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3 The Proposed SIS Rule slaughtering plants inspected by USDN Abstract The proposed SIS-C rule applies to plants in which only heifers and steers are slaughtered. Thus, it is applicable to approximately 80 of about 1,300 cattle ~ ~ ~~ - SIS-C involves an important change in pn~(Jpny wnere~y ~nuustIy assumes Auks responsibility for meat quality, permitting FSIS to concentrate on safety. By assuming the full costs and responsibility for quality, industry will have an economic incentive to enforce quality controls and correct manufacturing processes causing defects. The proposed rule describes new and streamlined postmortem procedures; uniform presentation standards for viscera and body parts; specific equipment, facilities, and inspection space requirements; and carcass and edible by-product finished product standards. To verify that product standards are being met by plant processing personnel, SIS-C plants with chain speeds exceeding 275 head per hour must employ quality control personnel to implement an FSIS-approved and monitored partial quality control (PQC) program (SIS-C/PQC) in which a statistical procedure known as cumulative sum (CUSUM) is used to evaluate wholesomeness and acceptability of products throughout a work shift and over longer periods. The committee examined various FSIS documents (Appendix B) supporting the proposed rule (AppendLx A) and assessed the impact of SIS-C on consumers, inspectors, and packers. The committee recommends that desired final product characteristics, not meat inspection as traditionally being done, should be the standard against which inspection systems or new technologies are judged. The scientific basis for traditional, SIS-C, and SIS-C/PQC meat inspection was found to be inadequate. The committee concluded that when quality control programs are effectively implemented, SIS-C/PQC is acceptable as an alternative to traditional inspection. The committee recommends that SIS-C without a PQC program should be an interim process lasting no more than 1 year. Strong concerns about SIS-C held by a number of FSIS inspectors led the committee to recommend that FSIS pay more attention to employee communication and education. Rationale and Assumptions of the Ruling The proposed rule defining the Streamlined Inspection System-CattIe and Staffing Standards (Fed. Regist., 1988; Appendrx A) details procedures, definitions, and numerical standards that could bewilder those not experienced with the meat packing industry. They include topics such as the candlepower of lighting, the size of mirrors, the diameter of stains, and whether organs should be observed and palpated, or merely observed. These details obscure the most important issue--the shift of responsibility for quality from FSTS to industry. For S S-C to work in practice, both FSIS and industry must fully subscribe to this new philosophy, which is the most important change in bovine 16

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meat inspection since 1906. Traditional meat inspection has placed FSIS and industry in an unsatisfactory relationship in which packers without total commitment to quality control throughout the slaughter and dressing processes expect FSIS inspectors to detect and deal with quality problems before the carcass leaves the slaughter floor. Traditionally, FSIS inspectors, who must ensure that only wholesome products enter commerce, spend 70 to 90% of their time identifying and dealing with dressing nonconformances and designated trimmable conditions2 that are obvious and easily identified. Some have little or no implication for public health. These defects can be corrected by packing plant employees. If industry had to assume the full costs and responsibility for dressing operations, it would have economic incentive to adopt effective quality controls and to correct manufacturing procedures that permit defects. S]S-C creates a new relationship between FSTS and industry. This partnership, with shared responsibility, permits FSTS inspectors to concentrate on pathologic lesions. It makes industry take active steps to prevent problems by identifying and resolving those points in the slaughter and dressing processes at which carcass contamination or dressing defects occur. Slaughter and dressing must be performed in a sanitary manner but can never be sterile operations. The procedures, machinery, and technology involved are intricate and must be seen to be understood. The carcass can be contaminated by contact with ingesta, feces, mud balls, equipment, and people. It would be safer for public health if contamination could be prevented rather than detected and lammed away afterward. Carcasses that are cleaner during and after dressing are less likely to have extensive (and invisibles surface bacterial contamination that can worsen during processing before the product reaches the consumer. SIS-C seeks to involve every plant worker, not just the federal inspectors, in prevention programs. An Overview and Commentary on STS-C and the Slaughter PQC Program Antemortem inspection and slaughter are identical in SIS-C and traditional systems. Postmortem inspection under SIS-C has three elements that differ from traditional systems: diminished postmortem inspection, uniform presentation of carcass and parts, and additional specific equipment and facility requirements (Table 3-1~. After postmortem inspection by FSTS inspectors, the carcass and edible by-products are Dressing nonconformances are defects on the carcass that result from errors in the handling, slaughtering, or dressing operations performed by establishment employees. These include bruises, hair, dirt, ingesta, feces, organ remnants, and machine grease. Designated trimmable conditions are abnormal conditions that are not caused by improper procedures, that are readily identifiable, and that do not affect the disposition of the carcass. These include fractures, arthritis, localized abscesses, and pigmentation. 17

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Table 3-! An Overview of the SIS-C/PQC Program Plant Quality Control Staff PQC Program Requirements: Approved by FSIS Compulsory if slaughtering > 275 head/hr Voluntary if < 275 header Principal Components of PQC Program: . Identification of critical control points (CCPs) in slaughter and dressing Development of standards at each CCP Specification of actions to be taken if CCP standards are not met Responsibilities of Plant Employees in PQC Program: Randomly sample head, tongue, carcass, and edible by-products; measure compliance with product standards Inform production supervisor of any process trends Plant Production Staff and FSIS Inspectorate Fed steers and heifers only (healthiest segment of population) Antemortem inspection (FSIS) Slaughter SIS-C Postmortem Inspection (FSIS) (Every carcass, every head, and every set of viscera) Streamlined postmortem procedures: . head . viscera . carcass Uniform presentation standards: head, tongue, viscera, carcass (scored under PQC in SIS-C/PQC plants) Specific equipment, facilities, and inspection space Dressing nonconformances and designated trimmable conditions removed by establishment employees Carcass produced to specific 'finished product standards' Edible by-products produced to specific 'edible by- product standards' Reinspection of carcasses at random by FSIS inspector, who also monitors establishment QC tests of compliance with product standards Process in control: plant producing product that meets standards over time Process out of control: plant producing product that does not meet standards. Establishment takes corrective action under inspector . . supervision 18

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examined by plant employees and all dressing nonconformances and designated trimmable conditions are removed. The goal of these procedures is to produce wholesome carcasses and edible by-products, according to specific product standards. To verify that product standards are being met, some SIS-C plants employ quality control personnel to implement a PQC program. These people randomly sample heads, tongues, carcasses, and edible by-products from the slaughter line and measure compliance with product standards by a statistical procedure known as CUSUM (see Chapter 4), which is monitored by the inspector. The goal is to evaluate the wholesomeness and acceptability of the products using these standards. Final oversight of product standards is provided by FSIS inspectors, who independently sample heads, tongues, and carcasses; measure their compliance with product standards; and compare their results with the plant's records. The frequency and nature of sampling, tests performed, standards, means of comparison, and definitions of terms are described in detail in the proposed rule (Fed. Regist., 1988~. The FSIS inspector must determine if slaughter and packing processes are "in control" (i.e., that the products meet or exceed standards). If it is "out of control," the establishment must take immediate corrective action under supervision of the inspector. Under SIS-C, packing plants slaughtering more than 275 cattle per hour must have an approved PQC program. For those with slower line speeds, the PQC program is optional. In plants without PQC, the FSIS inspector oversees product standard compliance by using the same procedures included in operations with a quality control program (Figure 3-1). SIS-C Postmortem Inspection Under SIS-C, as in traditional inspection, FSTS inspectors inspect every carcass, every head, and every set of viscera. FSIS insists that this will not change, since the law mandates 100% inspection. Streamlined Inspection Procedures 3-2). STS-C differs from traditional inspection in the following details (see also Table Ce~vical/head inspection Under SIS-C, the lateral retropharyngeal lymph nodes are not incised; the inspector observes but does not cut the masticatory muscles, which have been incised by a plant employee; and a plant employee, not the inspector, palpates the tongue. The inspector takes action when a palpable tongue abnormality is identified by the plant employee. Heads must be presented by the plant employees in a specified uniform manner to ensure timely and consistent inspection. 9 11

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WHOLE ANIMAL: SOURCES OF CONTAMINATION Hide - dirt, manure, moisture Internal - abscess, disease, sepsis _ 1 -` . ~ PLANT PROCESS CONTROL FEDERAL MEAT INSPECTION: _ Organoleptically detects lesions, Controls manufacturing defects then makes disposition based l l on health of the animal J Evaluate// Finished product standards PLANT QUALITY CONTROL: Quality control monitoring / / Figure 3-! Interactions Between Plant Process Control Operations and Plant Quality Control and Federal Meat Inspection Staff FSIS presented data to the committee to support its view that these changes in cervical/head inspection do not permit lesions of diseases to pass undetected or alter carcass disposition (Wesson, 1983). Some inspectors who spoke to members of the committee on site visits disagreed (see Appendix E). 20

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Table 3-2 SIS-C and Traditional Postmortem Inspection Proceduresa SIS-C Traditional Head Inspection Observe leading side and surfaces of head, eye, and incised leading lateral and medial muscles of mastication. Incise and observe leading parotid lymph node. Observe trailing incised medial and lateral muscles of mastication. Incise and observe trailing parotid lymph node. Incise and observe lymph nodes attached to the tongue--medial retropharyngeal (suprapharyngeal) and mandibular. Observe tongue and lateral retropharyngeal (atlantal) lymph nodes. Viscera/Carcass Inspection Head Inspection Incise lymph nodes attached to the tongue-- medial retropharyngeal (suprapharyngeal), lateral retropharyngeal (atlantal), and mandibular. Observe and palpate tongue. Observe surfaces of head and the eyes. Incise and observe parotid lymph nodes and lateral and medial muscles of mastication. Viscera Inspection Observe outer surfaces of eviscerated carcass (including dorsal surface) with the use of the mirror and observe the superficial inguinal (supramammary) and internal iliac lymph nodes. Observe pelvic and peritoneal cavities, kidneys, and the diaphragm. Observe pleural cavity and cut surfaces of muscles and bone. Observe mesenteric lymph nodes and abdominal viscera. Observe ruminoreticular junction. Observe esophagus and spleen. Incise and observe lung's lymph nodes- mediastinal (posterior, middle, anterior) and left tracheobronchial. Observe and palpate costar surfaces of lungs. Observe inner, cut, and outer surfaces of heart. Observe hepatic (portal) lymph nodes. Carcass Inspection Open bile duct (both directions), and observe its contents. Observe and palpate ventral surface of liver. Turn liver over, palpate renal impression; observe and palpate parietal (dorsal) surface. Observe eviscerated carcass. Observe mesenteric lymph nodes and abdominal viscera. Observe and palpate ruminoreticular junction. Observe esophagus and surface of spleen. Incise and observe lymph nodes of the lungs mediastinal (posterior, middle, anterior) and bronchial (right and left). Observe and palpate costar (curved) surfaces of lungs. Incise heart, from base to apex or vice versa, through interventricular septum, and observe cut and inner surfaces. Turn lung over; observe ventral (flat) surfaces and outer surface of heart. Incise and observe hepatic (portal) lymph nodes. Open bile duct (both directions) and observe its contents. Observe and palpate ventral surface of liver. Turn liver over, palpate renal impression, and observe and palpate parietal (dorsal) surface. Palpate and observe superficial inguinal (supramammary) and internal iliac lymph nodes. Observe lumbar region. Observe and palpate kidneys. Observe pillars of diaphragm and peritoneum. Observe pleura, cut surfaces of muscles, and bones, neck, and carcass exterior. a Source: FSIS, l989b. 21

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Viscera and carcass inspection Under SIS-C, unlike traditional inspection, inspection of viscera and carcasses takes place simultaneously, facilitating identification of corresponding parts and organs. Because of time constraints, it is important that plant personnel present the viscera in a specified manner (see section on Uniform Presentation Standards, below). As shown in Table 3-2, SIS-C differs from traditional inspection of viscera and carcasses in several ways. In SIS-C, the ruminoreticular junction (common site for abscesses) is not palpated; plant employees cut the heart muscle (inspector observes); various organs/lymph nodes are no longer palpated or incised; and the inspectors do not observe the split vertebral column and surrounding tissues, since the carcass is split further along the rail (beyond the viscera/carcass inspection station). These differences are a major source of discontent among inspectors. Under traditional inspection, FSTS inspectors viewed the interior and exterior of both sides of the eviscerated and split carcass and had an unobstructed view of the kidneys and diaphragm. Under STS-C, the last FSIS inspectors in the line are posted at the carcass- viscera station, where they examine viscera presented on a moving belt on one side, observe the inside of the corresponding whole (i.e., unsplit) eviscerated carcass as it passes by on a chain on the other side, and examine the back of the carcass for dirt or blemishes through a mirror. Except for randomly sampled split carcasses, this is the last time the inspectors view the carcass before it is washed and sent into the cooler. Under S1:S-C, in plants slaughtering fewer than 234 head per hour, a plant employee removes the kidneys for presentation with the viscera at the viscera/carcass station. At higher slaughter rates, kidneys are examined in the unsplit carcass. After carcasses pass the viscera-carcass station, plant employees trim dirt, stains, hair, and other blemishes from them. Under STS-C, there are no inspectors to ensure that trimming has been done correctly before the carcass is split and washed. This is the responsibility of the plant's certified trimmers. Their work is checked by plant quality control staff. Federal inspectors monitor the final products according to finished product standards and check that quality control is being performed as specified in Figure 3-~. Critics of SIS-C contend that inspectors should view the split vertebral column to detect discolorations, spinal abscesses, and other blemishes: this would require an additional inspector to be situated on the line after the carcass is split. FSTS management disagrees with the need for an inspector and believes that company trimmers can recognize and deal with any dressing nonconformances and designated trimmable conditions discovered on splitting. FSIS presented data to support its view that these procedural changes in viscera/carcass inspection do not permit lesions of diseases to pass undetected or alter carcass disposition (Wesson, 1983~. However, most inspectors interviewed by the committee and those who testified at the public hearing disagreed with the FSIS 22

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position. Uniform Presentation Standards Work-measurement studies were conducted by FSIS to determine the times needed for organoleptic SIS-C procedures. More inspectors are added when chain speeds are increased. Careful, consistent, and uniform presentation of heads, tongues, and viscera is important so that inspectors can spend their time examining for disease rather than sorting through haphazardly distributed organs on a moving belt. The consistency with which organs are presented for inspection is monitored under the SIS- C program. Certain procedures previously performed by FSIS inspectors are the responsibility of establishment personnel under STS-C, and the time formerly spent in performing these steps is used to inspect for lesions. The important aspects of presentation standards are: 0 palpating the tongue o incising masticatory muscles o opening heart chambers and incising the interventricular septum 0 positioning organs for ease and consistency of inspection Some inspectors claim their ability to detect eosinophilic myositis and cysts (the larval stage of the beef tapeworm) is compromised when cutting of heart and cheek muscles is delegated to plant employees. This opinion is based on the premise that the fee] of the inspector's knife passing through these lesions helps them recognize their presence and provides an opportunity to view the cut surfaces immediately before they are covered by seeping blood. Specific Equipments and Facilities FSIS specifies facility and equipment requirements for SIS-C. These include a special mirror positioned so that inspectors can view the back of the carcass as it passes while looking into the opened front of the carcass at kidneys and serosal surfaces. Lighting standards for each inspection station are also specified. The committee heard testimony that mirrors become covered with condensed moisture and do not always present an unobstructed view of disease conditions or dirt on the back of the carcass. Other testimony refuted this contention. The committee found the mirrors to be satisfactory for observing the backs of the carcasses in the SIS-C plants it visited; however, one inspector observed did not appear to be watching the mirror consistently. Carcass Dressing Requirements Plant production employees (as distinct from quality control employees) are 23

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responsible for removing dressing nonconformances and other designated trimmable conditions. They must adhere to finished product standards for carcasses and edible by-product standards. In STS-C plants, FSIS inspectors monitor compliance with the standards and take corrective action if the establishment has failed to apply the standards. There is, therefore, a two-tier system for quality control--production staff and FSTS inspectors. This approach was suggested in a previous Food and Nutrition Board report (NRC, 19SSa). In SIS-C/POC plants. there is a third tier--a Dlant oualitv control (OC) arouD- . _ ~ , ~ ~ ~ ~ - ~ ~ ~ that reports through a supervisor to the plant manager in a chain of command independent from that of the production staff. The actual independence of PQC staff has been questioned by critics of SIS-C/PQC, especially FSIS inspectors who allege that some plant QC employees are urged by management to neglect details that may slow the process. This QC group monitors the production process continually, performs random sampling to at least the minimal frequency stipulated in the proposed rule published in the Federal Register (Appendix A), and uses the finished product standards and CUSUM to measure process control. FSTS inspectors evaluate the ability of the company's production personnel to control the process by: o checking timeliness and accuracy of records o performing sample tests to correlate with plant QC's findings o checking presentation standards 0 applying product standards to the carcass, head, and edible by-products o performing CUSUM calculations Under both STS-C and SIS-C/PQC, FSIS veterinarians and inspectors are responsible for determining if the carcass and parts are wholesome before entering commerce. However, concern was expressed that FSIS can lose control of the final product once it has passed the final inspection (carcass-viscera) station. Assessing the Wholesomeness of the Carcass and Product A beef carcass reinspection program known as Acceptable Quality reeve! (AQUA) has been used in traditionally inspected plants for many years. In this program, carcasses are examined for wholesomeness, cleanliness, and acceptability, but the level of process control is not evaluated (see Chapter 4~. FSIS has developed a system in which CUSUM is used to continually monitor the entire slaughter and dressing process. Through it, FSIS and plant employees can learn whether the process is in control, out of control, improving, or deteriorating. The method for calculation of CUSUM, the definitions of all terms, and the details of all standards are set out in the Federal Register (Appendix A) and are discussed in Chapter 4. Sample size and sampling frequency as given in the Federal Register are shown in 24

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Table 3-3. Table 3-3 Size and Frequency of Sampling by Plant QC Personnel and FSIS Tnspectorsa Size of Sample Sampling Frequency By Plant QC Personnel By FSTS Inspectors Three half carcasses Once an hour Twice every ~ hours Five tongues Once an hour Twice every ~ hours Five heads Once an hour Twice every ~ hours Ten units of each edible Once every At least once every by-product 2 hoursa ~ hours aVariable by inspector. FSIS developed finished product standards to measure wholesomeness and acceptability, e.g., cleanliness. These standards define limits of conformance that products must meet to avoid the risk of having to rework, the product. They are applied after the carcass has been inspected for disease. They are not aimed at detecting public health problems or diseases missed during inspection. The limits represent the national average of products qualifying for designation as "U.S. Inspected and Passed" in all plants slaughtering all classes of cattle. Plant QC personnel and FSTS inspectors independently determine the total number of nonconformances for each subgroup, reduce this number to a CUSUM value, and measure this against predetermined standards (see Appendix A). When plants maintain process control at or below tolerances, final products should be within the limits of acceptability. Products that do not meet the acceptable standard indicate that there is a deficiency somewhere in the slaughter or dressing process. CUSUM calculations and finished product standards should alert the plant 3Rework is reprocessing the product to correct the condition or conditions causing the nonconformances. For carcasses, this usually means trimming to remove dressing non-conformances and designated trimmable conditions. 4Tolerance identifies a limit above which the product is deemed to be unacceptable. 25

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and FSIS inspectors to problem areas in the system. Because finished product standards are used to monitor the process, potential or emerging problems can be identified promptly provided the standards are appropriate. Test results over time can be used to define trends. If the production is not in control, certain specific actions are required. For example: o The line must slow by 10% to correct presentation problems (plant takes action). O Product/carcasses and by-products are held for rework if finished product standards are not met. The plant takes action. O FSIS inspectors have authority to increase sampling rates in trouble areas and to require that the operation temporarily slow or stop until problems are corrected. FSIS data comparing AQL scores under traditional inspection with SIS-C CUSUM scores in the same plant over time show that improvement in product cleanliness correlated with introduction of SIS-C (FSIS, 1989b; see also Appends B). However, correlation does not prove that SIS-C caused the improvement (see Chapter 4~. FSIS Data in Support of the Proposed Ruling FSIS presented the following documents to the committee in support of the proposed rule: o "A Study on the New Cattle Post-Mortem Inspection Procedure for Steers and Heifers" (Wesson, 1983~. In this study it was concluded that the new cattle postmortem inspection procedure was as effective as the traditional procedure in all areas except liver inspection. The new procedure proved more effective in identifying visible liver defects under the conditions of the test. Work-measurement studies showed that the new procedure will result in increased inspection productivity. The Wesson study involved a comparison of traditional and new inspection procedures at four steer/heifer slaughter plants with line speeds of 320, 225, 185, and 95 cattle per hour. Data from two other plants, in which cows and bulls were slaughtered, were omitted from the report. This omission was criticized by a witness at the public hearing. FSTS justified this omission because SIS-C is intended only for plants that slaughter steers and heifers. 0 "Development of Finished Product Standards for the SIS-C Inspection Procedure" (FSIS, 1989~. 26

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This manuscript described how FSTS develops finished product standards. O "Results of Finished Product Standards Test for STS-C Pilot Plants" (see Appendix B). This report charted the results of finished product standards test results for the SIS-C pilot plants. Data for the earliest month were compared with the corresponding month ~ year later and were graphed in comparison to the national average of carcass acceptability (tolerance). Four plants produced products well below tolerance. In one plant, the process was not controlled and corrective action was required. O "Comparison of Carcass Cleanliness Using Traditional and Streamlined Inspection Procedures" (see Appendix B). Carcass cleanliness was compared in a plant that switched from traditional inspection with AQL to STS-CattIe with finished product standards. Carcasses were scored with AQL under both systems of inspection. Product cleanliness improved after srs-c was introduced (see Chapter 4~. O "Slaughter and Condemnation Data for Steers and Heifers" (see Appendix B). Analysis of 1985- 1989 data from the FSIS Animal Disease Reporting System (ADRS) indicated no discernible difference in condemnation rates or causes of condemnation between STS-C procedures and traditional inspection, nor were there differences in the rates of carcasses passed with restrictions. However, the rate of condemnation in the five pilot plants increased after conversion to STS-C. The primary goal of inspection is to make decisions on the disposition of carcasses--not specific etiologic or morphologic diagnoses. Thus, condemnation data provided by FSIS reveal little about the public health merits of inspection. Diseases of public health importance that can be detected organoleptically at slaughter, such as cysticercosis and tuberculosis, are very rare (e.g., approximately three diagnosed cases of tuberculosis on average are found within each million animals slaughtered) and are detected with equal frequency under SIS-C and traditional systems (data provided by FSIS, see Appendrx B). Consumers Impact of SIS-C on Consumers, Inspectors, and Plants Although SIS-C is not directed primarily toward human health risks, it should have no adverse effect on the health of consumers of meat and edible by-products. Conditions of public health importance that are missed under SIS-C inspection are likely to be missed under traditional inspection as well. 27

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A consumer dissatisfied with a purchased product can seek redress from the supplier or not buy the product again. It is impossible, however, given the structure of the meat industry, for a customer unhappy about cleanliness of meat purchased from a supermarket to influence the practices of the packing plant from which that product came. The only purchasers potentially able to influence plants are the large fast-food and supermarket chains. Many of these have their own quality control procedures to assess the cleanliness and microbial burden of products. The committee asked FSIS if it had any evidence that the major chains used their own quality control data to choose suppliers; however, FSIS did not have this information. Inspectors FSTS inspectors and veterinarians have the frontline positions in safeguarding the acceptability of the nation's meat supply. If unwholesome or contaminated meat passes by them, the bacterial load could increase and contaminate other products as it passes into the chain of transport, storage, handling, and preparation to the ultimate consumer. FSIS staff in the field take their responsibilities very seriously; the committee was impressed by their sincerity and conscientiousness. The introduction and evaluation of SIS-C were complicated by unrelated and controversial issues, such as increased chain speeds, union-employer relations in the packing industry, working conditions, occupational safety (especially repetitive motion injuries), job security, and job stature. These issues obscured the essence of SIS-C-- that advancing technology and increasing public expectation necessitate a major overhaul of the philosophy, concepts, and details of the meat inspection system. This change (SIS-C) has caused conflict within FSIS that could have been avoided by better communication, training, and appreciation of the concerns of field inspectors about basic concepts of STS-C. For 80 years, FSIS has done an excellent job of training inspectors and developing a culture of responsibility for decisions on carcass disposition and standards of dressing and fabricating final product. Suddenly, with the introduction of SIS-C, inspectors were told that decisions they once controlled had been assigned to plant emniovees who are not trained in meat inspection. Under SIS. inspectors lost the ~ ~ A J .1 . . . ~ - ~ - - - opportunity to check the work ot plant employees in the reinspection process. Whatever the statistical merits may be, FSIS inspectors do not accept the agency position that reinspecting only 6 of between 4,000 and 6,000 sides of beef from an S- hour shift is adequate. Moreover, inspectors do not support the agency view that most microbial and chemical residue samples are generally taken to provide data for proactive intervention to prevent disease rather than for retrospective analysis. There are no substitutes for good data and solid scientific facts in developing and testing new rules and regulations. FSIS has compiled some data to persuade its own management of the merits of SIS-C and has presented arguments to convince them that change is appropriate. However, enthusiasm for SIS-C was not successfully 28

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communicated to many long-term field employees of the agency. It is clear that fewer FSIS inspectors are being used to staff plants under STS-C and SIS-C/PQC. FSIS could have used surplus inspectors to validate finished product standards, to study the frequency and numbers of reinspections needed, and to improve surveillance for microbial and chemical contaminants in SIS-C plants. These steps might have alleviated anxieties among rank-and-file meat inspectors worried about product quality. More inspectors could have been trained in SIS-C. Instead of aiming for a new inspection procedure on a par with the traditional, FSIS could have implemented an SIS-C program that incorporated the underlying philosophy of the earlier Food and Nutrition Board studies (NRC 19SSa, 1987a) and made clear technological advances. The committee believes the planning of such a program should begin with the decision that traditional inspection should no longer be the standard by which other systems are judged and that it is more rational to evaluate systems based on the desired characteristics of the final product. Plant Managers and Employees Managers and workers in STS-C plants have an important new role to play in ensuring product quality. This must be understood by all workers and inspectors--not just managers, quality control personnel, and certified trimmers. SIS-C plants are food processing plants--not meat packers or slaughterhouses. The committee heard much testimony about the characteristics of jobs in packing plants. These jobs are not viewed as being very attractive, and turnover is high. Many workers are recent immigrants with poor English language skills and come from countries with low standards of hygiene and food handling. Thus, FSIS and industry must establish training standards and a certification program for all plant employees involved in the slaughter, dressing, and handling of meat products. FSIS must also establish better employee training and retraining programs in STS-C/PQC concepts and other planned innovations so that all workers and managers are committed to the goals, concepts, and standards of new inspection programs. Conclusions and Recommendations o Traditional meat inspection, relying on organoleptic detection methods, can ensure satisfactory meat product quality but is not fully effective in protecting the public against contemporary foodborne health hazards, such as microorganisms, hormones, and residues of toxic chemicals and heavy metals. Therefore, traditional meat inspection should not be used as the gold standard against which inspection systems or new technologies are judged. o The desired characteristics of the final product should be the starting point for design and evaluation of inspection systems. For meat, desirable final product characteristics include, but are not limited to, the following: 29

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Aesthetically pleasingS (free from dirt, hair, bruises, grease, mud, ingesta, feces). Free from visible lesionsS (tumors, cysts, hemorrhages, inflammation, or other evidence of disease or injury). Have good keeping qualityS (low population of spoilage microorganisms). Low levels of bacterial pathogens and other infectious agents that can cause disease in humans. Hormones, antibiotics, toxins, pesticides, heavy metals, and other toxic substances, at or below established safe levels for humans. These desired characteristics of meat products relate to both safety and quality, which are not mutually exclusive because quality procedures can affect microbial burdens and thus indirectly influence safety. However, total emphasis on quality only obliquely addresses the crucial safety issues of preventing microbial and chemical contamination. The distinction between quality and safety is as follows: safer relates to the presence of pathogenic microorganisms or levels of chemical residues; quality concerns aesthetically pleasing appearance, absence of visible lesions, and good keeping characteristics through low levels of spoilage-causing microorganisms. All possible efforts should be made to minimize contamination of meats and to remove contaminated products from the food chain. Now, and for the foreseeable future, it is not possible to ensure that all raw meat products are totally free of microbial pathogens that can cause disease in humans. Inevitably, some portion of the meat supply will be contaminated with some detectable level of one or more pathogens. Ideally, it is hoped that contamination can be kept below established safe thresholds. However, as outlined in previous Food and Nutrition Board reports (NRC, 19SSa, 1987a), such thresholds are difficult to estimate because microbial populations can multiply rapidly and because human susceptibility to different diseases is highly variable. The best that can be done is to assess how closely inspection systems approach the ideal, if unattainable, goal of total freedom from microbial pathogens. Both traditional meat inspection and STS-C focus largely on visible lesions. Both systems partly address the microbial loads that determine keeping characteristics and sThese characteristics constitute quality. They are desirable but have no primary effect on human health. Meat quality also includes color, texture, tenderness, juiciness, marbling, and other desirable characteristics not considered in the report (see Appendix G). 30

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levels of pathogenic microorganisms by monitoring plant hygiene and refrigeration and by trimming carcasses visibly contaminated with feces, dirt, or hair. Except for occasional sampling, sporadic tracebacks, and voluntary residue avoidance programs, neither system addresses chemical residues. The major difference between the systems is that FSIS inspectors enforce efforts to control visible contamination under traditional systems, whereas in SIS-C, much of this responsibility is delegated to plant employees. In STS-C/PQC, both aesthetic appearance and freedom from visible lesions are addressed. Through increased hygiene and emphasis on an effective PQC program, SIS-C/PQC may reduce contamination with spoilage or pathogenic microorganisms. Thus, SIS-C/PQC is potentially superior to SIS-C and traditional inspection. In the absence of total quality commitment from industry, SIS-C alone (i.e., without PQC) is probably no better than traditional inspection and in some situations, can be less effective than traditional inspection because the reduced oversight by government inspectors is not compensated by a total commitment to product quality on the part of industry. o The beef packing industry should aggressively adopt improved quality control measures. In SIS-C, FSIS expects industry quality control personnel to prevent problems by identifying and correcting slaughter and dressing procedures during which carcass contamination or dressing defects occur. The committee found that some members of the meat packing industry had indeed taken such steps, for example, by improving employee hygiene (through training and increased use of rubber gloves, hair nets, aprons, and washing stations) and by wrapping hindquarters to prevent fecal smearing of carcasses during hide removal. These procedures, and others identified by frequent product and process evaluation during slaughter and dressing, help reduce microbial contamination. The committee found that some plants have exceeded FSIS expectations for SIS- C/PQC by implementing a comprehensive HACCP system (see Chapter 2) covering the desirable characteristics of meat products, including chemical residue analyses of feecistuffs and water, controls on the use of microbials and pharmaceuticals in feedlots, and rapid microbiological testing of a representative number of carcasses every day. Unfortunately, industry quality and safety data are not in the public record, nor has FSIS conducted independent studies to verify and quantity reported reductions in chemical and microbial contamination. O Inspection programs have the following limitations: By definition, traditional meat inspection can only ensure aesthetically pleasing appearance and freedom from visible lesions. STS-C also includes only aesthetically pleasing appearance and freedom from visible lesions. The difference between traditional meat inspection and SIS-C lies only in the persons responsible for the quality of the product. 31

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SIS-C/PQC is targeted to aesthetically pleasing appearance and freedom from visible lesions and, by enhanced attention to basic principles of hygiene, also can improve keeping quality and minimize contamination by microbial pathogens. Although not ideal, SIS-C/PQC appears better able than SIS-C or traditional inspection to meet the characteristics of an effective inspection program. Moreover, it is the only system of the three that can be readily extended (and has been extended by industry) to detect and reduce contamination or to become part of a full-fledged HACCP program that addresses all the desirable characteristics of products in a comprehensive prevention program rather than as a result of after-the-fact detection efforts. Although in-plant HACCP programs cannot decrease intestinal colonization of live cattle by microorganisms, such as Salmonella, which are pathogenic in humans, they can minimize public risk by decreasing the degree to which carcasses are contaminated with intestinal contents and exogenous fecal debris. STS-C alone, i.e., WIthOUt amp, Should be used only as a temporal transition phase no longer than ~ year as the plants move from traditional inspection to SIS-C~QC, because there is no logical basis for making PQC optional for plants operating at slow speeds, as suggested by FSIS. In this l-year SIS-C transition period, the following must be achieved: _% ~ _ Management and employees of both FSIS and the plant must learn to understand and share the goals of the plant PQC program. Plant personnel must be monitored closely by FSIS to ensure that the PQC program is strictly implemented as designed. Objective, easily understandable, and statistically analyzable data on finished product standards in the plant must be presented to inspectors to assure them that the system works and that plant employees are capable of implementing it. o SIS-C alone, i.e., without PQC, should not be used beyond the transition period because it includes less government oversight. 0 The scientific bases of traditional meat inspection, SIS-C, and SIS-C~QC are inadequate or nonexistent. However? FSIS now has access to data from its own studies and the experiences of the five pilot SIS-C plants, including chemical and heavy metal analysis, to design an improved system of inspection based on the proposed rule. o FSIS should regularly publish data in the scientific literature so that its work and conclusions can be scrutinized by peers and other experts outside the agency. The Wesson Study, for example, could have been submitted for publication in 32

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peer-reviewed scientific literature instead of being published as an agency monograph without extramural review. o o o SIS-C and SIS-C/PQC are restricted to fed steers and heifers--the healthiest portion of the cattle population. Traditional inspection will continue to be used for cull dairy cows and veal calves, which present the greatest risks from microbial and chemical contamination, even though this system is not able to protect consumers from these factors. FSIS should enhance its inspection procedures and microbial/chemical analyses in the traditional system and establish compulsory finished product standards to ensure that animals other than steers and heifers will yield products with characteristics as close as possible to those described above. FSIS should tailor its inspection and analysis in a muititiered system based on the degree of risk to the public's health presented by any one plant. For example: Plants with traditional inspection would be given increased FSIS monitoring of contamination by spoilage and pathogenic microorganisms and chemicals. Plants with a HACCP system covering all desirable product attributes would be . - g~ven minima Inspection. Plants with STS-C/PQC would have greater FSTS monitoring of contamination by spoilage and pathogenic microorganisms and chemicals, but decreased monitoring for visual defects. Plants with SIS-C (in a 1-year transition period) would receive increased FSTS monitoring of all desirable product attributes. In the I-year period of transition from SIS-C to SIS-C/PQC, the purpose of increased monitoring of ideal product attributes would be twofold: to increase the level of confidence of inspectors in the competence of plant employees by providing objective, statistically analyzable data and to monitor plant employees more closely in the intensive training/transitional phase. FSTS should seek advice from an expert consultant group on ways to improve communications with and understanding by its field inspectors, especially in the philosophy of food safety. Verbal and written testimony indicates that a major communication problem exists between FSIS management and field staff (see Appendix E). 33