I. PURPOSE

A. Verification Procedures for Lethality and Stabilization - Revision 2This directive is being re-issued to clarify that inspection program personnel (IPP) are not to issue a Noncompliance Record (NR) solely because an establishment uses the 1999 versions of FSIS Appendix A and B as scientific support. This change was made in response to askFSIS questions. This directive continues to provide IPP with instructions for verifying lethality and stabilization processes at establishments that make ready-to-eat (RTE) meat and poultry products. It also covers the stabilization processes in establishments that make not ready-to-eat (NRTE) heat treated, not fully cooked, meat and poultry products, including but not limited to partially cooked and char-marked meat patties and partially cooked poultry breakfast strips.

B. This directive replaces the older versions of the lethality and stabilization directives that were last issued in 1989 and 1999. FSIS combined the two older directives into one to streamline information. FSIS has updated and revised this directive in its entirety to clarify requirements for lethality and stabilization and make it consistent with Inspection Tasks that IPP perform, as described in FSIS Directive 5000.1, Verifying an Establishment’s Food Safety System and FSIS Directive 5000.6, Performance of the Hazard Analysis Verification (HAV) Task. This directive also includes new information for verifying lethality and stabilization processes during fermentation/acidification, saltcuring, and drying and for evaluating heating and cooling deviations. Lastly, this directive provides instructions for supervisory personnel in Section X assisting IPP to verify establishment’s lethality and stabilization procedures as described in FSIS Directive 5000.1 and FSIS Directive 5000.6.

II. CANCELLATION

FSIS Directive 7110.3, Time/Temperature Guidelines for Cooling Heated Products, Revision 1, 1/24/89

FSIS Directive 7111.1, Revision 1, Performance Standards for the Production of Certain Meat and Poultry Products, 6/22/17

III. BACKGROUND

A. Lethality is the process or combination of processes that ensures that no Salmonella organisms remain in the finished product, as well as reduces other pathogens and their toxins or toxic metabolites. FSIS has requirements for the specific log reductions of Salmonella that must be achieved in RTE cooked beef, roast beef, and cooked corned beef products (9 CFR 318.17(a)(1)) and fully cooked poultry products (9 CFR 381.150(a)(1)) to ensure that no Salmonella organisms remain in the finished product as well as recommendations for alternative lethalities that achieve an equivalent probability that no Salmonella organisms remain in the finished product. Examples of lethality processes include cooking, fermentation, salt-curing, and drying. The most commonly used scientific support for cooking are the process tables previously found in FSIS Appendix A Compliance Guidelines for Meeting Lethality Performance Standards for certain Meat and Poultry Products. FSIS has now included the process tables from Appendix A in the revised FSIS Salmonella Compliance Guidelines for Small and Very Small Meat and Poultry Establishments that Produce RTE Products and Revised Appendix A. In order for a meat or poultry product to meet the definition of a RTE product in 9 CFR 430.1 (that is a meat or poultry product in a form that is edible without any additional preparation to achieve food safety) it must undergo a lethality treatment and, if post-lethality exposed, meet one of the three Alternative requirements in 9 CFR 430.

B. Stabilization is the process of preventing the growth of Clostridium botulinum (C. botulinum) and limiting the growth of Clostridium perfringens (C. perfringens). C. botulinum and C. perfringens form spores that may survive cooking and multiply during cooling when the conditions favor their growth. C. botulinum causes illness by producing toxins in the product and C. perfringens causes illness by producing toxins in the human intestine when high levels are consumed. FSIS has requirements to prevent the growth of C. botulinum and limit the growth of C. perfringens for RTE cooked beef, roast beef, and cooked corned beef (9 CFR 318.17(a)(2)), partially cooked and char-marked meat patties (9 CFR 318.23(c)(1)), and fully cooked poultry and partially cooked poultry breakfast strips (9 CFR 381.150(a)(2)). Establishments may submit a waiver per 9 CFR 303.1(h) from the stabilization requirements to use a process that allows greater C. perfringens growth. FSIS has recommendations for the amount of C. perfringens growth that should occur during stabilization of other products not covered by the requirements. The most common stabilization process is the rapid cooling of heat treated meat and poultry products after cooking through the temperature range through which C. perfringens and C. botulinum spores can multiply (e.g., 130°F to 50°F). Other stabilization processes include hot-holding at temperatures at or above 130°F to ensure that vegetative cells of pathogens are eliminated and don’t multiply, as well as drying and fermentation that render the product shelf-stable or safe at room temperatures by reducing the pH or water activity. Low pH (≤ 4.6) and water activity (< 0.93) also prevent C. perfringens and C. botulinum growth. The most commonly used scientific support for stabilization is the options previously found in FSIS Appendix B Compliance Guidelines for Cooling Heat-Treated Meat and Poultry Products (Stabilization). FSIS has now included these options along with additional options for stabilization in the FSIS Compliance Guideline for Stabilization (Cooling and Hot-Holding) of Fully and Partially Heat-Treated RTE and NRTE Meat and Poultry Products Produced by Small and Very Small Establishments and Revised Appendix B.

IV. REQUIREMENTS FOR LETHALITY AND STABILIZATION OF RTE AND NRTE MEAT AND POULTRY PRODUCTS

A. FSIS considers all RTE products to be adulterated if they contain pathogens of public health concern (depending on the type and level) or their toxins that can cause illness in humans. There are some pathogens where any level would make the product adulterated (such as Salmonella, Listeria monocytogenes (Lm), and STEC) because it would be injurious to health (21 U.S.C. 601(m)(1)) and 453(g)(1)). There are other pathogens like C. perfringens which are only a public health concern when multiplication occurs at levels that could lead to toxin formation, which in such cases would indicate that the products were prepared, packed, or held under insanitary conditions (21 U.S.C. 601(m)(4) and 453(g)(4)). For C. perfringens, conditions that allow for 3-log growth or higher are a public health concern while for C. botulinum, conditions permitting any growth of vegetative cells are a public health concern.

B. NRTE products (e.g., char-marked patties, partially cooked poultry breakfast strips, or other heat treated products) contaminated with toxins such as botulinum toxin are also considered adulterated because cooking by consumers will not destroy the toxins rendering them injurious to health (21 U.S.C. 601(m)(1)) and 453(g)(1)). In addition, if levels of growth of C. perfringens (i.e., ≥ 3 logs) or C. botulinum (i.e., > 0.30 logs) occurs during stabilization that could be of public health concern, the product would be considered adulterated because it indicates products were prepared, packed, or held under insanitary conditions (21 U.S.C. 601(m)(4) and 453(g)(4)).

C. To ensure that products are not adulterated during lethality or stabilization FSIS has developed performance standards or targets for different pathogens in RTE and NRTE products that establishments should design their Hazard Analysis and Critical Control Points (HACCP) systems to meet. According to 9 CFR 417.2(c)(3), establishments must design their critical limits to meet all applicable performance standards or targets.

1. Performance standards are quantifiable pathogen reduction levels or growth limit requirements set by FSIS for lethality and stabilization of certain products.
2. Targets are quantifiable pathogen reduction levels or growth limits set by establishments to produce safe products in the absence of performance standards set by FSIS. Targets are used by establishments to demonstrate that the lethality and stabilization processes achieved by their food-safety systems prevent, eliminate, or reduce pathogens to acceptable levels. Establishments can choose to use Appendix A and B developed by FSIS or to identify and support their own targets.

D. FSIS regulations provide establishments with the flexibility to set targets to achieve a lower log reduction of Salmonella or allow for a higher outgrowth of C. perfringens, if they provide support that the process results in a safe product. IPP are to be aware that FSIS recommends that establishments achieve a 6.5 or 5-log reduction of Salmonella in cooked meat. To use a 5-log reduction for cooked meat products, establishments should provide additional support. The 5-log lethality for cooked meat products is the lowest level acceptable when coupled with on-going evidence of source material contamination control or a combination of treatments that achieve lethality. IPP are also to be aware that the stabilization process may allow a higher log outgrowth (e.g. 2-logs growth of C. perfringens rather than a 1-log growth) if the establishment provides additional sufficient support for the safety of the product.

NOTE: IPP are to be aware that risk assessments have demonstrated that achieving a 5-log reduction of Salmonella (instead of a 6.5-log reduction) in cooked products and allowing 2-logs outgrowth of C. perfringens (instead of a 1-log outgrowth) is less protective of public health. Therefore, to use these targets, establishments should provide additional support for their process as described in Section V.C. and Section V.D. below. Risk assessments have shown that for shelf-stable meat and poultry products, a 5-log reduction of Salmonella (instead of a 6.5-log or 7-log reduction) is sufficient therefore, no additional support is needed to use a 5-log reduction process in these products.

E.IPP are to be aware of the following related to performance standards and targets: See full PDF for Chart

See full PDF for additional Chapters: 

• PERFORMING A HACCP VERIFICATION TASK IN ESTABLISHMENTS THAT ACHIEVE LETHALITY BY COOKING AND STABILIZATION BY COOLING OR HOT HOLDING
• PERFORMING A HAZARD ANALYSIS VERIFICATION (HAV) TASK IN ESTABLISHMENTS THAT ACHIEVE LETHALITY BY COOKING AND STABILIZATION BY COOLING OR HOT HOLDING
• PERFORMING A HACCP VERIFICATION TASK IN ESTABLISHMENTS THAT ACHIEVE LETHALITY AND STABILIZATION BY PROCESSES SUCH AS FERMENTATION/ACIDIFICATION, SALT-CURING, AND DRYING
• PERFORMING A HAV IN ESTABLISHMENTS THAT ACHIEVE LETHALITY AND STABILIZATION BY PROCESSES SUCH AS FERMENTATION/ACIDIFICATION, SALT-CURING, AND DRYING
• DEVIATIONS FROM CRITICAL LIMITS AND UNFORESEEN HAZARDS
• SUPERVISORY PERSONNEL RESPONSIBILITIES
• DATA ANALYSIS
• QUESTIONS