may follow the subgroup limits for nonconformances and defects in the trim and processing defect levels for the HIMP OCP performance standards, or it may determine the upper limits for non- PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 4795 conformances using a statistical process control program. • The corrective actions that the establishment would take if the levels of defects and non-conformances exceed its evaluation criteria for RTC pork. Under this proposed rule, pork carcasses that meet the OCP performance standards under HIMP would be considered ‘‘suitable for cooking without the need for further processing,’’ and as such, meet the RTC pork product definition. Therefore, establishments operating under the NSIS that adopt the OCP HIMP performance standards as their criteria for determining whether they are producing RTC pork product would meet the regulatory requirements if: (1) They can document that the products resulting from their slaughter operations consistently meet these standards, and (2) FSIS inspectors do not observe persistent, unattended defects on the products resulting from the establishment’s slaughter operations. Establishments that adopt criteria other than the HIMP OCP standards would be required to have documentation to demonstrate how they will use these criteria to demonstrate that the products resulting from their slaughter operations meet the RTC pork product definition. In addition to record reviews, FSIS inspectors would verify that establishments operating under the NSIS are producing RTC pork product by visually observing carcasses as part of their inspection activities. The presence of persistent, unattended trim and dressing defects on carcasses at the end of the process would indicate that the establishment is not producing RTC pork product. It may also indicate a general lack of control in an establishment’s overall slaughter and dressing process. Thus, if inspectors observe persistent, unattended defects, FSIS would require that the establishment take appropriate actions to ensure that its process is under control and that it is operating under conditions necessary to produce safe, wholesome, and unadulterated RTC products. If inspection personnel through their record review or direct observation of carcasses find evidence that an establishment is producing pork that does not meet the RTC definition, the IIC would be authorized to take appropriate action to ensure that the establishment remedies the defects, including requiring that the establishment slow the evisceration line speed. E. Line Speeds Under NSIS Based on FSIS’s experience under HIMP, the Agency is proposing to allow E:\FR\FM\01FEP2.SGM 01FEP2 srobinson on DSK9F5VC42PROD with PROPOSALS2 4796 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules establishments operating under NSIS to determine their own evisceration line speeds if Agency personnel verify that process control is maintained. The maximum line speed under the existing regulations for market hogs is 1,106 head per hour (hph) with seven online inspectors. Experience from the HIMP pilot shows that HIMP establishments operate with an estimated average line speed of 1,099 hph, and that the line speeds varied from 885 hph to 1,295 hph (under waiver). Thus, although they are authorized to do so, market hog HIMP establishments do not operate at line speeds that are significantly faster than the current maximum line speeds for market hogs. Establishments determine their line speeds based on their equipment, animal size and herd condition, and their ability to maintain process control when operating at a given line speed. In addition, line speeds under HIMP depend on the number of employees the establishments hire and train to perform sorting activities. If FSIS finalizes the proposed NSIS, establishments choosing to operate under the NSIS will likely determine their line speeds based on the same factors that establishments considered when setting line speeds under HIMP for the past 16 years. Establishments operating under HIMP have demonstrated that they are capable of consistently producing safe, wholesome, and unadulterated pork products while operating at these line speeds. Moreover, they have consistently met pathogen reduction and other performance standards when operating at the line speeds they established under HIMP. The proposed new inspection system was informed by the Agency’s experience under HIMP and, as discussed later in this document, also incorporates additional measures that will apply to all swine slaughter establishments. These measures, which include testing for microbial organisms at pre-evisceration and post-chill, are designed to ensure that establishments maintain process control. FSIS recognizes that evaluation of the effects of line speed on food safety should include the effects of line speed on establishment employee safety. FSIS compared in-establishment injury rates between HIMP and traditional establishments from 2002 to 2010. The preliminary analysis shows that HIMP establishments had lower mean injury rates than non-HIMP establishments. The analysis uses injury rate data by occupational injury estimates that are derived from the BLS annual Survey of Occupational Injuries and Illnesses (SOII) http://www.bls.gov/iif/data.htm). VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 The survey captures data from Occupational Safety and Health Administration (OSHA) logs of workplace injuries and illnesses maintained by employers. Fifty-six FSIS inspected market hog slaughter establishments voluntarily submitted injury rate data to OSHA (approximately nine percent of all market hog slaughter establishments). From these 56 establishments, 27 low volume establishments were excluded, leaving 29 plants (5 HIMP and 24 Traditional). The low volume plants were excluded to provide a better comparison group of traditional plants because all HIMP plants are high volume plants. The results showed HIMP plants had a lower mean number of injuries using three OSHA injury rate measures: Total Case Rate (TCR), Days Away Transferred Restricted (DART), and Days Away From Work (DAFW). However, FSIS realizes that factors other than line speed may affect injury rates (e.g., automation and number of sorters per line). FSIS is requesting comments on the effects of faster line speeds on worker safety. Specifically, FSIS is requesting comments on whether line speeds for the NSIS should be set at the current regulatory limit of 1,106 hph or some other number. The Agency is also interested in comments on the availability of records or studies that contain data that OSHA or the National Institute for Occupational Safety and Health (NIOSH) may be able to use in analyzing the effects of increased line speed on the safety and health of employees throughout the establishment, including effects prior to and following the evisceration line. FSIS is also requesting comments on whether the Agency should maintain the 1,106 hph maximum line speed for establishments operating under NSIS but grant waivers from the maximum line speed to establishments that agree to work with the National Institute for Occupational Safety and Health NIOSH to evaluate the effects of waivers of line speed restrictions on employee health. FSIS is requesting comments on best practices and other measures that establishments can take to protect workers throughout the plant, including possible protective factors such as increasing the size of the workforce, rotating assignments, increased automation, or improved tools and techniques. FSIS is proposing to require each establishment that operates under the NSIS to provide an annual attestation to the management member of the local FSIS circuit safety committee stating that the establishment maintains a PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 program to monitor and document any work-related conditions that arise among establishment workers. The elements of this program would include: (1) Policies to encourage early reporting of symptoms of work-related injuries and illnesses, and assurance that the establishment has no policies or programs intended to discourage the reporting of injuries and illnesses. (2) Notification to employees of the nature and early symptoms of occupational illnesses and injuries, in a manner and language that workers can understand, including by posting in a conspicuous place or places where notices to employees are customarily posted, a copy of the FSIS/OSHA poster encouraging reporting and describing reportable signs and symptoms. (3) Monitoring on a regular and routine basis of injury and illness logs, as well as nurse or medical office logs, workers’ compensation data, and any other injury or illness information available. FSIS is also proposing to create a new severability clause (proposed 9 CFR 310.28), which would state that should a court of competent jurisdiction hold any provision of the proposed worker safety attestation requirement (proposed 9 CFR 310.27) to be invalid, such action would not affect any other provision of 9 CFR parts 309 and 310. As OSHA is the Federal agency with statutory and regulatory authority to promote workplace safety and health, FSIS would forward the annual attestations to OSHA for further review. OSHA, in turn, may use the information in the attestations in its own enforcement program. FSIS employees would not be responsible for determining the merit of the content of each establishment’s monitoring program or enforcement of noncompliance with this section. FSIS would work with OSHA to develop the poster that establishments must display providing information on the signs and symptoms of occupational injuries and illnesses experienced by market hog slaughter workers, and about workers’ rights to report these conditions without fear of retaliation. IV. Other Proposed Changes That Affect All Swine Slaughter Establishments A. Procedures To Address Enteric Pathogens, Fecal Material, Ingesta, and Milk Contamination as Hazards Reasonably Likely to Occur In 1997, FSIS published a Federal Register document entitled ‘‘Notice on complying with food safety standards under the HACCP system regulations’’ (62 FR 63254, November 28, 1997). The E:\FR\FM\01FEP2.SGM 01FEP2 srobinson on DSK9F5VC42PROD with PROPOSALS2 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules purpose of the document was to ensure that establishments understood the Agency’s zero tolerance policy for visible fecal material as food safety hazards, as establishments prepared to comply with the then newly enacted HACCP system regulations. The document explained that under 9 CFR 310.18, establishments must handle livestock carcasses and carcass parts to prevent contamination with fecal material and promptly remove contamination if it occurs. Based on this regulation, FSIS enforces a zero tolerance policy for visible fecal contamination. Then, the document explained that ‘‘to meet the zero tolerance standard, an establishment’s [HACCP] controls must (among other things) include limits that ensure that no visible fecal material is present by the point of post-mortem inspection of livestock carcasses’’ (citing 9 CFR 417.2(c)). Finally, the document explained that ‘‘Under the HACCP system regulations, critical control points to eliminate contamination with visible fecal material are predictable and essential components of all slaughter establishments’ HACCP plans.’’ As a result, all swine slaughter establishments’ HACCP plans currently include critical control points (CCPs) for preventing carcasses contaminated with visible fecal material at or after the final rail. FSIS also enforces a zero tolerance policy for contamination by ingesta and milk because the microbial pathogens associated with ingesta and milk contamination are likely sources of potential food safety hazards in slaughter establishments. As mentioned above, the regulations require establishments to handle livestock carcasses and carcass parts to prevent contamination and promptly remove contamination if it occurs (9 CFR 310.18) The regulations also require that lactating mammary glands and diseased mammary glands of swine be removed without opening the milk ducts or sinuses because if pus or other objectionable material is permitted to come in contact with the carcass, the parts of the carcass are contaminated and must be removed and condemned (9 CFR 310.17). Because such contamination is largely preventable, most slaughter establishments already have in place procedures designed to prevent and remove ingesta and milk. FSIS is now proposing to amend 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 post- VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 mortem inspection of swine carcasses. Such a requirement would ensure that establishments maintain the records to verify that they have implemented the necessary measures and, when necessary, have taken appropriate corrective actions to prevent carcasses contaminated with visible fecal material, ingesta, or milk at or after the final rail. Although the existing requirements for establishments to prevent visible fecal material, ingesta, or milk at or after the final rail, and the proposed requirement described above that establishments must have procedures addressing how they do so, are important safeguards, those safeguards would not be fully effective if an appropriate effort is not made to prevent contamination from occurring throughout the slaughter and dressing operation. Fecal material is a major vehicle for spreading pathogenic microorganisms, such as Salmonella, to raw pork products, and therefore, it is vital for establishments to maintain sanitary conditions and to prevent, to the maximum extent possible, contamination from occurring before slaughter and throughout the slaughter and dressing process. Under HACCP, establishments are responsible for identifying food safety hazards that are reasonably likely to occur in the production process and for implementing preventive measures to control those hazards. Failure to implement preventive measures throughout the slaughter and dressing process can lead to the creation of insanitary conditions in the establishment and increases the potential for carcasses and parts to become contaminated with enteric pathogens, fecal material, ingesta, and milk. Interventions with chemical antimicrobials applied at the end of the process are less likely to be fully effective on carcasses that contain high levels of pathogens, and these chemical treatments are not effective in preventing insanitary conditions throughout the slaughter establishment. To ensure that establishments implement appropriate measures to prevent carcasses from becoming contaminated with pathogens, and to ensure that both FSIS and establishments have the documentation they need to verify the effectiveness of these measures on an on-going basis, FSIS is proposing to require that all swine slaughter establishments develop, implement, and maintain written procedures to prevent contamination of carcasses and parts by enteric pathogens, fecal material, ingesta, and milk throughout the entire slaughter and PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 4797 dressing operation. FSIS is proposing that establishments incorporate these procedures into their HACCP systems and that they maintain records sufficient to document the implementation and monitoring of these procedures. These proposed requirements are necessary to fully implement the existing HACCP regulations. Information that FSIS has collected from investigations it has conducted in establishments that have received a Notice of Intended Enforcement due to Salmonella serotypes linked to human illness demonstrate the need for establishments to adopt preventive measures to control contamination throughout the entire production process, as well as the need to maintain documentation to verify the effectiveness of those measures on an ongoing basis. For example, FSIS conducted an investigation at a swine slaughter establishment that resulted in a Notice of Intended Enforcement after a State department of health conducted sampling and found the presence of Salmonella serotypes linked to human illness, and after FSIS requested a voluntary recall in 2015. FSIS reviewed the establishment’s controls, and records associated with the establishment’s sanitary dressing procedures and microbial interventions, and observed the establishment’s implementation of these controls and procedures. The Agency’s review found that the establishment had contamination of Salmonella throughout the slaughter process, including carcasses, environmental samples and pre-operational swabs. The cross contamination and failure to maintain sanitary procedures appeared to have overwhelmed any subsequent in-process interventions. FSIS determined that the establishment’s HACCP system was inadequate due to multiple or recurring noncompliance (see 9 CFR 500.4(a)). If this rule becomes final, establishments may choose to incorporate measures to address the prevention of contamination by enteric pathogens and contaminants (e.g., fecal, ingesta, and milk) into their procedures addressing how they prevent contamination from occurring during slaughter and dressing operations. Examples of such measures include: Sanitary dressing protocols, statistical process control programs, and sampling. Under this proposed rule, establishments will be required to incorporate these procedures into HACCP systems, and to maintain ongoing documentation to demonstrate that the procedures are effective. FSIS is E:\FR\FM\01FEP2.SGM 01FEP2 srobinson on DSK9F5VC42PROD with PROPOSALS2 4798 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules not proposing to prescribe the specific procedures that establishments must follow to prevent carcasses from becoming contaminated by enteric pathogens, fecal material, ingesta, or milk because the Agency believes that establishments should have the flexibility to implement the most appropriate measures that will best achieve the requirements of this proposed rule. However, on-going verification and documentation to demonstrate that an establishment’s process controls are effective in preventing food safety hazards are critical components of the food safety system. FSIS believes that microbiological test results that represent levels of microbial contamination at key steps in the slaughter process are necessary for establishments to provide comprehensive, objective evidence to demonstrate that they are effectively preventing carcasses from becoming contaminated with pathogens before and after they enter the cooler. In light of these changes, FSIS is proposing to rescind the generic E. coli testing requirements in 9 CFR 310.25 and to replace them with a new testing requirement that would provide establishments the flexibility to sample for other, potentially more useful indicator organisms. Under this proposal, establishments would continue to conduct sampling and analysis of carcasses for microbial organisms at the post-chill location, but in addition the Agency is proposing a second testing location at the preevisceration position in order to ensure establishments would be able to monitor the effectiveness of process control for enteric pathogens throughout the slaughter and dressing operation. Under this proposed rule, instead of following a prescribed microbiological testing program, each establishment would be responsible for developing and implementing its own microbiological sampling plan, which would be required to include carcass sampling at pre-evisceration and postchill. FSIS considers the microbial load of hog carcasses at pre-evisceration to be a valuable source of data about how well an establishment is taking into account the sanitary condition of live hogs coming to slaughter and the processing steps (i.e., washing, dehairing) they implement to reduce the external contamination of the carcass prior to evisceration. Following a similar logic, FSIS considers the microbial characteristics of hog carcasses post-chill (after all processing steps have taken place) to be a valuable source of data about how well an VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 establishment is minimizing contamination during chilling as well as the overall effectiveness of all process control interventions the establishment has chosen to apply throughout its production process. Because most establishments apply one or more interventions between the preevisceration and post-chill sampling points to help control microbiological hazards, FSIS would expect that a reduction in microbiological contamination between these two sampling points to be an indication of the effectiveness of those controls. The establishment would be responsible for determining which microbiological organisms would best help it to monitor the effectiveness of its process control procedures. Because FSIS is proposing that establishments’ microbiological sampling plans be part of their HACCP systems, all swine slaughter establishments would be required to provide scientific or technical documentation to support the judgments made in designing their sampling plans (see 9 CFR 417.4(a)). Under this proposal, establishments could develop sampling plans to test carcasses for enteric pathogens, such as Salmonella, at pre-evisceration and post chill, or they could test for an appropriate indicator organism. FSIS has developed draft sampling guidance to assist small and very small establishments in developing sampling plans that meet the Agency’s expectations for testing designs and sampling frequency should this rule become final. FSIS has posted this draft compliance guide on its web page (http://www.fsis.usda.gov/wps/portal/ fsis/topics/regulatory-compliance/ compliance-guides-index) and is requesting comments on the guidance. FSIS is proposing to prescribe a minimum frequency with which establishments would be required to collect two samples, one at preevisceration and one at post-chill, or, for very small and very low volume establishments, a single post-chill sample. Under the proposed rule, establishments, except for very small and very low volume establishments 10, would be required to collect samples at a frequency of once per 1,000 carcasses. Very small and very low volume establishments would be required to collect at least one sample during each 10 Very small establishments are establishments with fewer than 10 employees or annual sales of less than $2.5 million. 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. PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 week of operation each year. FSIS is proposing to allow very small and very low volume establishments to collect and analyze samples for microbial organisms at the post-chill point in the process only because these establishments typically are less automated and run at slower line speeds than larger establishments. The lower level of automation and the slower line speeds require less complicated measures for maintaining and monitoring process control on an ongoing basis. If, after consecutively collecting 13 weekly samples, very small and very low volume establishments can demonstrate that they are effectively maintaining process control, they can modify their sampling plans to collect samples less frequently. These proposed frequencies reflect the frequencies prescribed under the existing regulations for generic E. coli testing. In light of these changes, FSIS is proposing to remove the current requirement that swine establishments test carcasses for generic E. coli to monitor process control. FSIS is also proposing to eliminate the pathogen performance standards for market hogs in 9 CFR 310.25(b) because, as explained above, the codified standards are no longer in use. FSIS is proposing to allow establishments to substitute alternative sampling locations if they are able to demonstrate that the alternative sampling locations provide a definite improvement in monitoring process control than at pre-evisceration and post-chill. FSIS is also proposing to allow establishments to substitute alternative sampling frequencies if they are able to demonstrate that the alternative is an integral part of the establishments’ verification procedures for their HACCP plans. This proposed rule does not mandate that establishments meet specific performance standards for microbial testing. Because establishments would be required to incorporate their procedures for preventing contamination by enteric pathogens and other contamination (e.g., fecal material, ingesta, and milk) into their HACCP plans, or sanitation SOPs, or other prerequisite programs, establishments would be required to take appropriate corrective action when either the establishment or FSIS determines that the establishment’s procedures are not effective in preventing carcass contamination throughout the entire slaughter and dressing process. Establishments would also need to routinely evaluate the effectiveness of their procedures in preventing carcass contamination. E:\FR\FM\01FEP2.SGM 01FEP2 srobinson on DSK9F5VC42PROD with PROPOSALS2 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules Under this proposed rule, FSIS would verify the effectiveness of establishments’ process control procedures in preventing carcasses from becoming contaminated with enteric pathogens, fecal material, ingesta, and milk by reviewing the establishments’ monitoring records, including the establishments’ microbial testing results, observing establishments implementing their procedures, and inspecting carcasses and parts for visible fecal, ingesta, and milk contamination when conducting both online carcass inspection and offline verification inspection procedures. If inspection personnel determine that an establishment’s process control procedures are not effective in preventing contamination by enteric pathogens, fecal material, ingesta, and milk, the Agency would take appropriate regulatory action to ensure that the establishment’s production process is in control, and that product is not being adulterated. Such action could include performing additional visual inspections of products or equipment and facilities, increasing offline verification inspections, initiating Food Safety Assessments (FSAs), conducting hazard analysis verification procedures, and retaining or condemning product. Finally, FSIS is proposing to require that all official swine slaughter establishments develop, implement, and maintain in their HACCP systems written procedures to prevent contamination of the pre-operational environment by enteric pathogens. These procedures must include sampling and analysis of food-contact surfaces, reuse water, and equipment, including knives, in edible food production departments in the preoperational environment for microbial organisms to ensure that the surfaces are sanitary and free of enteric pathogens. The sampling frequency must be adequate to monitor the establishment’s ability to maintain sanitary conditions in the pre-operational environment. FSIS is proposing this environmental sampling requirement because in 2015, 152 people became ill after consumption of product produced at an establishment where FSIS found evidence during an investigation of insanitary conditions, including, but not limited to, tables and knives in the preoperational environment that were contaminated with Salmonella. The proposed environmental sampling requirement would reduce the risk of cross-contamination from insanitary conditions in the pre-operational environment. FSIS is requesting comments on this proposed VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 environmental sampling requirement. The proposed environmental sampling does not specifically include lairage (e.g., holding pens for live swine) although scientific literature conclusively shows that contamination occurs in this area of the establishment. FSIS is also asking for comments on how to ensure that lairage does not contribute to insanitary conditions. V. Implementation If this proposed rule becomes final, establishments interested in NSIS would need to notify FSIS in writing of their intent to operate under the new inspection system. The Agency is also considering establishing separate applicability dates for large, small, and very small establishments to comply with the proposed regulations that prescribe procedures for controlling visible fecal, ingesta, and milk contamination; the regulations that prescribe procedures for controlling contamination throughout the slaughter and dressing process; and the regulations that prescribe recordkeeping requirements. The applicability dates would provide additional time for small and very small establishments to comply with these provisions. The Agency is requesting comments on its proposed implementation plan, especially the phased in applicability dates for the proposed provisions in the rule that prescribe requirements for all swine slaughter establishments. VI. Executive Orders 12866 and 13563 Executive Orders 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, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This proposed rule has been designated a ‘‘significant’’ regulatory action under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget under Executive Order (E.O.) 12866. A. Request for Comments Summary FSIS is requesting comments on: 1. Whether or not the Agency should require establishments under NSIS to specify in their records the reason that the animals were removed from PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 4799 slaughter and how this information should be collected. 2. The draft compliance guides. 3. Whether or not the Agency should allow establishments that operate under the proposed NSIS to use discretion when deciding, on a lot-by-lot basis, whether or not to incise mandibular lymph nodes and palpate the viscera to detect the presence of animal diseases (e.g., M. Avium) if they submit documentation to FSIS supporting that the presence of M. Avium is not likely to occur, such as records documenting their on-farm controls. 4. The effects of faster line speeds on worker safety. a. Whether line speeds for the NSIS should be set at the current regulatory limit of 1,106 hph or some other number. b. The availability of records or studies that contain data that FSIS may be able to use in analyzing the effects of increased line speed on the safety and health of employees throughout the establishment, including effects prior to and following the evisceration line. c. Whether the Agency should maintain the 1,106 hph maximum line speed for establishments operating under NSIS but grant waivers from the maximum line speed to establishments that agree to work with the National Institute for Occupational Safety and Health to evaluate the effects of waivers of line speed restrictions on employee health. 5. The proposed sampling requirements, especially the environmental sampling requirement. 6. The proposed implementation plan, especially the phased in applicability dates for the proposed provisions in the rule that prescribe requirements for all swine slaughter establishments. In addition, FSIS is requesting the following data to further inform its consideration of the proposed rule. Further discussions of these requests are provided in their corresponding sections. 1. Are very small establishments that exclusively slaughter market hogs likely to convert to the NSIS? 2. How soon do establishments plan on adopting the NSIS? 3. Depending on establishment size, how many additional establishment employees would the NSIS system require? 4. What are the capital costs for establishments associated with the NSIS? 5. How long will it take establishment personnel such as a quality technician to collect, record, and analyze data required to verify that an E:\FR\FM\01FEP2.SGM 01FEP2 4800 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules establishment’s products meet the definition of RTC? 6. How many swine establishments have written sanitary dressing plans? 7. How many establishment employees perform sanitary dressing tasks in a swine slaughter establishment? 8. How many establishments conduct generic E. coli sampling at an alternative frequency? 9. What are the alternative frequencies at which establishments are conducting process control sampling? 10. How will changes in line speeds affect market hog prices, establishment hours of production, consumer prices, and export volumes? B. Need for the Rule The swine slaughter industry in the U.S. has evolved since the advent of the current swine inspection regulations used by the FSIS. 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.11 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, adherence to current regulations at large and high volume establishments that exclusively slaughter market hogs prevents 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, one that is less prescriptive, creates incentives for establishments to develop and invest in food quality controls and safety procedures, and allows FSIS to improve inspection methods, is needed. 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 88 percent between 2005 and 2015.12 According to the Food and Agricultural Organization, pork is consistently ranked as the top meat in per-capita consumption worldwide 13 and is ranked third in the United States.14 TABLE 2—U.S. PORK SUPPLY AND DEMAND U.S. production * Year 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 ..................................................................................... ..................................................................................... ..................................................................................... ..................................................................................... ..................................................................................... ..................................................................................... ..................................................................................... ..................................................................................... ..................................................................................... ..................................................................................... ..................................................................................... Imports * 20,705 21,074 21,962 23,367 23,020 22,456 22,775 23,268 23,204 22,858 24,517 Exports * 1,024 990 968 832 834 859 803 802 880 1,011 1,116 Domestic consumption * Per capita consumption ** 19,093 19,055 19,763 19,431 19,869 19,077 18,382 18,607 19,105 18,836 20,593 65 64 66 64 65 62 59 59 60 59 64 2,666 2,995 3,141 4,651 4,094 4,223 5,196 5,379 4,986 5,092 5,009 * Measured in carcass weight, million pounds. ** Measured in carcass weight, pounds. Source: USDA ERS Livestock and Meat Domestic Data. http://www.ers.usda.gov/data-products/livestock-meat-domestic-data.aspx#26105 accessed on 11/29/16. Last updated on 10/27/16. In 2016, there were approximately 612 swine slaughter establishments under Federal Inspection, Table 3.15 Combined, these establishments process roughly 118 million hogs annually. FSIS divides these swine into the following production categories for data collection: Roaster swine, market hog, sow, and boar/stag. Today, the majority (96%) of the pork products available in the market are derived from market hogs.16 TABLE 3—NUMBER OF SWINE SLAUGHTER ESTABLISHMENTS BY SIZE, 2016 Number of establishments HACCP processing size Total swine slaughter (head count) Total market hog slaughter (head count) Percent market hog 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 .......................................................................................................... srobinson on DSK9F5VC42PROD with PROPOSALS2 Large ................................................................................................................ Small ................................................................................................................ Very Small * ..................................................................................................... 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. 11 Key, Nigel and William McBride. 2007. The Changing Economics of U.S. Hog Production. USDA ERS. Report No. 52. 12 USDA ERS Livestock and Meat Domestic Data. http://www.ers.usda.gov/data-products/livestockmeat-domestic-data.aspx#26105. Accessed on 12/2/ 15. Last updated on 11/30/15. VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 13 FAO Livestock commodities. http:// www.fao.org/docrep/005/y4252e/y4252e05b.htm. Accessed on 11/29/16. 14 USDA ERS Livestock and Meat Domestic Data. http://www.ers.usda.gov/data-products/livestockmeat-domestic-data.aspx#26105. Accessed on 11/ 29/16. Last updated on 10/27/16. PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 15 USDA, FSIS, Public Health Information System (PHIS). 16 Source: PHIS. E:\FR\FM\01FEP2.SGM 01FEP2 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules As shown below in Table 4, many establishments now exclusively slaughter market hog, a species sub class which due to technological and managerial improvements, such as improved genetics, nutrition, and medical services, generally presents fewer food safety and quality issues.17 D. Overview of the Proposed Rule’s NSIS Eight of the proposed rule’s provisions apply to only those establishments that voluntarily participate in the NSIS. Meeting these provisions will likely increase an establishment’s labor and training costs. Additionally, only market hogs are eligible to participate in the NSIS. Due to these economic constraints discussed above, we expect that only large and small high volume establishments that exclusively slaughter market hogs would voluntarily participate in the NSIS. In 2016 there were 40 high volume establishments that exclusively slaughter market hogs, 27 large 18 (5 HIMP + 22 non-HIMP) 19 and 13 small establishments, Table 4. These establishments account for 92 percent of total swine slaughter, Table 4. Given their large share of the market and the 4801 ability to slaughter a sufficient amount of market hogs to justify the likely costs associated with NSIS, these establishments are expected to voluntarily implement the proposed NSIS. Therefore, this analysis calculates the costs and benefits associated with the voluntary provisions for these 40 market hog establishments. However, because the 5 HIMP establishments are already practicing the proposed NSIS methods, 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. FSIS is proposing to amend 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 postmortem inspection of swine carcasses. This requirement would address a weakness of the current 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 contamination from entering the cooler. While preventing swine carcasses contaminated with visible fecal material from entering the chiller 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 controls for them. Requiring establishments to keep daily written records to document the implementation and monitoring of their process control procedures is a positive step forward for public health. This ongoing documentation will allow both the establishment and FSIS to identify specific points in the production process where a lack of process control may have resulted in product contamination or insanitary conditions. This will allow the establishment to take the necessary corrective action to prevent further product contamination. FSIS seeks comment on the extent to which written sanitary dressing plans are necessary for ensuring that existing process controls are effective. While many establishments may already have written sanitary dressing plans, due to data limitations, this analysis assumes that every establishment will need to develop a written sanitary dressing plan. This assumption will help ensure a conservative estimate. Ongoing sanitary dressing 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. 17 Key, Nigel and William McBride. 2007. The Changing Economics of U.S. Hog Production. USDA ERS. Report No. 52. 18 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. 19 In 2016 there was 1 large establishment that did not exclusively slaughter market hogs. E. Overview of the Proposed Rule’s Mandatory Components All swine slaughter establishments would need to comply with the three mandatory provisions of the proposed rule, which are described in more detail in section IV. A. srobinson on DSK9F5VC42PROD with PROPOSALS2 1. Written Sanitary Dressing Plans VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 PO 00000 Frm 00023 Fmt 4701 Sfmt 4702 2. Process Control Sampling and Analysis for Microbial Organisms Under this proposed rule, instead of following a prescribed microbiological testing program, each establishment would be responsible for developing and implementing its own microbiological sampling plan, which would be required to include carcass sampling at pre-evisceration and postchill. Current microbiological standards E:\FR\FM\01FEP2.SGM 01FEP2 4802 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules prescribe that all establishments monitor process control by sampling for generic E. coli. High volume establishments are required to take one sample per 1,000 carcasses, or request an alternative rate. The Agency is seeking comment on both the number of establishments conducting alternative sampling rates and approved alternative sampling rates. Very low volume establishments are required to take 1 sample per week of operation up to 13 times a year. An industry survey found that many establishments elect to perform other microbiological tests in addition to testing for generic E. coli.20 3. Environmental Sampling FSIS is proposing to require that all official swine slaughter establishments develop, implement, and maintain in their HACCP systems written procedures to prevent contamination of the pre-operational environment by enteric pathogens. Such procedures must be incorporated into an establishment’s HACCP, sanitation SOP, or other prerequisite program. This analysis assumes an establishment will incorporate its procedures for controlling contamination in the preoperational environment into its sanitation SOP. These procedures must include sampling and analysis of food contact surfaces in the pre-operational environment at a frequency adequate to monitor the establishment’s ability to maintain sanitary conditions in the preoperational environment. F. Overview of the Proposed Rule’s Agency Impact This analysis also takes into consideration potential impacts to the Agency’s budget, which is expected to be impacted by changes in staffing and training requirements. 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 nonsupervisory 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 establishments expected to convert to NSIS, Table 5. When these establishments convert to NSIS, Agency personnel will require NSIS training. Additionally, the number of Agency personnel required to inspect the slaughter process will likely change, see Agency Staffing section for details. TABLE 5—CURRENT FSIS SLAUGHTER LINE POSITIONS AT NON-HIMP FACILITIES THAT SLAUGHTER EXCLUSIVELY MARKET HOGS Number of positions OPM job code 1862 ...................................... 1863 ...................................... 701 ........................................ 120 245 53 Total .................................. 418 Source: PHIS. G. Expected Cost of the Proposed Rule 1. Associated With the NSIS Components of the Rule This analysis estimates the cost associated with the proposed rule’s NSIS components. The Agency assumes that 22 large high volume and 13 small high volume establishments, that have a history of exclusively slaughtering market hogs, will adopt the NSIS portions of the rule. These 35 establishments have similar characteristics as 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, the benefits from adopting NSIS are expected to outweigh the 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. The Agency is seeking comment on this assumption. While the 5 HIMP establishments are expected to adopt the NSIS, they have already implemented the proposed changes associated with the NSIS by their participation in the HIMP program 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. This analysis excludes further consideration in the Preliminary Regulatory Impact Analysis of the costs of submitting an attestation of work related conditions due to its small expected cost.21 Costs examined generally fall under three categories: Labor, capital expenses, and developing written procedures. In the following sections, this analysis presents the costs and benefits that would be 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 which are likely to adopt the NSIS will incur additional costs associated with adoption. The Agency is seeking comment on this assumption. Note, the 5 HIMP establishments are not expected to incur any additional costs associated with adopting the NSIS and are therefore excluded from this portion. Also, based on actual NPIS adoption rates thus far, the assumptions presented in this analysis may be an overestimate of adoption of NSIS. TABLE 6—NSIS ADOPTION RATE Total number of establishments adopted srobinson on DSK9F5VC42PROD with PROPOSALS2 Year Large 1 2 3 4 ................................................................................................................................................... ................................................................................................................................................... ................................................................................................................................................... ................................................................................................................................................... 20 Viator C. et al. 2015. (a) Meat Industry Survey in Support of Public Health Risk-Based Inspection. P5–42. Question 3.1. VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 21 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 00024 Fmt 4701 Sfmt 4702 Percent adopted Small 4 8 12 17 2 4 7 10 17 34 54 77 submitting an annual attestation would cost all 28 large and 13 small establishments approximately $93.64 annually (2 minutes * $68.52 per hour * 41). E:\FR\FM\01FEP2.SGM 01FEP2 4803 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules TABLE 6—NSIS ADOPTION RATE—Continued Total number of establishments adopted Year Large 5 ................................................................................................................................................... srobinson on DSK9F5VC42PROD with PROPOSALS2 a. Costs of Additional Establishment Workers This analysis expects establishments operating under NSIS to experience an increase in labor costs. Under NSIS, establishments will be required to dedicate labor to sort and remove unfit animals before ante-mortem inspection and trim; identify defects, such as dressing defects, contamination, and pathology defects, on carcasses and parts before post-mortem inspection; ensure product is presented to Agency inspectors in an appropriate manner; identify carcasses condemned on antemortem inspection; denature all major portions of condemned carcasses onsite; maintain records to document the number of animals condemned on antemortem inspection; and notify Agency inspectors if they suspect that an animal or carcass has a reportable or foreign animal disease, while conducting sorting activities. Based on observations 22 of HIMP establishments, this increase in work is expected to require an increase in labor demand ranging from 6–10 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. The Agency seeks comment on the number of additional employees each establishment will require due to the NSIS. Costs associated with this labor fall into 3 categories: Wages and benefits, training, and continuing education. Establishment Labor Wage Increases Many of the 22 large and 13 small non-HIMP market hog establishments that are assumed will adopt NSIS operate multiple lines and shifts. Taking these multiple lines and shifts into consideration, the number of industry positions is expected to increase by 383. 22 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. VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 The majority of these, 369, are attributable to the large establishments (41 (number of lines) × 9),23 Table 7. The remaining 14 positions are attributable to the small establishments (14 (number of lines) × 1),24 Table 7. According to the Bureau of Labor Statistics (BLS) the expected hourly wage for a Slaughter and Meat Packer occupation (‘‘production employee’’) is $13.00.25 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).26 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 × $26.00 × 269 × 8), Table 7. The average small establishment slaughters on 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 estimates take into consideration the fact that some establishments operate multiple lines and multiple shifts. Training Online Sorters and CarcassInspection Helpers Establishments are expected to incur costs associated with initially training employees to fill these 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 23 Source: PHIS. 24 Source: PHIS. 25 BLS Occupational Employment Statistics, Occupational Employment and Wages, May 2016. 51–3023 Slaughters and Meat Packers http:// www.bls.gov/oes/current/oes513023.htm accessed on 7/24/17. Last modified 3/31/17. 26 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. PO 00000 Frm 00025 Fmt 4701 Sfmt 4702 Percent adopted Small 22 13 100 employee.27 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 expected 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.28 The additional annual training cost for new employees is expected 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 × $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, with a mid-point of $24.29 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 27 Viator. C. et al. 2015. (b) Costs of Food Safety Investments. Table 4–4. Training Costs for Management and Production Employees. 28 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. http://www.bls.gov/ news.release/jolts.t16.htm. Accessed on 7/21/17. Last updated on 3/16/17. 29 Viator. C. et al. 2015. (b) Table 4–4. Training Costs for Management and Production Employees. E:\FR\FM\01FEP2.SGM 01FEP2 4804 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules approximately $24,984 (1,041 × $24) 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 $16.45 million, applying a 3 percent discount rate over 10 years, Table 7. The majority of this cost is attributed to wages and benefits, Table 7. TABLE 7—ESTABLISHMENT LABOR COSTS [M$] Number of personnel One-Time cost Recurring cost ........................ 0.81 ........................ ........................ ........................ 0.03 ........................ ........................ $20.65 ........................ 0.24 0.02 0.71 ........................ 0.009 0.03 Totals: One-Time ............................................................................................................................................................................... Recurring Cost ...................................................................................................................................................................... Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ...................................................................................... Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ...................................................................................... 0.84 21.66 16.62 15.99 Type of establishment Type of expense Large ............................................................... Wages ............................................................ Initial Training ................................................. Training Due to Labor Turnover .................... Continuing Education ..................................... Wages ............................................................ Initial Training ................................................. Training Due to Labor Turnover .................... Continuing Education ..................................... Small ............................................................... b. Costs of Capital Improvements: Line Configuration and Inspection Stations As proposed, participating in NSIS does not necessitate capital improvements. As such, this analysis does not include capital expenditures. However, if establishments believe that capital expenditures would result in a benefit they may voluntarily reconfigure or update their facilities so as 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 to $250,000,30 and the creation of an inspection station, which can cost between $5,000 and $6,000.31 Establishments may reduce these costs by coordinating these facility updates with previously planned establishment renovations. The Agency is seeking comment on both the required and voluntary capital costs associated with the NSIS. srobinson on DSK9F5VC42PROD with PROPOSALS2 c. Costs of Developing Ante-Mortem Written Procedures Under the proposed rule, establishments operating under NSIS are required to develop and maintain in 30 In a May 2004 study, ERS estimated the cost of compliance per establishment with PR/HACCP rule. Capital expenditures in Hog Slaughter establishments were estimated to be $251,800. VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 their HACCP systems (HACCP plans, Sanitation Standard Operating Procedures, 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, fecal material, ingesta, and milk throughout the entire slaughter and dressing operation, a mandatory component of the proposed rule. Details of these costs can be found in the sanitary dressing costs section VI.2.a. d. Ready-To-Cook Pork Standards As proposed, establishments operating under NSIS are required to collect, record, and analyze documentation to demonstrate that the products resulting from their slaughter operation meet the proposed definition of RTC pork products. While the Agency is seeking comment on this requirement, this analysis estimates the labor costs to Ollinger, Michael, Danna Moore, Ram Chandran (2004). Meat and Poultry Establishments’ Food Safety Investments. USDA, Economic Research. 31 Modernization of Poultry Slaughter Inspection; Final Rule, 79 FR. 49566 (2014). PO 00000 Frm 00026 Fmt 4701 Sfmt 4702 369 1,476 435 1,041 14 56 17 39 conduct such documentation under two assumptions. First, FSIS assumes that establishments would assign the task to a quality control technician, QC, with an hourly compensation rate, which included wages, benefits, and overhead, of $68.52.32 Second, FSIS assumes that this work would take 1 hour at a large establishment and 1⁄2 hour at a small establishment. The Agency is seeking comment on this assumption. Based on information obtained through PHIS, the average large establishment operates 269 days per year. This equates to an annual cost of approximately $18,432 (268 * 1 * $68.52), or approximately $0.41 million for all 22 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 $0.39 million, applying a 3 percent discount rate over 10 years, Table 8. 32 To be consistent with analyses done by the Department of Health and Human Services, this analysis accounts for fringe benefits and overhead by multiplying wages by a factor of 2. E:\FR\FM\01FEP2.SGM 01FEP2 4805 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules TABLE 8—COST OF RTC REQUIREMENTS [M$] Number of establishments Type of market hog only establishment Large ........................................................................................................................................................................ Small ........................................................................................................................................................................ Recurring Labor 22 13 $0.41 0.11 Totals: Recurring Cost ...................................................................................................................................................................... Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ...................................................................................... Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ...................................................................................... 0.51 0.39 0.38 2. Costs Associated With the Mandatory Components of the Rule The mandatory costs of the proposed rule are expected to apply to all 612 swine slaughter establishments and begin within the first year after the rule is finalized. These costs are associated with (a) establishing and implementing written sanitary dressing plans to prevent contamination of carcasses and parts by enteric pathogens, fecal material, ingesta, and milk, throughout the entire slaughter and dressing operation; (b) modernizing process control sampling programs for microbial organisms; and (c) sampling the slaughter environment for microbiological contamination. a. Costs of Developing, Composing, Training, Monitoring, Recording, and Verifying Written Sanitary Dressing Plans Under the mandatory portion of the proposed rule affecting all federally inspected establishments that slaughter swine, FSIS is proposing to require that all official swine slaughter establishments develop, implement, and maintain in their HACCP systems written procedures to prevent the contamination of carcasses and parts by enteric pathogens, fecal material, ingesta, and milk throughout the entire slaughter and dressing operation. This cost component includes: (1) Developing these procedures into their food safety system, (2) training, and (3) monitoring, recordkeeping, and verification. Developing and Composing 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 the Research Triangle Institute’s (RTI) Costs of Food Safety Investments report,33 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 $365.34 To ensure a conservative cost estimate, this analysis assumes all 612 swine establishments will incur this cost. The Agency is seeking comment on this assumption. The cost to all large establishments is approximately $20,440 (28 * $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 612 swine slaughter establishments is approximately $0.03 million, Table 9. TABLE 9—WRITTEN SANITARY DRESSING PLAN DEVELOPMENT [M$] Number of plants HACCP size Large ........................................................................................................................................................................ Small ........................................................................................................................................................................ Very Small ............................................................................................................................................................... One-time cost 28 105 479 $0.02 0.04 0.17 Totals: One-Time Cost ...................................................................................................................................................................... Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ...................................................................................... Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ...................................................................................... 0.23 0.03 0.03 srobinson on DSK9F5VC42PROD with PROPOSALS2 Training Training programs should 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.35 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 actually spend on training. Due to data limitations, this analysis assumes the number of establishment employees 33 Viator. C. et al. 2015. (b) 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. 34 Viator. C. et al. 2015. (b) Table 4–2. Costs of Sanitation SOP Plan Development, Validation and Reassessment. 35 Viator, C. et al. 2015. (b). VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 PO 00000 Frm 00027 Fmt 4701 Sfmt 4702 E:\FR\FM\01FEP2.SGM 01FEP2 4806 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules conducting sanitary dressing tasks at swine establishments is equal to the number of employees conducting sanitary dressing tasks at beef slaughter establishments.36 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. The Agency is seeking comment on this assumption. 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 Bureau of Labor Statistics’, BLS, 2016 turnover rate for non-durable manufacturing goods.37 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 612 establishments is roughly $1.13 million, while the total recurring costs is roughly $0.49 million, Table 10. The annualized costs with a 3 percent discount rate over 10 years for Sanitary Dressing task related training is $0.62 million, Table 10. TABLE 10—SANITARY DRESSING TRAINING COSTS [M$] Training costs Number of establishments HACCP size Average number of employees One-time Initial Large .................................................................................... Small .................................................................................... Very Small ............................................................................ 179 25 3 Refresher $0.09 0.04 0.03 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 ...................................................................................... 1.13 0.49 0.62 0.64 Inspection Final Rule,38 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 expected to verify the plan each day of production. In addition, this analysis $0.61 0.32 0.20 New hires $0.18 0.09 0.06 Monitoring, Recordkeeping, and Verification This analysis also measures the annual monitoring, recordkeeping and verification costs associated with maintaining sanitary dressing procedures. Similar to the Modernization of Poultry Slaughter 28 105 479 Recurring 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 $0.85 million annually, applying a 3 percent discount rate over 10 years, Table 11. TABLE 11—MONITORING, RECORD KEEPING AND VERIFICATION COSTS [M$] Recurring costs HACCP Size Monitoring Large ................................................................................................................ Small ................................................................................................................ Very Small ....................................................................................................... Record keeping $0.07 0.20 0.58 Totals: Recurring Cost ...................................................................................................................................................................... Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ...................................................................................... Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ...................................................................................... 0.85 0.85 0.85 srobinson on DSK9F5VC42PROD with PROPOSALS2 Table 12 provides an overview of the one-time and recurring costs associated 36 The 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/ connect/6d37a1fc-a3e1-40b6-90cc-719bdb391522/ VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 $0.02 0.04 0.07 Combined $0.04 0.12 0.44 Summary Cost of Written Sanitary Dressing Procedures $0.016 0.038 0.070 Verification with requiring all establishments to develop written sanitary dressing procedures. Combined, these tasks are expected to cost the industry $1.50 million annualized, assuming a 3 percent discount rate over 10 years, Table 12. STEC_Survey_Comments_Summary.pdf ?MOD=AJPERES]. 37 This analysis uses the industry turnover rate for non-durable manufactured goods to estimate. Source: BLS Economic News Release Table 16. Annual total separations rates by industry and region, not seasonally adjusted. <http:// www.bls.gov/news.release/jolts.t16.htm> Accessed on 7/21/17. Last updated on 3/16/17. 38 79 FR 49566–49637, August 21, 2014. PO 00000 Frm 00028 Fmt 4701 Sfmt 4702 E:\FR\FM\01FEP2.SGM 01FEP2 4807 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules TABLE 12—SUMMARY OF COSTS ASSOCIATED WITH REQUIRING WRITTEN SANITARY DRESSING PROCEDURES [M$] One-time costs Number of establishments HACCP size Large .................................................................................... Small .................................................................................... Very Small ............................................................................ Development Recurring costs Initial training Training Monitoring, recording, validating 28 105 479 $0.02 0.04 0.17 $0.61 0.32 0.20 $0.27 0.14 0.09 $0.07 0.20 0.58 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 .. ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ 1.36 1.34 1.50 1.53 b. Process Control Sampling and Analysis for Microbial Organisms This section reviews the expected changes in costs associated with the proposed alterations to microorganism process control verification. These costs are limited to the changes associated with removing the requirement that swine establishments test carcasses for generic E. coli and replacing them with new testing requirements described above. While the proposed 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 expected 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 39 and Costs of Food Safety Investments report.40 Each of these categories is explained in detail below. reassessment under the proposed 9 CFR 310.25(a)(2)(i). The RTI Costs of Food Safety Investment 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.41 The annualized reassessment cost to industry is roughly $0.19 million, assuming a 3 percent discount rate over 10 years, Table 13. Process Control Sampling Plan Reassessment This analysis assumes establishments will incur one-time costs of conducting a process control sample plan TABLE 13—COSTS OF PROCESS CONTROL SAMPLING PLAN REASSESSMENT [M$] Number of establishments Per establishment (mid-point estimate) * 28 105 479 $0.05 243 243 $1.53 0.03 0.12 Totals: One-Time Cost ...................................................................................................................................................................... Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ...................................................................................... Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ...................................................................................... 1.67 0.19 0.22 HACCP size Large ............................................................................................................................................ Small ............................................................................................................................................ Very Small ................................................................................................................................... Total onetime costs * The values for Small and Very Small Establishments are in dollars. srobinson on DSK9F5VC42PROD with PROPOSALS2 Transferring From Prescriptive To Process Testing Requirements Current regulation prescribes that each slaughter facility will test for generic E. coli.42 In addition to mandated generic E. coli testing, many 39 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’ VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 establishments voluntarily conduct additional microbiological testing to verify process control. Common microbiologic tests include aerobic plate count (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.43 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. 40 Viator C. et al. 2015. (b). 41 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. 42 9 CFR 310.25. 43 Viator C. et al. 2015. (a) P5–42. Question 3.1. PO 00000 Frm 00029 Fmt 4701 Sfmt 4702 E:\FR\FM\01FEP2.SGM 01FEP2 4808 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules 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 would 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 28 large (28 * 1.00), 41 small high volume (51 * .80), 43 small low volume (54 * .80) and 342 very small (479 * .714) establishments that currently test for generic E. coli and at least one other microbial or pathogen indicator 44 would 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 and small high volume establishments conduct 1 test, every 1,000 carcasses, and all small low volume and very small establishments conduct 13 tests annually.45 The Agency is seeking comment on this assumption. 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 $24.92.46 To have the sample tested at a contracted lab, the cost is $48.76.47 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.48 For these 454 establishments, the combined reduction in testing costs of no longer being required to test for generic E. coli is expected to reduce annual testing costs by approximately $3.92 million, assuming a 3 percent discount rate over 10 years, Table 14. TABLE 14—RECURRING COSTS (SAVINGS) FROM NO LONGER REQUIRING GENERIC E. coli TESTING [M$] Number of establishments HACCP size Large ........................................................................................................................................................................ Small High Volume .................................................................................................................................................. Small Low Volume ................................................................................................................................................... Very Small ............................................................................................................................................................... (Savings) 28 41 43 342 ($3.28) (0.40) (0.02) (0.22) Totals: Recurring Cost ...................................................................................................................................................................... Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ...................................................................................... Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ...................................................................................... (3.92) (3.92) (3.92) srobinson on DSK9F5VC42PROD with PROPOSALS2 Process Control Sampling Rates The proposed rule would require large and small high volume establishments to take samples at preevisceration and post-chill, which would increase the number of samples taken from 1 sample per 1,000 carcasses to 2 samples per 1,000 carcasses for large and small high volume establishments. The proposed rule does not require small low volume and very small establishments to increase their sampling rates. Under the proposed regulations, large establishments annual process control sampling costs are expected to increase by roughly $2.34 million, which is roughly $83,639 per establishment ($2.34 million/28), Table 15. Small high volume establishments annual process control sampling costs are expected to increase by roughly $0.29 million, which is roughly $5,740 44 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 VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 ($0.29 million/51) per establishment, Table 15. Process Control Sample Recordkeeping This analysis takes into consideration the increase in record keeping 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 establishment slaughters approximately 3.77 million swine per year. As such, this analysis estimates that a large establishment currently takes approximately 3,774 samples annually (3,774,223/1,000). The average small high volume swine establishment slaughters 0.23 million swine per year and requires approximately 229 samples (228,784/1,000) annually. Assuming it takes 2.5 minutes to record the results of each sample, the average large establishment currently requires 9,435 minutes (2.5 * 3,774) per year and the average small high volume 71.4% of very small, 80% of small and 100% of large establishments conduct additional testing. 45 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. PO 00000 Frm 00030 Fmt 4701 Sfmt 4702 establishment currently requires 573 minutes (2.5 * 229) per year. Requiring establishments to increase their sampling rates from 1 to 2 samples per 1,000 head would increase the average large establishment’s annual number of samples to 7,548 samples annually (3,774,223/1,000 *2), which would require approximately 18,870 minutes (2.5 * 7,548) annually. The same requirement would increase a small high volume establishment’s annual sampling to 458 (228,784/1,000 * 2), which would require approximately 1,145 minutes (2.5 * 458) annually. As such, the expected additional time required for recordkeeping is approximately 9,435 minutes (18,870– 9,435) for large establishments and 572 minutes (1,145–573) for small high volume establishments. Assuming a quality control technician with a compensation rate of $68.52 per hour 49 conducts this work, the additional costs 46 Viator C. et al. 2015. (b) Table 5–1. C. et al. 2015. (b) Table 5–1. 48 Viator, C. et al. 2015. (b). 49 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. 47 Viator E:\FR\FM\01FEP2.SGM 01FEP2 4809 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules to the average large establishment is approximately $10,775 (9,435/60 * $68.52). Similarly, the additional cost to the average small high volume establishment is approximately $653 (572/60 * 68.52). Scaling this up to all establishments, the total increase in costs to all large establishments is approximately $0.30 million ($10,775 * 28) and $0.03 million ($653 * 51) for small high volume establishments, Table 15. The combined annualized sampling and recordkeeping cost to all large and small high volume establishments is roughly $2.97 million, applying a 3 percent discount rate over 10 years. Large establishments are expected to incur the majority of this cost. TABLE 15—COSTS CHANGES ASSOCIATED WITH INCREASE SAMPLING RATES [M$] Number of establishments Large .............................................................................................................. Small–High Volume ....................................................................................... Costs Sampling $2.64 0.33 Totals: Recurring Cost ...................................................................................................................................................................... Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ...................................................................................... Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ...................................................................................... 2.97 2.97 2.97 percent discount rate, Table 16. However, only the 454 establishments that currently conduct multiple types of microbiological tests are expected to experience a reduction in cost. The remaining establishments, roughly 158 small and very small establishments, are $2.34 0.29 Combined $0.30 0.03 Summary of Process Control Sampling Costs Changes Overall, the changes in sampling requirements under the proposed rule are expected to reduce industry wide sampling costs by about $0.76 million annualized over 10 years, applying a 3 28 51 Recordkeeping expected to incur a portion of the onetime costs associated with plan reassessment, Table 16. Cost increases associated with testing and recordkeeping will be exclusively borne by large and small high volume establishments. TABLE 16—SUMMARY OF CHANGES TO PROCESS CONTROL SAMPLING [M$] Cost (savings) Type of change One-time Recurring $1.67 ........................ ........................ ........................ ........................ ($3.92) 2.63 0.33 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 ...................................................................................... 1.67 (0.95) (0.76) (0.72) Plan Reassessment ................................................................................................................................................. Converting to Process Control Sampling ................................................................................................................ Testing Costs ........................................................................................................................................................... Recordkeeping ......................................................................................................................................................... srobinson on DSK9F5VC42PROD with PROPOSALS2 c. Environmental Sampling As proposed, all swine slaughter establishments will be required to control for enteric pathogen contamination in the pre-operational environment. Such controls will have to be included in an establishment’s HACCP system, requiring a plan reassessment. This analysis assumes establishments will coordinate this work with the HACCP plan reassessment required by the development of written sanitary dressing procedures. As such the cost of incorporating pre-operational environment sampling plans into an establishment’s HACCP system is included in the reassessment costs VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 associated with written sanitary dressing procedures. While establishments will set sampling frequency so as to ensure effective control, this analysis assumes each large establishment will take 4 samples per 30 days of operation per line, while each small high volume establishment will take 2 samples per 30 days of operation per line, and small low volume and very small establishments will take 1 sample per 30 days of operation per line.50 Under this 50 In absence of other data we assumed establishments would conduct environmental sampling similar to the recommended frequencies described on Page 91 in: FSIS Compliance Guidelines: Controlling Listeria monocytogenes in Post-lethality Exposed Ready-to-Eat Meat and Poultry Products. January 2014. Accessed on 12/3/ PO 00000 Frm 00031 Fmt 4701 Sfmt 4702 assumption, the annual number of tests required by the entire industry is approximately 3,266. The Agency is seeking comment on this assumption. Establishments are permitted to conduct a variety of tests, including testing for Aerobic Plate Count, APC, Coliforms, Generic E. coli, Total Plate Count, TPC, and Salmonella. The laboratory testing 15. Available at http://www.fsis.usda.gov/wps/wcm/ connect/d3373299-50e6-47d6-a577-e74a1e549fde/ Controlling-Lm-RTE-Guideline.pdf?MOD=AJPERES. Industry is familiar with this methodology for sampling food-contact-surfaces in the post-lethality environment to ensure that the surfaces are sanitary and free of Listeria monocytogenes or an indicator organism. We assumed industry would take a similar approach in sampling food-contact-surfaces in market hog establishments to meet the proposed environmental sampling requirements. E:\FR\FM\01FEP2.SGM 01FEP2 4810 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules costs for these test range from $15 to $32, with an average mean testing cost of $19, Table 17.51 $32, with an average mean testing cost of $19, Table 17.51 TABLE 17—LABORATORY TESTING COSTS Test Minimum APC .............................................................................................................................................. Coliforms ...................................................................................................................................... E. coli ........................................................................................................................................... Salmonella ................................................................................................................................... TPC .............................................................................................................................................. Average ........................................................................................................................................ Mean $16 15 15 17 16 16 Maximum $18 18 18 25 16 19 $20 22 22 32 17 23 Source: Viator. C. et al. 2015. Costs of Food Safety Investments. Table 5–1. Laboratory Testing Costs. To ensure a conservative estimate this analysis assumes establishments will test for Salmonella, which is the most expensive option, Table 17. Under these assumptions, the combined total annual environmental sampling cost is approximately $0.08 million (3,266 × $25). The annualized cost of these combined expenditures is roughly $0.08 million, assuming a 3 percent discount rate over 10 years, Table 18. TABLE 18—COSTS OF ENVIRONMENTAL SAMPLING [M$] Number of establishments HACCP size Large ........................................................................................................................................................................ Small High Volume .................................................................................................................................................. Small Low Volume ................................................................................................................................................... Very Small ............................................................................................................................................................... Sampling costs 28 51 54 479 0.03 0.02 0.004 0.03 Totals: Recurring Cost ...................................................................................................................................................................... Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ...................................................................................... Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ...................................................................................... 0.08 0.08 0.08 Summary of Voluntary and Mandatory Costs The total annualized value of all costs to industry, under the assumed five year adoption rate as shown in Table 6, is roughly $17.84 million, assuming a 10 year annualization and a 3 percent discount rate, Table 19. Large establishments that voluntarily switch to the NSIS incur the majority of costs. For example, the recurring labor costs associated with the NSIS is the single largest recurring cost to industry and is mostly incurred by large establishments. It should be noted that the five HIMP pilot establishments have already incurred these costs, suggesting for those five establishments, the benefits of NSIS outweigh the costs. It also suggests that the benefits of adopting NSIS outweigh the costs for other establishments as well. Training staff accounts for the bulk of the costs associated with written sanitary dressing procedures. Sampling costs are expected to decrease for those establishments that currently conduct microbiological tests in addition to generic E. coli. TABLE 19—COMBINED COSTS TO INDUSTRY [M$] Number of establishments srobinson on DSK9F5VC42PROD with PROPOSALS2 Type of cost Voluntary: Establishment Labor ............................................................................................................. Ready to Cook ...................................................................................................................... Mandatory: Written Sanitary Dressing Plan ............................................................................................ Process Control Sampling .................................................................................................... Environmental Sampling ....................................................................................................... Total costs One-time Recurring 35 35 $0.84 ........................ $21.66 0.51 612 612 612 1.36 1.67 0.0 1.34 (0.95) 0.08 Totals *: Number of Establishments .................................................................................................................................................... One-Time Cost ...................................................................................................................................................................... Recurring Cost ...................................................................................................................................................................... Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ...................................................................................... 612 3.88 22.65 17.84 51 Viator. C. et al. 2015. (b) Table 5–1. Laboratory Testing Costs. VerDate Sep<11>2014 21:57 Jan 31, 2018 Jkt 244001 PO 00000 Frm 00032 Fmt 4701 Sfmt 4702 E:\FR\FM\01FEP2.SGM 01FEP2 4811 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules TABLE 19—COMBINED COSTS TO INDUSTRY—Continued [M$] Number of establishments Type of cost Total costs One-time Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ...................................................................................... Totals Mandatory *: Number of Establishments .................................................................................................................................................... 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 ...................................................................................... Totals Voluntary *: Number of Establishments .................................................................................................................................................... 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 ...................................................................................... Recurring 17.24 612 $3.03 $0.48 $0.82 $0.88 35 $0.84 $22.17 $17.02 $16.36 * Note, some of the totals may not equal the sum due to rounding. H. Expected Benefits of the Proposed Rule srobinson on DSK9F5VC42PROD with PROPOSALS2 1. Expected 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 expected to reduce pathogen levels in swine slaughter establishments. 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 HACCP-based Inspection Models Project (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. 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 change in carcass contamination prevalence under the inspection procedures of NSIS. Changes in expected numbers of Salmonella illness are estimated based on a proportional relationship between carcass contamination prevalence and illnesses that has been published in the peer-reviewed literature.52 53 This 52 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. VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 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, if the proportion of carcasses with no detectable Salmonella contamination increases with implementation of the NSIS, illnesses caused by consumers’ exposure to these carcasses are expected to decrease proportionally. The market hog Salmonella illness risk model estimates that the prevalence of Salmonella detected in carcasses will decline on average from an initial prevalence of 0.9407% to a final prevalence of 0.9066% if the 35 establishments identified adopt the new inspection system. The uncertainty of the final prevalence ranges from 0.8982% to 0.915%, at the 10th and 90th percentiles, respectively. 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.54 53 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. 54 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 PO 00000 Frm 00033 Fmt 4701 Sfmt 4702 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.55 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 768 and 4,287 decreased cases, respectively. The total case uncertainty distribution is dependent on the uncertainty in the change in Salmonella prevalence in market hogs which has an average percent uncertainty of a 3.626% decrease and is bounded at the 10th and 90th percentiles by a decrease of 1.0989% and 6.1362%, respectively. public health from performance standards applied in slaughter establishments, Food Control,28. 55 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\01FEP2.SGM 01FEP2 4812 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules The prevalence estimates are modeled with data variability and robust uncertainty components taken from sampling data and model parameter estimates. 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, without intervention. With adoption of the new inspection system, the average number of cases is likely to decrease to 67,324 with 10th and 90th percentiles of 38,653 and 101,417 cases, respectively. The market hog risk assessment estimates that if the 35 establishments expected to covert to the NSIS over 5 years do so, the number of human illness attributed to products derived from market hogs could reduce by an average of 2,533 Salmonella illnesses. The combined robust model estimate of total 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 768 and 4,287 decreased cases, respectively. 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 $3,682.56 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 20. The cost savings assuming the lowest cost per illness and only 768 cases avoided, which corresponds to the 10th percentile, is $0.25 million, Table 20. Alternatively, the cost savings assuming the highest cost per illness and 4,287 averted illnesses, which corresponds to the 90th percentile, is $24.95 million, Table 20. 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 20. 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 detectable with Salmonella. TABLE 20—HEALTH BENEFITS FROM AVERTED CASES OF SALMONELLA Cost per illness * Illnesses averted by scenario Percentile Low Mid High $321 $3,682 $5,820 Scenario costs, $M 10th .................................................................................................................. Mean ................................................................................................................ 90th .................................................................................................................. 768 2,533 4,287 ($0.25) (0.81) (1.38) ($2.83) (9.33) (15.79) Totals (Low)(M$): Recurring Cost ...................................................................................................................................................................... Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ...................................................................................... Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ...................................................................................... Totals (Mid)(M$): Recurring Cost ...................................................................................................................................................................... Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ...................................................................................... Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ...................................................................................... Totals (High)(M$): Recurring Cost ...................................................................................................................................................................... Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ...................................................................................... Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ...................................................................................... ($4.47) (14.74) (24.95) ($0.25) ($0.19) ($0.18) ($9.33) ($7.09) ($6.81) ($24.95) ($18.97) ($18.22) * 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. The proposed regulation is expected to reduce the regulatory burden on establishments by shifting from prescriptive to performance based regulation. Specifically, the proposed rule amends requirements related to slaughter line speeds,57 microbiological testing, and sorting activities. Based on the Evaluation of HACCP Inspection Models Project (HIMP) for Market Hogs report, the five HIMP establishments’ average line speed were approximately 12.49 percent faster than comparable establishments.58 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 56 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. 57 According to the Evaluation of HACCP Inspection Models Project (HIMP) for Market Hogs Final Report, November 2014, ‘‘In CY 2013, the estimated line speeds at the 5 HIMP market hog establishments varied from 885 to 1,285 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’’. 58 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-+himp Accessed on 1/6/2017. Last updated on 11/14/2014. srobinson on DSK9F5VC42PROD with PROPOSALS2 2. Other Benefits Associated With Modernizing Existing Regulations VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 PO 00000 Frm 00034 Fmt 4701 Sfmt 4702 E:\FR\FM\01FEP2.SGM 01FEP2 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules American Meat Institutes’ average pork packer margins for 2010–2014, which was reported to be $4.10 per head in NAMI’s 2015 Meat and Poultry Facts.59 The pork packer margin is the price the packer receives less the cost of the hog and production costs, making the packer margin an approximation for producer surplus. FSIS requests comment on refining this estimate so as to distinguish between accounting profit and economic profit—the latter being more precisely associated with producer surplus. Assuming establishments increase their line speeds by 12.49 percent and have a packer margin of $4.10 per head, an average large establishment’s surplus could increase by approximately $2.04 million, while an average small high volume establishment’s surplus could increase by $0.18 million, all else being equal. Combined, such an increase in efficiency at all 35 establishments would increase producer surplus by roughly $47.33 million 60 (22 × $2.04 million + 13 × $0.18 million), which has an annualized benefit of roughly $47.33 million, assuming a 3 percent discount rate over 10 years, Table 21. This estimate takes into consideration the 4813 assumed five year adoption rate. However, this increase in surplus may be an overestimate given that an increase in line speeds may change market hog prices, establishment production costs, retail prices, and export volumes. Additionally, consumer benefits would be conditional on how an increase in line speed affects retail prices. As such, the Agency is seeking comment on the extent to which such an increase in line speeds would affect market hog prices, establishment hours of production, consumer prices, and export volumes.61 TABLE 21—INDUSTRIAL EFFICIENCY, (BENEFITS) M$ Change in efficiency Number of establishments Type of establishment Large ............................................................................................................................................ Small ............................................................................................................................................ Combined * ................................................................................................................................... 22 13 35 Per establishment Combined ($2.04) (0.18) ........................ ($44.97) (2.37) (47.33) Totals: Recurring Cost ...................................................................................................................................................................... Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ...................................................................................... Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ...................................................................................... (47.33) (36.14) (34.74) * Note, some of the totals may not equal the sum due to rounding. estimated to be approximately $0.30 million. Both of these annualized estimates apply a 3 percent discount rate over 10 years. Details of these costs are provided below. srobinson on DSK9F5VC42PROD with PROPOSALS2 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.62 The five establishments that participated in the pilot project account for 15 percent of total swine production. Additionally, NSIS inspection increases the Agency’s ability to conduct more process and product verification and 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 HATS categories in HIMP market hog establishments compared to approximately 4.29 hours per shift in the 21 non-HIMP market hog comparison establishments.63 Under 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. Under the proposed rule, the Agency would shift Agency resources from online to offline activities. This analysis estimates such a shift will reduce labor expenses by approximately $6.67 million annually, Table 22. However, Agency personnel at NSIS establishments will require additional training, the annualized cost of which is 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 and up to 2 FTEs at a small market hog establishment. Under NSIS, a single slaughter line at a large establishment is expected to require 6 FTEs, while a small market hog establishment is expected to require 3 FTEs. Large establishments with two slaughter lines are expected to require 10 FTEs, while a small market hog establishment with 2 slaughter lines is expected to require 4 FTEs. 59 Nalivka, J.S., The 2015 Meat and Poultry Facts, NAMI December 2015. 60 Note, some of the totals may not equal the sum due to rounding. 61 The Agency further notes that marginal costs typically increase as a function of production quantity, in which case profit margins reach zero for the last unit of production; indeed, the phenomenon of rising marginal costs is consistent with the observation of HIMP line speed increases that are less than the maximum increase that is theoretically permissible. Assuming linearity of the relevant marginal cost curve would yield a margin of $2.05 per head, thus making producer surplus half the amount estimated here as the change in industrial efficiency. Meanwhile, if demand and supply elasticities for pork products are similar— which may or may not be plausible—then consumer surplus would increase by half the industrial efficiency amount estimated here, thus making the overall efficiency change estimate a reasonable approximation for the total (consumer plus producer) surplus gain. 62 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-+himp Accessed on 1/6/2017. Last updated on 11/14/2014. 63 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-+himp Accessed on 1/6/2017. Last updated on 11/14/2014. VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 I. Expected Budgetary Impacts PO 00000 Frm 00035 Fmt 4701 Sfmt 4702 1. Agency Staffing E:\FR\FM\01FEP2.SGM 01FEP2 4814 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules This analysis considers likely staffing changes at the 22 large and 13 small establishments which are expected to convert to NSIS over a course of five years. Combined, these establishments operate 46 shifts and 55 lines.64 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 22. If all 22 large non-HIMP and 13 small high volume market hog only establishments convert to the NSIS, the Agency would 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 would have up to 3 FTEs assigned to them and each of the 32 shifts at the large establishments would have up 2 FTEs assigned to them ((41 lines × 3 FTEs) + (32 shifts × 2 FTEs) = 187 FTEs). Likewise, under NSIS, the 13 small establishments would 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 22. This cost estimate includes expected grade increases associated with converting to the NSIS. As is shown in Table 22, 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 would require 147 fewer FTEs for swine slaughter inspection, with an expected annual decrease in costs of roughly $8.73 million, which is equal to roughly $6.67 million a year, assuming a 3 percent discount rate, Table 22. TABLE 22—EXPECTED CHANGES IN AGENCY STAFFING [M$] Traditional Type Number positions Proposed 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) Totals: Recurring Cost ...................................................................................................................................................................... Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ...................................................................................... Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ...................................................................................... (8.73) (6.67) (6.42) Since 2008, the Agency has annually lost, through attrition, 270 food inspectors on average. See Table 23 for details. The Agency plans to utilize all personnel made available as a result of conversion to NSIS to fill these vacant positions. TABLE 23—ANNUAL TURNOVER OF FOOD INSPECTORS srobinson on DSK9F5VC42PROD with PROPOSALS2 Fiscal year 2008 2009 2010 2011 2012 2013 2014 2015 Number of positions ...................................... ...................................... ...................................... ...................................... ...................................... ...................................... ...................................... ...................................... 307 264 231 268 266 246 273 305 64 The 22 large establishments operate 41 slaughter lines during 32 shifts, while the 13 small VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 small establishments, Table 24. 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 program, 2. Agency Training this analysis assumes NSIS methods training will take 3 days and 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 6, the Agency expects to train 266 ($550,942 for all large establishments personnel (218 CSIs and 48 PHVs), with and $81,697 for all small pay grades ranging from GS–8 to GS–13, establishments), Table 24. This one-time on NSIS methods. The majority of these cost equals approximately $0.07 million personnel, 228, are associated with 22 if it were annualized over 10 years large establishments, while the under a 3 percent discount rate, Table remaining 38 are associated with 13 24. TABLE 23—ANNUAL TURNOVER OF FOOD INSPECTORS—Continued establishments operate 14 lines during 14 shifts, source PHIS. PO 00000 Frm 00036 Fmt 4701 Sfmt 4702 E:\FR\FM\01FEP2.SGM 01FEP2 4815 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules TABLE 24—THREE DAY NSIS TRAINING COURSE [M$] Cost of trainee Number of inspectors requiring training Type of establishment Large .................................................................................... Small .................................................................................... Replacement labor Costs of wages and benefits for trainees 228 38 Combined costs $0.56 0.08 Totals: One-Time Cost ...................................................................................................................................................................... Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ...................................................................................... Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ...................................................................................... 0.64 0.07 0.07 As proposed, 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. $0.21 0.03 Costs of wages and benefits for replacements $0.34 0.06 Fill an Increase Need for Consumer Safety Inspectors 228 38 Number of replacement inspectors required been included in the Agency Staffing section above. The combined one-time cost for converting FIs into CSIs is roughly $2.16 million, Table 25. Nearly half of this cost stems from the need for replacement labor. Again, under the proposed five year adoption rate, as set forth in Table 6, and under a 3 percent discount rate the annualized costs is approximately $0.23 million, Table 25. Training includes a four-week meat inspector course and a one-day computer familiarization course. If all 22 large establishments convert to NSIS, the Agency will need an additional 82 CSIs. Likewise, if all 13 small market hog establishments convert, the Agency will need an additional 16 CSIs. Converting a FI into a CSI may result in a grade increase, the cost of which has TABLE 25—COST OF CONVERTING A FOOD INSPECTOR INTO A CONSUMER SAFETY INSPECTOR [M$] Labor Training component Trainee Four Week MI Course ..................................................................................... One Day Computer Training ............................................................................ Replacement $2.09 0.07 Totals: One-Time Cost ...................................................................................................................................................................... Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ...................................................................................... Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ...................................................................................... 2.16 0.23 0.25 The Agency’s budget is expected to be impacted both by changes to personnel and training requirements. First, there will be a reduced need for Agency personnel to inspect a slaughter line operating under NSIS. If all 22 large and 13 small establishments convert to NSIS over the course of five years, the Agency would require approximately 147 fewer FTEs to inspect the 55 65 slaughter lines operating at these establishments. The annual remuneration value of these 147 positions is roughly $8.73 million, Table 26. Second, the Agency will need to train approximately 266 personnel on NSIS methods at a one-time cost of approximately $0.64 million, Table 26. Third, the Agency plans to meet the $0.98 0.05 Combined costs $0.59 ........................ Combined Expected Budgetary Impacts $0.52 0.03 Travel, M&IE, and lodging increase in demand for CSIs by converting existing FIs into CSIs. The one-time cost of doing so is approximately $2.16 million, Table 26. The annualized value of the combined changes to the Agency’s budget is a net reduction of roughly $6.38 million, over 10 years assuming a 3 percent discount rate, Table 26. TABLE 26—COMBINED CHANGES TO FSIS’S BUDGET [M$] srobinson on DSK9F5VC42PROD with PROPOSALS2 Total costs One-time Recurring ........................ $0.64 2.16 ($8.73) ........................ ........................ Totals: One-Time Cost ...................................................................................................................................................................... 2.80 Changes to Agency Staffing .................................................................................................................................... Three Day NSIS Training ........................................................................................................................................ Converting Food Inspectors into Consumer Safety Inspectors .............................................................................. 65 Source: PHIS. VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 PO 00000 Frm 00037 Fmt 4701 Sfmt 4702 E:\FR\FM\01FEP2.SGM 01FEP2 4816 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules TABLE 26—COMBINED CHANGES TO FSIS’S BUDGET—Continued [M$] Total costs One-time Recurring Cost ...................................................................................................................................................................... Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ...................................................................................... Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ...................................................................................... J. Net Benefits With the expected impact on the Agency’s budget and industry’s revenue included, and assuming all large and small exclusively market hog Recurring (8.73) (6.38) (6.09) Table 27. The majority of the costs are experienced by the 35 non-HIMP establishments expected to voluntarily switch to the NSIS in the form of increased labor needs. establishments convert to NSIS (5 HIMP, 22 large, and 13 Small high volume), the rule is anticipated to have a net benefit of approximately $31.77 million a year, annualized over 10 years assuming a 3 percent discount rate, TABLE 27—NET COSTS AND (BENEFITS) [M$] Number of establishments One-time ........................ ** 40 612 ........................ ........................ ........................ $3.88 0.84 3.03 ........................ ........................ 2.80 $22.65 22.17 0.48 (9.33) (47.33) (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 ...................................................................................... 6.68 (42.75) (31.77) (30.40) Costs To Industry ........................................................................................................................ Voluntary * ............................................................................................................................. Mandatory ............................................................................................................................. Health Benefits *** ........................................................................................................................ Industrial Efficiency ...................................................................................................................... Impacts to Agency’s Budget ........................................................................................................ Recurring * Further explanation and details on the NSIS adoption rate are provided in section G. Expected Cost of the Proposed Rule, Table 6: NSIS Adoption Rate and section J. Net Benefits, Table 28: Quantified Cost and (Benefits) of Various Adoption Rates. ** Note, this includes 5 HIMP establishments, which are not expected to incur any cost or benefits associated with the NSIS. *** Further explanation and details on the range of health benefits have been provided in section H. Expected Benefits Associated With Public Health, Table 20: Health Benefits from Averted Cases of Salmonella. The value of health benefits ranges from $0.19 million to $18.97 million, with a mean of $9.33 million. Given the lack of data with which to make cost-benefit comparisons across the industry, Table 28 provides a range of possible adoption scenarios and their corresponding costs and benefits. Under scenario A, only the 5 HIMP establishments adopt the NSIS. Because these 5 establishments are already operating under NSIS practices, there would not be any additional voluntary costs or benefits associated with these 5 establishments adopting the NSIS. However, all 612 establishments would incur costs associated with the proposed rule’s mandatory components. As such, scenario A has a net cost. Scenario B assesses the net cost and benefits of just 6 establishments adopting the NSIS (5 HIMP and 1 large). This scenario reveals that the rule is net beneficial if just 1 large establishment adopts the NSIS in addition to the 5 HIMP establishments. Scenarios C, D, and E measure the net costs and benefits of 50, 75, and 100 percent of the 40 establishments converting to the NSIS, respectively. Each of these scenarios are net beneficial. TABLE 28—QUANTIFIED COST AND (BENEFITS) OF VARIOUS ADOPTION RATES [M$] ∧ srobinson on DSK9F5VC42PROD with PROPOSALS2 Number to Adopt * A B C D E ................................... ................................... ................................... ................................... ................................... Costs (Benefits) Net Mandatory @ 5 6 23 32 40 $0.82 0.82 0.82 0.82 0.82 NSIS Health $0.0 0.86 8.35 13.09 17.02 Line speeds $0.0 (0.27) (3.59) (5.52) (7.09) $0.0 (2.04) (18.01) (27.82) (36.14) Agency budget $0.0 (0.38) (3.14) (4.88) (6.38) $0.82 (1.00) (15.57) (24.30) (31.77) * 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. VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 PO 00000 Frm 00038 Fmt 4701 Sfmt 4702 E:\FR\FM\01FEP2.SGM 01FEP2 4817 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules K. Alternatives TABLE 29—ALTERNATIVE POLICY OPTIONS Alternatives Benefits Costs A. No action (Baseline) ........................ 1. No additional costs to industry ........ B. Mandatory Portion of the Proposed Rule Only. 1. In comparison to the baseline, potential $0.76M in Process Control Sampling cost savings. 1. Potential $7.09M in averted illnesses. 2. Potential $36.14M in Industrial Efficiency. 3. Potential $0.76M in Process Control Sampling cost savings. 4. Roughly $6.67M in Agency Labor Savings. 1. Potentially more than $7.09M in averted illnesses. 2. Potential $36.14M in Industrial Efficiency. 3. Potential $0.76M in Process Control Sampling cost savings. 4. Roughly $2.72M in Agency Labor Savings. 1. Potential for inefficient use of agency resources. 2. No potential increase in industrial efficiency. 3. Lack of incentive for establishments to innovate and improve their process controls. 4. No potential health benefits. 1. In comparison to the baseline, potential $1.58M in Other Industry Costs. 1. Potential $16.62M Increase in Industry Labor Costs. C. Proposed Rule (40 Establishments Adopt NSIS). D. Require All 612 Establishments Adopt NSIS. srobinson on DSK9F5VC42PROD with PROPOSALS2 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 NSIS. These benefits include the establishment’s ability to innovate and develop process controls which increase foodborne hazard detection and more efficiently use all of their resources. Taking no action would also forgo potential industrial efficiency increases. 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 proposed rule. B—The Mandatory Portion of the Proposed Rule FSIS considered limiting the proposed rule to only include the mandatory sections. Under such a scenario quantified benefits are limited to an estimated $0.76 million reduction in process control sampling costs. This cost reduction is expected to be off-set by a $1.58 million increase in other industry costs associated with requiring written sanitary dressing plans and environmental sampling. In comparison to the baseline, this scenario has a net cost of roughly $0.82 million. VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 2. Potential $1.97M in Other Industry Costs. 3. Roughly $0.30M in Agency Training Costs. 1. Potential $25.9M Increase in Industry Labor. 2. Potential $3.3M in Other Industry Costs. 3. Roughly $0.68M in Agency Training Costs. 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 expected $6.67 million. However, because FIs will 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 proposed 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 expected net cost as compared to the baseline as well as the decrease in net benefits as compared to the proposed rule. PO 00000 Frm 00039 Fmt 4701 Sfmt 4702 Net Costs of $0.82M. Benefits of $31.77M. Benefits of $16.83M. C—The Proposed Rule Applying a 3 percent discount rate over 10 years the costs associated with the proposed rule include $16.62 million in additional industry labor costs, $1.97 million in other industry costs including costs associated with meeting ready to cook standards, written sanitary dressing plans, and environmental sampling, and $0.3 million in Agency training costs. The quantified health benefits of the proposed 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 is expected to increase their efficiency by $36.14 million, assuming a 3 percent discount rate. The proposed rule is also expected to reduce industry costs associated with process control sampling by roughly $0.76 million, assuming a 3 percent discount rate. Additionally, the proposed rule is expected to reduce the Agency’s labor costs by roughly $6.67 million, assuming a 3 percent discount rate. In comparison to the baseline, the proposed rule has an estimated net benefit of $31.77 million, assuming a 3 percent discount rate over 10 years and as such the Agency recommends the proposed rule. E:\FR\FM\01FEP2.SGM 01FEP2 srobinson on DSK9F5VC42PROD with PROPOSALS2 4818 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules 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 HIMP, 27 large, and 13 small high volume establishments expected to convert under the proposed rule to include 572 additional establishments. This expansion would include low volume establishments that slaughter all types of swine as well as 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 $36.14 million increase in industrial efficiency, $0.76 million in industrial savings associated with process control sampling requirements, and $2.72 million in Agency labor cost savings, assuming a 3 percent discount rate over 10 years. 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 proposed 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 proposed 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. While compared to the baseline, this alternative reduces Agency labor costs; it would result in additional promotions reducing the benefit in comparison to the proposed rule. In comparison to the baseline, the potential costs associated with this alternative include a $25.90 million increase in industrial labor, a $3.30 million increase in other industry costs which include costs associated with ready to cook standards, written sanitary dressing plans, and environmental sampling, and roughly $0.68 million in Agency training costs. In comparison to the proposed rule, the additional increases in costs to industry predominately fall on small and very small business. While this alternative has a net benefit of $16.83 million, assuming a 3 percent discount rate over VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 10 years, the Agency rejects it because its net benefit is less than the proposed rule. VII. Regulatory Flexibility Act Assessment The FSIS Administrator has made a preliminary determination that this proposed rule would 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. At the beginning of section VI is a list of specific economic issues that the Agency is seeking comment on. Section VI also provides additional details on costs incurred by small businesses. The proposed rule’s mandatory requirements would 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 plant, applying a 3 percent discount rate over 10 years. Second, the mandatory proposed changes to process control sampling requirements are expected to decrease small establishments’ sampling costs by roughly $1,296 per establishment annually, applying a 3 percent discount rate over 10 years. In addition to this sampling cost reduction, the Agency would allow small and very small establishments to modify their sampling plans to collect samples less frequently once they have collected 13 consecutive weekly samples and have demonstrated that they are effectively maintaining process control. FSIS is also proposing to allow establishments to develop sampling plans that are more tailored to their specific establishment, and thus more effective in monitoring their specific process control than the current generic E. coli criteria. Third, the mandatory environmental sampling program is expected to increase the average small and very small establishments’ costs by $87 per establishment annually, assuming a 3 percent discount rate over ten years. Therefore, the proposed rule’s PO 00000 Frm 00040 Fmt 4701 Sfmt 4702 mandatory requirements are expected to increase small establishments’ costs by roughly $660 ($1,869¥$1,296 + $87 = $660) per establishment annually, an amount that is expected to have little effect on small entities. To put this in perspective, the average small and very small establishment slaughters over 21 thousand swine annually. Using the American Meat Institute’s average pork packer dollars per head margins for 2010–2014, the average small and very small establishment’s marginal revenue is $0.09 million (21,858 (heads slaughtered) x $4.10 (average margin per head)). Additionally, the voluntary NSIS portion of the rule is expected to provide an overall cost savings for the 13 small high volume establishments or roughly $87,449 per establishment that adopt the NSIS. This estimate takes into consideration the increase in labor cost ($43,439 per establishment), cost associated with meeting ready-to-cook standards ($6,300 per establishments) and cost savings from increased industrial efficiency ($137,189 per establishment). See section VI for additional details. Executive Order 13771 Consistent with E.O. 13771 (82 FR 9339, February 3, 2017), we have estimated that this proposed rule would yield cost savings. Assuming a 7 percent discount rate and a perpetual time horizon and a starting year of 2018, the proposed rule would yield approximately $24.97 million (2016$) in cost savings, not including health benefits. Therefore, if finalized as proposed, this rule is expected to be an E.O. 13771 deregulatory action. VIII. E-Government Act FSIS and USDA are committed to achieving the purposes of the EGovernment Act (44 U.S.C. 3601, et. seq.) by, among other things, promoting the use of the internet and other information technologies and providing increased opportunities for citizen access to Government information and services, and for other purposes. IX. Executive Order 12988, Civil Justice Reform This proposed rule has been reviewed under Executive Order 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. E:\FR\FM\01FEP2.SGM 01FEP2 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules X. Executive Order 13175 XII. Environmental Impact This rule has been reviewed in accordance with the requirements of Executive Order 13175, ‘‘Consultation and Coordination with Indian Tribal Governments.’’ E.O. 13175 requires Federal agencies to consult and coordinate with tribes on a governmentto-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. FSIS has assessed the impact of this rule on Indian tribes and determined that this rule does not, to our knowledge, have tribal implications that require tribal consultation under E.O. 13175. If a Tribe requests consultation, FSIS will work with the Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions and modifications identified herein are not expressly mandated by Congress. 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 Environmental Assessment (EA) or an Environmental Impact Statement (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 the proposed NSIS are expected to 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 sales is very small, the Agency has determined that the change in the 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. XI. 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. srobinson on DSK9F5VC42PROD with PROPOSALS2 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: 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). VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 XIII. Paperwork Reduction Act In accordance with section 3507(d) of the Paperwork Reduction Act of 1995, the information collection or recordkeeping requirements included in this proposed rule have been submitted for approval to OMB. Title: Swine Slaughter Inspection. Type of Collection: New. Abstract: Under this proposed rule, establishments operating under NSIS would have to develop, implement, and PO 00000 Frm 00041 Fmt 4701 Sfmt 4702 4819 maintain in their HACCP systems written procedures for the segregation, identification, and disposition of animals exhibiting signs of moribundity, central nervous system disorders, or pyrexia. In addition, each official swine slaughter establishment would need to maintain, as part of its HACCP system, written procedures for (1) preventing throughout the entire slaughter and dressing operation, contamination of carcasses and parts by enteric pathogens, fecal material, ingesta, and milk and (2) preventing contamination of the pre-operational environment by enteric pathogens. The procedures addressing prevention of contamination by enteric pathogens would need to include microbial testing. Furthermore, all swine slaughter establishments operating would have to maintain records that document that the products resulting from its slaughter operations meet the definition of RTC pork products. Each establishment operating under the NSIS would also need to submit on an annual basis an attestation to the management member of the local FSIS circuit safety committee stating that it maintains a program to monitor and document any work-related conditions of establishment workers. The requirement that 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 proposed rule would create no new burden on establishments. The proposed requirement that swine slaughter establishments monitor their systems through microbial testing and recordkeeping would create a new information collection burden. For each sample on which a microbiological test is conducted, there are two ‘‘responses’’ for the establishment: One response for the actual collecting of the sample and sending it to the laboratory for analysis, and the other for recording the sample result. Under the proposed rule, large establishments would test and record microbiological results for enteric pathogens, at both pre-evisceration and post-chill, 13 times a day; small highvolume establishments, one-time a day; and small low-volume and very small establishments, 13 times a year. FSIS estimates that large establishments would test and record microbial results for the pre-operational environment weekly; small establishments, biweekly; small low-volume and very small establishments, monthly. Estimated Annual Recordkeeping Burden: Swine Slaughter Inspection. E:\FR\FM\01FEP2.SGM 01FEP2 4820 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules Respondents: Official swine establishments. Estimated Number of Respondents: 612 (28 large, 51 small high volume, 54 small low volume, and 479 very small). Estimated Average Annual Number of Responses (samples) per Respondent: Large establishments 6,846; small high volume establishments 430; and small low volume and very small establishments 25. Estimated number of respondents Respondents Large establishments .......... Small high volume establishments. Small low volume establishments. Very small establishments .. Microbial testing ordkeeping. Microbial testing ordkeeping. Microbial testing ordkeeping. Microbial testing ordkeeping. Total Recordkeeping Burden for process control. Small high volume establishments. Small low volume establishments. Very small establishments .. 191,688 2.5 7,987 data rec- 49 430 21,070 2.5 878 data rec- 54 25 1,350 2.5 56 data rec- 479 25 11,975 2.5 499 612 7,326 226,083 ........................ 9,420 Estimated Average Annual Number of Responses per Respondent: Large establishments 6,846; small high volume establishments 430; and small low volume and very small establishments 25. srobinson on DSK9F5VC42PROD with PROPOSALS2 Average annual number of responses per respondent Estimated Total Annual Responses: 226,083. Estimated Total Annual Recordkeeping Burden: 47,655 hours. Total annual responses Time per respone in minutes Total annual burden hours Microbial testing data recordkeeping. Microbial testing ................. 28 6,846 191,688 12.5 39,702 49 430 21,070 12.5 4,389 Microbial testing ................. 54 25 1,350 15 338 Microbial testing ................. 479 25 11,975 15 2,993 ............................................. 612 7,326 226,083 ........................ 47,655 FSIS is also proposing a new regulation that would create a new information collection burden, in that it would require 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. This is a new recordkeeping requirement that FSIS has submitted to OMB for approval. 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 number of respondents Respondents VerDate Sep<11>2014 Total annual burden hours 6,846 Estimated number of respondents Total Reporting Burden ....... Large establishments .......... Time per respone in minutes 28 Respondents Large establishments .......... Total annual responses data rec- ............................................. Estimated Annual Reporting Burden: Swine Slaughter Inspection. Respondents: Official swine establishments. Estimated Number of Respondents: 612 (28 large, 51 small high volume, 54 small low volume, and 479 very small). Average annual number of responses per respondent Estimated Total Annual Responses: 226,558. Estimated Total Annual Recordkeeping Burden: 9,440 hours. Attestation on Work-Related Conditions. 20:42 Jan 31, 2018 Jkt 244001 PO 00000 Frm 00042 Average annual number of responses per respondent 28 Fmt 4701 Sfmt 4702 Estimated Maximum Number of Respondents: 41. Estimated Average Annual Number of Responses per Respondent: Large establishments 1; small high volume establishments 1. Estimated Maximum Total Potential Annual Responses: 41. Estimated Total Annual Recordkeeping Burden: 1.37 hours. Total annual responses 1 E:\FR\FM\01FEP2.SGM 28 01FEP2 Time per respone in minutes Total annual burden hours 2 .93 4821 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules Estimated number of respondents Respondents Small high volume establishments. Average annual number of responses per respondent Total annual burden hours 13 1 49 2 .43 ............................................. 41 1 41 ........................ 1.37 publication on-line through the FSIS web page located at: http://www.fsis. usda.gov/federal-register. FSIS also will make copies of this Total No. Respondents ......... 612 publication available through the FSIS Average Annual No. Responses per Respondent .. 14,693 Constituent Update, which is used to Total Annual Responses ...... 453,157 provide information regarding FSIS Average Hours per Repolicies, procedures, regulations, sponse ............................... .125 Federal Register notices, FSIS public Total Annual Burden Hours .. 57,216.37 meetings, and other types of information that could affect or would be of interest Copies of this information collection to our constituents and stakeholders. assessment can be obtained from Gina The Update is available on the FSIS web Kouba, Office of Policy and Program page. Through the web page, FSIS is Development, Food Safety and able to provide information to a much Inspection Service, USDA, 1400 broader, more diverse audience. In Independence Avenue SW, Room 6065, addition, FSIS offers an email South Building, Washington, DC 20250; subscription service which provides (202) 720–5627. automatic and customized access to Comments are invited on: (a) Whether selected food safety news and the proposed collection of information information. This service is available at: is necessary for the proper performance http://www.fsis.usda.gov/subscribe. of FSIS’s functions, including whether Options range from recalls to export the information will have practical information, regulations, directives, and utility; (b) the accuracy of FSIS’s notices. Customers can add or delete estimate of the burden of the proposed subscriptions themselves, and have the collection of information, including the option to password protect their validity of the methodology and accounts. assumptions used; (c) ways to enhance XV. Proposed Regulatory Amendments the quality, utility, and clarity of the information to be collected; and (d) List of Subjects ways to minimize the burden of the information collection on those who are 9 CFR Part 301 to respond, including through the use of Meat inspection. appropriate automated, electronic, 9 CFR Part 309 mechanical, or other technological Animal diseases, meat inspection, collection techniques or other forms of reporting and recordkeeping information technology. Comments may be sent to both Gina requirements. Kouba, Office of Policy and Program 9 CFR Part 310 Development, at the address provided Animal diseases, meat inspection. above, and the Desk Officer for For the reasons stated in the Agriculture, Office of Information and preamble, FSIS is proposing to amend 9 Regulatory Affairs, Office of CFR Chapter III as follows: Management and Budget, Washington, DC 20253. To be most effective, PART 301—TERMINOLOGY; comments should be sent within 60 ADULTERATION AND MISBRANDING days of the publication date of this STANDARDS proposed rule. All responses to this notice will be summarized and included ■ 1. The authority citation for part 301 in the request for OMB approval. All continues to read as follows: comments will also become a matter of Authority: 7 U.S.C. 138–138i, 450, 1901– public record. SUMMARY OF BURDEN SWINE SLAUGHTER INSPECTION srobinson on DSK9F5VC42PROD with PROPOSALS2 Time per respone in minutes Attestation on Work-Related Conditions. Total Reporting Burden XIV. Additional Public Notification Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register VerDate Sep<11>2014 Total annual responses 20:42 Jan 31, 2018 Jkt 244001 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: ■ PO 00000 Frm 00043 Fmt 4701 Sfmt 4702 § 301.2 Definitions. * * * * * Ready-to-cook (RTC) pork product. Any slaughtered pork product free from bile, hair, scurf, dirt, hooves, toe nails, claws, bruises, edema, scabs, skin lesions, icterus, foreign material, and odor, which is suitable for cooking without need of further processing. * * * * * PART 309—ANTE-MORTEM INSPECTION 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. ■ 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 SOP, or other prerequisite program. (c) The establishment must identify carcasses of livestock that establishment employees have sorted and removed from slaughter or that FSIS inspectors have condemned on ante-mortem inspection with a unique tag, tattoo, or similar device. The establishment must immediately denature all major portions of the carcass on-site and dispose of the carcass according to 9 CFR part 314.3. (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. These records are subject to review and evaluation by FSIS personnel. E:\FR\FM\01FEP2.SGM 01FEP2 4822 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules (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. determined by the inspection service, if a mirror is used, it must comply with the requirements of § 307.2(m)(6). * * * * * ■ 7. Amend § 310.18 by adding paragraphs (c) through (e) to read as follows: PART 310—POST-MORTEM INSPECTION § 310.18 Contamination of carcasses, organs, or other parts. 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. srobinson on DSK9F5VC42PROD with PROPOSALS2 * * * * * (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 9 CFR 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 of the regulations as provided by 9 CFR 303.1(h). The Administrator also may permit establishments that slaughter market hogs and other classes of swine to slaughter market hogs under NSIS and slaughter 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 VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 * * * * (c) Procedures for controlling contamination throughout the slaughter and dressing operation. Official swine slaughter establishments must develop, implement, and maintain written procedures to prevent contamination of carcasses and parts by enteric pathogens, fecal, 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 small establishments or very low volume establishments, must collect and analyze samples for microbial organisms at the pre-evisceration and post-chill points in the process. Very small establishments and 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, or jowl areas. (i) Very small establishments are establishments with fewer than 10 employees or annual sales of less than $2.5 million. (ii) Very low volume establishments annually slaughter no more than 20,000 swine, or a combination of swine and other livestock not exceeding 6,000 cattle and 20,000 total of all livestock. (iii) An establishment may substitute alternative sampling locations if: (A) The establishment has support to demonstrate the alternative sampling locations are able to provide a definite improvement in monitoring process control than at pre-evisceration and post-chill; and (B) FSIS does not determine, and notify the establishment in writing, that the alternative sampling locations are inadequate to verify the effectiveness of the establishment’s process controls for enteric pathogens. PO 00000 Frm 00044 Fmt 4701 Sfmt 4702 (2) Sampling frequency. Establishments, except for very small and very low volume establishments as defined in paragraphs (c)(1)(i) and (ii) 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 small and very low volume establishments as defined in paragraphs (c)(1)(i) and (ii) 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 small and very low volume establishments as defined in paragraph (c)(1)(i) and (ii) of this section must collect and analyze samples at least once during each week of operation starting June 1 of every year. If, after consecutively collecting 13 weekly samples, very small and very low volume establishments can demonstrate that they are effectively maintaining process control, they may modify their sampling plans. (iii) An establishment may substitute an alternative frequency if: (A) The alternative is an integral part of the establishment’s verification procedures for its HACCP plan; and (B) FSIS does not determine, and notify the establishment in writing, that the alternative frequency is inadequate to verify the effectiveness of the establishment’s process controls for enteric pathogens. (iv) Establishments must sample at a frequency that is adequate to monitor their ability to maintain process control for enteric pathogens. Establishments must maintain accurate records of all test results and retain these records as provided in paragraph (e) of this section. (d) Procedures for controlling contamination in the pre-operational environment. Official swine slaughter establishments must develop, implement, and maintain written procedures to prevent contamination of the pre-operational environment by enteric pathogens. Establishments must incorporate these procedures into their HACCP plans, sanitation SOPs, or other prerequisite programs. These procedures must include sampling and analysis of food contact surfaces in the pre-operational environment for microbial organisms to ensure that the surfaces are sanitary and free of enteric pathogens and that water used to clean food contact surfaces is free of enteric pathogens. The sampling frequency must be adequate to monitor the establishment’s ability to maintain sanitary conditions in the pre- E:\FR\FM\01FEP2.SGM 01FEP2 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules operational environment. Establishments must maintain accurate records of all test results and retain these records as provided in paragraph (e) of this section. (e) Recordkeeping requirements. Official swine slaughter establishments must maintain daily records sufficient to document the implementation and monitoring of the procedures required under paragraphs (c), (d) and (e) of this section. Records required by this section may be maintained on computers if the establishment implements appropriate controls to ensure the integrity of the electronic data. Records required by this section must be maintained for at least one year and must be accessible to FSIS. ■ 8. Amend § 310.25 as follows: ■ a. Remove paragraph (a)(2)(ii)(C); ■ b. Remove the second sentence in paragraph (a)(2)(iii)(A); ■ c. Remove ‘‘20,000 swine,’’ in paragraph (a)(2)(v)(A); ■ d. Remove the ‘‘swine’’ row in Table 1—Evaluation of E. Coli Test Results; ■ e. Remove the ‘‘Hogs’’ and ‘‘fresh pork sausages’’ rows and footnote (b) from Table 2—Salmonella Performance Standards. ■ 9. Add § 310.26 to read as follows: § 310.26 Establishment responsibilities under the new swine slaughter inspection system. srobinson on DSK9F5VC42PROD with PROPOSALS2 (a) Facilities. The establishment must comply with the facilities requirements in 9 CFR part 307. If the establishment has less than three inspection stations, 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. The establishment must develop, implement, and maintain VerDate Sep<11>2014 20:42 Jan 31, 2018 Jkt 244001 written procedures to ensure that market hog carcasses contaminated 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 SOP, or other prerequisite program. These procedures must cover establishment sorting activities required under this section. (c) Line speed limits. The line speed limits in 9 CFR 310.1 do not apply to the establishment, provided that they are able to maintain effective process control and prevent contamination of carcasses and parts by fecal material and enteric pathogens. Establishments operating under NSIS must reduce their line speed as directed by the Inspectorin-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 the products resulting from its slaughter operation meet the definition of readyto-cook pork product in 9 CFR 301.2. These records are subject to review and evaluation by FSIS personnel. (2) The establishment must maintain records to document the number of animals disposed of per day by plant sorters or condemned per day by FSIS inspectors upon post-mortem inspection. These records are subject to review and evaluation by FSIS personnel. ■ 10. Add § 310.27 to read as follows: PO 00000 Frm 00045 Fmt 4701 Sfmt 9990 § 310.27 4823 Attestation requirements. Each establishment that participates in the New Swine Slaughter Inspection System (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. ■ 11. Add § 310.28 to read as follows: § 310.28 Severability. Should a court of competent jurisdiction hold any provision of 9 CFR 310.27 to be invalid, such action will not affect any other provision of 9 CFR parts 309 or 310. Done in Washington, DC, on January 19, 2018. Paul Kiecker, Acting Administrator. [FR Doc. 2018–01256 Filed 1–31–18; 8:45 am] BILLING CODE 3410–DM–P E:\FR\FM\01FEP2.SGM 01FEP2

Agencies

[Federal Register Volume 83, Number 22 (Thursday, February 1, 2018)]
[Proposed Rules]
[Pages 4780-4823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01256]



[[Page 4779]]

Vol. 83

Thursday,

No. 22

February 1, 2018

Part II





Department of Agriculture





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Food Safety and Inspection Service





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9 CFR Parts 301, 309, and 310





Modernization of Swine Slaughter Inspection; Proposed Rule

Federal Register / Vol. 83 , No. 22 / Thursday, February 1, 2018 / 
Proposed Rules

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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: Proposed rule.

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

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

ADDRESSES: FSIS invites interested persons to submit comments on this 
rule. Comments may be submitted by one of the following methods:
     Federal eRulemaking Portal: This website provides the 
ability to type short comments directly into the comment field on this 
web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for 
submitting comments.
     Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. 
Department of Agriculture, Food Safety and Inspection Service, Patriots 
Plaza 3, 1400 Independence Avenue SW, Mailstop 3782, Room 8-163A, 
Washington, DC 20250-3700.
     Hand- or courier-delivered submittals: Deliver to Patriots 
Plaza 3, 355 E Street SW, Room 8-163A, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2016-0017. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or comments received, go 
to the FSIS Docket Room at Patriots Plaza 3, 355 E Street SW, Room 8-
164, Washington, DC 20250-3700, between 8:00 a.m. and 4:30 p.m., Monday 
through Friday.

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

SUPPLEMENTARY INFORMATION: 

Executive Summary

    FSIS began experimenting with new approaches to slaughter 
inspection based on Hazard Analysis and Critical Control Point Systems 
(HACCP) principles shortly after publishing the Pathogen Reduction/
HACCP rule in 1996. In 1997, the Agency developed the HACCP-Based 
Inspection Models Project (HIMP) study to determine whether applying 
new Government slaughter inspection procedures, along with new plant 
responsibilities, could promote innovation and provide at least the 
same food safety and consumer protection. FSIS initiated the HIMP study 
in 20 young chicken, five young turkey, and five market hog 
establishments on a waiver basis.
    In 2014, the Agency amended the poultry products inspection 
regulations to establish a new optional inspection system for young 
chicken and all turkey slaughter establishments informed by the 
Agency's experiences under HIMP (79 FR 49566, August 21, 2014). The New 
Poultry Inspection System (NPIS) was designed to facilitate pathogen 
reduction in poultry products, improve the effectiveness of poultry 
slaughter inspection, make better use of the Agency's resources, and 
remove unnecessary regulatory obstacles to innovation. The risk model 
employed to assess the potential impact of the NPIS modeled scenarios 
involving an increase in targeted inspection activities (specifically 
unscheduled offline inspection activities). The results of this model, 
constructed on the assumption that the number of offline procedures 
performed in poultry establishments under the NPIS would increase 
proportionally to the number observed in HIMP establishments, suggested 
that implementing the NPIS would likely result in public health 
benefits, in the form of fewer poultry-associated foodborne Salmonella 
illnesses per year. Consistent with the underlying assumptions of the 
model, it is reasonable to conclude that inspection systems in which 
Agency resources are used to continue core online inspection activities 
while enhancing the frequency and focus of unscheduled offline 
activities directly related to food safety, such as HIMP and the NPIS, 
would likely result in a lower prevalence of carcasses contaminated 
with Salmonella, which in turn would likely lead to fewer human 
illnesses.
    In addition to establishing the NPIS for young chickens and 
turkeys, FSIS also amended the poultry products inspection regulations 
that apply to all establishments that slaughter poultry other than 
ratites. The new requirements ensure that all poultry slaughter 
establishments implement appropriate measures in their HACCP plans, 
sanitation standard operating procedures (sanitation SOPs), or other 
prerequisite programs (hereafter referred to as their ``HACCP 
systems'') to prevent contamination of carcasses and parts by enteric 
pathogens and visible fecal material throughout the entire slaughter 
operation, and ensure that both FSIS and establishments have the 
documentation they need to verify the effectiveness of these measures 
on an ongoing basis.
    FSIS is now proposing to amend the Federal meat inspection 
regulations to establish a new optional inspection system for market 
hog slaughter establishments, the New Swine Slaughter Inspection System 
(NSIS), informed by the Agency's experiences under HIMP. FSIS is 
proposing this new inspection system to facilitate pathogen reduction 
in pork products; improve compliance with the HMSA; improve the 
effectiveness of market hog slaughter inspection; make better use of 
the Agency's resources; and remove unnecessary regulatory obstacles to 
innovation by revoking maximum line speeds and allowing establishments 
flexibility to reconfigure evisceration lines. If establishment 
personnel sorted and removed unfit animals before ante-mortem 
inspection and trimmed and identified defects on carcasses and parts 
before post-mortem inspection by FSIS inspectors, FSIS inspectors would 
be presented with healthier animals and carcasses that have fewer 
defects to inspect, which would allow inspectors to conduct a more 
efficient and effective inspection of each animal and each

[[Page 4781]]

carcass. Such a system would allow FSIS inspectors to conduct a more 
efficient inspection. As a result, FSIS could assign fewer inspectors 
to online inspection, freeing up Agency resources to conduct more 
offline inspection activities that FSIS has determined are more 
effective in ensuring food safety, such as verifying compliance with 
sanitation, HACCP, and humane handling requirements.
    Key elements of the proposed NSIS include: (1) Requiring 
establishment personnel to sort and remove unfit animals before ante-
mortem inspection by FSIS and to trim and identify defects on carcasses 
and parts before post-mortem inspection by FSIS; (2) requiring 
establishment personnel to identify animals or carcasses that they have 
sorted and removed for disposal before FSIS inspection with a unique 
tag, tattoo, or similar device and immediately denature all major 
portions of the carcass on-site, and maintain records to document the 
total number of animals and carcasses sorted and removed per day; (3) 
requiring establishment personnel to immediately notify FSIS inspectors 
if they suspect an animal or carcass with a reportable or foreign 
animal disease (e.g., African swine fever, classical swine fever, or 
Nipah virus encephalitis) while conducting sorting activities; (4) 
shifting Agency resources to conduct more offline inspection activities 
that are more effective in ensuring food safety, which would allow for 
up to two offline verification inspectors per line per shift and would 
reduce the number of online inspectors to a maximum of three per line 
per shift; (5) requiring establishments to maintain records documenting 
that products resulting from their slaughter operations meet the new 
proposed definition of Ready-to-cook (RTC) pork product, which would be 
defined as any slaughtered pork product free from bile, hair, scurf, 
dirt, hooves, toe nails, claws, bruises, edema, scabs, skin lesions, 
icterus, foreign material, and odor which is suitable for cooking 
without need of further processing; and (6) revoking maximum line 
speeds and authorizing establishments to determine their own line 
speeds based on their ability to maintain process control for 
preventing fecal contamination and meeting microbial performance 
measures during the slaughter operation. FSIS projects that the new 
system is unlikely to result in a higher prevalence of Salmonella on 
market hog carcasses and may even result in a lower prevalence of 
Salmonella on market hog carcasses, which in turn may lead to fewer 
human illnesses. In addition, the new system should improve animal 
welfare and compliance with the Humane Methods of Slaughter Act (HMSA) 
because more FSIS resources will be available to verify humane handling 
as an offline activity.
    Under the proposed rule, market hog slaughter establishments that 
do not choose to operate under the NSIS may continue to operate under 
their existing inspection system (hereafter referred to as 
``traditional inspection''). As mentioned above, NSIS provides public 
health protection at least equivalent to traditional inspection. FSIS 
recognizes that some establishments may not be prepared to make the 
investment in facilities and labor needed to convert to NSIS. In 
addition, many small, very low volume establishments slaughter more 
than one type of livestock species and the facilities updates need to 
convert to the proposed NSIS may not accommodate the slaughter of 
livestock other than market hogs. Therefore, FSIS is proposing to give 
establishments the flexibility to operate under the system that is best 
suited to their operations.
    FSIS is also proposing several changes that would affect all 
establishments that slaughter swine, regardless of the inspection 
system under which they operate. FSIS is proposing to require that all 
official swine slaughter establishments develop, implement, and 
maintain in their HACCP systems written procedures to prevent the 
contamination of carcasses and parts by enteric pathogens, fecal 
material, ingesta, and milk throughout the entire slaughter and 
dressing operation. These procedures must include sampling and analysis 
for microbial organisms to monitor process control for enteric 
pathogens, as well as written procedures to prevent visible fecal 
material, ingesta, and milk contamination.
    FSIS is proposing to prescribe a minimum frequency with which 
establishments would be required to collect two samples, one at pre-
evisceration and one at post-chill (i.e., the point in the slaughter 
process after the carcass has chilled in the cooler and after all 
slaughter interventions are completed), or, for very small and very low 
volume establishments, a single post-chill sample. FSIS considers the 
microbial load of hog carcasses at pre-evisceration to be a valuable 
source of data about how well an establishment is taking into account 
the sanitary condition of live hogs coming to slaughter and the 
processing steps (i.e., washing, dehairing) they implement to reduce 
the external contamination of the carcass prior to evisceration. FSIS 
also considers the microbial characteristics of hog carcasses post-
chill (after all processing steps have taken place) to be a valuable 
source of data about how well an establishment is minimizing 
contamination during chilling as well as the overall effectiveness of 
all process control interventions the establishment has chosen to apply 
throughout its production process. Because most establishments apply 
one or more interventions between the pre-evisceration and post-chill 
sampling points to help control microbiological hazards, FSIS would 
expect that a reduction in microbiological contamination between these 
two sampling points to be an indication of the effectiveness of those 
controls.
    Under the proposed rule, establishments, except for very small and 
very low volume establishments, would be required to collect pre-
evisceration and post chill samples at a frequency of once per 1,000 
carcasses. Very small and very low volume establishments would be 
required to collect at least one sample during each week of operation 
each year. If, after consecutively collecting 13 weekly samples, very 
small and very low volume establishments can demonstrate that they are 
effectively maintaining process control, they can modify their sampling 
plans to collect samples less frequently. FSIS is proposing to allow 
very small and very low volume establishments to collect and analyze 
samples for microbial organisms at the post-chill point in the process 
only because these establishments typically are less automated and run 
at slower line speeds than larger establishments. The lower level of 
automation and the slower line speeds require less complicated measures 
for maintaining and monitoring process control on an ongoing basis. 
These proposed frequencies reflect the frequencies prescribed under the 
existing regulations for generic Escherichia coli (E. coli) testing. 
FSIS is proposing to remove the current requirement that swine 
establishments test carcasses for generic E. coli to monitor process 
control and to remove the codified Salmonella pathogen reduction 
performance standards for swine and replace them with the new testing 
requirements described above. The new testing requirements would allow 
establishments to develop sampling plans that are more tailored to the 
specific establishment, and thus more effective in monitoring their 
specific process control than the current generic E. coli criteria.
    FSIS is proposing to allow establishments to substitute alternative 
sampling locations if they are able to

[[Page 4782]]

demonstrate that the alternative sampling locations are able to provide 
a definite improvement in monitoring process control than at pre-
evisceration and post-chill. FSIS interprets ``definite improvement'' 
to mean any improvement of equipment, substances, methods, processes, 
or procedures affecting the slaughter of livestock and poultry or 
processing of meat, poultry, or egg products. FSIS is also proposing to 
allow establishments to substitute alternative sampling frequencies if 
they are able to demonstrate that the alternative is an integral part 
of the establishments' verification procedures for their HACCP plans 
and are able to provide a definite improvement in monitoring process 
control than at the prescribed frequency. FSIS is requesting comments 
on the proposed sampling requirements, particularly the incremental 
value (from both a process-improvement and public health standpoint) of 
pre-evisceration sampling over what is provided by post-chill sampling.
    Finally, FSIS is proposing to require that all official swine 
slaughter establishments develop, implement, and maintain in their 
HACCP systems written procedures to prevent contamination of the pre-
operational environment by enteric pathogens. The pre-operational 
environment comprises food contact surfaces, reuse water, and 
equipment, including knives, in edible food production departments 
before slaughter operations begin. These procedures would need to 
include sampling and analysis of food-contact surfaces in the pre-
operational environment for microbial organisms to ensure that the 
surfaces are sanitary and free of enteric pathogens. The sampling 
frequency would need to be adequate to monitor the establishment's 
ability to maintain sanitary conditions in the pre-operational 
environment. Please see the draft compliance guide for additional 
information about implementation of this provision. FSIS is proposing 
this requirement as a direct result of a recent outbreak of foodborne 
illness associated with a hog slaughter establishment where food 
contact surfaces were found to be contaminated with the outbreak 
strain. FSIS is requesting comments on this proposed sampling 
requirement and the extent to which interventions in the pre-
operational environment are needed to ensure food safety.
    In Table 1 below, FSIS presents the estimated costs and benefits of 
the proposed rule. Later portions of the regulatory impact analysis 
section contain explanation of the assumptions, alternative adoption 
scenarios, and a discussion of the uncertainty surrounding the net 
benefits associated with how much of the industry would choose to adopt 
NSIS.

                                        Table 1--Net Costs and (Benefits)
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                                                                  establishments     One-time        Recurring
----------------------------------------------------------------------------------------------------------------
Costs To Industry...............................................  ..............           $3.88          $22.65
    Voluntary *.................................................           ** 40            0.84           22.17
    Mandatory...................................................             612            3.03            0.48
Potential Health Benefits ***...................................  ..............  ..............          (9.33)
Industrial Efficiency...........................................  ..............  ..............         (47.33)
Impacts to Agency's Budget......................................  ..............            2.80          (8.73)
----------------------------------------------------------------------------------------------------------------
    Totals:
        One-Time Cost...........................................................................           $6.68
        Recurring Cost..........................................................................         (42.75)
        Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.............................         (31.77)
        Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.............................         (30.40)
----------------------------------------------------------------------------------------------------------------
* Further explanation and details on the NSIS adoption rate are provided in section G. Expected Cost of the
  Proposed Rule, Table 6: NSIS Adoption Rate and section J. Net Benefits, Table 28: Quantified Cost and
  (Benefits) of Various Adoption Rates.
** Note, this includes 5 HIMP establishments, which are not expected to incur any costs or benefits associated
  with the NSIS.
*** Further explanation and details on the range of health benefits have been provided in section H. Expected
  Benefits Associated With Public Health, Table 20: Health Benefits from Averted Cases of Salmonella. The value
  of health benefits ranges from $0.19 million to $18.97 million, with a mean of $9.33 million.

Statutory Authority

    FSIS inspects and regulates the production of meat and meat food 
products prepared for distribution in commerce under the authority of 
the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.). The 
FMIA provides that the Secretary shall cause to be made by inspectors 
an examination and inspection of all amenable species before they enter 
into any establishment in which they are to be slaughtered and the meat 
and meat food products thereof are to be used in commerce (21 U.S.C. 
603(a)). All amenable species found to show symptoms of disease are to 
be set apart and slaughtered separately; the carcasses of such animals 
are to be subject to a careful inspection (21 U.S.C. 603(a)). The FMIA 
requires that the livestock be slaughtered and handled in connection 
with slaughter in a manner that is consistent with the HMSA (21 U.S.C. 
603(b)). Under the HMSA, the handling of livestock in connection with 
slaughter must be carried out only by humane methods (7 U.S.C. 1902).
    The FMIA also requires inspectors to conduct a post-mortem 
examination and inspection, and any necessary reinspection, of 
carcasses and parts of amenable species prepared for human food (21 
U.S.C. 604). The FMIA requires that all carcasses and parts found to be 
adulterated be condemned (21 U.S.C. 604). Under the FMIA, a meat or 
meat food product is adulterated, among other circumstances, if it 
bears or contains any poisonous or deleterious substance that may 
render it injurious to health; it is unhealthful, unwholesome, or 
otherwise unfit for human consumption; it was prepared, packaged, or 
held under insanitary conditions whereby it may have been rendered 
injurious to health; or if damage or inferiority has been concealed in 
any manner (21 U.S.C. 601(m)(1), (3), (4), and (8)). Finally, 21 U.S.C. 
621 provides that the Secretary shall make such rules and regulations 
as are necessary for the efficient execution of the provisions of the 
FMIA. FSIS regulations and inspection programs are designed to verify 
that livestock are handled and slaughtered humanely, and that meat and 
meat food products are

[[Page 4783]]

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

Table of Contents of Proposed Rule Discussion

I. Background
    A. Traditional Market Hog Slaughter Inspection Under Existing 
Regulations
    1. Description of the Inspection System Under Existing 
Regulations
    2. Need for Modernization
    B. Regulations for Microbiological Testing Under Traditional 
Inspection
    1. Generic E. Coli Criteria for Measuring Process Control
    2. Salmonella Pathogen Reduction/HACCP Performance Standards
    C. Waivers of Regulatory Requirements
    1. Waivers to Test New Technology
    2. Salmonella Initiative Program Waivers
II. Consideration of Need for a New Swine Slaughter Inspection 
System
    A. Early Development of the Inspection Models Program
    B. Existing HACCP-Based Inspection Models Program
    C. U.S. General Accountability Office (GAO) and the USDA's 
Office of the Inspector General (OIG) Reports on HIMP
    D. Analysis of HIMP
    1. FSIS Evaluation of HIMP
    a. Overview of the HIMP Report
    b. Verification by Offline Inspectors of the Establishment 
Executing Its HIMP Process Control Plan Under Which Establishment 
Employees Sort Acceptable and Unacceptable Carcasses and Parts
    c. Verification of the Establishment Executing Its HACCP System 
Under 9 CFR Parts 416 and 417
    d. Verification of the Outcomes of the Establishment Process 
Control Plan, Both Organoleptic and Microbiologic
    e. Conclusion of HIMP Report
    f. Verification of Humane Handling
    E. Public Health Benefits Projected From Allocating More 
Inspection Resources to Food Safety-Related Inspection Activities
    1. Market Hog Risk Assessment
    2. Model
    3. Conclusions of the Market Hog Risk Assessment
III. Proposed NSIS
    A. Live Market Hog Sorting by Establishment Personnel
    B. Post-Mortem Carcass Sorting by Establishment Employees and 
Online Carcass Inspection
    C. Offline Verification Inspection
    D. RTC Pork Product
    E. Line Speeds Under NSIS
IV. Other Proposed Changes That Affect All Swine Slaughter 
Establishments
    A. Procedures To Address Enteric Pathogens, Fecal Material, 
Ingesta, and Milk Contamination as Hazards Reasonably Likely to 
Occur
V. Implementation
VI. Executive Orders 12866 and 13563
    A. Request for Comments Summary
    B. Need for the Rule
    C. Overview of the Market
    D. Overview of the Proposed Rule's NSIS
    E. Overview of the Proposed Rule's Mandatory Components
    F. Overview of the Proposed Rule's Agency Impact
    G. Expected Cost of the Proposed Rule
    1. Costs Associated With the NSIS Components of the Rule
    a. Costs of Additional Establishment Workers
    b. Costs of Capital Improvements: Line Configuration and 
Inspection Stations
    c. Costs of Developing Ante-Mortem Written Procedures
    d. Ready-to-Cook Standards
    2. Costs Associated With the Mandatory Components of the Rule
    a. Costs of Developing, Composing, Training, Monitoring, 
Recording, and Verifying Written Sanitary Dressing Plans
    b. Process Control Sampling and Analysis for Microbial Organisms
    c. Environmental Sampling
    H. Expected Benefits of the Proposed Rule
    1. Expected Benefits Associated With Public Health
    2. Other Benefits Associated With Modernizing Existing 
Regulations
    I. Expected Budgetary Impacts
    1. Agency Staffing
    2. Agency Training
    J. Net Benefits
    K. Alternatives
VII. Regulatory Flexibility Act Assessment
VIII. E-Government Act
IX. Executive Order 12988, Civil Justice Reform
X. Executive Order 13175
XI. USDA Nondiscrimination Statement
XII. Environmental Impact
XIII. Paperwork Reduction Act
XIV. Additional Public Notification
XV. Proposed Regulatory Amendments

I. Background

A. Traditional Market Hog Slaughter Inspection Under Existing 
Regulations

1. Description of the Inspection System Under Existing Regulations
    Under the existing regulations for traditional inspection, FSIS 
ante-mortem inspectors examine all market hogs for visible signs of 
condemnable diseases or conditions while they are at rest and in motion 
(see 9 CFR part 309). FSIS ante-mortem inspectors direct establishment 
personnel to set apart animals showing signs of condemnable diseases or 
conditions into separate ``U.S. Suspect'' pens for further examination 
by the FSIS Public Health Veterinarian (PHV). The FSIS PHV determines 
whether the animals shall be identified as ``U.S. Condemned'' and 
disposed of in accordance with 9 CFR 309.13 (9 CFR 309.2).
    Most establishments under traditional inspection that slaughter 
only market hogs voluntarily segregate animals that show signs of 
diseases or conditions from healthy animals before the Agency performs 
ante-mortem inspection (see FSIS Directive 6100.1, Ante-mortem 
Livestock Inspection available at http://www.fsis.usda.gov/wps/wcm/connect/2b2e7adc-961e-4b1d-b593-7dc5a0263504/6100.1.pdf?MOD=AJPERES). 
Market hog establishment personnel segregate animals that appear to be 
normal and healthy from abnormal or unhealthy animals that appear to 
have condemnable diseases or conditions (e.g., animals exhibiting signs 
of neurologic conditions, pyrexia, or severe lameness) into ``subject'' 
pens, where they are subject to additional FSIS inspection. FSIS 
requires these establishments to document their segregation procedures 
in their HACCP plans or prerequisite programs. FSIS inspectors examine 
all animals found by the establishment to be normal at rest, and five 
to ten percent of those animals in motion. If any animals exhibit signs 
of condemnable conditions, FSIS inspectors direct establishment 
employees to move the animals to the ``U.S. Suspect'' pens for final 
disposition by the FSIS PHV. The FSIS PHV examines all animals in the 
``subject'' pens, and directs establishment employees to move animals 
to ``U.S. Suspect'' pens for final disposition. FSIS inspectors observe 
establishment employees performing segregation procedures at least once 
per month. Because establishment employees are responsible for 
identifying and removing market hogs that are not fit for slaughter 
before FSIS ante-mortem inspection, FSIS inspectors are presented with 
healthier animals that are more likely to pass inspection. Therefore, 
under the voluntary segregation procedures, FSIS inspectors are able to 
conduct a more efficient and effective ante-mortem inspection to 
determine whether each animal is fit for slaughter.
    During post-mortem inspection at all market hog slaughter 
establishments, FSIS online inspectors inspect the head, viscera, and 
carcass of each animal for localized defects and direct establishment 
employees to remove the defects through trimming (9 CFR 310.1(b)(3)). 
FSIS online inspectors perform manual incisions, palpations, and other 
organoleptic inspections (i.e., using sight, smell, and touch) to 
detect signs of disease or contamination. In large establishments, up 
to seven online inspectors are assigned per line per shift to cover 
inspection stations for the head, viscera, and carcass at fixed points 
along the slaughter and evisceration line. In small or very small 
establishments, one inspector may perform all of the post-mortem

[[Page 4784]]

inspection procedures on each animal. FSIS online inspectors identify 
and retain carcasses and parts with visible animal diseases and 
conditions. The FSIS PHV thoroughly examines retained carcasses and 
parts to determine whether they should be condemned; establishment 
personnel then dispose of condemned carcasses under FSIS supervision in 
accordance with 9 CFR part 314.
    Under the existing regulations for traditional inspection, 
establishments conduct no post-mortem carcass sorting to identify which 
carcasses and parts appear eligible to bear the mark of inspection, 
which carcasses and parts contain removable defects correctable through 
trimming, and which carcasses and parts should be submitted to FSIS for 
condemnation because of generalized diseases or conditions. These 
sorting functions are conducted by establishment personnel under HIMP. 
Rather, the existing regulations for traditional inspection require 
establishments to assign competent assistants to take such actions as 
directed by FSIS online inspectors after the inspectors have conducted 
the initial sorting activities (see 9 CFR 307.2(g)). Therefore, under 
the existing regulations for traditional inspection, establishments 
rely on FSIS online inspectors to effectively control and direct their 
processing. Moreover, because FSIS online inspectors are responsible 
for identifying unacceptable carcasses and parts, it takes online 
inspectors more time to conduct a carcass-by-carcass inspection than 
would be necessary if establishments sorted carcasses and parts, 
trimmed dressing defects and contamination that do not impact the FSIS 
inspectors' ability to assess the fitness of the carcass or part, and 
identified pathology defects, before the carcasses and parts were 
inspected.
    More FSIS resources also could be devoted to offline inspection 
activities if initial sorting and tagging functions were performed by 
establishment personnel. Under the existing regulations, only FSIS 
inspectors may direct the application and removal of ``U.S. Condemned'' 
tags from animals and carcasses condemned by FSIS inspectors on ante-
mortem and post-mortem inspection (9 CFR 309.13 and 310.5). The tag 
must remain on the carcass until it goes into the tank, or the carcass 
is otherwise disposed of in accordance with 9 CFR part 314. 
Establishments are required to denature condemned carcasses and parts 
if they do not have tanking facilities and the carcasses and parts are 
to be rendered or otherwise disposed of off-site (see 9 CFR 314.3). 
FSIS inspectors enter the number on each ``U.S. Condemned'' tag into 
the Public Health Information System (PHIS). Under the existing 
regulations, most ``U.S. Condemned'' tags are applied during ante-
mortem inspection to animals that arrive dead. Because FSIS inspectors 
are responsible for removing all of the ``U.S. Condemned'' tags and 
documenting each ``U.S. Condemned'' tag number into PHIS, it takes 
inspectors more time to complete ante-mortem and post-mortem 
inspections than it would if establishments sorted and removed these 
animals before FSIS inspection and maintained records that could be 
verified by FSIS, as appropriate, and reported their daily totals to 
FSIS inspectors.
    In addition to the post-mortem inspection activities conducted by 
online inspectors, offline inspectors conduct additional food safety 
related activities such as verifying that establishments' processing 
meets their HACCP critical limits and verifying whether sanitation SOPs 
are effective.
2. Need for Modernization
    Modernization of market hog slaughter inspection is necessary 
because traditional inspection was developed before FSIS issued its 
HACCP regulations, and before the Agency began targeting its resources 
to address public health risks associated with foodborne pathogens. 
Traditional inspection obscures the proper roles of industry and 
inspection personnel by assigning to FSIS inspectors responsibility for 
sorting acceptable animals from unacceptable animals, finding carcass 
defects, identifying production control problems for the establishment, 
and verifying corrective actions in addition to determining whether the 
carcasses meet regulatory requirements. Additionally, traditional 
inspection requires FSIS to allocate significant inspection personnel 
resources towards online inspection activities in large and high volume 
market hog establishments to detect quality defects and conditions that 
present minimal food safety risks, thus limiting the resources 
available for offline inspection activities such as verifying the 
effectiveness of HACCP plans and sanitation SOPs. FSIS has concluded, 
based on the Agency's analysis of the market hog HIMP pilot (discussed 
in more detail below), conducting more offline activities will be more 
effective in ensuring food safety and humane handling verification 
tasks.
    Traditional inspection requires inspectors to conduct time-
intensive ante-mortem and post-mortem sorting activities. This 
necessitates FSIS to allocate significant personnel resources to 
conduct activities that are more appropriately the responsibility of 
the establishment. As a result, traditional inspection limits line 
speeds, even if establishments can demonstrate that they are able to 
produce safe, unadulterated, wholesome products at more efficient 
rates. It also limits large and high volume market hog slaughter 
establishments' incentive to improve their processing methods and to 
develop more efficient slaughter and dressing technologies.
    For example, under traditional inspection, the maximum line speed 
authorized for slaughter lines with one or two inspectors is partially 
based upon the distance walked (in feet) by the inspector between work 
stations to conduct the sorting activities mentioned above (see 9 CFR 
310.1(b)(3)). For slaughter lines with three or more inspectors, line 
speeds may also depend on whether FSIS online inspectors observe the 
back of the carcasses by looking in a mirror or whether they must turn 
the carcass to observe the back of the carcass (see 9 CFR 310.1(b)(3)). 
The maximum line speed under the existing regulations for market hogs 
is 1,106 head per hour (hph) with seven online inspectors. 
Establishments determine their line speeds based on their equipment, 
size and condition of the animals, and their ability to maintain 
process control when operating at a given line speed.
    Additionally, traditional inspection restricts establishments' 
ability to reconfigure and consolidate lines if they determine that 
they need more space to conduct other activities in their facilities. 
For example, establishments slaughtering 1,025 market hogs per hour 
must configure their evisceration lines to accommodate three online 
head inspectors, three online viscera inspectors, and one online 
carcass inspector. The regulations require that establishments provide 
an inspection station consisting of five feet of unobstructed line 
space for each head or carcass inspector and, for viscera table kills, 
eight feet for each viscera inspector on the inspector's side of the 
table (9 CFR 307.2 (m)(1)). As a result, the current regulations for 
traditional inspection prevent large and high volume market hog 
slaughter establishments from consolidating inspection stations or 
otherwise reconfiguring their evisceration lines in order to make room 
for more innovative, automated equipment such as head dropping 
equipment, bung equipment (which separates digestive and urinary organs 
from pelvic attachments),

[[Page 4785]]

eviscerating equipment, and back saws. Traditional inspection is 
generally sufficient for low volume establishments and for 
establishments that slaughter classes of swine other than market hogs 
because these establishments typically are less automated and run at 
slower line speeds than larger establishments.
    Additionally, traditional inspection was developed when visually 
detectable animal diseases such as pneumonias, erysipelas, hog cholera, 
cystercercosis, parasites, and arthritis were more prevalent and 
considered to be more of a concern than they are today. The line speed 
limits prescribed under traditional inspection reflect the Agency's 
previous focus on the detection of visible defects and animal diseases 
and do not give establishments the flexibility to address these 
conditions before presenting the carcasses and parts to FSIS 
inspectors.
    Traditional inspection focuses substantial FSIS resources on 
detecting visible trim and dressing defects that are not directly 
related to food safety, particularly in light of what is now known 
about the role microbial contamination plays in causing foodborne human 
illness. The traditional inspection model needs to be updated in light 
of the significant advances that have been made in the control or 
eradication of many animal diseases that were more prevalent and were 
considered to present a greater concern when the existing inspection 
systems were designed, particularly in generally healthy classes of 
animals such as market hogs.
    Moreover, the analysis in FSIS's ``Assessment of the Potential 
Change in Human Health Risk Associated with Modernizing Inspection of 
Market Hog Slaughter Establishments'' (hereafter referred to as the 
market hog risk assessment) conducted by FSIS suggests a statistically 
significant correlation between increased scheduled and unscheduled 
offline inspection procedures and a reduction in the prevalence of 
Salmonella in market hog establishments. Projecting out illness 
reductions based on reduction in Salmonella prevalence in 35 plants 
results in wide uncertainty, but the model confidently estimates that 
the level of protection from Salmonella illnesses would be at least as 
good as the current system. Based on these results, the redeployment of 
Agency resources dedicated to online inspection under the traditional 
inspection system to unscheduled offline activities, such as increased 
HACCP and sanitation SOP verification, has the potential to contribute 
to improved food safety resulting from a lower prevalence of carcasses 
contaminated with Salmonella, which may in turn lead to fewer human 
illnesses. While prevalence of Salmonella measured in FSIS's market hog 
baseline study is low, Salmonella is a pathogen of public health 
concern for pork products, and the data available are adequate to 
estimate the potential changes in prevalence with changes in FSIS's 
swine inspection system.

B. Regulations for Microbiological Testing Under Traditional Inspection

1. Generic E. Coli Criteria for Measuring Process Control
    The existing regulations require that official swine slaughter 
establishments conduct regular testing for generic E. coli at the end 
of the chilling process or after the final wash as a means to verify 
process control (9 CFR 310.25(a)(1)). These regulations prescribe 
requirements for collecting the samples, obtaining analytical results, 
and maintaining records of such results (9 CFR 310.25(a)(2), (3), and 
(4)). They also include criteria for evaluating an establishment's 
generic E. coli testing results (9 CFR 310.25(a)(5)). The regulations 
provide that generic E. coli testing results that do not meet the 
criteria described in the regulations indicate that the establishment 
may not be maintaining process controls sufficient to prevent fecal 
contamination (9 CFR 310.25(a)(6)). If an establishment is not meeting 
the E. coli test results criteria, the regulations state that FSIS will 
take further action as appropriate to ensure that all applicable 
provisions of the law are being met (9 CFR 310.25(a)(6)).
    In 2014, FSIS rescinded the regulations that required that poultry 
establishments test carcasses for generic E. coli to monitor for 
process control (79 FR 49565, August 21, 2014). The final regulations 
replaced the generic E. coli regulations with new testing requirements 
that allow establishments to develop sampling plans that are more 
tailored to the specific establishment, and thus are more effective in 
monitoring their specific process control than the former generic E. 
coli criteria. The Agency concluded that the use of generic E. coli as 
an indicator for process control may not be as useful in certain 
poultry slaughter operations as originally thought. Therefore, FSIS 
made the change to allow poultry establishments to use other more 
relevant indicators of process control.
    The Agency is aware that most swine slaughter establishments 
currently conduct additional sampling for micro-organisms other than 
generic E. coli (e.g., Salmonella spp. and aerobic plate count bacteria 
(APC)) because they have found these organisms to be more relevant 
indicators of their process control. Therefore, FSIS is proposing to 
remove the generic E. coli sampling requirements for swine slaughter 
establishments to give establishments more flexibility in monitoring 
their process control and to make the Federal meat inspection 
regulations more consistent with the Federal poultry products 
inspection regulations. FSIS is proposing that all swine slaughter 
establishments collect and analyze carcass samples for microbiological 
analysis at the pre-evisceration and post-chill points in the process. 
The discussion of the proposed testing requirements is set out later in 
this document.
2. Salmonella Pathogen Reduction/HACCP Performance Standards
    In addition to generic E. coli criteria, the existing regulations 
contain Salmonella pathogen reduction performance standards for market 
hogs (9 CFR 310.25(b)). The codified performance standards are based on 
the prevalence of Salmonella found by two nationwide microbiological 
baseline surveys conducted from April 1995 to March 1996 and from June 
1997 to May 1998. The regulations provide for FSIS to collect and 
analyze unannounced Salmonella samples sets in swine slaughter 
establishments to detect whether these establishments are meeting the 
pathogen reduction performance standards (9 CFR 310.25(b)(2)). The 
performance standards set a maximum number of Salmonella-positive 
samples allowable per sample set and are defined on a product class 
basis so that an establishment operating at the baseline level would 
have an 80 percent chance of meeting the standard. Establishments are 
required to take corrective actions when FSIS determines that they are 
not meeting the performance standards (9 CFR 310.25(b)(3)(i) and (ii)).
    Under the regulations, an establishment's failure to take the 
corrective actions necessary to comply with the Salmonella performance 
standards, or an establishment's failure to meet the standards on the 
third consecutive series of FSIS-conducted tests for that product, 
constitutes a failure to maintain sanitary conditions and to maintain 
an adequate HACCP plan (9 CFR 310.25(b)(3)(iii)). The regulations 
provide that such failure will cause FSIS to suspend inspection 
services (9 CFR 310.25(b)(3)(iii)). However, the Agency's ability to

[[Page 4786]]

directly enforce the pathogen reduction performance standards has been 
limited since 2001, after a ruling by the U.S. Court of Appeals for the 
Fifth Circuit in Supreme Beef Processors, Inc. v. USDA. In that case, 
the court enjoined FSIS from suspending inspection services against a 
meat grinding operation for failure to meet the Salmonella performance 
standards. Since that time, FSIS has used Salmonella failures as a 
basis to conduct an in-depth evaluation of the establishment's HACCP 
systems, including its HACCP plan and sanitation SOPs.
    From August 2010 to August 2011, FSIS conducted a third market hog 
baseline survey to estimate the national prevalence of Salmonella in 
market hogs (The Nationwide Microbiological Baseline Data Collection 
Program: Market Hogs Survey August 2010-2011 available at http://www.fsis.usda.gov/wps/wcm/connect/d5c7c1d6-09b5-4dcc-93ae-f3e67ff045bb/Baseline_Data_Market_Hogs_2010-2011.pdf?MOD=AJPERES). The third market 
hog baseline survey included 253 establishments that produce 
approximately 99.9 percent of market hogs slaughtered in the United 
States. For the third baseline survey, FSIS collected samples in 152 
random establishments from market hog carcasses at two points in the 
slaughter process: Pre-evisceration and post-chill. The Salmonella 
percent positive rate at pre-evisceration was 69.64 percent, but at 
post-chill it was reduced to 2.70 percent. The third baseline survey's 
percent positive rate at post-chill was significantly lower than the 
rates found in the two earlier surveys mentioned above, which reported 
Salmonella percent positive rates of 8.7 percent and 6.9 percent, 
respectively. Based on the data from the third baseline survey, FSIS 
estimated prevalence of Salmonella in market hogs was 1.66 percent with 
a 95 percent confidence interval between 0.82 percent and 2.51 percent. 
Because the estimated prevalence of Salmonella was low, and FSIS did 
not find enough pathogen positives to justify the resources needed 
(e.g., time and supplies) to conduct carcass swabbing, the Agency 
determined that this type of sampling was not an effective use of 
resources for verifying process control. As a result, FSIS did not 
develop new Salmonella performance standards for market hogs. Rather, 
in September 2011, FSIS discontinued its Salmonella verification 
sampling program for market hogs to make better use of its resources.
    Therefore, FSIS is proposing to eliminate the pathogen performance 
standards for market hogs in 9 CFR 310.25(b) because verifying the 
codified standards was not a good use of Agency resources and the 
standards have not been used since 2011. Instead, FSIS has decided to 
focus on its resources on sampling raw pork parts for pathogens of 
public health concern, as well as for indicator organisms.
    FSIS is currently addressing Salmonella through the Salmonella 
Initiative Program (SIP) described below. In addition, FSIS has 
published a compliance guideline to help official establishments 
control and reduce the spread of Salmonella in hog slaughter facilities 
(79 FR 633, January 6, 2014). The guidance is available on the FSIS web 
page at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index. The guidance provides information 
on best practices that may be applied at a hog slaughter facility to 
prevent, eliminate, or reduce levels of Salmonella on hogs at all 
stages of slaughter and dressing. Importantly, FSIS has identified 
microbial performance measures, as guidance, at the pre-evisceration 
and post chill points.
    Moreover, FSIS is currently conducting exploratory sampling of raw 
pork products for pathogens of public health concern, as well as for 
indicator organisms (80 FR 12618). A summary of the Phase I positive 
sampling results collected from May 2015 to November 2015 are as 
follows: 16.7 percent Salmonella, 1 percent Campylobacter, 4.5 percent 
Methicillin-Resistant Staphylococcus aureus (MRSA), 1 percent 
Toxoplasma gondii, 1.5 percent Yersinia enterocolitica, 0 percent E. 
coli O157:H7, and 5 percent non-O157 shiga toxin-producing E. coli 
(non-O157 STEC). FSIS has posted more detailed sampling results on its 
website at https://www.fsis.usda.gov/wps/wcm/connect/68f5f6f2-9863-41a5-a5c4-25cc6470c09f/Sampling-Project-Results-Data.pdf?MOD=AJPERES. 
The Agency may develop pathogen reduction performance standards for 
pork parts at a later date. In 2019, the Agency will use this data to 
determine whether standards or additional policies (e.g., training, 
guidance to industry, or instructions to field personnel) are needed to 
address Salmonella in pork products.

C. Waivers of Regulatory Requirements

1. Waivers To Test New Technology
    The regulations in 9 CFR 303.2(h) and 381.3(b) provide for the 
Administrator to waive for limited periods any provisions of the 
regulations to permit experimentation so that new procedures, 
equipment, or processing techniques may be tested to facilitate 
definite improvements. Under these regulations, FSIS may only grant 
waivers from the provisions in the regulations that are not in conflict 
with the purposes or provisions of the FMIA or PPIA (9 CFR 303.1(h) and 
381.3(b)).
    FSIS decides whether to grant requests for waivers based on 
proposals and documentation submitted by establishments to demonstrate 
that the use of a new technology is scientifically sound; that it will 
facilitate definite improvements; and that issuing the waiver will not 
conflict with the provisions of the FMIA or PPIA.\1\ If FSIS determines 
that the information submitted by an establishment supports the 
requested waiver, the Agency will waive the appropriate provisions in 
the regulation for a limited period of time to allow the establishment 
to conduct an in-plant trial. The purpose of the in-plant trial is to 
gather data on the effects of the use of the new technology. FSIS 
reviews the data that is developed in the trial to determine whether 
they establish that the purpose of the waiver is being met.
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    \1\ For Agency New Technology waiver procedures, see http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/New-Technologies.
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2. Salmonella Initiative Program Waivers
    Under SIP, the Agency grants meat and poultry slaughter 
establishments waivers of regulatory requirements on condition that 
they will conduct regular microbial testing and share the resulting 
data with FSIS. The Agency described preliminary details of SIP in a 
January 28, 2008, Federal Register notice (73 FR 4767-4774) and 
announced its final terms and conditions in the July 13, 2011, Federal 
Register notice (76 FR 41186). SIP benefits public health in that it 
encourages slaughter establishments to conduct testing for microbial 
pathogens, which is a key feature of effective process control, and to 
respond to testing results by taking steps when necessary to regain 
process control. In addition, SIP enables FSIS to use establishment 
data to inform Agency policy aimed at enhancing public health 
protection.
    SIP establishments test for Salmonella, Campylobacter (if 
applicable), and generic E. coli or other indicator organisms and share 
all sample results with FSIS. Establishments that had been operating 
under regulatory waivers before FSIS implemented the SIP were required 
to participate in SIP or forfeit their waivers. The list of 
establishments

[[Page 4787]]

participating in SIP is available on FSIS's website at https://www.fsis.usda.gov/wps/wcm/connect/188bf583-45c9-4837-9205-37e0eb1ba243/Waiver_Table.pdf?MOD=AJPERES. To date the regulations waived for swine 
slaughter establishments under SIP include: 9 CFR 310.1(b)(3)-- line 
speed; 9 CFR 310.25(a)-- generic E. coli testing \2\; 9 CFR 310.25(b)--
Salmonella performance standards; 9 CFR 310.18(a)-- contamination of 
organs; 9 CFR 310.11--cleaning and hair removal; and 9 CFR 310.14--
handling of bruised parts. All swine slaughter establishments operating 
under SIP waivers will continue to operate under waivers and will 
continue to conduct testing under SIP if their waivers are not 
addressed in the final rule resulting from this proposal. If their 
waivers are addressed in the final rule resulting from this proposal, 
their waivers will end.
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    \2\ Some establishments continue to sample for generic e. coli 
to monitor their process control. The SIP waivers allow these 
establishments to use alternative sampling locations and 
frequencies.
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II. Consideration of Need for a New Swine Slaughter Inspection System

A. Early Development of the Inspection Models Program

    In 1996, FSIS published its Pathogen Reduction/HACCP (PR/HACCP) 
final rule as the first step of a comprehensive initiative to target 
the Agency's resources to address the public health risks associated 
with foodborne pathogens, which cannot be detected by organoleptic 
inspection (61 FR 38868, July 25, 1996). Under FSIS's PR/HACCP 
regulations, establishments are required to develop and implement a 
system of preventive controls to ensure that their products are safe. 
This approach gives establishments more flexibility to determine how 
they can best meet the Agency's regulatory requirements. FSIS verifies 
the adequacy and effectiveness of establishments' HACCP systems.
    In 1997, in order to improve food safety and the effectiveness of 
inspection systems, reduce the risk of foodborne illness in the United 
States, remove unnecessary regulatory obstacles to innovation, and make 
better use of the Agency's resources, FSIS announced, in a Federal 
Register notice, that the Agency would be developing a new HIMP study 
(62 FR 31553, June 10, 1997). During the HIMP study, FSIS would design 
and test various new inspection models in a series of trials in 
volunteer meat and poultry slaughter establishments.
    Under the initial HIMP inspection models approach, establishment 
personnel were responsible for sorting and removing animals unfit for 
slaughter and identifying and removing abnormal carcasses and parts, 
and FSIS inspection personnel performed inspection activities that 
focused on the areas of greatest risk in the hog slaughter inspection 
system in each establishment.
    In 1998, the American Federation of Government Employees, several 
FSIS inspectors, and a public interest organization filed suit to 
enjoin FSIS from implementing the HIMP model. The plaintiffs alleged 
that HIMP violated the requirement in the FMIA that government 
inspectors conduct a post-mortem inspection of each carcass. 
Specifically, the FMIA provides that the Secretary shall cause to be 
made by inspectors a post-mortem inspection of the carcasses and parts 
thereof of all amenable species to be prepared at any slaughtering, 
meat-canning, salting, packing, rendering, or similar establishment (21 
U.S.C. 604). The district court upheld HIMP, finding that the word 
``inspection'', as used in the statute, does not necessarily mandate a 
direct, physical examination of each carcass by an FSIS inspector, and 
that the model program was a rational policy judgment within the 
discretion afforded to the Secretary.
    The plaintiffs appealed, and the Court of Appeals for the District 
of Columbia Circuit reversed the district court's decision. The Court 
of Appeals found that the FMIA requires Federal inspectors--rather than 
plant employees--to make the decision whether each carcass is 
adulterated within the meaning of the statute (AFGE v. Glickman, 215 
F.3d 7, 11 (D.C. Circ. 2000)). The case was remanded to the district 
court for further proceedings.
    In response to the Court of Appeals' opinion, FSIS modified HIMP to 
position up to three \3\ online inspectors at fixed locations along the 
slaughter lines: In the area where the carcass and head were separated; 
where the carcass and viscera were separated; and at the pre-wash 
carcass verification location. These inspectors were responsible for 
examining the head, viscera, and carcass of each hog. The modified 
models project also included FSIS offline inspectors who were 
responsible for conducting HACCP and sanitation system verification 
activities and for closely examining a sample of carcasses for food 
safety defects to ensure that the establishment's process was under 
control and that adulterated carcasses and parts were not getting past 
the establishment sorters. On remand, the district court found that 
HIMP, as modified, complied with both the applicable statutory 
provisions and the opinion issued by the Court of Appeals.
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    \3\ FSIS is able to assign fewer than three online inspectors if 
the physical configuration of the slaughter line allows one 
inspector to inspect both the head and viscera or the viscera and 
carcass. For example, in one establishment, the chain that carries 
the carcass is adjacent to the viscera pans, which enables one 
inspector to examine both the carcass and viscera.
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    The plaintiffs again appealed to the Court of Appeals for the D.C. 
Circuit. The plaintiffs argued that the modified inspection procedures 
were not in compliance with the Court of Appeals' prior opinion because 
FSIS had delegated some inspection duties to plant employees who were 
responsible for sorting defective carcasses and making preliminary 
decisions regarding adulteration. The Court of Appeals rejected this 
argument, finding that the FMIA does not prohibit plant employees from 
paring down the overall number of carcasses by sorting and removing 
carcasses before they reach the Federal inspector (AFGE v. Veneman, 284 
F.3d 125, 131 (D.C. Cir. 2002)). The Court held that the modified 
inspection model program satisfied the FMIA because it required Federal 
inspectors to personally examine all hog carcasses, heads, and viscera, 
as required by 21 U.S.C. 604.
    The plaintiffs also argued that the line speeds allowed in the HIMP 
plants were too fast to allow Federal inspectors to make a critical 
appraisal of each carcass. The Court found that FSIS's decision to 
allow higher line speeds was reasonable in light of the fact that 
establishment employees are required to sort carcasses and parts and 
identify defects prior to Federal inspection, resulting in fewer 
adulterated carcasses and parts being presented for Federal inspection. 
The Court also noted that although the FMIA delineates what must be 
inspected and by whom, it does not define exactly what constitutes an 
inspection. The court concluded that HIMP, as modified, reflected a 
reasonable design of an inspection system by the agency charged with 
responsibility for administering the FMIA and that it would rely on the 
Agency's experience and informed judgment in evaluating the validity of 
the system under the law. Under these circumstances, the Court of 
Appeals upheld HIMP, as modified.

B. Existing HACCP-Based Inspection Models Program

    The revised HIMP study was initiated in five market hog slaughter 
establishments on a waiver basis.
    Similar to the voluntary segregation procedures described above in 
establishments that slaughter only

[[Page 4788]]

market hogs under traditional inspection, establishment personnel sort 
animals before they are presented to FSIS ante-mortem inspectors under 
HIMP. Establishment personnel sort animals that appear to be healthy 
into ``Normal'' pens and animals that appear to have condemnable 
diseases or conditions into ``Subject'' pens. Establishment personnel 
remove and dispose of dead and moribund animals and animals suspected 
of having central nervous system disorders (CNS) or pyrexia. Under 
HIMP, FSIS inspectors examine all animals found by the establishment to 
be normal at rest, and five to ten percent of those animals in motion. 
If any animals exhibit signs of condemnable conditions, FSIS inspectors 
direct establishment employees to move the animals to the ``U.S. 
Suspect'' pens for final disposition by the FSIS PHV. FSIS PHVs examine 
all animals in the establishment's ``Subject'' pens, and direct 
establishment employees to move animals to ``U.S. Suspect'' pens for 
final disposition by the FSIS PHV. The FSIS PHV determines if any 
animals must be identified as ``U.S. Condemned'' and disposed of in 
accordance with 9 CFR 309.13 (9 CFR 309.2). While establishment 
personnel sort and remove animals unfit for slaughter, only FSIS 
inspectors have the authority to condemn an animal. FSIS inspectors 
observe establishment employees performing sorting procedures at least 
twice per shift under HIMP compared to at least once per month under 
the voluntary segregation procedures permitted under traditional 
inspection of market hogs.
    Under HIMP, post-mortem inspection is conducted by up to three 
online inspectors who visually inspect the head, viscera, and carcass 
of each hog at fixed locations on the evisceration line. Before FSIS 
online inspection, establishment personnel sort carcasses and parts and 
trim dressing defects and contamination (e.g., hair, bruises, feces, 
ingesta, and milk). Establishment employees also mark with ink 
localized pathology defects intended for removal under FSIS supervision 
(e.g. localized nephritis and localized arthritis) and carcasses and 
parts intended for disposal under FSIS supervision (e.g., carcasses and 
parts with malignant lymphoma). Online inspection is conducted much 
more efficiently and effectively under HIMP than under traditional 
inspection because establishment personnel have already sorted 
carcasses and parts, trimmed dressing defects and contamination, and 
identified pathology defects on the carcasses, thereby correcting most 
removable defects, before the FSIS online inspectors perform their 
carcass-by-carcass inspection.
    Under HIMP, offline inspection consists of system verification 
activities through which FSIS continuously monitors and evaluates 
establishment process control. FSIS conducts more offline, food safety 
related verification inspection activities under HIMP than under 
traditional inspection. Some examples of food safety related 
verification inspection activities include: HACCP, sanitation SOP, and 
other prerequisite program verification procedures, including 24 
carcass verification checks per shift specifically for generalized 
diseases and conditions and for contamination (compared to 11 carcass 
verification checks per shift under traditional inspection). FSIS also 
conducts more offline humane handling verification tasks under HIMP 
than under traditional inspection.
    FSIS has concluded that the HIMP model has a number of benefits, 
such as focusing FSIS inspection personnel on the areas of greatest 
risk in the hog slaughter system and providing an incentive to 
establishments to improve and innovate, while ensuring effective online 
inspection.

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

    In 2013, the U.S. General Accountability Office (GAO) and the 
USDA's Office of the Inspector General (OIG) evaluated FSIS's HIMP 
pilot study and issued findings and recommendations.4 5 GAO 
identified strengths in the pilot study, including that of giving 
plants responsibility and flexibility for ensuring food safety and 
quality and allowing FSIS inspectors to focus more on food safety 
activities. However, GAO also identified what it believed to be data 
gaps in the HIMP pilot study. GAO recommended that FSIS collect and 
analyze information to determine if the HIMP pilot study is meeting its 
purpose, and FSIS agreed with the recommendation.
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    \4\ GAO, 2013. More Disclosure and Data Needed to Clarify Impact 
of Changes to Poultry and Hog Inspections, http://www.gao.gov/assets/660/657144.pdf.
    \5\ OIG, 2013. Food Safety and Inspection Service--Inspection 
and Enforcement Activities at Swine Slaughter Plants, https://www.usda.gov/oig/webdocs/24601-0001-41.pdf.
---------------------------------------------------------------------------

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

D. Analysis of HIMP

1. FSIS Evaluation of HIMP
    In 2014, in response to the GAO and OIG reports, FSIS conducted a 
comprehensive analysis of data collected from the operation of HIMP in 
market hog establishments and prepared a written report (the ``Hog HIMP 
Report'') that presents a thorough evaluation of the models tested. 
Based on this evaluation, FSIS concluded that market hog slaughter 
establishments participating in HIMP were performing as well as 
comparable large non-HIMP market hog establishments and meeting FSIS 
requirements for operating under waivers through the HIMP project.
    A summary of the Hog HIMP Report is provided below. The full Hog 
HIMP Report is available on the FSIS website at: http://www.fsis.usda.gov/wps/wcm/connect/f7be3e74-552f-4239-ac4c-59a024fd0ec2/Evaluation-HIMP-Market-Hogs.pdf?MOD=AJPERES. Before implementation of 
the HIMP project, an independent consulting firm, Research Triangle 
Institute (RTI) collected baseline organoleptic and microbiological 
data in the five market hog slaughter establishments that volunteered 
to participate in the HIMP program. These data reflect the performance 
of the establishments under traditional inspection and provided the 
basis to establish HIMP performance standards for food safety defects 
and non-food safety ``Other Consumer Protection'' (OCP) defects.
    FSIS established three categories of food safety related 
performance standards under HIMP for these conditions: ``FS-1'' 
addresses infectious conditions (e.g., septicemia, toxemia, pyemia, and 
cysticercosis); ``FS-2'' addresses contamination from fecal material, 
ingesta, and milk; and ``FS-3'' addresses certain conditions identified 
at ante-mortem (e.g. moribund, pyretic, and neurologic conditions). 
FSIS has a zero tolerance policy for food safety conditions identified 
as FS-1, FS-2, and FS-3 to protect consumers from conditions that may 
be harmful. Therefore, the HIMP performance standard for food safety 
defects was set at zero.
    FSIS established the performance standard for non-food safety OCP

[[Page 4789]]

defects based on the performance level of the establishment 
representing the 75th percentile for each category of OCP defects 
(i.e., slightly below the fourth of the five baseline results for each 
category). FSIS established three categories of OCP performance 
standards for various types of trim and dressing defects that primarily 
affect the quality of products: ``OCP-1'' addresses carcass pathology 
defects (e.g., arthritis, emaciation, and erysipelas) and was set at 
4.1 percent of carcasses, ``OCP-2'' addresses visceral pathology 
defects (e.g., cystic kidneys, enteritis, and nephritis) and was set at 
7.2 percent of carcasses, and ``OCP-3'' addresses miscellaneous defects 
such as bile, bruises, and skin lesions and was set at 20.5 percent of 
carcasses. The HIMP performance standards were finalized in November 
2000 (see 65 FR 65828, November 2, 2000). To participate in the 
program, establishments operating under HIMP are required to maintain 
process control plans to meet the performance standards for food safety 
and non-food safety OCP defects. The HIMP performance standards are a 
measure for comparing the performance of establishments operating under 
the HIMP inspection system with performance when operating under the 
current non-HIMP, traditional inspection system.
a. Overview of the HIMP Report
    The Hog HIMP Report describes FSIS's microbiological and inspection 
findings in the five market hog slaughter establishments participating 
in HIMP and compares them with 21 non-HIMP establishments of comparable 
production volume, line speed, and days of operation. The evaluation is 
based on establishment performance results for calendar years CY2006 
through CY2010, and CY2012 through CY2013. Establishment performance 
results from CY2006 to CY2010 are based on data from the previously 
used Performance Based Inspection System (PBIS) database and results 
from CY2012 to CY2013 are based on data from the new Public Health 
Information System (PHIS) database. FSIS began transitioning 
establishments from PBIS to the PHIS in April 2011. The period April 
2011 to December 2011 was a transitional period during which the 
inspection results for some establishments were recorded under PBIS, 
while others were recorded under PHIS. The data under the two systems 
are not completely compatible because inspection task codes and 
noncompliance records (NRs) were recorded differently in PHIS than in 
PBIS. For this reason, the transitional period CY2011 is not included 
in the Hog HIMP Report, and the analysis of CY2006 through CY2010 data 
is separate from the CY2012 through CY2013 data.
    Across HIMP and non-HIMP establishments, analyses compared the 
number of offline inspection procedures, the rates of health-related 
regulatory non-compliances, Salmonella positive rates, and violative 
chemical residue rates. FSIS evaluated offline inspection procedures to 
determine whether comparable levels of inspection are being performed 
in HIMP establishments compared to non-HIMP establishments. The Hog 
HIMP Report found that establishments participating in HIMP performed 
as well as comparable large non-HIMP establishments and met the 
Agency's requirements for participating in the HIMP project.
b. Verification by Offline Inspectors of the Establishment Executing 
Its HIMP Process Control Plan Under Which Establishment Employees Sort 
Acceptable and Unacceptable Carcasses and Parts
    The Hog HIMP Report found that the rate of ante- and post-mortem 
sorting by HIMP establishment personnel was comparable to the rate of 
ante- and post-mortem condemnation by FSIS inspectors at non-HIMP 
market hog establishments (3.0 per 1,000 hogs compared to 2.7 per 1,000 
hogs, respectively). The Hog HIMP Report also found that FSIS 
inspectors in HIMP establishments performed more offline inspection 
activities than in non-HIMP establishments to verify that the 
establishments are executing their HIMP slaughter process control 
plans. In CY2010, FSIS inspectors performed an average of 2,061 offline 
verification inspections per HIMP market hog establishment compared to 
an average of 1,482 offline verification inspection procedures per non-
HIMP establishment. Accordingly, FSIS inspectors performed 1.4 times 
more offline verification inspection procedures in HIMP market hog 
establishments than in non-HIMP market hog establishments. In CY2013, 
FSIS inspectors performed an average of 19,180 Public Health Regulation 
(PHR) \6\ verification tasks per HIMP market hog establishment compared 
to an average of 14,099 PHR verification tasks per non-HIMP 
establishment. Thus, FSIS inspectors performed 1.4 times more of the 
offline inspection verifications of mandatory regulations in HIMP 
market hog establishments than in non-HIMP market hog establishments. 
The HIMP Report concluded that this increased level of offline 
inspection activities provides increased assurance that HIMP 
establishments are maintaining OCP and food safety defects at levels 
that are to or less than the levels in non-HIMP establishments.
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    \6\ PHRs consists of regulations and specific provisions of 
regulations that have higher rates of noncompliance three months 
before a pathogen positive or enforcement action. The inclusion of 
provisions of regulations in the PHR list allows FSIS to focus on 
specific health related provisions of regulations that may be most 
informative for prioritizing Food Safety Assessments (FSAs). FSAs 
are in-depth evaluations of an establishment's food safety system. 
FSAs can be routine or for cause.
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c. Verification of the Establishment Executing Its HACCP System Under 9 
CFR Parts 416 and 417
    The sanitation SOP regulations in 9 CFR 416 and the HACCP 
regulations in 9 CFR 417 are among the regulations most strongly 
related to public health. The Hog HIMP Report found that in CY2010, 
FSIS inspectors performed 1.5 times more offline sanitation SOP and 
HACCP inspection verifications of public health-related regulations in 
HIMP than non-HIMP market hog comparison establishments. In CY2012 and 
CY2013, FSIS inspectors performed 1.1 times more offline sanitation SOP 
and HACCP inspection verifications of public health-related regulations 
in HIMP than non-HIMP market hog comparison establishments.
    The regression analysis of historical data that was included in 
FSIS's ``Risk Assessment for Guiding Public Health-Based Poultry 
Slaughter Inspection,'' which was used to inform the final rule 
``Modernization of Poultry Slaughter Inspection'' (79 FR 49565), showed 
a statistically significant correlation between unscheduled offline 
inspection procedures and reduction in the prevalence of Salmonella and 
Campylobacter positive samples. Based on these modeling results, FSIS 
thought it was reasonable to conclude that the redeployment of Agency 
resources to unscheduled offline activities was likely to contribute to 
improved food safety resulting from a lower prevalence of carcasses 
contaminated with Salmonella and Campylobacter, which in turn could 
lead to fewer human illnesses. Depending on how reallocation of 
inspection activities was implemented, it was likely that changes in 
off-line inspection could have resulted in a decrease in the numbers of 
positive microbial samples in FSIS-regulated young chicken and young 
turkey establishments. Specifically, the scenario that only increased 
unscheduled inspection procedures performed much better than the 
scenario that did not target specific

[[Page 4790]]

types of procedures, and the results suggest a reasonable degree of 
confidence that the discriminate scenario would do no harm. That 
poultry slaughter risk assessment is available on FSIS's website at 
http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/haccp/haccp-based-inspection-models-project/himp-study-plans-resources/poultry-slaughter-inspection. The risk model and model results are also 
posted on-line as a technical support document for the risk assessment 
on the FSIS website. The market hog risk assessment uses a similar 
approach and model as the poultry slaughter risk assessment and 
estimates the reduction in illnesses likely to result from the 
reallocation of inspectors contemplated by this proposed rule. The 
market hog risk assessment is discussed in more detail below.
d. Verification of the Outcomes of the Establishment Process Control 
Plan, Both Organoleptic and Microbiologic
    To assess the microbiological outcomes of HIMP establishments' 
process control plans, the Hog HIMP Report analyzed data from FSIS's 
Salmonella verification program. For the years CY2006-CY2009, the 
differences in Salmonella positive rates between HIMP market hog 
establishments and non-HIMP comparison establishments were not 
statistically significant for any of the years. The Hog HIMP Report 
also analyzed data from FSIS's Salmonella baseline study on market hog 
slaughter establishments, conducted from August 2010 to August 2011. 
The Salmonella positive rates in HIMP market hog establishments were 
not statistically significantly different from those in the subset of 
21 non-HIMP comparison establishments. This is probably the result of 
the small sample size relative to the low Salmonella positive rate. 
However, in the August 2010 to August 2011 baseline study the 
Salmonella positive rates in HIMP market hog establishments were 
statistically significantly lower than those in all 147 non-HIMP market 
hog establishments (which included the subset of 21 non-HIMP comparison 
establishments, as well as all other non-HIMP market hog 
establishments) (0.65 percent versus 3.05 percent).
    The Hog HIMP Report also analyzed data from FSIS's residue sampling 
program for chemical contaminants including approved and unapproved 
veterinary drugs, pesticides, and environmental compounds. FSIS 
conducts directed sampling scheduled by FSIS Headquarters and 
inspector-generated sampling when the FSIS PHV suspects that an animal 
may have a violative level of chemical residue. The Hog HIMP Report 
found no differences in the number of scheduled directed samples 
collected in the HIMP market hog establishments and those in the non-
HIMP market hog comparison establishments. However, the Hog HIMP Report 
found that FSIS offline inspectors at the HIMP market hog 
establishments were able to collect 2.7 times more inspector-generated 
residue samples than inspectors at the non-HIMP market hog comparison 
establishments for CY2009-2010, and 1.7 times more for CY2012-2013 
because the inspectors had more time to conduct offline activities. 
Data from FSIS's residue sampling program showed that from CY2006 to 
CY2010, the number of samples that tested positive for violative levels 
of chemical residues in HIMP market hog establishments were not 
statistically significantly different from those in the non-HIMP market 
hog comparison establishments (zero versus six (0.057 percent of 
samples)). However, from CY2012 to CY2013, the amount of samples that 
tested positive for violative levels of chemical residues in HIMP 
market hog establishments was statistically significantly lower than 
non-HIMP market hog comparison establishments (nine violative levels 
(0.15 percent of samples) versus 115 (0.76 percent of samples). The Hog 
HIMP Report explained that this difference could suggest that the HIMP 
market hog establishments are exercising active control of potential 
chemical hazards in their products, and that this approach may result 
from better control over contract grower relationships by the five HIMP 
market hog establishments.
e. Conclusion of HIMP Report
    The Hog HIMP Report concluded that HIMP market hog establishments 
are receiving more offline food safety related inspection verification 
checks than the non-HIMP market hog comparison establishments, and that 
the HIMP inspection system, which provides for increased offline 
inspection activities that are directly related to food safety, results 
in greater compliance with sanitation and HACCP regulations (9 CFR 
parts 416 and 417); carcasses with equivalent or lower levels of 
Salmonella contamination; and carcasses with lower levels of violative 
chemical residues.
f. Verification of Humane Handling
    FSIS inspectors verify that establishments comply with the HMSA by 
performing Humane Activities Tracking System (HATS) tasks that are 
divided into nine categories. The HATS tasks provide FSIS with data on 
the time that FSIS inspectors spend verifying whether (1) 
establishments adapt their facilities to inclement weather; (2) 
humanely handle livestock during truck unloading; (3) provide water and 
feed to livestock in holding pens; (4) humanely handle livestock during 
ante-mortem inspection; (5) humanely handle ``U.S. Suspect'' and 
disabled livestock; (6) move livestock without excessive prodding or 
the use of sharp objects after ante-mortem inspection; (7) prevent 
livestock from slipping and falling; (8) effectively administer 
stunning methods that produce unconsciousness in the animals; and (9) 
ensure that animals do not regain consciousness throughout the 
shackling, sticking, and bleeding process. FSIS inspectors enter the 
hours devoted to verifying humane handling activities for the HATS 
categories. The data is entered into PHIS in one-quarter hour 
increments (e.g., .25, .5, .75, 1.0).
    The Hog HIMP Report did not address compliance with the HMSA, but 
FSIS reviewed HATS task data in PHIS from January 2013 through 
September 2015 and compared the number of offline humane handling 
activities performed in five HIMP market hog establishments and the 
same 21 comparable large non-HIMP market hog establishments that FSIS 
used in the Hog HIMP Report. The Agency found that FSIS inspectors 
spent more time verifying that specific humane handling and slaughter 
requirements were met in HIMP market hog establishments than in non-
HIMP market hog establishments. FSIS inspectors devoted approximately 
5.33 hours per shift to verifying humane handling activities for the 
HATS categories in HIMP market hog establishments compared to 
approximately 4.29 hours per shift in the 21 non-HIMP market hog 
comparison establishments. FSIS also compared the rate of humane 
handling NRs issued in HIMP market hog establishments and non-HIMP 
market hog establishments. FSIS inspectors documented fewer humane 
handling NRs in HIMP market hog establishments than in non-HIMP market 
hog establishments. From January 2013 through September 2015, FSIS 
recorded 11 humane handling NRs in five HIMP market hog establishments 
and 117 NRs in the 21 non-HIMP market hog comparison establishments. It 
should be noted that none of the 11 NRs recorded in the HIMP 
establishments documented market hogs being forced to

[[Page 4791]]

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

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

1. Market Hog Risk Assessment
    FSIS completed a quantitative risk assessment to determine how 
performing a greater number of offline inspection procedures in market 
hog slaughter establishments might affect the number of human illnesses 
from Salmonella. These offline inspection procedures primarily involve 
activities that FSIS inspection personnel perform to verify the 
effectiveness of establishment sanitary operations and other food 
safety-related activities. The Hog HIMP Report, discussed above, found 
that FSIS inspectors performed more offline inspections to verify 
compliance with sanitation SOP and HACCP regulations in HIMP 
establishments than they do in non-HIMP establishments. The risk 
assessment is available for viewing by the public in the FSIS docket 
room and on the FSIS website at: http://www.fsis.usda.gov/regulations_&_policies/Proposed_Rules/index.asp.
    FSIS developed the market hog risk assessment to help the Agency 
inform its judgement about the potential impact of changes to FSIS's 
swine inspection system on risks to public health associated with pork 
products. To give the Agency the information it needed, the market hog 
risk assessment focused on three risk management questions:
    (1) What predicted effects will various models for increasing the 
number of offline inspection tasks in non-HIMP establishments have on 
human salmonellosis rates?
    (2) Where can inspectors be relocated to have the most impact 
toward reducing Salmonella prevalence and corresponding human illness?
    (3) What is the magnitude of uncertainty about the predicted 
prevalence of pathogens and corresponding illness effects?
2. Model
    FSIS developed a risk assessment model for exploring the potential 
relationships between current variations in inspection personnel 
assignments and prevalence of Salmonella on hog carcasses, and 
estimating the subsequent possible reductions in human illnesses 
attributable to that pathogen. FSIS paired inspection data with 
Salmonella prevalence data for the same establishments and timeframes. 
As explained above, FSIS based this risk assessment model on the model 
for the risk assessment that FSIS used to inform the final rule 
``Modernization of Poultry Slaughter Inspection'' (79 FR 49565).
    FSIS employed a stochastic simulation model using multi-variable 
logistic regressions to identify correlations between (1) the numbers 
of offline food-safety inspection procedures, both scheduled and 
unscheduled, along with the numbers of non-compliances and scheduled-
but-not-completed procedures, and (2) contamination of hog carcasses 
with Salmonella.\7\ The correlations were used to predict the potential 
effect that devoting more resources to those offline procedures might 
have on human illness attributable to the consumption of pork products. 
Stochastic simulations were used to account for statistical uncertainty 
in the estimates relating inspection procedures in an establishment to 
detection of Salmonella in samples from hog carcasses. Illness 
estimates were based on data from the Centers for Disease Control and 
Prevention (CDC), and uncertainty distributions were used to account 
for the variability in annual Salmonella illnesses and statistical 
uncertainty about the relationship between the pathogen prevalence 
levels at the establishments and the corresponding annual number of 
illnesses that could be attributed to the pathogens.
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    \7\ Scheduled procedures are assigned to inspectors at an 
establishment by PBIS or PHIS. Unscheduled procedures are performed 
according to inspector needs at an establishment and may include 
verification checks for fecal, ingesta, and milk, or they may be a 
response to unforeseen hazards or unsanitary conditions arising from 
sanitation SOP failures, or the need to verify corrective actions 
taken under the establishment's HACCP plan.
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3. Conclusions of the Market Hog Risk Assessment
    The regression analysis of historical data included in the market 
hog risk assessment showed a statistically significant correlation 
between (1) increased scheduled and unscheduled offline procedures and 
decreased scheduled but not performed procedures and (2) reduction in 
the prevalence of Salmonella positive samples. Based on these results, 
the redeployment of Agency resources to scheduled and unscheduled 
offline activities, along with a reduction in scheduled but not 
performed procedures, is likely to contribute to food safety resulting 
from a lower prevalence of carcasses contaminated with Salmonella, 
which in turn we expect to lead to fewer human illnesses.
    In answer to the first risk-management question, the market hog 
risk assessment results suggest that, depending on how reallocation of 
inspection activities is implemented, it is likely that changes in 
offline inspection would not result in an increase in the prevalence of 
Salmonella in hog carcasses, and could even result in a decrease in the 
prevalence of Salmonella in hog carcasses. Specifically, the scenario 
that simultaneously increases unscheduled and scheduled inspection 
procedures and decreases scheduled but not performed procedures 
performs better than scenarios that target the three specific types of 
procedures one at a time. Under the scenario where all types of 
procedures are targeted for increase, with resulting decrease in 
scheduled but not performed procedures and decrease in instances of 
observed and reported establishment non-compliance, the model estimates 
an average decrease of 2,533 Salmonella-related illnesses per year 
attributable to pork products. FSIS assumes that 65,869 expected annual 
Salmonella illnesses are attributed to consumption of pork products. 
Thus, a reduction of 2,533 expected Salmonella illnesses annually, 
would reflect a 3.8 percent reduction in Salmonella illnesses 
attributable to pork products.
    Responding to the second question, modeling and scenario analysis 
results suggest that increasing scheduled and unscheduled procedures 
and decreasing scheduled but not performed procedures would be most 
effective in reducing pathogen occurrence on carcasses because of 
consistency in the decision variable parameter's effect across all 
models. However, each category of offline procedures relates to an 
individual decrease in Salmonella contaminated carcasses which if any 
one of the three categories or a combination of categories of offline 
procedures were implemented still would result in decreased 
contamination, but less than if the scenario combining all three 
decision variables was adopted.
    In answer to the third risk-management question, on the uncertainty 
of the results for pathogen prevalence and illness reductions, FSIS's 
modeling approach includes the inherent uncertainty about the 
relationship between the frequency of inspection activities and 
pathogen prevalence, about the actual change in future inspection 
activities that would

[[Page 4792]]

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

III. Proposed NSIS

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

A. Live Market Hog Sorting by Establishment Personnel

    Under the proposed NSIS, establishment personnel would be required 
to sort market hogs and remove for disposal animals unfit for slaughter 
before they are presented to FSIS PHVs for inspection and final 
disposition. Establishment personnel would sort animals that appear to 
be healthy into ``Normal'' pens and animals that appear to have 
diseases or abnormal conditions into ``Subject'' pens. Establishment 
personnel may also sort and remove animals with localized conditions 
(e.g., animals with arthritis or abscesses) or animals that do not meet 
establishment specifications (e.g., hogs that are the wrong size or 
underweight) to be diverted to another official establishment for 
slaughter. Establishment personnel would remove and properly dispose of 
dead and moribund animals and animals suspected of having CNS 
conditions or pyrexia. Under the proposed NSIS, FSIS inspectors would 
inspect all animals found by the establishment to be normal at rest, 
and five to ten percent of those animals in motion. If any animals 
exhibit signs of condemnable conditions, FSIS inspectors would direct 
establishment employees to move the animals to the ``U.S. Suspect'' 
pens for final disposition by the FSIS PHV. The FSIS PHV would inspect 
all animals in the ``Subject'' and ``U.S. Suspect'' pens and render a 
final disposition decision. FSIS inspectors would observe establishment 
employees performing sorting procedures at least twice per shift. 
During this time, FSIS inspectors would verify that animals that are 
intended to be disposed of are humanely euthanized and that animals 
that are intended to be diverted to another official establishment are 
eligible for transport. FSIS inspectors also would conduct HACCP 
verification tasks in PHIS at least twice per shift to verify that 
establishments meet the regulatory requirements found in 9 CFR 417 for 
implementation, monitoring, recordkeeping, prerequisite programs (when 
applicable), and corrective actions. Under the proposed rule, if any 
market hogs become non-ambulatory disabled after ante-mortem 
inspection, establishments would be required to move them to the 
``Subject'' pens for re-inspection by FSIS PHVs. All sorting would be a 
function of the establishment's HACCP plan or pre-requisite program. 
Because establishments operating under the proposed NSIS would be 
required to sort and remove market hogs that are unfit for slaughter 
before FSIS ante-mortem inspection, FSIS is proposing that 
establishments under the proposed NSIS address, as part of their HACCP 
system, procedures for sorting animals showing signs of diseases or 
abnormalities from healthy animals. These procedures must cover 
establishment sorting activities for dead and moribund swine and swine 
suspected of having CNS conditions or pyrexia.
    FSIS also is proposing to require that establishments immediately 
notify FSIS inspectors in the rare circumstance that they suspect 
animals of having notifiable or foreign animal diseases during sorting 
activities. For example, establishments may suspect that market hogs 
have notifiable or foreign animal diseases if they observe animals with 
abnormal lesions or behavior, or an abnormal change in the amount of 
animals that arrive to the establishment dead. Notifiable diseases are 
those that are designated by the World Animal Health Organization 
(Office International des Epizooties or OIE). The list of notifiable 
diseases includes anthrax, cysticercosis, scabies, bovine tuberculosis, 
myiasis (screwworm), and vesicular diseases. Of these diseases, 
anthrax, cysticercosis, and bovine tuberculosis are transmissible to 
humans. The complete list is available on OIE's website at http://www.oie.int/en/animal-health-in-the-world/oie-listed-diseases-2016/. 
FSIS would report any animal disease issues to the USDA Animal and 
Plant Health Inspection Service (APHIS).
    Under the proposed NSIS, FSIS would maintain its zero tolerance for 
market hogs exhibiting signs of moribundity, CNS conditions, and 
pyrexia. Market hogs exhibiting signs of these generalized diseases or 
conditions, if not sorted and removed by the establishment before ante-
mortem inspection, would be condemned by FSIS PHVs, as under the 
existing regulations (9 CFR 309.3). FSIS PHVs would issue an NR for 
every animal exhibiting signs of moribundity, CNS conditions, or 
pyrexia found by the FSIS inspector after the establishment sorting 
step is completed.
    Additionally, under the proposed NSIS, FSIS would maintain its zero 
tolerance for violative levels of chemical residues. Establishments 
would be required to address chemical hazards through their HACCP 
program including preventing animals with violative levels of chemical 
residues from being presented for slaughter. FSIS inspectors would 
continue to select animals at post-mortem and perform chemical residue 
sample collection and testing procedures in accordance with FSIS 
Directive 10,800.1, Residue Sampling, Testing and Other Verification 
Procedures under the National Residue Program for Meat and Poultry 
Products (available on FSIS's website at http://www.fsis.usda.gov/wps/wcm/connect/147066f0-564c-4590-b36f-97ffc5ab9797/10800.1.pdf?MOD=AJPERES).
    Under the proposed NSIS, establishment personnel would be required 
to identify carcasses of market hogs sorted and removed by 
establishment employees before FSIS inspection and intended for 
disposal and destruction with a unique tag, tattoo, or similar device. 
Establishment personnel also would be required to immediately denature 
all carcasses and parts removed as unacceptable by plant sorters on-
site, even if establishments have tanking facilities, to ensure that 
the carcasses and parts are properly disposed of and never enter 
commerce. Under the proposed NSIS, establishment personnel would be 
required to maintain records to

[[Page 4793]]

document the number of animals and carcasses and parts sorted and 
removed by establishment personnel per day. These records and 
procedures would be subject to daily review by FSIS inspectors. Under 
NSIS, FSIS inspectors would document in PHIS the total number of 
animals that the establishment employees have sorted and removed per 
day. Under the proposed rule, FSIS would still direct the application 
and removal of ``U.S. Condemned'' tags to animals condemned during 
ante-mortem inspection. FSIS would also continue to enter each and 
every ``U.S. Condemned'' tag into PHIS. However, FSIS inspectors should 
be able to complete these tasks faster because they would be presented 
animals that have been sorted by establishment employees and are thus 
more likely to pass ante-mortem inspection and not have condemnable 
conditions.
    In addition to the total number of animals sorted and removed by 
establishment personnel per day before FSIS ante-mortem and post-mortem 
inspection, FSIS is requesting comments on whether or not the Agency 
should require establishments under NSIS to specify in their records 
the reason that the animals were removed from slaughter, including 
animals sorted and removed because they were dead on arrival or 
suspected of having CNS conditions, pneumonia, pyrexia, septicemia, 
erysipelas, or tuberculosis (e.g., 20 sorted and removed; 10 pneumonia, 
10 dead on arrival) and how this information should be collected. Under 
traditional inspection, FSIS inspectors record similar condemnation 
information into PHIS for APHIS' swine slaughter condemnation 
monitoring system; however, this information is not being collected 
under HIMP. APHIS Veterinary Services (VS) uses this type of data to 
monitor changes in the rate or count of swine condemnations by swine 
type (market, roaster, sow, and boar) and by selected condemnation 
categories (e.g., central nervous system disorders, dead on arrival, 
pneumonia, pyrexia, septicemia, erysipelas, and tuberculosis). APHIS 
conducts weekly monitoring to compare baseline (expected) condemnation 
counts by condemnation category to current weekly counts to identify 
noteworthy increases (signals) in condemnations in near-real time. 
APHIS produces a weekly report, and shares it with the National Pork 
Board to identify any noteworthy increases in condemnations which could 
indicate the emergence of disease and may warrant further 
investigation. FSIS and APHIS recognize that ``presumptive diagnoses'' 
by establishment personnel under the NSIS may not be as accurate as 
condemnation information entered by an FSIS PHV under traditional 
inspection. However, FSIS and APHIS believe that the self-reported 
information may still be useful and significant in monitoring disease 
conditions in the United States.

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

    Under the proposed NSIS, establishment personnel would be required 
to sort carcasses and parts and trim dressing defects and contamination 
(e.g., hair, bruises, feces, ingesta, and milk) before the carcasses 
and parts are presented to an FSIS online inspector for post-mortem 
inspection. Establishment personnel also would be required to mark with 
ink, or otherwise identify, localized pathological defects intended for 
removal under FSIS supervision (e.g. localized nephritis and localized 
arthritis) and carcasses and parts intended for disposal under FSIS 
supervision (e.g., carcasses and parts with malignant lymphoma). Under 
the proposed NSIS, the head, and viscera of each hog must be handled in 
a way as to identify them with the rest of the carcass and as being 
derived from the particular animal involved, until FSIS's post-mortem 
inspection of the carcass and parts thereof have been complete. FSIS 
would not complete an inspection of the carcass if the head or viscera 
were missing before the final rail, unless the head or viscera were 
properly disposed of under FSIS supervision. Consistent with 
traditional inspection, only FSIS inspectors would be authorized to 
condemn carcasses and parts.
    Carcasses and parts contaminated with fecal material, ingesta, or 
milk or that exhibit signs of septicemia, toxemia, pyemia, or 
cysticercosis during post-mortem examination are likely to contain 
infectious agents, such as bacteria, virus, richettsia, fungus, 
protozoa, or helminth organisms, which can be transmitted to humans. 
For this reason, they present a food safety risk if they are permitted 
to enter the cooler. Therefore, FSIS is proposing that establishments 
under the new system address, as part of their HACCP systems, 
procedures for ensuring that carcasses and parts contaminated with 
fecal material, ingesta, or milk or affected by septicemia, toxemia, 
pyemia, or cysticercosis are trimmed or identified by the establishment 
before they are presented to the FSIS carcass inspector and disposed of 
under FSIS supervision. These procedures must cover establishment 
sorting activities for these conditions.
    Under this proposal, FSIS would maintain its zero tolerance for 
carcasses and parts contaminated by fecal material, ingesta, or milk, 
or affected by septicemia, toxemia, pyemia, or cysticercosis. If FSIS 
online inspectors discover a carcass contaminated by fecal material, 
ingesta, or milk, they would stop the line for carcass reexamination 
and trimming by the establishment unless the establishment elected to 
provide a rail-out loop to rail contaminated carcasses offline for 
reexamination, trimming, and positioning back on the line for 
reinspection, consistent with the existing regulations (9 CFR 310.17 
and 310.18) and FSIS Directive 6420.2, Verification of Procedures for 
Controlling Fecal Material, Ingesta, and Milk in Slaughter Operations 
(available on FSIS's website at http://www.fsis.usda.gov/wps/wcm/connect/478aca76-37c5-4dc3-9925-1556402d8daf/PHIS_6420.2.pdf?MOD=AJPERES). An NR would be issued by the FSIS offline 
inspector at or after the final rail for every carcass contaminated by 
fecal material, ingesta, or milk. FSIS online inspectors would also 
stop the line if they discover carcasses exhibiting septicemia, 
toxemia, pyemia, or cysticercosis, as under the existing regulations (9 
CFR 311.16 and 311.17). The carcasses would be retained for FSIS PHV 
disposition. An NR would be issued by the PHV for every carcass 
affected by septicemia, toxemia, pyemia, or cysticercosis that reaches 
the online carcass inspection station. Moreover, because establishments 
would be required to address these food safety hazards in their HACCP 
systems, the Agency continuously would assess the effectiveness of an 
establishment's procedures for ensuring that carcasses are prevented 
from becoming contaminated with fecal material, ingesta, or milk, and 
that carcasses affected by septicemia, toxemia, pyemia, or 
cysticercosis do not reach the final FSIS inspection station.
    FSIS is not proposing to prescribe specific sorter training or 
certification to give establishments operating under the NSIS the 
flexibility to select the training program that would best assist them 
to meet the requirements of this proposed rule. However, the Agency has 
developed a draft guidance document to assist establishments in 
training their sorters should this rule become final. The draft 
guidance is based on the training that FSIS provides to online 
inspection personnel that are responsible for identifying these non-
food safety defects on carcasses and

[[Page 4794]]

parts under traditional inspection. FSIS has posted this draft 
compliance guide on its web page (http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index) and is 
requesting comments on the guidance.
    FSIS believes that training of sorters is important to ensure that 
they are able to properly perform their duties. Proper training is 
necessary if sorters are to make accurate decisions on how to address 
animal disease conditions and trim and dressing defects. Under the 
proposed NSIS, if sorters do not make these decisions correctly, FSIS 
inspection personnel would take appropriate action such as stopping the 
line, issuing NRs, and directing the establishment to reduce the line 
speed. FSIS would thereby ensure that the establishment is able to 
maintain process control as evidenced by preventing fecal contamination 
and meeting microbial performance measures, that the establishment 
sorters are able to successfully perform their duties, and that the 
FSIS online inspectors are able to conduct a proper food safety 
inspection.
    Establishments that operate under the proposed NSIS would have 
greater flexibility over their production process. For example, 
establishments operating under the proposed NSIS would have the 
flexibility to reconfigure lines if they decided to change the way that 
the head, viscera, and carcasses are presented to FSIS inspectors to 
improve ergonomics and process control and to maintain optimum line 
speed. FSIS would still inspect the head, viscera, and carcass of each 
animal. However, under the proposed NSIS, establishments may 
reconfigure their lines so that they present a ready-to-inspect head, 
viscera, and carcass for FSIS post-mortem inspection in one location or 
separately in two or three locations. FSIS would assign one to three 
inspectors to conduct online inspection activities, depending on need 
and line configuration. These inspectors would also rotate to conduct 
offline inspection activities. FSIS would assign one online inspector 
only if the Agency had the data and experience (including processes and 
procedures) to ensure that one inspector is able to conduct all online 
post-mortem inspection activities. Under the proposed NSIS, all 
establishments with fewer than three inspection stations would be 
required to provide a mirror at the carcass inspection station in 
accordance with 9 CFR 307.2 (m)(6) so that the inspector standing at 
the inspection station can readily view the back of the carcass for 
evidence that could impact food safety.
    Under NSIS, as under HIMP, establishment sorters would be required 
to incise mandibular lymph nodes and palpate the viscera to detect the 
presence of animal diseases (e.g., Mycobacterium Avium) as part of 
their sorting activities before FSIS post-mortem inspection. FSIS is 
requesting comments on whether or not the Agency should allow 
establishments that operate under the proposed NSIS to use discretion 
when deciding, on a lot-by-lot basis, whether or not to incise 
mandibular lymph nodes and palpate the viscera to detect the presence 
of animal diseases (e.g., M. Avium) if they submit documentation to 
FSIS supporting that the presence of M. Avium is not likely to occur, 
such as records documenting their on-farm controls. In the last 10-15 
years, industry led initiatives like the Pork Quality Assurance Plus 
certification program (http://www.pork.org/pqa-plus-certification) and 
the Common Industry Audit (http://www.pork.org/common-industry-audit) 
have improved biosecurity practices which not only reduce disease 
spread but also address risk factors for M. Avium such as exposure to 
birds.8 9 Because on-farm practices have improved, the 
prevalence of M. Avium in U.S. swine is very low. After reviewing PHIS 
condemnation data from 21 large market hog establishments from 2012 
through 2015, FSIS found that only 0.9 percent of all condemnations are 
due to M. Avium. The animal disease M. Avium does not present a food 
safety concern, and can be detected visually by inspectors.
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    \8\ United States Department of Agriculture, Animal and Plant 
Health Inspection Service. (2008). National Animal Health Monitoring 
System Swine 2006, Part IV: Changes in the U.S. Pork Industry, 1990-
2006. Retrieved from https://www.aphis.usda.gov/animal_health/nahms/swine/downloads/swine2006/Swine2006_dr_PartIV.pdf.
    \9\ United States Department of Agriculture, Animal and Plant 
Health Inspection Service. (2015). National Animal Health Monitoring 
System Swine 2012, Part 1: Baseline Reference of Swine Health and 
Management in the United States, 2012. Retrieved from https://www.aphis.usda.gov/animal_health/nahms/swine/downloads/swine2012/Swine2012_dr_PartI.pdf.
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    Moreover, Denmark and the Netherlands already conduct alternative 
post-mortem visual inspections and allow establishments to use 
discretion when determining, on a lot-by-lot basis, whether or not to 
incise lymph nodes and palpate the viscera. Under the FMIA and the 
regulations that implement it, meat and meat products imported into the 
United States must be produced under standards for safety, 
wholesomeness, and labeling accuracy that are equivalent to those of 
the United States (21 U.S.C. 620). FSIS has reviewed Denmark's and the 
Netherlands' market hog slaughter inspection systems and found them to 
be equivalent to the United States' market hog slaughter inspection 
system. FSIS determined that visual post-mortem inspection will still 
allow veterinary inspectors to palpate and incise lymph nodes and 
organs (as occurs in traditional inspection) at their discretion. Each 
herd of hogs that arrives at establishments to be slaughtered is 
accompanied by historical ``Supply-Chain Information,'' which consists 
of paperwork that documents the health status and history of each herd, 
complete traceback information, as well as details about the 
originating farm (e.g., history of disease, use of medications, and on-
farm practices that contribute to maintenance of the herd's health.) 
FSIS concluded that this documentation, as well as any ante-mortem 
inspection observances, will be sufficient to inform the veterinary 
inspector's decision whether or not to perform visual inspection or 
traditional inspection. Importantly, because lymphatic tissue may be 
contaminated with pathogens, not incising the lymphatic tissue may 
reduce contamination of food contact surfaces and other carcasses.
    FSIS also is proposing to require establishment personnel to 
maintain records to document the number of carcasses and parts disposed 
of by establishment personnel per day as part of their sorting 
activities. The records would not need to include the number of 
carcasses condemned by FSIS. These records would be subject to review 
by FSIS inspectors. Under NSIS, FSIS inspectors would document in PHIS 
the total number of carcasses and parts sorted and disposed of by plant 
employees per day. FSIS inspectors would continue to enter dispositions 
for each and every carcass condemned by FSIS into PHIS.

C. Offline Verification Inspection

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

[[Page 4795]]

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

D. RTC Pork Product

    As discussed above, under HIMP, OCP standards are non-food safety 
standards concerned primarily with diseases of no public health 
significance and carcass processing defects. Data collected from market 
hog establishments operating under HIMP show that from CY 2012 through 
2013, HIMP establishments maintained OCP defect levels that average 
about half the corresponding OCP performance standards derived from the 
performance of non-HIMP establishments. Thus, the data show that 
establishments operating under the HIMP system do exceptionally well in 
controlling OCP defects.
    Accordingly, FSIS is not proposing OCP requirements as a condition 
for establishments to participate in the proposed NSIS. Under this 
proposal, establishments operating under NSIS would be allowed to 
implement the process controls that they have determined will best 
allow them to produce an RTC pork product that is wholesome and not 
adulterated. The new proposed definition of RTC pork product is any 
slaughtered pork product free from bile, hair, scurf, dirt, hooves, toe 
nails, claws, bruises, edema, scabs, skin lesions, icterus, foreign 
material, and odor which is suitable for cooking without need of 
further processing.
    Under the proposed NSIS, establishments would have the flexibility 
to design and implement measures to address OCP defects that are best 
suited to their operations. They would also be responsible for 
determining the type of records that will best document that they are 
meeting the RTC pork product definition. The records would be subject 
to review and evaluation by FSIS inspectors.
    For their record reviews, FSIS inspectors would verify that 
establishments operating under the proposed NSIS have written criteria 
for determining whether carcasses meet the RTC definition and that they 
are documenting that the pork products resulting from their slaughter 
operations meet these criteria before packaging or further processing 
that would conceal a defect. Records that would meet the proposed 
requirements include:
     The records system that the establishment uses to document 
that it is producing RTC pork. For example, an establishment may use 
statistical process control charts, HACCP records, or other 
documentation.
     The points in the operation where the establishment 
monitors carcasses to determine whether they meet the RTC definition 
and records the results of its monitoring activities. For example, an 
establishment may conduct monitoring and record the results at a pre-
evisceration and a post-chill station.
     The frequency with which the establishment conducts 
monitoring activities. The records should specify how often the 
establishment monitors carcasses per line per shift. For example, an 
establishment may conduct and document its monitoring activities at 
least every two hours per line per shift at the pre-evisceration 
location and at least twice per shift per line for post-chill location.
     The definitions of the OCP non-conformances or processing 
and trim defects for which the establishment is monitoring. For 
example, the establishment may be monitoring carcasses for processing 
and trim non-conformances as specified for trim and processing OCP 
defects specified under the HIMP OCP performance standards, or defects 
as defined in a published study or a study that the establishment 
conducted itself. If the establishment references a study, it should 
give a brief description of the study and have the supporting 
information on file.
     The criteria that the establishment would use to determine 
that the products resulting from its slaughter operation meet the RTC 
definition. For example, an establishment may follow the subgroup 
limits for non-conformances and defects in the trim and processing 
defect levels for the HIMP OCP performance standards, or it may 
determine the upper limits for non-conformances using a statistical 
process control program.
     The corrective actions that the establishment would take 
if the levels of defects and non-conformances exceed its evaluation 
criteria for RTC pork.
    Under this proposed rule, pork carcasses that meet the OCP 
performance standards under HIMP would be considered ``suitable for 
cooking without the need for further processing,'' and as such, meet 
the RTC pork product definition. Therefore, establishments operating 
under the NSIS that adopt the OCP HIMP performance standards as their 
criteria for determining whether they are producing RTC pork product 
would meet the regulatory requirements if: (1) They can document that 
the products resulting from their slaughter operations consistently 
meet these standards, and (2) FSIS inspectors do not observe 
persistent, unattended defects on the products resulting from the 
establishment's slaughter operations. Establishments that adopt 
criteria other than the HIMP OCP standards would be required to have 
documentation to demonstrate how they will use these criteria to 
demonstrate that the products resulting from their slaughter operations 
meet the RTC pork product definition.
    In addition to record reviews, FSIS inspectors would verify that 
establishments operating under the NSIS are producing RTC pork product 
by visually observing carcasses as part of their inspection activities. 
The presence of persistent, unattended trim and dressing defects on 
carcasses at the end of the process would indicate that the 
establishment is not producing RTC pork product. It may also indicate a 
general lack of control in an establishment's overall slaughter and 
dressing process. Thus, if inspectors observe persistent, unattended 
defects, FSIS would require that the establishment take appropriate 
actions to ensure that its process is under control and that it is 
operating under conditions necessary to produce safe, wholesome, and 
unadulterated RTC products. If inspection personnel through their 
record review or direct observation of carcasses find evidence that an 
establishment is producing pork that does not meet the RTC definition, 
the IIC would be authorized to take appropriate action to ensure that 
the establishment remedies the defects, including requiring that the 
establishment slow the evisceration line speed.

E. Line Speeds Under NSIS

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

[[Page 4796]]

establishments operating under NSIS to determine their own evisceration 
line speeds if Agency personnel verify that process control is 
maintained. The maximum line speed under the existing regulations for 
market hogs is 1,106 head per hour (hph) with seven online inspectors. 
Experience from the HIMP pilot shows that HIMP establishments operate 
with an estimated average line speed of 1,099 hph, and that the line 
speeds varied from 885 hph to 1,295 hph (under waiver). Thus, although 
they are authorized to do so, market hog HIMP establishments do not 
operate at line speeds that are significantly faster than the current 
maximum line speeds for market hogs. Establishments determine their 
line speeds based on their equipment, animal size and herd condition, 
and their ability to maintain process control when operating at a given 
line speed. In addition, line speeds under HIMP depend on the number of 
employees the establishments hire and train to perform sorting 
activities. If FSIS finalizes the proposed NSIS, establishments 
choosing to operate under the NSIS will likely determine their line 
speeds based on the same factors that establishments considered when 
setting line speeds under HIMP for the past 16 years.
    Establishments operating under HIMP have demonstrated that they are 
capable of consistently producing safe, wholesome, and unadulterated 
pork products while operating at these line speeds. Moreover, they have 
consistently met pathogen reduction and other performance standards 
when operating at the line speeds they established under HIMP. The 
proposed new inspection system was informed by the Agency's experience 
under HIMP and, as discussed later in this document, also incorporates 
additional measures that will apply to all swine slaughter 
establishments. These measures, which include testing for microbial 
organisms at pre-evisceration and post-chill, are designed to ensure 
that establishments maintain process control.
    FSIS recognizes that evaluation of the effects of line speed on 
food safety should include the effects of line speed on establishment 
employee safety. FSIS compared in-establishment injury rates between 
HIMP and traditional establishments from 2002 to 2010. The preliminary 
analysis shows that HIMP establishments had lower mean injury rates 
than non-HIMP establishments. The analysis uses injury rate data by 
occupational injury estimates that are derived from the BLS annual 
Survey of Occupational Injuries and Illnesses (SOII) http://www.bls.gov/iif/data.htm). The survey captures data from Occupational 
Safety and Health Administration (OSHA) logs of workplace injuries and 
illnesses maintained by employers. Fifty-six FSIS inspected market hog 
slaughter establishments voluntarily submitted injury rate data to OSHA 
(approximately nine percent of all market hog slaughter 
establishments). From these 56 establishments, 27 low volume 
establishments were excluded, leaving 29 plants (5 HIMP and 24 
Traditional). The low volume plants were excluded to provide a better 
comparison group of traditional plants because all HIMP plants are high 
volume plants. The results showed HIMP plants had a lower mean number 
of injuries using three OSHA injury rate measures: Total Case Rate 
(TCR), Days Away Transferred Restricted (DART), and Days Away From Work 
(DAFW). However, FSIS realizes that factors other than line speed may 
affect injury rates (e.g., automation and number of sorters per line).
    FSIS is requesting comments on the effects of faster line speeds on 
worker safety. Specifically, FSIS is requesting comments on whether 
line speeds for the NSIS should be set at the current regulatory limit 
of 1,106 hph or some other number. The Agency is also interested in 
comments on the availability of records or studies that contain data 
that OSHA or the National Institute for Occupational Safety and Health 
(NIOSH) may be able to use in analyzing the effects of increased line 
speed on the safety and health of employees throughout the 
establishment, including effects prior to and following the 
evisceration line. FSIS is also requesting comments on whether the 
Agency should maintain the 1,106 hph maximum line speed for 
establishments operating under NSIS but grant waivers from the maximum 
line speed to establishments that agree to work with the National 
Institute for Occupational Safety and Health NIOSH to evaluate the 
effects of waivers of line speed restrictions on employee health. FSIS 
is requesting comments on best practices and other measures that 
establishments can take to protect workers throughout the plant, 
including possible protective factors such as increasing the size of 
the workforce, rotating assignments, increased automation, or improved 
tools and techniques.
    FSIS is proposing to require each establishment that operates under 
the NSIS to provide an annual attestation to the management member of 
the local FSIS circuit safety committee stating that the establishment 
maintains a program to monitor and document any work-related conditions 
that arise among establishment workers. The elements of this program 
would include:
    (1) Policies to encourage early reporting of symptoms of work-
related injuries and illnesses, and assurance that the establishment 
has no policies or programs intended to discourage the reporting of 
injuries and illnesses.
    (2) Notification to employees of the nature and early symptoms of 
occupational illnesses and injuries, in a manner and language that 
workers can understand, including by posting in a conspicuous place or 
places where notices to employees are customarily posted, a copy of the 
FSIS/OSHA poster encouraging reporting and describing reportable signs 
and symptoms.
    (3) Monitoring on a regular and routine basis of injury and illness 
logs, as well as nurse or medical office logs, workers' compensation 
data, and any other injury or illness information available.
    FSIS is also proposing to create a new severability clause 
(proposed 9 CFR 310.28), which would state that should a court of 
competent jurisdiction hold any provision of the proposed worker safety 
attestation requirement (proposed 9 CFR 310.27) to be invalid, such 
action would not affect any other provision of 9 CFR parts 309 and 310.
    As OSHA is the Federal agency with statutory and regulatory 
authority to promote workplace safety and health, FSIS would forward 
the annual attestations to OSHA for further review. OSHA, in turn, may 
use the information in the attestations in its own enforcement program. 
FSIS employees would not be responsible for determining the merit of 
the content of each establishment's monitoring program or enforcement 
of noncompliance with this section. FSIS would work with OSHA to 
develop the poster that establishments must display providing 
information on the signs and symptoms of occupational injuries and 
illnesses experienced by market hog slaughter workers, and about 
workers' rights to report these conditions without fear of retaliation.

IV. Other Proposed Changes That Affect All Swine Slaughter 
Establishments

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

    In 1997, FSIS published a Federal Register document entitled 
``Notice on complying with food safety standards under the HACCP system 
regulations'' (62 FR 63254, November 28, 1997). The

[[Page 4797]]

purpose of the document was to ensure that establishments understood 
the Agency's zero tolerance policy for visible fecal material as food 
safety hazards, as establishments prepared to comply with the then 
newly enacted HACCP system regulations. The document explained that 
under 9 CFR 310.18, establishments must handle livestock carcasses and 
carcass parts to prevent contamination with fecal material and promptly 
remove contamination if it occurs. Based on this regulation, FSIS 
enforces a zero tolerance policy for visible fecal contamination. Then, 
the document explained that ``to meet the zero tolerance standard, an 
establishment's [HACCP] controls must (among other things) include 
limits that ensure that no visible fecal material is present by the 
point of post-mortem inspection of livestock carcasses'' (citing 9 CFR 
417.2(c)). Finally, the document explained that ``Under the HACCP 
system regulations, critical control points to eliminate contamination 
with visible fecal material are predictable and essential components of 
all slaughter establishments' HACCP plans.'' As a result, all swine 
slaughter establishments' HACCP plans currently include critical 
control points (CCPs) for preventing carcasses contaminated with 
visible fecal material at or after the final rail.
    FSIS also enforces a zero tolerance policy for contamination by 
ingesta and milk because the microbial pathogens associated with 
ingesta and milk contamination are likely sources of potential food 
safety hazards in slaughter establishments. As mentioned above, the 
regulations require establishments to handle livestock carcasses and 
carcass parts to prevent contamination and promptly remove 
contamination if it occurs (9 CFR 310.18) The regulations also require 
that lactating mammary glands and diseased mammary glands of swine be 
removed without opening the milk ducts or sinuses because if pus or 
other objectionable material is permitted to come in contact with the 
carcass, the parts of the carcass are contaminated and must be removed 
and condemned (9 CFR 310.17). Because such contamination is largely 
preventable, most slaughter establishments already have in place 
procedures designed to prevent and remove ingesta and milk.
    FSIS is now proposing to amend 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 post-mortem 
inspection of swine carcasses. Such a requirement would ensure that 
establishments maintain the records to verify that they have 
implemented the necessary measures and, when necessary, have taken 
appropriate corrective actions to prevent carcasses contaminated with 
visible fecal material, ingesta, or milk at or after the final rail.
    Although the existing requirements for establishments to prevent 
visible fecal material, ingesta, or milk at or after the final rail, 
and the proposed requirement described above that establishments must 
have procedures addressing how they do so, are important safeguards, 
those safeguards would not be fully effective if an appropriate effort 
is not made to prevent contamination from occurring throughout the 
slaughter and dressing operation. Fecal material is a major vehicle for 
spreading pathogenic microorganisms, such as Salmonella, to raw pork 
products, and therefore, it is vital for establishments to maintain 
sanitary conditions and to prevent, to the maximum extent possible, 
contamination from occurring before slaughter and throughout the 
slaughter and dressing process.
    Under HACCP, establishments are responsible for identifying food 
safety hazards that are reasonably likely to occur in the production 
process and for implementing preventive measures to control those 
hazards. Failure to implement preventive measures throughout the 
slaughter and dressing process can lead to the creation of insanitary 
conditions in the establishment and increases the potential for 
carcasses and parts to become contaminated with enteric pathogens, 
fecal material, ingesta, and milk. Interventions with chemical 
antimicrobials applied at the end of the process are less likely to be 
fully effective on carcasses that contain high levels of pathogens, and 
these chemical treatments are not effective in preventing insanitary 
conditions throughout the slaughter establishment.
    To ensure that establishments implement appropriate measures to 
prevent carcasses from becoming contaminated with pathogens, and to 
ensure that both FSIS and establishments have the documentation they 
need to verify the effectiveness of these measures on an on-going 
basis, FSIS is proposing to require that all swine slaughter 
establishments develop, implement, and maintain written procedures to 
prevent contamination of carcasses and parts by enteric pathogens, 
fecal material, ingesta, and milk throughout the entire slaughter and 
dressing operation. FSIS is proposing that establishments incorporate 
these procedures into their HACCP systems and that they maintain 
records sufficient to document the implementation and monitoring of 
these procedures. These proposed requirements are necessary to fully 
implement the existing HACCP regulations.
    Information that FSIS has collected from investigations it has 
conducted in establishments that have received a Notice of Intended 
Enforcement due to Salmonella serotypes linked to human illness 
demonstrate the need for establishments to adopt preventive measures to 
control contamination throughout the entire production process, as well 
as the need to maintain documentation to verify the effectiveness of 
those measures on an ongoing basis.
    For example, FSIS conducted an investigation at a swine slaughter 
establishment that resulted in a Notice of Intended Enforcement after a 
State department of health conducted sampling and found the presence of 
Salmonella serotypes linked to human illness, and after FSIS requested 
a voluntary recall in 2015. FSIS reviewed the establishment's controls, 
and records associated with the establishment's sanitary dressing 
procedures and microbial interventions, and observed the 
establishment's implementation of these controls and procedures. The 
Agency's review found that the establishment had contamination of 
Salmonella throughout the slaughter process, including carcasses, 
environmental samples and pre-operational swabs. The cross 
contamination and failure to maintain sanitary procedures appeared to 
have overwhelmed any subsequent in-process interventions. FSIS 
determined that the establishment's HACCP system was inadequate due to 
multiple or recurring noncompliance (see 9 CFR 500.4(a)). If this rule 
becomes final, establishments may choose to incorporate measures to 
address the prevention of contamination by enteric pathogens and 
contaminants (e.g., fecal, ingesta, and milk) into their procedures 
addressing how they prevent contamination from occurring during 
slaughter and dressing operations. Examples of such measures include: 
Sanitary dressing protocols, statistical process control programs, and 
sampling.
    Under this proposed rule, establishments will be required to 
incorporate these procedures into HACCP systems, and to maintain on-
going documentation to demonstrate that the procedures are effective. 
FSIS is

[[Page 4798]]

not proposing to prescribe the specific procedures that establishments 
must follow to prevent carcasses from becoming contaminated by enteric 
pathogens, fecal material, ingesta, or milk because the Agency believes 
that establishments should have the flexibility to implement the most 
appropriate measures that will best achieve the requirements of this 
proposed rule. However, on-going verification and documentation to 
demonstrate that an establishment's process controls are effective in 
preventing food safety hazards are critical components of the food 
safety system. FSIS believes that microbiological test results that 
represent levels of microbial contamination at key steps in the 
slaughter process are necessary for establishments to provide 
comprehensive, objective evidence to demonstrate that they are 
effectively preventing carcasses from becoming contaminated with 
pathogens before and after they enter the cooler.
    In light of these changes, FSIS is proposing to rescind the generic 
E. coli testing requirements in 9 CFR 310.25 and to replace them with a 
new testing requirement that would provide establishments the 
flexibility to sample for other, potentially more useful indicator 
organisms. Under this proposal, establishments would continue to 
conduct sampling and analysis of carcasses for microbial organisms at 
the post-chill location, but in addition the Agency is proposing a 
second testing location at the pre-evisceration position in order to 
ensure establishments would be able to monitor the effectiveness of 
process control for enteric pathogens throughout the slaughter and 
dressing operation.
    Under this proposed rule, instead of following a prescribed 
microbiological testing program, each establishment would be 
responsible for developing and implementing its own microbiological 
sampling plan, which would be required to include carcass sampling at 
pre-evisceration and post-chill. FSIS considers the microbial load of 
hog carcasses at pre-evisceration to be a valuable source of data about 
how well an establishment is taking into account the sanitary condition 
of live hogs coming to slaughter and the processing steps (i.e., 
washing, dehairing) they implement to reduce the external contamination 
of the carcass prior to evisceration. Following a similar logic, FSIS 
considers the microbial characteristics of hog carcasses post-chill 
(after all processing steps have taken place) to be a valuable source 
of data about how well an establishment is minimizing contamination 
during chilling as well as the overall effectiveness of all process 
control interventions the establishment has chosen to apply throughout 
its production process. Because most establishments apply one or more 
interventions between the pre-evisceration and post-chill sampling 
points to help control microbiological hazards, FSIS would expect that 
a reduction in microbiological contamination between these two sampling 
points to be an indication of the effectiveness of those controls. The 
establishment would be responsible for determining which 
microbiological organisms would best help it to monitor the 
effectiveness of its process control procedures.
    Because FSIS is proposing that establishments' microbiological 
sampling plans be part of their HACCP systems, all swine slaughter 
establishments would be required to provide scientific or technical 
documentation to support the judgments made in designing their sampling 
plans (see 9 CFR 417.4(a)). Under this proposal, establishments could 
develop sampling plans to test carcasses for enteric pathogens, such as 
Salmonella, at pre-evisceration and post chill, or they could test for 
an appropriate indicator organism. FSIS has developed draft sampling 
guidance to assist small and very small establishments in developing 
sampling plans that meet the Agency's expectations for testing designs 
and sampling frequency should this rule become final. FSIS has posted 
this draft compliance guide on its web page (http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index) 
and is requesting comments on the guidance.
    FSIS is proposing to prescribe a minimum frequency with which 
establishments would be required to collect two samples, one at pre-
evisceration and one at post-chill, or, for very small and very low 
volume establishments, a single post-chill sample. Under the proposed 
rule, establishments, except for very small and very low volume 
establishments \10\, would be required to collect samples at a 
frequency of once per 1,000 carcasses. Very small and very low volume 
establishments would be required to collect at least one sample during 
each week of operation each year. FSIS is proposing to allow very small 
and very low volume establishments to collect and analyze samples for 
microbial organisms at the post-chill point in the process only because 
these establishments typically are less automated and run at slower 
line speeds than larger establishments. The lower level of automation 
and the slower line speeds require less complicated measures for 
maintaining and monitoring process control on an ongoing basis. If, 
after consecutively collecting 13 weekly samples, very small and very 
low volume establishments can demonstrate that they are effectively 
maintaining process control, they can modify their sampling plans to 
collect samples less frequently. These proposed frequencies reflect the 
frequencies prescribed under the existing regulations for generic E. 
coli testing. In light of these changes, FSIS is proposing to remove 
the current requirement that swine establishments test carcasses for 
generic E. coli to monitor process control. FSIS is also proposing to 
eliminate the pathogen performance standards for market hogs in 9 CFR 
310.25(b) because, as explained above, the codified standards are no 
longer in use.
---------------------------------------------------------------------------

    \10\ Very small establishments are establishments with fewer 
than 10 employees or annual sales of less than $2.5 million. 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.
---------------------------------------------------------------------------

    FSIS is proposing to allow establishments to substitute alternative 
sampling locations if they are able to demonstrate that the alternative 
sampling locations provide a definite improvement in monitoring process 
control than at pre-evisceration and post-chill. FSIS is also proposing 
to allow establishments to substitute alternative sampling frequencies 
if they are able to demonstrate that the alternative is an integral 
part of the establishments' verification procedures for their HACCP 
plans.
    This proposed rule does not mandate that establishments meet 
specific performance standards for microbial testing. Because 
establishments would be required to incorporate their procedures for 
preventing contamination by enteric pathogens and other contamination 
(e.g., fecal material, ingesta, and milk) into their HACCP plans, or 
sanitation SOPs, or other prerequisite programs, establishments would 
be required to take appropriate corrective action when either the 
establishment or FSIS determines that the establishment's procedures 
are not effective in preventing carcass contamination throughout the 
entire slaughter and dressing process. Establishments would also need 
to routinely evaluate the effectiveness of their procedures in 
preventing carcass contamination.

[[Page 4799]]

    Under this proposed rule, FSIS would verify the effectiveness of 
establishments' process control procedures in preventing carcasses from 
becoming contaminated with enteric pathogens, fecal material, ingesta, 
and milk by reviewing the establishments' monitoring records, including 
the establishments' microbial testing results, observing establishments 
implementing their procedures, and inspecting carcasses and parts for 
visible fecal, ingesta, and milk contamination when conducting both 
online carcass inspection and offline verification inspection 
procedures.
    If inspection personnel determine that an establishment's process 
control procedures are not effective in preventing contamination by 
enteric pathogens, fecal material, ingesta, and milk, the Agency would 
take appropriate regulatory action to ensure that the establishment's 
production process is in control, and that product is not being 
adulterated. Such action could include performing additional visual 
inspections of products or equipment and facilities, increasing offline 
verification inspections, initiating Food Safety Assessments (FSAs), 
conducting hazard analysis verification procedures, and retaining or 
condemning product.
    Finally, FSIS is proposing to require that all official swine 
slaughter establishments develop, implement, and maintain in their 
HACCP systems written procedures to prevent contamination of the pre-
operational environment by enteric pathogens. These procedures must 
include sampling and analysis of food-contact surfaces, reuse water, 
and equipment, including knives, in edible food production departments 
in the pre-operational environment for microbial organisms to ensure 
that the surfaces are sanitary and free of enteric pathogens. The 
sampling frequency must be adequate to monitor the establishment's 
ability to maintain sanitary conditions in the pre-operational 
environment. FSIS is proposing this environmental sampling requirement 
because in 2015, 152 people became ill after consumption of product 
produced at an establishment where FSIS found evidence during an 
investigation of insanitary conditions, including, but not limited to, 
tables and knives in the pre-operational environment that were 
contaminated with Salmonella. The proposed environmental sampling 
requirement would reduce the risk of cross-contamination from 
insanitary conditions in the pre-operational environment. FSIS is 
requesting comments on this proposed environmental sampling 
requirement. The proposed environmental sampling does not specifically 
include lairage (e.g., holding pens for live swine) although scientific 
literature conclusively shows that contamination occurs in this area of 
the establishment. FSIS is also asking for comments on how to ensure 
that lairage does not contribute to insanitary conditions.

V. Implementation

    If this proposed rule becomes final, establishments interested in 
NSIS would need to notify FSIS in writing of their intent to operate 
under the new inspection system. The Agency is also considering 
establishing separate applicability dates for large, small, and very 
small establishments to comply with the proposed regulations that 
prescribe procedures for controlling visible fecal, ingesta, and milk 
contamination; the regulations that prescribe procedures for 
controlling contamination throughout the slaughter and dressing 
process; and the regulations that prescribe recordkeeping requirements. 
The applicability dates would provide additional time for small and 
very small establishments to comply with these provisions. The Agency 
is requesting comments on its proposed implementation plan, especially 
the phased in applicability dates for the proposed provisions in the 
rule that prescribe requirements for all swine slaughter 
establishments.

VI. Executive Orders 12866 and 13563

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

A. Request for Comments Summary

    FSIS is requesting comments on:
    1. Whether or not the Agency should require establishments under 
NSIS to specify in their records the reason that the animals were 
removed from slaughter and how this information should be collected.
    2. The draft compliance guides.
    3. Whether or not the Agency should allow establishments that 
operate under the proposed NSIS to use discretion when deciding, on a 
lot-by-lot basis, whether or not to incise mandibular lymph nodes and 
palpate the viscera to detect the presence of animal diseases (e.g., M. 
Avium) if they submit documentation to FSIS supporting that the 
presence of M. Avium is not likely to occur, such as records 
documenting their on-farm controls.
    4. The effects of faster line speeds on worker safety.
    a. Whether line speeds for the NSIS should be set at the current 
regulatory limit of 1,106 hph or some other number.
    b. The availability of records or studies that contain data that 
FSIS may be able to use in analyzing the effects of increased line 
speed on the safety and health of employees throughout the 
establishment, including effects prior to and following the 
evisceration line.
    c. Whether the Agency should maintain the 1,106 hph maximum line 
speed for establishments operating under NSIS but grant waivers from 
the maximum line speed to establishments that agree to work with the 
National Institute for Occupational Safety and Health to evaluate the 
effects of waivers of line speed restrictions on employee health.
    5. The proposed sampling requirements, especially the environmental 
sampling requirement.
    6. The proposed implementation plan, especially the phased in 
applicability dates for the proposed provisions in the rule that 
prescribe requirements for all swine slaughter establishments.
    In addition, FSIS is requesting the following data to further 
inform its consideration of the proposed rule. Further discussions of 
these requests are provided in their corresponding sections.
    1. Are very small establishments that exclusively slaughter market 
hogs likely to convert to the NSIS?
    2. How soon do establishments plan on adopting the NSIS?
    3. Depending on establishment size, how many additional 
establishment employees would the NSIS system require?
    4. What are the capital costs for establishments associated with 
the NSIS?
    5. How long will it take establishment personnel such as a quality 
technician to collect, record, and analyze data required to verify that 
an

[[Page 4800]]

establishment's products meet the definition of RTC?
    6. How many swine establishments have written sanitary dressing 
plans?
    7. How many establishment employees perform sanitary dressing tasks 
in a swine slaughter establishment?
    8. How many establishments conduct generic E. coli sampling at an 
alternative frequency?
    9. What are the alternative frequencies at which establishments are 
conducting process control sampling?
    10. How will changes in line speeds affect market hog prices, 
establishment hours of production, consumer prices, and export volumes?

B. Need for the Rule

    The swine slaughter industry in the U.S. has evolved since the 
advent of the current swine inspection regulations used by the FSIS. 
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.\11\ 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, adherence to current regulations at large 
and high volume establishments that exclusively slaughter market hogs 
prevents 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, one that is less prescriptive, creates incentives for 
establishments to develop and invest in food quality controls and 
safety procedures, and allows FSIS to improve inspection methods, is 
needed.
---------------------------------------------------------------------------

    \11\ Key, Nigel and William McBride. 2007. The Changing 
Economics of U.S. Hog Production. USDA 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 88 percent 
between 2005 and 2015.\12\ According to the Food and Agricultural 
Organization, pork is consistently ranked as the top meat in per-capita 
consumption worldwide \13\ and is ranked third in the United 
States.\14\
---------------------------------------------------------------------------

    \12\ USDA ERS Livestock and Meat Domestic Data. http://www.ers.usda.gov/data-products/livestock-meat-domestic-data.aspx#26105. Accessed on 12/2/15. Last updated on 11/30/15.
    \13\ FAO Livestock commodities. http://www.fao.org/docrep/005/y4252e/y4252e05b.htm. Accessed on 11/29/16.
    \14\ USDA ERS Livestock and Meat Domestic Data. http://www.ers.usda.gov/data-products/livestock-meat-domestic-data.aspx#26105. Accessed on 11/29/16. Last updated on 10/27/16.

                                      Table 2--U.S. Pork Supply and Demand
----------------------------------------------------------------------------------------------------------------
                                       U.S.                                          Domestic       Per capita
              Year                 production *      Imports *       Exports *     consumption *  consumption **
----------------------------------------------------------------------------------------------------------------
2005............................          20,705           1,024           2,666          19,093              65
2006............................          21,074             990           2,995          19,055              64
2007............................          21,962             968           3,141          19,763              66
2008............................          23,367             832           4,651          19,431              64
2009............................          23,020             834           4,094          19,869              65
2010............................          22,456             859           4,223          19,077              62
2011............................          22,775             803           5,196          18,382              59
2012............................          23,268             802           5,379          18,607              59
2013............................          23,204             880           4,986          19,105              60
2014............................          22,858           1,011           5,092          18,836              59
2015............................          24,517           1,116           5,009          20,593              64
----------------------------------------------------------------------------------------------------------------
* Measured in carcass weight, million pounds.
** Measured in carcass weight, pounds.
Source: USDA ERS Livestock and Meat Domestic Data. http://www.ers.usda.gov/data-products/livestock-meat-domestic-data.aspx#26105 accessed on 11/29/16. Last updated on 10/27/16.

    In 2016, there were approximately 612 swine slaughter 
establishments under Federal Inspection, Table 3.\15\ Combined, these 
establishments process roughly 118 million hogs annually. FSIS divides 
these swine into the following production categories for data 
collection: Roaster swine, market hog, sow, and boar/stag. Today, the 
majority (96%) of the pork products available in the market are derived 
from market hogs.\16\
---------------------------------------------------------------------------

    \15\ USDA, FSIS, Public Health Information System (PHIS).
    \16\ 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.


[[Page 4801]]

    As shown below in Table 4, many establishments now exclusively 
slaughter market hog, a species sub class which due to technological 
and managerial improvements, such as improved genetics, nutrition, and 
medical services, generally presents fewer food safety and quality 
issues.\17\
---------------------------------------------------------------------------

    \17\ Key, Nigel and William McBride. 2007. The Changing 
Economics of U.S. Hog Production. USDA ERS. Report No. 52.
---------------------------------------------------------------------------

D. Overview of the Proposed Rule's NSIS

    Eight of the proposed rule's provisions apply to only those 
establishments that voluntarily participate in the NSIS. Meeting these 
provisions will likely increase an establishment's labor and training 
costs. Additionally, only market hogs are eligible to participate in 
the NSIS. Due to these economic constraints discussed above, we expect 
that only large and small high volume establishments that exclusively 
slaughter market hogs would voluntarily participate in the NSIS. In 
2016 there were 40 high volume establishments that exclusively 
slaughter market hogs, 27 large \18\ (5 HIMP + 22 non-HIMP) \19\ and 13 
small establishments, Table 4. These establishments account for 92 
percent of total swine slaughter, Table 4. Given their large share of 
the market and the ability to slaughter a sufficient amount of market 
hogs to justify the likely costs associated with NSIS, these 
establishments are expected to voluntarily implement the proposed NSIS. 
Therefore, this analysis calculates the costs and benefits associated 
with the voluntary provisions for these 40 market hog establishments. 
However, because the 5 HIMP establishments are already practicing the 
proposed NSIS methods, they are not expected to incur any additional 
new costs nor contribute to any increase in quantified benefits 
associated with adopting the NSIS.
---------------------------------------------------------------------------

    \18\ 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.
    \19\ 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 Proposed Rule's Mandatory Components

    All swine slaughter establishments would need to comply with the 
three mandatory provisions of the proposed rule, which are described in 
more detail in section IV. A.
1. Written Sanitary Dressing Plans
    FSIS is proposing to amend 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 post-mortem 
inspection of swine carcasses. This requirement would address a 
weakness of the current 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 contamination from entering 
the cooler. While preventing swine carcasses contaminated with visible 
fecal material from entering the chiller 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 
controls for them. Requiring establishments to keep daily written 
records to document the implementation and monitoring of their process 
control procedures is a positive step forward for public health. This 
ongoing documentation will allow both the establishment and FSIS to 
identify specific points in the production process where a lack of 
process control may have resulted in product contamination or 
insanitary conditions. This will allow the establishment to take the 
necessary corrective action to prevent further product contamination. 
FSIS seeks comment on the extent to which written sanitary dressing 
plans are necessary for ensuring that existing process controls are 
effective.
    While many establishments may already have written sanitary 
dressing plans, due to data limitations, this analysis assumes that 
every establishment will need to develop a written sanitary dressing 
plan. This assumption will help ensure a conservative estimate. Ongoing 
sanitary dressing documentation will allow both the establishment and 
FSIS to identify specific points in the production process where a lack 
of process control may have resulted in product contamination or 
insanitary conditions.
2. Process Control Sampling and Analysis for Microbial Organisms
    Under this proposed rule, instead of following a prescribed 
microbiological testing program, each establishment would be 
responsible for developing and implementing its own microbiological 
sampling plan, which would be required to include carcass sampling at 
pre-evisceration and post-chill. Current microbiological standards

[[Page 4802]]

prescribe that all establishments monitor process control by sampling 
for generic E. coli. High volume establishments are required to take 
one sample per 1,000 carcasses, or request an alternative rate. The 
Agency is seeking comment on both the number of establishments 
conducting alternative sampling rates and approved alternative sampling 
rates. Very low volume establishments are required to take 1 sample per 
week of operation up to 13 times a year. An industry survey found that 
many establishments elect to perform other microbiological tests in 
addition to testing for generic E. coli.\20\
---------------------------------------------------------------------------

    \20\ Viator C. et al. 2015. (a) Meat Industry Survey in Support 
of Public Health Risk-Based Inspection. P5-42. Question 3.1.
---------------------------------------------------------------------------

3. Environmental Sampling
    FSIS is proposing to require that all official swine slaughter 
establishments develop, implement, and maintain in their HACCP systems 
written procedures to prevent contamination of the pre-operational 
environment by enteric pathogens.
    Such procedures must be incorporated into an establishment's HACCP, 
sanitation SOP, or other prerequisite program. This analysis assumes an 
establishment will incorporate its procedures for controlling 
contamination in the pre-operational environment into its sanitation 
SOP. These procedures must include sampling and analysis of food 
contact surfaces in the pre-operational environment at a frequency 
adequate to monitor the establishment's ability to maintain sanitary 
conditions in the pre-operational environment.

F. Overview of the Proposed Rule's Agency Impact

    This analysis also takes into consideration potential impacts to 
the Agency's budget, which is expected to be impacted by changes in 
staffing and training requirements. 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 establishments expected 
to convert to NSIS, Table 5. When these establishments convert to NSIS, 
Agency personnel will require NSIS training. Additionally, the number 
of Agency personnel required to inspect the slaughter process will 
likely change, see Agency Staffing section for details.

  Table 5--Current FSIS Slaughter Line Positions at Non-HIMP Facilities
                 That Slaughter Exclusively Market Hogs
------------------------------------------------------------------------
                                                             Number of
                      OPM job code                           positions
------------------------------------------------------------------------
1862....................................................             120
1863....................................................             245
701.....................................................              53
                                                         ---------------
  Total.................................................             418
------------------------------------------------------------------------
Source: PHIS.

G. Expected Cost of the Proposed Rule

1. Associated With the NSIS Components of the Rule
    This analysis estimates the cost associated with the proposed 
rule's NSIS components. The Agency assumes that 22 large high volume 
and 13 small high volume establishments, that have a history of 
exclusively slaughtering market hogs, will adopt the NSIS portions of 
the rule. These 35 establishments have similar characteristics as 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, the benefits from 
adopting NSIS are expected to outweigh the 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. The Agency is seeking comment on this 
assumption. While the 5 HIMP establishments are expected to adopt the 
NSIS, they have already implemented the proposed changes associated 
with the NSIS by their participation in the HIMP program 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. This analysis excludes further 
consideration in the Preliminary Regulatory Impact Analysis of the 
costs of submitting an attestation of work related conditions due to 
its small expected cost.\21\ Costs examined generally fall under three 
categories: Labor, capital expenses, and developing written procedures.
---------------------------------------------------------------------------

    \21\ 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 28 large and 13 small 
establishments approximately $93.64 annually (2 minutes * $68.52 per 
hour * 41).
---------------------------------------------------------------------------

    In the following sections, this analysis presents the costs and 
benefits that would be 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 which are likely to adopt the NSIS will incur 
additional costs associated with adoption. The Agency is seeking 
comment on this assumption. Note, the 5 HIMP establishments are not 
expected to incur any additional costs associated with adopting the 
NSIS and are therefore excluded from this portion. Also, based on 
actual NPIS adoption rates thus far, the assumptions presented in this 
analysis may be an overestimate of adoption of NSIS.

                                           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

[[Page 4803]]

 
5...............................................................              22              13             100
----------------------------------------------------------------------------------------------------------------

a. Costs of Additional Establishment Workers
    This analysis expects establishments operating under NSIS to 
experience an increase in labor costs. Under NSIS, establishments will 
be required to dedicate labor to sort and remove unfit animals before 
ante-mortem inspection and trim; identify defects, such as dressing 
defects, contamination, and pathology defects, on carcasses and parts 
before post-mortem inspection; ensure product is presented to Agency 
inspectors in an appropriate manner; identify carcasses condemned on 
ante-mortem inspection; denature all major portions of condemned 
carcasses on-site; maintain records to document the number of animals 
condemned on ante-mortem inspection; and notify Agency inspectors if 
they suspect that an animal or carcass has a reportable or foreign 
animal disease, while conducting sorting activities. Based on 
observations \22\ of HIMP establishments, this increase in work is 
expected to require an increase in labor demand ranging from 6-10 
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. The 
Agency seeks comment on the number of additional employees each 
establishment will require due to the NSIS. Costs associated with this 
labor fall into 3 categories: Wages and benefits, training, and 
continuing education.
---------------------------------------------------------------------------

    \22\ 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.
---------------------------------------------------------------------------

Establishment Labor Wage Increases
    Many of the 22 large and 13 small non-HIMP market hog 
establishments that are assumed will adopt NSIS operate multiple lines 
and shifts. Taking these multiple lines and shifts into consideration, 
the number of industry positions is expected to increase by 383. The 
majority of these, 369, are attributable to the large establishments 
(41 (number of lines) x 9),\23\ Table 7. The remaining 14 positions are 
attributable to the small establishments (14 (number of lines) x 
1),\24\ Table 7. According to the Bureau of Labor Statistics (BLS) the 
expected hourly wage for a Slaughter and Meat Packer occupation 
(``production employee'') is $13.00.\25\ 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).\26\ 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 on 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.
---------------------------------------------------------------------------

    \23\ Source: PHIS.
    \24\ Source: PHIS.
    \25\ BLS Occupational Employment Statistics, Occupational 
Employment and Wages, May 2016. 51-3023 Slaughters and Meat Packers 
http://www.bls.gov/oes/current/oes513023.htm accessed on 7/24/17. 
Last modified 3/31/17.
    \26\ 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.
---------------------------------------------------------------------------

Training Online Sorters and Carcass-Inspection Helpers
    Establishments are expected to incur costs associated with 
initially training employees to fill these 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.\27\ 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 * $549), Table 7.
---------------------------------------------------------------------------

    \27\ Viator. C. et al. 2015. (b) Costs of Food Safety 
Investments. Table 4-4. Training Costs for Management and Production 
Employees.
---------------------------------------------------------------------------

    To account for expected 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.\28\ The additional annual training cost 
for new employees is expected 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 $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.
---------------------------------------------------------------------------

    \28\ 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. http://www.bls.gov/news.release/jolts.t16.htm. 
Accessed on 7/21/17. 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, with a mid-point of $24.\29\ 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

[[Page 4804]]

approximately $24,984 (1,041 x $24) and small establishments accounting 
for approximately $936 (39 x 24).
---------------------------------------------------------------------------

    \29\ Viator. C. et al. 2015. (b) 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 $16.45 million, applying a 3 percent 
discount rate 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
         Type of establishment               Type of expense         personnel     One-Time cost  Recurring 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  ..............            0.03
----------------------------------------------------------------------------------------------------------------
    Totals:
        One-Time................................................................................            0.84
        Recurring Cost..........................................................................           21.66
        Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.............................           16.62
        Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.............................           15.99
----------------------------------------------------------------------------------------------------------------

b. Costs of Capital Improvements: Line Configuration and Inspection 
Stations
    As proposed, participating in NSIS does not necessitate capital 
improvements. As such, this analysis does not include capital 
expenditures. However, if establishments believe that capital 
expenditures would result in a benefit they may voluntarily reconfigure 
or update their facilities so as 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 to $250,000,\30\ and the creation of an inspection station, 
which can cost between $5,000 and $6,000.\31\ Establishments may reduce 
these costs by coordinating these facility updates with previously 
planned establishment renovations. The Agency is seeking comment on 
both the required and voluntary capital costs associated with the NSIS.
---------------------------------------------------------------------------

    \30\ In a May 2004 study, ERS estimated the cost of compliance 
per establishment with PR/HACCP rule. Capital expenditures in Hog 
Slaughter establishments were estimated to be $251,800.
    Ollinger, Michael, Danna Moore, Ram Chandran (2004). Meat and 
Poultry Establishments' Food Safety Investments. USDA, Economic 
Research.
    \31\ Modernization of Poultry Slaughter Inspection; Final Rule, 
79 FR. 49566 (2014).
---------------------------------------------------------------------------

c. Costs of Developing Ante-Mortem Written Procedures
    Under the proposed rule, establishments operating under NSIS are 
required to develop and maintain in their HACCP systems (HACCP plans, 
Sanitation Standard Operating Procedures, 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, fecal 
material, ingesta, and milk throughout the entire slaughter and 
dressing operation, a mandatory component of the proposed rule. Details 
of these costs can be found in the sanitary dressing costs section 
VI.2.a.
d. Ready-To-Cook Pork Standards
    As proposed, establishments operating under NSIS are required to 
collect, record, and analyze documentation to demonstrate that the 
products resulting from their slaughter operation meet the proposed 
definition of RTC pork products. While the Agency is seeking comment on 
this requirement, this analysis estimates the labor costs to conduct 
such documentation under two assumptions. First, FSIS assumes that 
establishments would assign the task to a quality control technician, 
QC, with an hourly compensation rate, which included wages, benefits, 
and overhead, of $68.52.\32\ Second, FSIS assumes that this work would 
take 1 hour at a large establishment and \1/2\ hour at a small 
establishment. The Agency is seeking comment on this assumption. Based 
on information obtained through PHIS, the average large establishment 
operates 269 days per year. This equates to an annual cost of 
approximately $18,432 (268 * 1 * $68.52), or approximately $0.41 
million for all 22 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.
---------------------------------------------------------------------------

    \32\ 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.

[[Page 4805]]



                    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               0.39
         Over 10 Years..................................
        Annualized Costs, Assuming a 7% Discount Rate               0.38
         Over 10 Years..................................
------------------------------------------------------------------------

2. Costs Associated With the Mandatory Components of the Rule
    The mandatory costs of the proposed rule are expected to apply to 
all 612 swine slaughter establishments and begin within the first year 
after the rule is finalized. These costs are associated with (a) 
establishing and implementing written sanitary dressing plans to 
prevent contamination of carcasses and parts by enteric pathogens, 
fecal material, ingesta, and milk, throughout the entire slaughter and 
dressing operation; (b) modernizing process control sampling programs 
for microbial organisms; and (c) sampling the slaughter environment for 
microbiological contamination.
a. Costs of Developing, Composing, Training, Monitoring, Recording, and 
Verifying Written Sanitary Dressing Plans
    Under the mandatory portion of the proposed rule affecting all 
federally inspected establishments that slaughter swine, FSIS is 
proposing to require that all official swine slaughter establishments 
develop, implement, and maintain in their HACCP systems written 
procedures to prevent the contamination of carcasses and parts by 
enteric pathogens, fecal material, ingesta, and milk throughout the 
entire slaughter and dressing operation. This cost component includes: 
(1) Developing these procedures into their food safety system, (2) 
training, and (3) monitoring, recordkeeping, and verification.
Developing and Composing
    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 the Research Triangle Institute's (RTI) 
Costs of Food Safety Investments report,\33\ 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.\34\ To ensure a 
conservative cost estimate, this analysis assumes all 612 swine 
establishments will incur this cost. The Agency is seeking comment on 
this assumption. The cost to all large establishments is approximately 
$20,440 (28 * $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 612 swine slaughter establishments is approximately $0.03 
million, Table 9.
---------------------------------------------------------------------------

    \33\ Viator. C. et al. 2015. (b) 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.
    \34\ Viator. C. et al. 2015. (b) Table 4-2. Costs of Sanitation 
SOP Plan Development, Validation and Reassessment.

           Table 9--Written Sanitary Dressing Plan Development
                                  [M$]
------------------------------------------------------------------------
                                             Number of
               HACCP size                     plants       One-time cost
------------------------------------------------------------------------
Large...................................              28           $0.02
Small...................................             105            0.04
Very Small..............................             479            0.17
------------------------------------------------------------------------
    Totals:
        One-Time Cost...................................            0.23
        Annualized Costs, Assuming a 3% Discount Rate               0.03
         Over 10 Years..................................
        Annualized Costs, Assuming a 7% Discount Rate               0.03
         Over 10 Years..................................
------------------------------------------------------------------------

Training
    Training programs should 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.\35\ 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 actually spend on training. Due to data limitations, 
this analysis assumes the number of establishment employees

[[Page 4806]]

conducting sanitary dressing tasks at swine establishments is equal to 
the number of employees conducting sanitary dressing tasks at beef 
slaughter establishments.\36\ 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. The Agency is seeking comment on this 
assumption.
---------------------------------------------------------------------------

    \35\ Viator, C. et al. 2015. (b).
    \36\ 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 Bureau of Labor Statistics', BLS, 
2016 turnover rate for non-durable manufacturing goods.\37\ 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 612 
establishments is roughly $1.13 million, while the total recurring 
costs is roughly $0.49 million, Table 10. The annualized costs with a 3 
percent discount rate over 10 years for Sanitary Dressing task related 
training is $0.62 million, Table 10.
---------------------------------------------------------------------------

    \37\ This analysis uses the industry turnover rate for non-
durable manufactured goods to estimate. Source: BLS Economic News 
Release Table 16. Annual total separations rates by industry and 
region, not seasonally adjusted. <http://www.bls.gov/news.release/jolts.t16.htm Accessed on 7/21/17. Last updated on 3/16/
17.

                                   Table 10--Sanitary Dressing Training Costs
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                                                                  Training costs
                                                                 -----------------------------------------------
           HACCP size                Number of    Average number     One-time                Recurring
                                  establishments   of employees  -----------------------------------------------
                                                                      Initial        New hires       Refresher
----------------------------------------------------------------------------------------------------------------
Large...........................              28             179           $0.61           $0.18           $0.09
Small...........................             105              25            0.32            0.09            0.04
Very Small......................             479               3            0.20            0.06            0.03
----------------------------------------------------------------------------------------------------------------
    Totals:
        One-Time Cost...........................................................................            1.13
        Recurring Cost..........................................................................            0.49
        Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.............................            0.62
        Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.............................            0.64
----------------------------------------------------------------------------------------------------------------

Monitoring, Recordkeeping, and Verification
    This analysis also measures the annual monitoring, recordkeeping 
and verification costs associated with maintaining sanitary dressing 
procedures. Similar to the Modernization of Poultry Slaughter 
Inspection Final Rule,\38\ 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 expected 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 $0.85 million 
annually, applying a 3 percent discount rate over 10 years, Table 11.
---------------------------------------------------------------------------

    \38\ 79 FR 49566-49637, August 21, 2014.

                           Table 11--Monitoring, Record Keeping and Verification Costs
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                                 Recurring costs
-----------------------------------------------------------------------------------------------------------------
                   HACCP Size                       Monitoring    Record keeping   Verification      Combined
----------------------------------------------------------------------------------------------------------------
Large...........................................          $0.016           $0.02           $0.04           $0.07
Small...........................................           0.038            0.04            0.12            0.20
Very Small......................................           0.070            0.07            0.44            0.58
----------------------------------------------------------------------------------------------------------------
    Totals:
        Recurring Cost..........................................................................            0.85
        Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.............................            0.85
        Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.............................            0.85
----------------------------------------------------------------------------------------------------------------

Summary Cost 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 $1.50 million annualized, assuming a 3 percent 
discount rate over 10 years, Table 12.

[[Page 4807]]



            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...........................              28           $0.02           $0.61           $0.27           $0.07
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...........................  ..............  ..............  ..............            1.36
        Recurring Cost..........................  ..............  ..............  ..............            1.34
        Annualized Costs, Assuming a 3% Discount  ..............  ..............  ..............            1.50
         Rate Over 10 Years.....................
        Annualized Costs, Assuming a 7% Discount  ..............  ..............  ..............            1.53
         Rate Over 10 Years.....................
----------------------------------------------------------------------------------------------------------------

b. Process Control Sampling and Analysis for Microbial Organisms
    This section reviews the expected changes in costs associated with 
the proposed alterations to microorganism process control verification. 
These costs are limited to the changes associated with removing the 
requirement that swine establishments test carcasses for generic E. 
coli and replacing them with new testing requirements described above. 
While the proposed 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 expected 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 \39\ and Costs of Food 
Safety Investments report.\40\ Each of these categories is explained in 
detail below.
---------------------------------------------------------------------------

    \39\ 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.
    \40\ Viator C. et al. 2015. (b).
---------------------------------------------------------------------------

Process Control Sampling Plan Reassessment
    This analysis assumes establishments will incur one-time costs of 
conducting a process control sample plan reassessment under the 
proposed 9 CFR 310.25(a)(2)(i). The RTI Costs of Food Safety Investment 
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.\41\ The 
annualized reassessment cost to industry is roughly $0.19 million, 
assuming a 3 percent discount rate over 10 years, Table 13.
---------------------------------------------------------------------------

    \41\ 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--Costs of Process Control Sampling Plan Reassessment
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                                                                        Per
                                                                     Number of     establishment    Total one-
                           HACCP size                             establishments    (mid-point      time costs
                                                                                    estimate) *
----------------------------------------------------------------------------------------------------------------
Large...........................................................              28           $0.05           $1.53
Small...........................................................             105             243            0.03
Very Small......................................................             479             243            0.12
----------------------------------------------------------------------------------------------------------------
    Totals:
        One-Time Cost...........................................................................            1.67
        Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.............................            0.19
        Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.............................            0.22
----------------------------------------------------------------------------------------------------------------
* The values for Small and Very Small Establishments are in dollars.

Transferring From Prescriptive To Process Testing Requirements
    Current regulation prescribes that each slaughter facility will 
test for generic E. coli.\42\ In addition to mandated generic E. coli 
testing, many establishments voluntarily conduct additional 
microbiological testing to verify process control. Common microbiologic 
tests include aerobic plate count (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.\43\

[[Page 4808]]

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.
---------------------------------------------------------------------------

    \42\ 9 CFR 310.25.
    \43\ 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 would 
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 28 large (28 * 1.00), 41 small high volume (51 * .80), 43 
small low volume (54 * .80) and 342 very small (479 * .714) 
establishments that currently test for generic E. coli and at least one 
other microbial or pathogen indicator \44\ would 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.
---------------------------------------------------------------------------

    \44\ 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 and 
small high volume establishments conduct 1 test, every 1,000 carcasses, 
and all small low volume and very small establishments conduct 13 tests 
annually.\45\ The Agency is seeking comment on this assumption. 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 
$24.92.\46\ To have the sample tested at a contracted lab, the cost is 
$48.76.\47\ 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.\48\ For these 454 establishments, the 
combined reduction in testing costs of no longer being required to test 
for generic E. coli is expected to reduce annual testing costs by 
approximately $3.92 million, assuming a 3 percent discount rate over 10 
years, Table 14.
---------------------------------------------------------------------------

    \45\ 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.
    \46\ Viator C. et al. 2015. (b) Table 5-1.
    \47\ Viator C. et al. 2015. (b) Table 5-1.
    \48\ Viator, C. et al. 2015. (b).

 Table 14--Recurring Costs (Savings) From No Longer Requiring Generic E.
                              coli Testing
                                  [M$]
------------------------------------------------------------------------
                                             Number of
               HACCP size                 establishments     (Savings)
------------------------------------------------------------------------
Large...................................              28         ($3.28)
Small High Volume.......................              41          (0.40)
Small Low Volume........................              43          (0.02)
Very Small..............................             342          (0.22)
------------------------------------------------------------------------
    Totals:
        Recurring Cost..................................          (3.92)
        Annualized Costs, Assuming a 3% Discount Rate             (3.92)
         Over 10 Years..................................
        Annualized Costs, Assuming a 7% Discount Rate             (3.92)
         Over 10 Years..................................
------------------------------------------------------------------------

Process Control Sampling Rates
    The proposed rule would require large and small high volume 
establishments to take samples at pre-evisceration and post-chill, 
which would increase the number of samples taken from 1 sample per 
1,000 carcasses to 2 samples per 1,000 carcasses for large and small 
high volume establishments. The proposed rule does not require small 
low volume and very small establishments to increase their sampling 
rates. Under the proposed regulations, large establishments annual 
process control sampling costs are expected to increase by roughly 
$2.34 million, which is roughly $83,639 per establishment ($2.34 
million/28), Table 15. Small high volume establishments annual process 
control sampling costs are expected to increase by roughly $0.29 
million, which is roughly $5,740 ($0.29 million/51) per establishment, 
Table 15.
Process Control Sample Recordkeeping
    This analysis takes into consideration the increase in record 
keeping 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 
establishment slaughters approximately 3.77 million swine per year. As 
such, this analysis estimates that a large establishment currently 
takes approximately 3,774 samples annually (3,774,223/1,000). The 
average small high volume swine establishment slaughters 0.23 million 
swine per year and requires approximately 229 samples (228,784/1,000) 
annually. Assuming it takes 2.5 minutes to record the results of each 
sample, the average large establishment currently requires 9,435 
minutes (2.5 * 3,774) per year and the average small high volume 
establishment currently requires 573 minutes (2.5 * 229) per year. 
Requiring establishments to increase their sampling rates from 1 to 2 
samples per 1,000 head would increase the average large establishment's 
annual number of samples to 7,548 samples annually (3,774,223/1,000 
*2), which would require approximately 18,870 minutes (2.5 * 7,548) 
annually. The same requirement would increase a small high volume 
establishment's annual sampling to 458 (228,784/1,000 * 2), which would 
require approximately 1,145 minutes (2.5 * 458) annually. As such, the 
expected additional time required for recordkeeping is approximately 
9,435 minutes (18,870-9,435) for large establishments and 572 minutes 
(1,145-573) for small high volume establishments. Assuming a quality 
control technician with a compensation rate of $68.52 per hour \49\ 
conducts this work, the additional costs

[[Page 4809]]

to the average large establishment is approximately $10,775 (9,435/60 * 
$68.52). Similarly, the additional cost to the average small high 
volume establishment is approximately $653 (572/60 * 68.52). Scaling 
this up to all establishments, the total increase in costs to all large 
establishments is approximately $0.30 million ($10,775 * 28) and $0.03 
million ($653 * 51) for small high volume establishments, Table 15.
---------------------------------------------------------------------------

    \49\ 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.
---------------------------------------------------------------------------

    The combined annualized sampling and recordkeeping cost to all 
large and small high volume establishments is roughly $2.97 million, 
applying a 3 percent discount rate over 10 years. Large establishments 
are expected to incur the majority of this cost.

                         Table 15--Costs Changes Associated With Increase Sampling Rates
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                                                                      Costs
                                                    Number of   ------------------------------------------------
                                                 establishments     Sampling      Recordkeeping      Combined
----------------------------------------------------------------------------------------------------------------
Large..........................................              28           $2.34            $0.30           $2.64
Small-High Volume..............................              51            0.29             0.03            0.33
----------------------------------------------------------------------------------------------------------------
    Totals:
        Recurring Cost..........................................................................            2.97
        Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.............................            2.97
        Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.............................            2.97
----------------------------------------------------------------------------------------------------------------

Summary of Process Control Sampling Costs Changes
    Overall, the changes in sampling requirements under the proposed 
rule are expected to reduce industry wide sampling costs by about $0.76 
million annualized over 10 years, applying a 3 percent discount rate, 
Table 16. However, only the 454 establishments that currently conduct 
multiple types of microbiological tests are expected to experience a 
reduction in cost. The remaining establishments, roughly 158 small and 
very small establishments, are expected to 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 and small high volume establishments.

        Table 16--Summary of Changes to Process Control Sampling
                                  [M$]
------------------------------------------------------------------------
                                                  Cost (savings)
             Type of change              -------------------------------
                                             One-time        Recurring
------------------------------------------------------------------------
Plan Reassessment.......................           $1.67  ..............
Converting to Process Control Sampling..  ..............         ($3.92)
Testing Costs...........................  ..............            2.63
Recordkeeping...........................  ..............            0.33
------------------------------------------------------------------------
    Totals:
        One-Time Cost...................................            1.67
        Recurring Cost..................................          (0.95)
        Annualized Costs, Assuming a 3% Discount Rate             (0.76)
         Over 10 Years..................................
        Annualized Costs, Assuming a 7% Discount Rate             (0.72)
         Over 10 Years..................................
------------------------------------------------------------------------

c. Environmental Sampling
    As proposed, all swine slaughter establishments will be required to 
control for enteric pathogen contamination in the pre-operational 
environment. Such controls will have to be included in an 
establishment's HACCP system, requiring a plan reassessment. This 
analysis assumes establishments will coordinate this work with the 
HACCP plan reassessment required by the development of written sanitary 
dressing procedures. As such the cost of incorporating pre-operational 
environment sampling plans into an establishment's HACCP system is 
included in the reassessment costs associated with written sanitary 
dressing procedures.
    While establishments will set sampling frequency so as to ensure 
effective control, this analysis assumes each large establishment will 
take 4 samples per 30 days of operation per line, while each small high 
volume establishment will take 2 samples per 30 days of operation per 
line, and small low volume and very small establishments will take 1 
sample per 30 days of operation per line.\50\ Under this assumption, 
the annual number of tests required by the entire industry is 
approximately 3,266. The Agency is seeking comment on this assumption. 
Establishments are permitted to conduct a variety of tests, including 
testing for Aerobic Plate Count, APC, Coliforms, Generic E. coli, Total 
Plate Count, TPC, and Salmonella. The laboratory testing

[[Page 4810]]

costs for these test range from $15 to $32, with an average mean 
testing cost of $19, Table 17.\51\
---------------------------------------------------------------------------

    \50\ In absence of other data we assumed establishments would 
conduct environmental sampling similar to the recommended 
frequencies described on Page 91 in: FSIS Compliance Guidelines: 
Controlling Listeria monocytogenes in Post-lethality Exposed Ready-
to-Eat Meat and Poultry Products. January 2014. Accessed on 12/3/15. 
Available at http://www.fsis.usda.gov/wps/wcm/connect/d3373299-50e6-47d6-a577-e74a1e549fde/Controlling-Lm-RTE-Guideline.pdf?MOD=AJPERES. 
Industry is familiar with this methodology for sampling food-
contact-surfaces in the post-lethality environment to ensure that 
the surfaces are sanitary and free of Listeria monocytogenes or an 
indicator organism. We assumed industry would take a similar 
approach in sampling food-contact-surfaces in market hog 
establishments to meet the proposed environmental sampling 
requirements.
    \51\ Viator. C. et al. 2015. (b) Table 5-1. Laboratory Testing 
Costs.

                                       Table 17--Laboratory Testing Costs
----------------------------------------------------------------------------------------------------------------
                              Test                                    Minimum          Mean           Maximum
----------------------------------------------------------------------------------------------------------------
APC.............................................................             $16             $18             $20
Coliforms.......................................................              15              18              22
E. coli.........................................................              15              18              22
Salmonella......................................................              17              25              32
TPC.............................................................              16              16              17
Average.........................................................              16              19              23
----------------------------------------------------------------------------------------------------------------
Source: Viator. C. et al. 2015. Costs of Food Safety Investments. Table 5-1. Laboratory Testing Costs.

    To ensure a conservative estimate this analysis assumes 
establishments will test for Salmonella, which is the most expensive 
option, Table 17. Under these assumptions, the combined total annual 
environmental sampling cost is approximately $0.08 million (3,266 x 
$25). The annualized cost of these combined expenditures is roughly 
$0.08 million, assuming a 3 percent discount rate over 10 years, Table 
18.

                Table 18--Costs of Environmental Sampling
                                  [M$]
------------------------------------------------------------------------
                                             Number of
               HACCP size                 establishments  Sampling costs
------------------------------------------------------------------------
Large...................................              28            0.03
Small High Volume.......................              51            0.02
Small Low Volume........................              54           0.004
Very Small..............................             479            0.03
------------------------------------------------------------------------
    Totals:
        Recurring Cost..................................            0.08
        Annualized Costs, Assuming a 3% Discount Rate               0.08
         Over 10 Years..................................
        Annualized Costs, Assuming a 7% Discount Rate               0.08
         Over 10 Years..................................
------------------------------------------------------------------------

Summary of Voluntary and Mandatory Costs

    The total annualized value of all costs to industry, under the 
assumed five year adoption rate as shown in Table 6, is roughly $17.84 
million, assuming a 10 year annualization and a 3 percent discount 
rate, Table 19. 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 establishments have already incurred 
these costs, suggesting for those five establishments, the benefits of 
NSIS outweigh the costs. It also suggests that the benefits of adopting 
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 are expected to decrease 
for those establishments that currently conduct microbiological tests 
in addition to generic E. coli.

                                      Table 19--Combined Costs to Industry
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                                                                            Total costs
                          Type of cost                               Number of   -------------------------------
                                                                  establishments     One-time        Recurring
----------------------------------------------------------------------------------------------------------------
Voluntary:
    Establishment Labor.........................................              35           $0.84          $21.66
    Ready to Cook...............................................              35  ..............            0.51
Mandatory:
    Written Sanitary Dressing Plan..............................             612            1.36            1.34
    Process Control Sampling....................................             612            1.67          (0.95)
    Environmental Sampling......................................             612             0.0            0.08
----------------------------------------------------------------------------------------------------------------
    Totals *:
        Number of Establishments................................................................             612
        One-Time Cost...........................................................................            3.88
        Recurring Cost..........................................................................           22.65
        Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.............................           17.84

[[Page 4811]]

 
        Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.............................           17.24
    Totals Mandatory *:
        Number of Establishments................................................................             612
        One-Time Cost...........................................................................           $3.03
        Recurring Cost..........................................................................           $0.48
        Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.............................           $0.82
        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..........................................................................          $22.17
        Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.............................          $17.02
        Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.............................          $16.36
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.

H. Expected Benefits of the Proposed Rule

1. Expected 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 expected to reduce pathogen levels in 
swine slaughter establishments. 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 HACCP-based Inspection Models 
Project (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. 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 
change in carcass contamination prevalence under the inspection 
procedures of NSIS.
    Changes in expected numbers of Salmonella illness are estimated 
based on a proportional relationship between carcass contamination 
prevalence and illnesses that has been published in the peer-reviewed 
literature.52 53 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, if the 
proportion of carcasses with no detectable Salmonella contamination 
increases with implementation of the NSIS, illnesses caused by 
consumers' exposure to these carcasses are expected to decrease 
proportionally.
---------------------------------------------------------------------------

    \52\ 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.
    \53\ 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.
---------------------------------------------------------------------------

    The market hog Salmonella illness risk model estimates that the 
prevalence of Salmonella detected in carcasses will decline on average 
from an initial prevalence of 0.9407% to a final prevalence of 0.9066% 
if the 35 establishments identified adopt the new inspection system. 
The uncertainty of the final prevalence ranges from 0.8982% to 0.915%, 
at the 10th and 90th percentiles, respectively. 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.\54\
---------------------------------------------------------------------------

    \54\ 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.\55\ 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 768 and 
4,287 decreased cases, respectively. The total case uncertainty 
distribution is dependent on the uncertainty in the change in 
Salmonella prevalence in market hogs which has an average percent 
uncertainty of a 3.626% decrease and is bounded at the 10th and 90th 
percentiles by a decrease of 1.0989% and 6.1362%, respectively.
---------------------------------------------------------------------------

    \55\ 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.

---------------------------------------------------------------------------

[[Page 4812]]

    The prevalence estimates are modeled with data variability and 
robust uncertainty components taken from sampling data and model 
parameter estimates. 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, without 
intervention. With adoption of the new inspection system, the average 
number of cases is likely to decrease to 67,324 with 10th and 90th 
percentiles of 38,653 and 101,417 cases, respectively.
    The market hog risk assessment estimates that if the 35 
establishments expected to covert to the NSIS over 5 years do so, the 
number of human illness attributed to products derived from market hogs 
could reduce by an average of 2,533 Salmonella illnesses. The combined 
robust model estimate of total 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 768 and 
4,287 decreased cases, respectively. 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.\56\ 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 20. The cost savings assuming 
the lowest cost per illness and only 768 cases avoided, which 
corresponds to the 10th percentile, is $0.25 million, Table 20. 
Alternatively, the cost savings assuming the highest cost per illness 
and 4,287 averted illnesses, which corresponds to the 90th percentile, 
is $24.95 million, Table 20. 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 20. 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 
detectable with Salmonella.
---------------------------------------------------------------------------

    \56\ 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 20--Health Benefits From Averted Cases of Salmonella
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per illness *
                                                     Illnesses   -----------------------------------------------
                   Percentile                       averted by          Low             Mid            High
                                                     scenario    -----------------------------------------------
                                                                       $321           $3,682          $5,820
----------------------------------------------------------------------------------------------------------------
                                                                                Scenario costs, $M
                                                 ---------------------------------------------------------------
10th............................................             768         ($0.25)         ($2.83)         ($4.47)
Mean............................................           2,533          (0.81)          (9.33)         (14.74)
90th............................................           4,287          (1.38)         (15.79)         (24.95)
----------------------------------------------------------------------------------------------------------------
    Totals (Low)(M$):
        Recurring Cost..........................................................................         ($0.25)
        Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.............................         ($0.19)
        Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.............................         ($0.18)
    Totals (Mid)(M$):
        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.............................         ($6.81)
    Totals (High)(M$):
        Recurring Cost..........................................................................        ($24.95)
        Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.............................        ($18.97)
        Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.............................        ($18.22)
----------------------------------------------------------------------------------------------------------------
* 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.

2. Other Benefits Associated With Modernizing Existing Regulations
    The proposed regulation is expected to reduce the regulatory burden 
on establishments by shifting from prescriptive to performance based 
regulation. Specifically, the proposed rule amends requirements related 
to slaughter line speeds,\57\ microbiological testing, and sorting 
activities. Based on the Evaluation of HACCP Inspection Models Project 
(HIMP) for Market Hogs report, the five HIMP establishments' average 
line speed were approximately 12.49 percent faster than comparable 
establishments.\58\ 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

[[Page 4813]]

American Meat Institutes' average pork packer margins for 2010-2014, 
which was reported to be $4.10 per head in NAMI's 2015 Meat and Poultry 
Facts.\59\ The pork packer margin is the price the packer receives less 
the cost of the hog and production costs, making the packer margin an 
approximation for producer surplus. FSIS requests comment on refining 
this estimate so as to distinguish between accounting profit and 
economic profit--the latter being more precisely associated with 
producer surplus.
---------------------------------------------------------------------------

    \57\ According to the Evaluation of HACCP Inspection Models 
Project (HIMP) for Market Hogs Final Report, November 2014, ``In CY 
2013, the estimated line speeds at the 5 HIMP market hog 
establishments varied from 885 to 1,285 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''.
    \58\ 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-+himp Accessed on 1/6/2017. Last updated on 11/
14/2014.
    \59\ Nalivka, J.S., The 2015 Meat and Poultry Facts, NAMI 
December 2015.
---------------------------------------------------------------------------

    Assuming establishments increase their line speeds by 12.49 percent 
and have a packer margin of $4.10 per head, an average large 
establishment's surplus could increase by approximately $2.04 million, 
while an average small high volume establishment's surplus could 
increase by $0.18 million, all else being equal. Combined, such an 
increase in efficiency at all 35 establishments would increase producer 
surplus by roughly $47.33 million \60\ (22 x $2.04 million + 13 x $0.18 
million), which has an annualized benefit of roughly $47.33 million, 
assuming a 3 percent discount rate over 10 years, Table 21. 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, 
consumer benefits would be conditional on how an increase in line speed 
affects retail prices. As such, the Agency is seeking comment on the 
extent to which such an increase in line speeds would affect market hog 
prices, establishment hours of production, consumer prices, and export 
volumes.\61\
---------------------------------------------------------------------------

    \60\ Note, some of the totals may not equal the sum due to 
rounding.
    \61\ The Agency further notes that marginal costs typically 
increase as a function of production quantity, in which case profit 
margins reach zero for the last unit of production; indeed, the 
phenomenon of rising marginal costs is consistent with the 
observation of HIMP line speed increases that are less than the 
maximum increase that is theoretically permissible. Assuming 
linearity of the relevant marginal cost curve would yield a margin 
of $2.05 per head, thus making producer surplus half the amount 
estimated here as the change in industrial efficiency. Meanwhile, if 
demand and supply elasticities for pork products are similar--which 
may or may not be plausible--then consumer surplus would increase by 
half the industrial efficiency amount estimated here, thus making 
the overall efficiency change estimate a reasonable approximation 
for the total (consumer plus producer) surplus gain.

                                 Table 21--Industrial Efficiency, (Benefits) M$
----------------------------------------------------------------------------------------------------------------
                                                                                       Change in efficiency
                                                                     Number of   -------------------------------
                      Type of establishment                       establishments        Per
                                                                                   establishment     Combined
----------------------------------------------------------------------------------------------------------------
Large...........................................................              22         ($2.04)        ($44.97)
Small...........................................................              13          (0.18)          (2.37)
Combined *......................................................              35  ..............         (47.33)
----------------------------------------------------------------------------------------------------------------
    Totals:
        Recurring Cost..........................................................................         (47.33)
        Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.............................         (36.14)
        Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.............................         (34.74)
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.

    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.\62\ 
The five establishments that participated in the pilot project account 
for 15 percent of total swine production.
---------------------------------------------------------------------------

    \62\ 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-+himp Accessed on 1/6/2017. Last updated on 11/
14/2014.
---------------------------------------------------------------------------

    Additionally, NSIS inspection increases the Agency's ability to 
conduct more process and product verification and 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 HATS categories in HIMP 
market hog establishments compared to approximately 4.29 hours per 
shift in the 21 non-HIMP market hog comparison establishments.\63\ 
Under 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.
---------------------------------------------------------------------------

    \63\ 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-+himp Accessed on 1/6/2017. Last updated on 11/
14/2014.
---------------------------------------------------------------------------

I. Expected Budgetary Impacts

    Under the proposed rule, the Agency would shift Agency resources 
from online to offline activities. This analysis estimates such a shift 
will reduce labor expenses by approximately $6.67 million annually, 
Table 22. However, Agency personnel at NSIS establishments will require 
additional training, the annualized cost of which is estimated to be 
approximately $0.30 million. Both of these annualized estimates apply a 
3 percent discount rate over 10 years. 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 and up to 2 FTEs at a 
small market hog establishment. Under NSIS, a single slaughter line at 
a large establishment is expected to require 6 FTEs, while a small 
market hog establishment is expected to require 3 FTEs. Large 
establishments with two slaughter lines are expected to require 10 
FTEs, while a small market hog establishment with 2 slaughter lines is 
expected to require 4 FTEs.

[[Page 4814]]

    This analysis considers likely staffing changes at the 22 large and 
13 small establishments which are expected to convert to NSIS over a 
course of five years. Combined, these establishments operate 46 shifts 
and 55 lines.\64\ 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 22. 
If all 22 large non-HIMP and 13 small high volume market hog only 
establishments convert to the NSIS, the Agency would 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 would have up to 3 FTEs 
assigned to them and each of the 32 shifts at the large establishments 
would 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 would 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 22. This cost estimate 
includes expected grade increases associated with converting to the 
NSIS. As is shown in Table 22, 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 would require 147 fewer FTEs for swine 
slaughter inspection, with an expected 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, Table 22.
---------------------------------------------------------------------------

    \64\ The 22 large establishments operate 41 slaughter lines 
during 32 shifts, while the 13 small establishments operate 14 lines 
during 14 shifts, source PHIS.

                                                      Table 22--Expected Changes in Agency Staffing
                                                                          [M$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Traditional                    Proposed 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
                                                         -----------------------------------------------------------------------------------------------
    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 23 for details. The Agency plans 
to utilize all personnel made available as a result of conversion to 
NSIS to fill these vacant positions.

              Table 23--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
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 
expects to train 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 24. 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 program, 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 ($550,942 for all large establishments and 
$81,697 for all small establishments), Table 24. This one-time cost 
equals approximately $0.07 million if it were annualized over 10 years 
under a 3 percent discount rate, Table 24.

[[Page 4815]]



                                    Table 24--Three Day NSIS Training Course
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                          Cost of trainee                Replacement labor
                                 ----------------------------------------------------------------
                                     Number of                       Number of    Costs of wages
      Type of establishment         inspectors    Costs of wages    replacement    and benefits   Combined costs
                                     requiring     and benefits     inspectors          for
                                     training      for 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
----------------------------------------------------------------------------------------------------------------

Fill an Increase Need for Consumer Safety Inspectors
    As proposed, 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 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 25. Nearly half of this cost stems from 
the need for replacement labor. Again, under the proposed five year 
adoption rate, as set forth in Table 6, and under a 3 percent discount 
rate the annualized costs is approximately $0.23 million, Table 25.

                 Table 25--Cost of Converting a Food Inspector Into a Consumer Safety Inspector
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                                               Labor
               Training component                --------------------------------  Travel, M&IE,  Combined costs
                                                      Trainee       Replacement     and lodging
----------------------------------------------------------------------------------------------------------------
Four Week MI 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
----------------------------------------------------------------------------------------------------------------

Combined Expected Budgetary Impacts
    The Agency's budget is expected to be impacted both by changes to 
personnel and training requirements. First, there will be a reduced 
need for Agency personnel to inspect a slaughter line operating under 
NSIS. If all 22 large and 13 small establishments convert to NSIS over 
the course of five years, the Agency would require approximately 147 
fewer FTEs to inspect the 55 \65\ slaughter lines operating at these 
establishments. The annual remuneration value of these 147 positions is 
roughly $8.73 million, Table 26. Second, the Agency will need to train 
approximately 266 personnel on NSIS methods at a one-time cost of 
approximately $0.64 million, Table 26. 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 26. 
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 26.
---------------------------------------------------------------------------

    \65\ Source: PHIS.

               Table 26--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

[[Page 4816]]

 
        Recurring Cost..................................          (8.73)
        Annualized Costs, Assuming a 3% Discount Rate             (6.38)
         Over 10 Years..................................
        Annualized Costs, Assuming a 7% Discount Rate             (6.09)
         Over 10 Years..................................
------------------------------------------------------------------------

J. Net Benefits

    With the expected impact on the Agency's budget and industry's 
revenue included, and assuming all 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 
$31.77 million a year, annualized over 10 years assuming a 3 percent 
discount rate, Table 27. The majority of the costs are experienced by 
the 35 non-HIMP establishments expected to voluntarily switch to the 
NSIS in the form of increased labor needs.

                                       Table 27--Net Costs and (Benefits)
                                                      [M$]
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                                                                  establishments     One-time        Recurring
----------------------------------------------------------------------------------------------------------------
Costs To Industry...............................................  ..............           $3.88          $22.65
    Voluntary *.................................................           ** 40            0.84           22.17
    Mandatory...................................................             612            3.03            0.48
Health Benefits ***.............................................  ..............  ..............          (9.33)
Industrial Efficiency...........................................  ..............  ..............         (47.33)
Impacts to Agency's Budget......................................  ..............            2.80          (8.73)
----------------------------------------------------------------------------------------------------------------
    Totals:
        One-Time Cost...........................................................................            6.68
        Recurring Cost..........................................................................         (42.75)
        Annualized Costs, Assuming a 3% Discount Rate Over 10 Years.............................         (31.77)
        Annualized Costs, Assuming a 7% Discount Rate Over 10 Years.............................         (30.40)
----------------------------------------------------------------------------------------------------------------
* Further explanation and details on the NSIS adoption rate are provided in section G. Expected Cost of the
  Proposed Rule, Table 6: NSIS Adoption Rate and section J. Net Benefits, Table 28: Quantified Cost and
  (Benefits) of Various Adoption Rates.
** Note, this includes 5 HIMP establishments, which are not expected to incur any cost or benefits associated
  with the NSIS.
*** Further explanation and details on the range of health benefits have been provided in section H. Expected
  Benefits Associated With Public Health, Table 20: Health Benefits from Averted Cases of Salmonella. The value
  of health benefits ranges from $0.19 million to $18.97 million, with a mean of $9.33 million.

    Given the lack of data with which to make cost-benefit comparisons 
across the industry, Table 28 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 would 
not be any additional voluntary costs or benefits associated with these 
5 establishments adopting the NSIS. However, all 612 establishments 
would incur costs associated with the proposed 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 40 establishments 
converting to the NSIS, respectively. Each of these scenarios are net 
beneficial.

                                           Table 28--Quantified Cost and (Benefits) of Various Adoption Rates
                                                                      [M$] [caret]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Costs                                (Benefits)
                                             Number to   --------------------------------------------------------------------------------       Net
                                              Adopt *       Mandatory @        NSIS           Health        Line speeds    Agency budget
--------------------------------------------------------------------------------------------------------------------------------------------------------
A.......................................               5           $0.82            $0.0            $0.0            $0.0            $0.0           $0.82
B.......................................               6            0.82            0.86          (0.27)          (2.04)          (0.38)          (1.00)
C.......................................              23            0.82            8.35          (3.59)         (18.01)          (3.14)         (15.57)
D.......................................              32            0.82           13.09          (5.52)         (27.82)          (4.88)         (24.30)
E.......................................              40            0.82           17.02          (7.09)         (36.14)          (6.38)         (31.77)
--------------------------------------------------------------------------------------------------------------------------------------------------------
* 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.
[caret] Annualized Assuming a 3% Discount Rate Over 10 Years.


[[Page 4817]]

K. Alternatives

                                      Table 29--Alternative Policy Options
----------------------------------------------------------------------------------------------------------------
          Alternatives                   Benefits                  Costs                        Net
----------------------------------------------------------------------------------------------------------------
A. No action (Baseline)........  1. No additional costs   1. Potential for
                                  to industry.             inefficient use of
                                                           agency resources.
                                                          2. No potential
                                                           increase in industrial
                                                           efficiency.
                                                          3. Lack of incentive
                                                           for establishments to
                                                           innovate and improve
                                                           their process controls.
                                                          4. No potential health
                                                           benefits.
B. Mandatory Portion of the      1. In comparison to the  1. In comparison to the  Costs of $0.82M.
 Proposed Rule Only.              baseline, potential      baseline, potential
                                  $0.76M in Process        $1.58M in Other
                                  Control Sampling cost    Industry Costs.
                                  savings.
C. Proposed Rule (40             1. Potential $7.09M in   1. Potential $16.62M     Benefits of $31.77M.
 Establishments Adopt NSIS).      averted illnesses.       Increase in Industry
                                                           Labor Costs.
                                 2. Potential $36.14M in
                                  Industrial Efficiency.
                                 3. Potential $0.76M in   2. Potential $1.97M in
                                  Process Control          Other Industry Costs.
                                  Sampling cost savings.
                                 4. Roughly $6.67M in     3. Roughly $0.30M in
                                  Agency Labor Savings.    Agency Training Costs.
D. Require All 612               1. Potentially more      1. Potential $25.9M      Benefits of $16.83M.
 Establishments Adopt NSIS.       than $7.09M in averted   Increase in Industry
                                  illnesses.               Labor.
                                 2. Potential $36.14M in  2. Potential $3.3M in
                                  Industrial Efficiency.   Other Industry Costs.
                                 3. Potential $0.76M in   3. Roughly $0.68M in
                                  Process Control          Agency Training Costs.
                                  Sampling cost savings.
                                 4. Roughly $2.72M in
                                  Agency Labor Savings.
----------------------------------------------------------------------------------------------------------------

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 NSIS. These 
benefits include the establishment's ability to innovate and develop 
process controls which increase foodborne hazard detection and more 
efficiently use all of their resources. Taking no action would also 
forgo potential industrial efficiency increases. 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 proposed rule.
B--The Mandatory Portion of the Proposed Rule
    FSIS considered limiting the proposed rule to only include the 
mandatory sections. Under such a scenario quantified benefits are 
limited to an estimated $0.76 million reduction in process control 
sampling costs. This cost reduction is expected to be off-set by a 
$1.58 million increase in other industry costs associated with 
requiring written sanitary dressing plans and environmental sampling. 
In comparison to the baseline, this scenario has a net cost of roughly 
$0.82 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 expected $6.67 million. However, 
because FIs will 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 proposed 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 
expected net cost as compared to the baseline as well as the decrease 
in net benefits as compared to the proposed rule.
C--The Proposed Rule
    Applying a 3 percent discount rate over 10 years the costs 
associated with the proposed rule include $16.62 million in additional 
industry labor costs, $1.97 million in other industry costs including 
costs associated with meeting ready to cook standards, written sanitary 
dressing plans, and environmental sampling, and $0.3 million in Agency 
training costs. The quantified health benefits of the proposed 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 is expected to increase their efficiency by $36.14 million, 
assuming a 3 percent discount rate. The proposed rule is also expected 
to reduce industry costs associated with process control sampling by 
roughly $0.76 million, assuming a 3 percent discount rate. 
Additionally, the proposed rule is expected to reduce the Agency's 
labor costs by roughly $6.67 million, assuming a 3 percent discount 
rate. In comparison to the baseline, the proposed rule has an estimated 
net benefit of $31.77 million, assuming a 3 percent discount rate over 
10 years and as such the Agency recommends the proposed rule.

[[Page 4818]]

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 
HIMP, 27 large, and 13 small high volume establishments expected to 
convert under the proposed rule to include 572 additional 
establishments. This expansion would include low volume establishments 
that slaughter all types of swine as well as 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 
$36.14 million increase in industrial efficiency, $0.76 million in 
industrial savings associated with process control sampling 
requirements, and $2.72 million in Agency labor cost savings, assuming 
a 3 percent discount rate over 10 years. 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 proposed 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 proposed 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. While compared to the 
baseline, this alternative reduces Agency labor costs; it would result 
in additional promotions reducing the benefit in comparison to the 
proposed rule.
    In comparison to the baseline, the potential costs associated with 
this alternative include a $25.90 million increase in industrial labor, 
a $3.30 million increase in other industry costs which include costs 
associated with ready to cook standards, written sanitary dressing 
plans, and environmental sampling, and roughly $0.68 million in Agency 
training costs. In comparison to the proposed rule, the additional 
increases in costs to industry predominately fall on small and very 
small business. While this alternative has a net benefit of $16.83 
million, assuming a 3 percent discount rate over 10 years, the Agency 
rejects it because its net benefit is less than the proposed rule.

VII. Regulatory Flexibility Act Assessment

    The FSIS Administrator has made a preliminary determination that 
this proposed rule would 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. At the beginning of section VI is a list of specific 
economic issues that the Agency is seeking comment on. Section VI also 
provides additional details on costs incurred by small businesses.
    The proposed rule's mandatory requirements would 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 plant, applying a 3 
percent discount rate over 10 years. Second, the mandatory proposed 
changes to process control sampling requirements are expected to 
decrease small establishments' sampling costs by roughly $1,296 per 
establishment annually, applying a 3 percent discount rate over 10 
years. In addition to this sampling cost reduction, the Agency would 
allow small and very small establishments to modify their sampling 
plans to collect samples less frequently once they have collected 13 
consecutive weekly samples and have demonstrated that they are 
effectively maintaining process control. FSIS is also proposing to 
allow establishments to develop sampling plans that are more tailored 
to their specific establishment, and thus more effective in monitoring 
their specific process control than the current generic E. coli 
criteria. Third, the mandatory environmental sampling program is 
expected to increase the average small and very small establishments' 
costs by $87 per establishment annually, assuming a 3 percent discount 
rate over ten years. Therefore, the proposed rule's mandatory 
requirements are expected to increase small establishments' costs by 
roughly $660 ($1,869-$1,296 + $87 = $660) per establishment annually, 
an amount that is expected to have little effect on small entities. To 
put this in perspective, the average small and very small establishment 
slaughters over 21 thousand swine annually. Using the American Meat 
Institute's average pork packer dollars per head margins for 2010-2014, 
the average small and very small establishment's marginal revenue is 
$0.09 million (21,858 (heads slaughtered) x $4.10 (average margin per 
head)). Additionally, the voluntary NSIS portion of the rule is 
expected to provide an overall cost savings for the 13 small high 
volume establishments or roughly $87,449 per establishment that adopt 
the NSIS. This estimate takes into consideration the increase in labor 
cost ($43,439 per establishment), cost associated with meeting ready-
to-cook standards ($6,300 per establishments) and cost savings from 
increased industrial efficiency ($137,189 per establishment). See 
section VI for additional details.

Executive Order 13771

    Consistent with E.O. 13771 (82 FR 9339, February 3, 2017), we have 
estimated that this proposed rule would yield cost savings. Assuming a 
7 percent discount rate and a perpetual time horizon and a starting 
year of 2018, the proposed rule would yield approximately $24.97 
million (2016$) in cost savings, not including health benefits. 
Therefore, if finalized as proposed, this rule is expected to be an 
E.O. 13771 deregulatory action.

VIII. 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.

IX. Executive Order 12988, Civil Justice Reform

    This proposed rule has been reviewed under Executive Order 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.

[[Page 4819]]

X. Executive Order 13175

    This rule has been reviewed in accordance with the requirements of 
Executive Order 13175, ``Consultation and Coordination with Indian 
Tribal Governments.'' E.O. 13175 requires Federal agencies to consult 
and coordinate with 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.
    FSIS has assessed the impact of this rule on Indian tribes and 
determined that this rule does not, to our knowledge, have tribal 
implications that require tribal consultation under E.O. 13175. If a 
Tribe requests consultation, FSIS will work with the Office of Tribal 
Relations to ensure meaningful consultation is provided where changes, 
additions and modifications identified herein are not expressly 
mandated by Congress.

XI. 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).

XII. 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 
Environmental Assessment (EA) or an Environmental Impact Statement 
(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 the proposed NSIS are expected to 
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 sales is very small, the 
Agency has determined that the change in the 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.

XIII. Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995, the information collection or recordkeeping requirements 
included in this proposed rule have been submitted for approval to OMB.
    Title: Swine Slaughter Inspection.
    Type of Collection: New.
    Abstract: Under this proposed rule, establishments operating under 
NSIS would have to develop, implement, and maintain in their HACCP 
systems written procedures for the segregation, identification, and 
disposition of animals exhibiting signs of moribundity, central nervous 
system disorders, or pyrexia. In addition, each official swine 
slaughter establishment would need to maintain, as part of its HACCP 
system, written procedures for (1) preventing throughout the entire 
slaughter and dressing operation, contamination of carcasses and parts 
by enteric pathogens, fecal material, ingesta, and milk and (2) 
preventing contamination of the pre-operational environment by enteric 
pathogens. The procedures addressing prevention of contamination by 
enteric pathogens would need to include microbial testing. Furthermore, 
all swine slaughter establishments operating would have to maintain 
records that document that the products resulting from its slaughter 
operations meet the definition of RTC pork products. Each establishment 
operating under the NSIS would also need to submit on an annual basis 
an attestation to the management member of the local FSIS circuit 
safety committee stating that it maintains a program to monitor and 
document any work-related conditions of establishment workers.
    The requirement that 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 proposed rule would create no new 
burden on establishments.
    The proposed requirement that swine slaughter establishments 
monitor their systems through microbial testing and recordkeeping would 
create a new information collection burden. For each sample on which a 
microbiological test is conducted, there are two ``responses'' for the 
establishment: One response for the actual collecting of the sample and 
sending it to the laboratory for analysis, and the other for recording 
the sample result. Under the proposed rule, large establishments would 
test and record microbiological results for enteric pathogens, at both 
pre-evisceration and post-chill, 13 times a day; small high-volume 
establishments, one-time a day; and small low-volume and very small 
establishments, 13 times a year. FSIS estimates that large 
establishments would test and record microbial results for the pre-
operational environment weekly; small establishments, biweekly; small 
low-volume and very small establishments, monthly.
    Estimated Annual Recordkeeping Burden: Swine Slaughter Inspection.

[[Page 4820]]

    Respondents: Official swine establishments.
    Estimated Number of Respondents: 612 (28 large, 51 small high 
volume, 54 small low volume, and 479 very small).
    Estimated Average Annual Number of Responses (samples) per 
Respondent: Large establishments 6,846; small high volume 
establishments 430; and small low volume and very small establishments 
25.
    Estimated Total Annual Responses: 226,558.
    Estimated Total Annual Recordkeeping Burden: 9,440 hours.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          Average annual
                                                                             Estimated       number of     Total annual      Time per      Total annual
                Respondents                                                  number of     responses per     responses      respone in     burden hours
                                                                            respondents     respondent                        minutes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large establishments......................  Microbial testing data                    28           6,846         191,688             2.5           7,987
                                             recordkeeping.
Small high volume establishments..........  Microbial testing data                    49             430          21,070             2.5             878
                                             recordkeeping.
Small low volume establishments...........  Microbial testing data                    54              25           1,350             2.5              56
                                             recordkeeping.
Very small establishments.................  Microbial testing data                   479              25          11,975             2.5             499
                                             recordkeeping.
                                                                         -------------------------------------------------------------------------------
    Total Recordkeeping Burden for process  ............................             612           7,326         226,083  ..............           9,420
     control.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Estimated Annual Reporting Burden: Swine Slaughter Inspection.
    Respondents: Official swine establishments.
    Estimated Number of Respondents: 612 (28 large, 51 small high 
volume, 54 small low volume, and 479 very small).
    Estimated Average Annual Number of Responses per Respondent: Large 
establishments 6,846; small high volume establishments 430; and small 
low volume and very small establishments 25.
    Estimated Total Annual Responses: 226,083.
    Estimated Total Annual Recordkeeping Burden: 47,655 hours.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          Average annual
                                                                             Estimated       number of     Total annual      Time per      Total annual
                Respondents                                                  number of     responses per     responses      respone in     burden hours
                                                                            respondents     respondent                        minutes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large establishments......................  Microbial testing data                    28           6,846         191,688            12.5          39,702
                                             recordkeeping.
Small high volume establishments..........  Microbial testing...........              49             430          21,070            12.5           4,389
Small low volume establishments...........  Microbial testing...........              54              25           1,350              15             338
Very small establishments.................  Microbial testing...........             479              25          11,975              15           2,993
                                                                         -------------------------------------------------------------------------------
Total Reporting Burden....................  ............................             612           7,326         226,083  ..............          47,655
--------------------------------------------------------------------------------------------------------------------------------------------------------

    FSIS is also proposing a new regulation that would create a new 
information collection burden, in that it would require 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. This is 
a new recordkeeping requirement that FSIS has submitted to OMB for 
approval.
    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: 41.
    Estimated Average Annual Number of Responses per Respondent: Large 
establishments 1; small high volume establishments 1.
    Estimated Maximum Total Potential Annual Responses: 41.
    Estimated Total Annual Recordkeeping Burden: 1.37 hours.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          Average annual
                                                                             Estimated       number of     Total annual      Time per      Total annual
                Respondents                                                  number of     responses per     responses      respone in     burden hours
                                                                            respondents     respondent                        minutes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large establishments......................  Attestation on Work-Related               28               1              28               2             .93
                                             Conditions.

[[Page 4821]]

 
Small high volume establishments..........  Attestation on Work-Related               13               1              49               2             .43
                                             Conditions.
                                                                         -------------------------------------------------------------------------------
    Total Reporting Burden................  ............................              41               1              41  ..............            1.37
--------------------------------------------------------------------------------------------------------------------------------------------------------


              Summary of Burden Swine Slaughter Inspection
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Total No. Respondents...................................             612
Average Annual No. Responses per Respondent.............          14,693
Total Annual Responses..................................         453,157
Average Hours per Response..............................            .125
Total Annual Burden Hours...............................       57,216.37
------------------------------------------------------------------------

    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 
methodology and assumptions used; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the information collection on those who are 
to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology.
    Comments may be sent to both Gina Kouba, Office of Policy and 
Program Development, at the address provided above, and the Desk 
Officer for Agriculture, Office of Information and Regulatory Affairs, 
Office of Management and Budget, Washington, DC 20253. To be most 
effective, comments should be sent within 60 days of the publication 
date of this proposed rule. All responses to this notice will be 
summarized and included in the request for OMB approval. All comments 
will also become a matter of public record.

XIV. 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 also will make copies of this publication available through 
the FSIS Constituent Update, which is used to provide information 
regarding FSIS policies, procedures, regulations, Federal Register 
notices, FSIS public meetings, and other types of information that 
could affect or would be of interest to our constituents and 
stakeholders. The Update is 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 to export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves, and have the option to password 
protect their accounts.

XV. Proposed 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 proposing to amend 
9 CFR Chapter III as follows:

PART 301--TERMINOLOGY; ADULTERATION AND MISBRANDING STANDARDS

0
1. The authority citation for part 301 continues 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 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 SOP, or other 
prerequisite program.
    (c) The establishment must identify carcasses of livestock that 
establishment employees have sorted and removed from slaughter or that 
FSIS inspectors have condemned on ante-mortem inspection with a unique 
tag, tattoo, or similar device. The establishment must immediately 
denature all major portions of the carcass on-site and dispose of the 
carcass according to 9 CFR part 314.3.
    (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. These records are subject to review and evaluation by FSIS 
personnel.

[[Page 4822]]

    (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.

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 9 CFR 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 of the regulations 
as provided by 9 CFR 303.1(h). The Administrator also may permit 
establishments that slaughter market hogs and other classes of swine to 
slaughter market hogs under NSIS and slaughter 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).
* * * * *
0
7. Amend Sec.  310.18 by adding paragraphs (c) through (e) to read as 
follows:


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

* * * * *
    (c) Procedures for controlling contamination throughout the 
slaughter and dressing operation. Official swine slaughter 
establishments must develop, implement, and maintain written procedures 
to prevent contamination of carcasses and parts by enteric pathogens, 
fecal, 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 small establishments or very low volume establishments, 
must collect and analyze samples for microbial organisms at the pre-
evisceration and post-chill points in the process. Very small 
establishments and 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, or jowl areas.
    (i) Very small establishments are establishments with fewer than 10 
employees or annual sales of less than $2.5 million.
    (ii) Very low volume establishments annually slaughter no more than 
20,000 swine, or a combination of swine and other livestock not 
exceeding 6,000 cattle and 20,000 total of all livestock.
    (iii) An establishment may substitute alternative sampling 
locations if:
    (A) The establishment has support to demonstrate the alternative 
sampling locations are able to provide a definite improvement in 
monitoring process control than at pre-evisceration and post-chill; and
    (B) FSIS does not determine, and notify the establishment in 
writing, that the alternative sampling locations are inadequate to 
verify the effectiveness of the establishment's process controls for 
enteric pathogens.
    (2) Sampling frequency. Establishments, except for very small and 
very low volume establishments as defined in paragraphs (c)(1)(i) and 
(ii) 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 small and very low volume 
establishments as defined in paragraphs (c)(1)(i) and (ii) 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 small and very low volume establishments as defined in 
paragraph (c)(1)(i) and (ii) of this section must collect and analyze 
samples at least once during each week of operation starting June 1 of 
every year. If, after consecutively collecting 13 weekly samples, very 
small and very low volume establishments can demonstrate that they are 
effectively maintaining process control, they may modify their sampling 
plans.
    (iii) An establishment may substitute an alternative frequency if:
    (A) The alternative is an integral part of the establishment's 
verification procedures for its HACCP plan; and
    (B) FSIS does not determine, and notify the establishment in 
writing, that the alternative frequency is inadequate to verify the 
effectiveness of the establishment's process controls for enteric 
pathogens.
    (iv) Establishments must sample at a frequency that is adequate to 
monitor their ability to maintain process control for enteric 
pathogens. Establishments must maintain accurate records of all test 
results and retain these records as provided in paragraph (e) of this 
section.
    (d) Procedures for controlling contamination in the pre-operational 
environment. Official swine slaughter establishments must develop, 
implement, and maintain written procedures to prevent contamination of 
the pre-operational environment by enteric pathogens. Establishments 
must incorporate these procedures into their HACCP plans, sanitation 
SOPs, or other prerequisite programs. These procedures must include 
sampling and analysis of food contact surfaces in the pre-operational 
environment for microbial organisms to ensure that the surfaces are 
sanitary and free of enteric pathogens and that water used to clean 
food contact surfaces is free of enteric pathogens. The sampling 
frequency must be adequate to monitor the establishment's ability to 
maintain sanitary conditions in the pre-

[[Page 4823]]

operational environment. Establishments must maintain accurate records 
of all test results and retain these records as provided in paragraph 
(e) of this section.
    (e) Recordkeeping requirements. Official swine slaughter 
establishments must maintain daily records sufficient to document the 
implementation and monitoring of the procedures required under 
paragraphs (c), (d) and (e) of this section. Records required by this 
section may be maintained on computers if the establishment implements 
appropriate controls to ensure the integrity of the electronic data. 
Records required by this section must be maintained for at least one 
year and must be accessible to FSIS.
0
8. Amend Sec.  310.25 as follows:
0
a. Remove paragraph (a)(2)(ii)(C);
0
b. Remove the second sentence in paragraph (a)(2)(iii)(A);
0
c. Remove ``20,000 swine,'' in paragraph (a)(2)(v)(A);
0
d. Remove the ``swine'' row in Table 1--Evaluation of E. Coli Test 
Results;
0
e. Remove the ``Hogs'' and ``fresh pork sausages'' rows and footnote 
(b) from Table 2--Salmonella Performance Standards.
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. If the establishment has less than 
three inspection stations, 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. The 
establishment must develop, implement, and maintain written procedures 
to ensure that market hog carcasses contaminated 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 SOP, or 
other prerequisite program. These procedures must cover establishment 
sorting activities required under this section.
    (c) Line speed limits. The line speed limits in 9 CFR 310.1 do not 
apply to the establishment, provided that they are able to maintain 
effective process control and prevent contamination of carcasses and 
parts by fecal material and enteric pathogens. Establishments operating 
under 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 the products resulting from its slaughter operation meet 
the definition of ready-to-cook pork product in 9 CFR 301.2. These 
records are subject to review and evaluation by FSIS personnel.
    (2) The establishment must maintain records to document the number 
of animals disposed of per day by plant sorters or condemned per day by 
FSIS inspectors upon post-mortem inspection. 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 New Swine Slaughter 
Inspection System (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 9 
CFR 310.27 to be invalid, such action will not affect any other 
provision of 9 CFR parts 309 or 310.

    Done in Washington, DC, on January 19, 2018.
Paul Kiecker,
Acting Administrator.
[FR Doc. 2018-01256 Filed 1-31-18; 8:45 am]
 BILLING CODE 3410-DM-P