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Best Practices. Pathogen Control During. Tenderizing/Enhancing of. Whole Muscle Cuts

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Best Practices Pathogen Control During Tenderizing/Enhancing of Whole Muscle Cuts 1 Supported by: National Cattlemen s Beef Association American Meat Institute National Meat Association Southwest Meat
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Best Practices Pathogen Control During Tenderizing/Enhancing of Whole Muscle Cuts 1 Supported by: National Cattlemen s Beef Association American Meat Institute National Meat Association Southwest Meat Association March The American Meat Institute, National Cattlemen s Beef Association, National Meat Association, and Southwest Meat Association are pleased to have developed these industry Best Practices for Pathogen Control for Tenderizing Operations of Whole Muscle Cuts. In September 2003 leading manufacturers of non-intact meat products collaborated under the guidance of the American Meat Institute, National Meat Association, Southwest Meat Association, National Cattlemen s Beef Association, and industry members developed the Best Practices for review by the Beef Industry Food Safety Council (BIFSCo). Additionally, the Best Practices for Beef Slaughter and Best Practices for Handling Vacuum Packed Sub-Primal Beef Cuts were used as resources. The operating practices at every company may vary slightly from these Best Practices, depending on differing operating situations. Producers of non-intact whole-muscle cuts are urged to consider these Best Practices as guidelines for their own internal practices and documentation. These practices are the best conditions known as of the date of publication. The following individuals and companies are due thanks for their contribution to the development of these Best Practices: Dell Allen, Cargill (retired) Sharon Beals, Tyson Foods Dane Bernard, Keystone Foods Vince DeGrado, Rosen Meat Group Lynn Graves Delmore, California State Polytechnic University, San Luis Obispo Scott Eilert, Cargill Brian Farnsworth & Dr. Forrest Dryden, Hormel Foods Jerome Lawler, Swift & Company Jose L. Prego, Cozzini Group Skip Seward, American Meat Institute 3 INDUSTRY BEST PRACTICES FOR PATHOGEN CONTROL DURING TENDERIZING/ENHANCING OF WHOLE MUSCLE CUTS Purpose This document is designed to discuss Best Practices that can be implemented throughout the tenderizing or enhancing operation, as well as during cleaning and sanitizing operations, to reduce the likelihood that contamination with potential pathogens (specifically E. coli O157:H7) will occur. There are multiple ways to reach the optimal end-result, and each operator must be able to apply the practices and procedures that best fit their individual operation. This document is not designed to force the use of any specific system or technology, but to stress the importance of validating that the tenderizing or enhancing system is optimized to reduce the risk of contamination. Introduction FSIS defines non-intact beef products as ground beef; beef injected with solution, beef that has been mechanically tenderized by needling, cubing, Frenching, or pounding devices, and beef that has been reconstructed into formed entrees. Whole muscle cuts (e.g., chucks, ribs, tenderloins, strip loins, top sirloin butts, rounds) may be treated to increase tenderness or to add ingredients for quality purposes, often before subsequent fabrication at the same or external location. Treatments may include solid-needle tenderizing or hollow-needle tenderizing where a solution is pumped into the whole muscle. In the latter case, the solution typically is recirculated, refrigerated and treated to ensure the quality of the pumping solution. It is important that the management of these operations be such that the equipment, refrigeration, solutions and product are optimized for quality and safety. Producers of raw non-intact beef products recognize that these products may pose a risk if potential pathogens are moved to the interior portions of the meat products (Krizner, 1999; Phebus et al., 2000; Lambert et al., 2001; Hajmeer et al., 2002), and the product is not cooked adequately to destroy the pathogens inside the meat product. As is discussed below, the likelihood of potential pathogens being transferred to the inside from the outside of the product is very, very low because of a very low prevalence of pathogens on meat portions being tenderized or enhanced (Ransom et al., 2002; Warren et al., 2003). If equipment used in the operation is contaminated somehow, and not cleaned and sanitized, the tenderizing or enhancing equipment, and perhaps the solution to be injected, may become the vehicle of the contamination. To reduce the risk, it is extremely important that processors implement Best Practices by focusing on cleaning and sanitation practices associated with the tenderizing and enhancing operations. One of the primary considerations in assessing the likelihood of contamination of products that are tenderized or enhanced is whether or not contamination (E. coli O157:H7) is a hazard reasonably likely to occur on the surface of intact meat portions before the tenderizing or enhancing operation. Several studies indicated that E. coli O157:H7 is not a hazard reasonably likely to occur on the surface of intact meat portions. A study was conducted by Warren et al. 4 (2003) where sponge samples were taken of 1,014 subprimal cuts from six beef processing plants over a five-week period. Only two samples (0.2%) tested positive for E. coli O157:H7; enumeration indicated that each sample had 3.0 CFU per 200 cm 2 sampled. Two later studies were conducted by ABC Research Corporation (Gainesville, FL) throughout 2004 to determine the prevalence of E. coli O157:H7 and indicator organisms on the surface of beef sub-primals that would be used as raw materials for tenderizing or enhancing operations. These studies used cuts of meat specifically used for tenderizing or enhancing operations, namely, briskets, round chuck and middles. One study (I) focused on raw materials produced during the winter months (January and February); the second study (II) collected data during the late summer and fall (August into November). In study I, 600 samples comprising six sub-primal cut types (100/type) were collected from five plants from the southern Midwest, Midwest, northern Midwest and the Southeast. Each sample was a sponge sample of the entire surface of a sub-primal. None of the 600 samples had E. coli O157:H7. In study II, 599 samples (following the same scheme described above for study I) tested negative for E. coli O157:H7. Based on limits of methodologies and the results from studies I and II, the authors concluded that the overall incidence of E. coli O157:H7 on beef sub-primals was 0.083%. This document provides Best Practices for tenderizing and enhancing operations and can be used by establishments to develop plant specific programs. Although these Best Practices are applicable to both production of raw and fully cooked tenderized and/or enhanced items, this document primarily focuses on the manufacture of raw non-intact products (excluding ground beef). These Best Practices are designed to provide a recommended set of practices and procedures that processors may want to adopt in their entirety or in part to ensure optimal quality and food safety. It should be noted that the following items are not addressed in this document, but they should be covered by existing Sanitation Standard Operating Procedures (SSOPs) and/or other plant-specific processing programs. Personnel disease control, hygiene, clothing, training, etc. Plant and grounds construction and design, product flow, drainage, etc. Sanitary operations general maintenance, cleaning and sanitizing, pest control, etc. Sanitary facilities and controls water supply, plumbing, sewage disposal, rubbish and offal disposal, etc. Freezer and coolers monitored and maintained to ensure temperature control, recording devices, alarms, etc. Equipment maintenance and calibration adequate frequency for thermometers, recording devices, compressed air equipment, etc. Further details regarding these items listed above can be found in 21 CFR Part 110 Current Good Manufacturing Practices in Manufacturing, Packing, or Holding Human Food (Appendix A). This document (21 CFR 110) was developed by the Food and Drug Administration and serves as a good resource for more information on any of the above areas. 5 INDUSTRY BEST PRACTICES FOR PATHOGEN CONTROL DURING TENDERIZING/ENHANCING OF WHOLE MUSCLE CUTS Raw Material Control Best Practices begin with optimizing raw material (whole muscle cuts) quality and safety. Tenderizing and enhancing operations should identify requirements for raw material suppliers and have a system for verification that the requirements are being met and achieving the goals of the quality and safety program. Criteria to select raw material suppliers should include that suppliers have process interventions in place to reduce or eliminate potential enteric pathogens. Raw material suppliers should have validated process interventions and/or validated critical control points (CCPs) in place to prevent, eliminate or reduce E. coli O157:H7 to a non-detectable level. Validation may include scientific literature and/or plant specific validation using indicator organisms, and it should be specific to the process being applied at the establishment. This can be incorporated into the processor s purchase specifications or other plant programs to ensure that all raw materials are produced using validated CCPs or process interventions. This is true for both domestic and imported suppliers of raw materials to be used in production of non-intact product. Another important criterion for supplier selection is the ability and demonstrated maintenance of cold chain management. This includes rapid chilling of hot carcasses to control microbial growth and proper carcass rotation within the cooler to ensure timely fabrication. Lastly, it is important for non-intact beef processors to have specific data on E. coli O157:H7 incidence to support the position taken during the hazard analysis as not reasonably likely to occur. These data must relate to the raw materials and/or finished product(s). Routine microbiological testing may include sampling and testing for E. coli O157:H7. Other microbiological testing includes analyses for Salmonella, Aerobic Plate Count (APC), Total Plate Count (TPC), coliforms, and generic E. coli. For all microbiological testing, it is important that there be a written protocol for sample collection, lab analysis and proficiency testing, as well as the procedures for reporting the results. It is important to establish how the results will be used before the data are collected. Most of these microbiological tests are used for tracking supplier trends over time; however, each establishment must clearly define how they are going to use the information and the consequences of failing to meet internal microbiological guidelines. Supplier Evaluations Raw material suppliers are critical to both food safety and quality aspects of producing tenderized and enhanced products. In addition to well-defined requirements it is important that there are procedures established to evaluate the raw material supply whether from an internal or external vendor source. The following guidelines developed for the Raw Ground Products Best Practices can be used to help design a system for evaluating supply sources for other non-intact raw materials. 6 A. New Supplier Approval: Each new supplier should provide written acknowledgement of the processor s purchase specifications and the supplier s willingness to comply. Each supplier should meet the guidelines outlined in the purchase specifications for microbial testing and profiling. A processing operation may want to establish an intensified sampling program to determine if the new supplier can consistently meet the specifications. Each supplier should have a plant audit conducted on a specified frequency to ensure compliance with the purchase specifications and other programs. The audits may be conducted by the processor or by a third-party auditor. The audit requirements should be provided to the new supplier as part of the purchase specifications. Processors should conduct quality inspections of incoming materials to ensure that they are acceptable. B. Ongoing Suppliers: Processing operations should periodically provide an update of the purchase specifications to each supplier and request on updated acknowledgement of receipt of the specifications and the supplier s willingness to comply. Data should be collected and tracked to identify supplier trends and help make purchasing decisions, e.g.,: Microbial profile data (e.g., E. coli O157:H7, Salmonella, generic E. coli, TPC, APC, coliforms) Foreign object contamination Defects (e.g., unacceptable indigenous inclusions) Plant audit results Age of product at receipt Temperature of product at receipt On-time delivery Temperature Control Cold chain management is a continuum from the time a carcass leaves the slaughter process and enters the chilling process through processing, packaging, storage and distribution. The goal is to achieve and maintain the temperature that will inhibit the growth of foodborne pathogens and slow the growth of spoilage microflora. The minimum growth temperatures for the pathogens of most concern are 44.6 F (7 C) for salmonellae and F (7-8 C) for pathogenic E. coli (ICMSF, 1996). If cold chain control is violated at any point in the chain, product safety and quality may be compromised. Cold chain management is especially important at the tenderizing or enhancing operation. Specific points where temperature should be controlled, other control points related to temperature control, and examples of operating limits in tenderizing or enhancing operations include: Receiving and storage of raw materials at 45 F or lower (40 F optimal) Processing raw materials using a First In First Out (FIFO) rotation 7 Monitoring raw materials and finished products using a cooler control program Verifying the potability of process water Maintaining process water at 45 F or lower (40 F optimal) Maintaining finished product temperatures at 45 F or lower (40 F optimal) throughout their shelf life Controlling brine solutions to 45 F or lower (40 F optimal) Pre-chilling shipping containers to 45 F or lower (40 F optimal) before loading Maintaining temperatures at 45 F or lower (40 F optimal) throughout transport While temperatures are specified at 45 F or lower in the above list based on the growth limitations for pathogenic Salmonella and E. coli O157:H7, it is generally recognized that the colder the temperature the better. Process Controls There are three general types of processing that are recognized within tenderizing and enhancing operations. These include: Needle Tenderizing, Brine-Injecting (Enhancing), and Suspension Injecting. Specific Best Practices will be presented for each of these categories due to unique differences between the processes. Needle Tenderized Products Documented GMPs (including needle integrity checks) exist for tenderizing operations Established protocol exists for managing rework, including traceability and a time frame for incorporation into manufacturing Traceability program is in place for all finished products Biosecurity program exists to prevent tampering with operational equipment, and raw materials Enhanced/Brine-Injected Products Letters of guarantee and certificates of analysis exist for ingredients used in pumping solution (brine or pickle solution) Documented GMPs (including needle integrity checks) exist for injecting operations Chilled water feeding system is preferable to complete chilling of brine following mixing Maximum age is established for reuse brine (pickle) solutions (e.g., 24 hours), with a mandatory break in the use cycle (e.g., every 24 hours) Use of an antimicrobial intervention (e.g., filtration, UV) for re-circulating pickle solution is implemented if needed as determined by the hazard analysis Established protocol exists for managing rework, including traceability and a time frame for incorporation into manufacturing Traceability program is in place for all finished products Biosecurity program exists to prevent tampering with operational equipment, raw materials and pickle solutions 8 Meat Protein Suspension Injection Products 1 Letters of guarantee and certificates of analysis exist for ingredients used in the processing of the suspension solution (to include all meat and non-meat ingredients in the brine or pickle solution, as well as documentation on supplier evaluation on the sources the trim raw material used) Documented GMPs (including needle integrity checks) exist for injecting operations Chilled water feeding system is preferable to complete chilling of brine following mixing and as the suspension is generated from it Maximum age is established for reuse brine (pickle) solutions (e.g., 24 hours), with a mandatory break in the use cycle (e.g., every 24 hours) Maximum age is established for reuse suspension solutions (e.g., 8 hours), with a mandatory break in the use cycle (e.g., every hours) Use of an antimicrobial intervention (e.g., UV) for re-circulating pickle solution is implemented if needed as determined by the hazard analysis Established protocol exists for managing rework, including traceability and a time frame for incorporation into manufacturing Traceability program is in place for all finished products Biosecurity program exists to prevent tampering with operational equipment, raw materials and pickle solutions Interventions/Inhibitors New antimicrobial intervention and inhibitors that may be applicable in tenderizing or enhancing operations continue to be developed. Current applied technologies include the application of antimicrobial solutions to the raw materials before processing, treatment of the brine with an inhibitory process (e.g., UV filtration), and the use of an intervention or inhibitor applied to the finished product or packaging materials. A list of potential interventions at the time this document was written is included in Appendix B. Lotting All non-intact processors should have a lotting mechanism for coding and recording all products to allow trace back and trace forward of products throughout the manufacturing and distribution system. FSIS recognizes that the establishment will define a lot and expects scientific or other supportive basis for defining the lot. Lotting systems can range from very simplistic, e.g., handwritten numbering, to very elaborate, e.g., computerized, automated bar coding. Lotting is often based on some unit of time (e.g., hour, shift, day); however lotting can be driven by other factors including raw material source, production line or processing room. 1 Cozzini s SUSPENTEC TM system is a patented method of reducing meat, poultry or fish trimmings to micron size and incorporating them into traditional brines to create a suspension; the suspensions can then be injected into whole-muscle products. The use of this equipment is governed by FSIS Policy Memo PM041B. At the time this document was put together, Cozzini s SUSPEN TEC TM system was the only such technology available for Beef, Pork and Poultry. These practices may or may not be applicable to other suspension technologies when they become available. 9 Some processors may choose to further divide lots of product into sub-lots. By creating smaller lot units, process control can be demonstrated and documented more frequently; and there is a potential to minimize the volume of product implicated in the event a recall is ever required. Additionally, establishments should maintain records associated with all production lots. Information to be recorded is dependent on the individual system; however the following data typically are recorded: Raw material vendor, vendor lot Process date, time of production Raw material, brine, room and product temperature Microbiological data Equipment evaluations A more detailed discussion of lotting can be found in the Best Practices for Raw Ground Products document (www.bifsco.org/bestpractices.htm ). Finished Product Microbiological Testing Finished
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