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This guideline provides information on the Agency regulatory requirements associated with safe production of ready- to-eat (RTE) products with respect to the destruction of Salmonella and other pathogens. It applies to small and very small meat and poultry official establishments although all meat and poultry establishments may apply the recommendations in this guideline. It relates to 9 CFR 318.17(a)(1), 9 CFR 318.23, 381.150(a)(1), and 9 CFR 417.
FSIS Cooking Guideline for
Meat and Poultry Products
(Revised Appendix A)
December, 2021
Document ID: FSIS-GD-2021-
Table of Contents
General Considerations for Designing HACCP Systems to Achieve Lethality by Cooking
Table 2. Time-Temperature Combinations for Meat Products to Achieve Lethality
Table 4. Time-Temperature Combinations for Turkey Products to Achieve Lethality
Preface
This is a revised version of the FSIS Cooking Guideline for Meat and Poultry Products (Revised Appendix A). It has been updated in response to comments received on the previous version and renamed. In addition, the guideline has been revised to include recommendations from previous versions and new updates based on up-to-date science. The guideline also includes changes to improve its readability.
This guideline represents FSIS’s current thinking on these topics. Establishments that utilized previous versions of Appendix A as support should either:
- Update to this 2021 FSIS Cooking Guideline (Revised Appendix A) or
- Identify alternative support by December 14, 2022.
The information in this guideline is provided to assist meat and poultry establishments in meeting the regulatory requirements. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way. This document is intended only to provide clarity to industry regarding existing requirements under the regulations. Under the regulations, meat and poultry establishments may choose to implement different procedures than those outlined in this guideline, but they would need to validate and support how those procedures are effective.
This guideline is focused on small and very small plants in support of the Small Business Administration’s initiative to provide small businesses with compliance assistance under the Small Business Regulatory Enforcement Fairness Act (SBREFA). However, all meat and poultry establishments may apply the recommendations in this guideline. It is important that small and very small establishments have access to a full range of scientific and technical support, and the assistance needed to establish safe and effective Hazards Analysis and Critical Control Point (HACCP) systems. Although large plants can benefit from the information, focusing the guideline on the needs of small and very small establishments provides them with assistance that may be otherwise unavailable to them.
Purpose of this Guideline
This guideline contains information to assist meat and poultry establishments producing products that undergo cooking in complying with the HACCP regulatory requirements in 9 CFR 417. This guideline includes information on:
- Biological hazards during cooking.
- Regulatory requirements associated with the safe production of cooked ready-to- eat (RTE) products.
- Options establishments can use to achieve lethality of Salmonella and other pathogens.
- Processes that do not have validated research available (referred to as “scientific gaps”) and options establishments can use until research is available.
- Resources for alternative support.
- Recommendations for evaluating cooking deviations.
Establishments can always seek guidance from State university extension service specialists and HACCP Coordinators on developing programs and plans not provided in this guideline to comply with HACCP regulatory requirements.
History of this Guideline and Reason for Reissuance
In the 1970s and 1980s, FSIS included prescriptive time, temperature, and humidity operating parameters in the regulations for cooked beef, roast beef, and cooked corned beef (42 FR 44217; 47 FR 31854; 48 FR 24314) in response to several outbreaks associated with these products and research performed to determine how to prepare them safely. When the Pathogen Reduction/Hazard Analysis and Critical Control Points (PR/HACCP) final rule published in 1996, FSIS eliminated the prescriptive cooking regulations and replaced them with performance standards requiring a 6.5-Log reduction in Salmonella or alternative lethality for roast beef, cooked beef, and corned beef, minimum internal temperature and holding times for fully cooked patties that achieve a 5-Log reduction in Salmonella , and a 7-Log reduction in Salmonella or alternative lethality for poultry products (9 CFR 318.17(a)(1), 9 CFR 318.23, 9 CFR 381.150(a)(1); see General Considerations for Designing HACCP Systems to Achieve Lethality by Cooking, page 18. FSIS converted these former regulations to “Safe Harbors” in an appendix to the final rule called Appendix A (64 FR 732). Establishments have been using FSIS’s Appendix A, as published in 1999, as support for cooking processes for many years. The original requirements and subsequent guidance have been important to prevent human illness outbreaks and ensure the production of safe food. See General Considerations for Designing HACCP Systems to Achieve Lethality by Cooking, page 18 for more information on the current regulatory requirements.
Over time, FSIS determined that some of its recommendations in the 1999 version of Appendix A were vague, putting establishments at risk of producing unsafe products. Additionally, some elements of the 1999 version of Appendix A were misunderstood or overlooked, resulting in FSIS guidance being applied in ways that increased food safety risks to consumers and potential risks to industry, including the risk of foodborne illness outbreaks. FSIS also determined establishments were broadly applying the recommendations for operating parameters in Appendix A beyond those meat and poultry products it was originally designed to support.
To provide the needed updates and clarifications, FSIS issued revisions of both its Cooking (Appendix A) and Stabilization (Appendix B) guidelines in 2017. The 2017 version of the guidelines took into account new and emerging technologies, processes, and science. FSIS has updated this guideline in response to comments received on the 2017 version and has included additional options for cooking support based on updated
because of the development and validation of the Danish Meat Research Institute (DMRI) Staphtox model in 2018.
- Where gaps exist, recommendations from its older cooking guidance can be used until research is completed (see, Table 5. Scientific Gaps where Critical Operating Parameters From Older Guidance May be Used, page 43 ) for: 1. Products cooked for short times at high temperatures. 2. Products cooked using microwave cooking methods that are not designed to control relative humidity. 3. Products cooked using cooking methods that are not designed to control relative humidity. 4. Other processes that may inherently maintain relative humidity around the meat and poultry filling but cannot follow one of the relative humidity options. 5. Processes where the drying step comes before cooking under moist conditions. 6. Products with long heating come-up-times (CUTs).
- That information is included about a listeriosis outbreak associated with a cooked country-cured ham product and recommendations for establishments that cook a similar product once (page 90 ).
For Appendix A, FSIS removed:
- Information about how establishments could remove poultry rolls from the cooking medium before product has achieved the target endpoint temperature and immediately apply another heating or processing method (64 FR 732). Since FSIS has clarified that limiting heating CUT is a critical operating parameter for applying any of FSIS cooking guidance (including these older options), the parameter to “immediately fully cook” poultry rolls subject to multiple heating mediums and processes has been removed.
- Specific recommendations for conducting a Salmonella baseline study on raw source materials as support for using cooking critical operating parameters that achieve a 5-Log reduction in Salmonella for meat products instead of a 6.5 or 7- Log reduction. This information was removed since it was interpreted to apply to all establishments when it was only intended for establishments that wanted to support a lower level of pathogen reduction from cooking. In addition, FSIS is not aware of any establishments that have pursued such baseline sampling.
In addition to these changes, the guidelines format was restructured to make it easier to use as described in the next section. This list of changes is not comprehensive, so
establishments should read the section titled FSIS Critical Operating Parameters for Cooking and other relevant sections as needed.
How to Effectively Use this Guideline
As explained above in the Changes from the Previous Versions, the guidelines format was restructured to make it easier to use. Specifically, the guideline is organized to include the following topics in the body of the guideline:
- Biological hazards during cooking.
- Regulatory requirements associated with the safe production of cooked ready-to- eat (RTE) products.
- Options establishments can use to achieve lethality of Salmonella and other pathogens.
- Processes that do not have validated research available (referred to as “scientific gaps”) and options establishments can use until research is available.
Information included in the body of the guideline is intended as scientific support that can be used alone by establishments to meet Element 1 of validation (9 CFR 417.4(a)(1)) and to support decisions in the hazard analysis (9 CFR 417.5(a)(1)).
The following topics are included in attachments to the guideline:
- Resources for alternative support and
- Recommendations for evaluating cooking deviations.
Information provided in the attachments is not sufficient to use as sole support and additional documentation is needed. For example, Attachment A1. Customized Processes and Alternative Lethality Support (page 55 ), contains descriptions or brief summaries of available scientific articles. However, the summaries are not considered adequate support on their own because they do not contain the details of each study. For this reason, establishments must have the full copy of the article on-file as scientific support for their HACCP System. The summaries are provided to help establishments identify journal articles related to their process. Each establishment needs to determine if the operating parameters of a particular study match the establishment’s process. Establishments are not limited to using the scientific articles listed and summarized as support. In addition, Attachment A2. Cooking Deviations (page 66 ), contains recommendations for evaluating product safety in the event of a deviation but this information is not considered adequate support on its own because establishments should perform predictive microbial modeling and may conduct sampling and testing in order to support product disposition. Other information included in attachments is intended to be supplementary.
FSIS Cooking Guideline for Meat and Poultry Products
(Revised Appendix A)
Background
What is Lethality?
Lethality treatments are processes used by establishments to eliminate Salmonella and other pathogens in RTE products. Lethality treatments achieve a specific reduction in the number of Salmonella and other pathogens in the product ( i.e., an “X-Log 10 colony forming units per gram 1 (CFU/g)” reduction). The combination of one or more lethality treatments must be sufficient to eliminate or adequately reduce Salmonella and other pathogens to undetectable levels and prevent the production of toxins or toxic metabolites in the RTE product ( e.g., from Staphylococcus aureus ). Establishments may use a variety of different lethality processes, such as:
- Cooking the product (covered in this guideline).
- Fermentation.
- Drying.
- Salt-curing.
- Other processes that make the product safe for consumption.
Products and Processes Covered by this
Guideline
This guideline addresses lethality of pathogens ( e.g., Salmonella ) in meat and poultry products^2 by heat treatment (cooking) including for products that are cooked to lethality but classified under a not-ready-to-eat HACCP plan.
NOTE: FSIS has provided additional information about the safe production of meat and poultry jerky products in
(^1) In the rest of this document, Log 10 colony forming units per gram (Log 10 CFU/g) will be annotated simply as “Log.” All notations of “Log” should be read as in the unit Log 10 CFU/g unless other information is provided. (^2) Throughout this document references to “meat and poultry products” may be considered inclusive of meat by-products, meat food products, and poultry food products as defined in 9 CFR 301.2 and 9 CFR 381.1, unless otherwise stated ( e.g., Products and Processes Not Covered by This Guidance).
KEY DEFINITIONS
A ready-to-eat (RTE) product is defined as a meat or poultry product that is in a form that is edible by the end consumer without additional preparation to achieve food safety and that may receive additional preparation for palatability, aesthetic, or culinary purposes ( CFR 430.1).
Lethality is the process (or combination of processes) that ensure a specific, reduction in the number of Salmonella and other pathogens in the product ( i.e., an “x-Log” reduction). Lethality processes eliminate or adequately reduce Salmonella and other pathogens and prevent the formation of their toxins or toxic metabolites, facilitating the production of a safe RTE food product.
the FSIS Compliance Guideline for Meat and Poultry Jerky Produced by Small and Very Small Establishments. The information for jerky production remains in a separate guideline because of the complexities of the process, including drying procedures, and to help address questions from small and very small processing establishments.
Products and Processes Not Covered by this Guideline
The recommendations in this guideline do not apply to the following specific products:
Fish of the Order Siluriformes ( e.g., catfish) FSIS cooking guidance was not validated for fish of the order Siluriformes. Therefore, this guidance should not be used for fish.
Fish establishments may use the cooking guidance in Table A-3 of The Food and Drug Administration’s (FDA’s) Fish and Fishery Products Hazards and Control Guidance as support for the cooking step of fish products. The time-temperature recommendations are designed to achieve a 6-Log reduction in Listeria monocytogene s ( Lm).
Pork Rind Pellets Establishments may cook pork skins in pork fat or oil for several hours rendering the fat and reducing the skin into pellets. This intermediate product is then further processed by frying to produce a finished product such as pork rinds, cracklins (cracklings), or chicharrones. FSIS cooking guidance does not apply to the cooking or rendering of pork skins into a pellet. Establishments may use the cooking requirements in 9 CFR 94.8(b)(4) as support for cooking pork skins into a pellet. Although these are Animal Plant and Health Inspection Service (APHIS) requirements for imported pork skins from countries where foot-and-mouth disease, African swine fever, classical swine fever, or swine vesicular disease exist, these cooking requirements ensure at least a 6.5-Log reduction of Salmonella ( Juneja, et al., 2001a; Murphy et al., 2003; Murphy et al., 2004).
NOTE: FSIS cooking guidance may be used for cooking of pork skins for products other than pork rind pellets ( e.g., for use in pickled products) and for frying of pork rind pellets into popped pork skins. Guidance for monitoring the cooking critical limit for these products can be found in the Key Question on page 21.
Rendered Lard and Tallow FSIS cooking guidance does not apply to the rendering of animal fats, such as lard and tallow, which, due to the high fat content, generally need to reach higher temperatures and longer dwell^3 times to achieve the same reductions in Salmonella (Ramirez- Hernandez et al. , 2018). However, based on the D values (time at a constant temperature necessary to destroy 90% or 1-Log of the target organism) reported by Ramirez-Hernandez et al. (2018), the cooking requirements for rendering in 9 CFR 315.1(a) are adequate to ensure an animal fat rendering process achieves at least 6.5-
(^3) “Dwell time” ref ers to the time a product is held at a specific temperature. Other commonly used terms
such as “hold time” or “rest time” may be considered synonymous for the purpose of this guideline.
NOTE: As noted under the Products and Processes Covered by this Guideline, this guideline may be used for products that are cooked to lethality but classified under a Not RTE (NRTE) HACCP plan. For such products, please refer to the product reclassification guidance in the Listeria Guideline, Attachment 1.2 on pages 22-23 and Appendix 1.2 on pages 28-29 for guidance related to labeling, HACCP categorization, and intended use.
RTE Multi-hurdle Products This guidance does not address the safe production of products that rely on multiple hurdles to achieve lethality and shelf-stability ( e.g., fermented and dried sausage). However, some regulatory information associated with such products is included in General Considerations for Designing HACCP Systems to Achieve Lethality by Cooking, page 18.
NOTE: Stabilization requirements and recommendations for cooling meat and poultry products after heat treatment are described in the FSIS Stabilization Guideline for Meat and Poultry Products.
Biological Hazards of Concern During Cooking
The following section is designed to complement FSIS’s Meat and Poultry Hazards and Control Guide and to further assist establishments in conducting a hazard analysis for cooked meat and poultry products as required by 9 CFR 417.2(a)(1) and for supporting decisions in their hazard analysis as required by 9 CFR 417.5(a)(1).
The following hazard is present in raw products whose outgrowth during the heating come-up time should be controlled:
- Staphylococcus aureus ( S. aureus )
The following are hazards present in raw products that the lethality treatment should be designed to destroy:
- Salmonella
- Shiga toxin-producing Escherichia E. coli (STEC) (in beef)
- Campylobacter (in poultry)
- Lm
- Trichinae spiralis and Toxoplasma gondii (in pork, especially feral or non- confinement raised swine)
NOTE: Although all of these hazards are a concern, Salmonella is considered an indicator of lethality because the thermal destruction of Salmonella in cooked products would indicate the destruction of most other pathogens (64 FR 732).
More details about S. aureus and Salmonella (an indicator of lethality) can be found on the following page.
S. aureus S. aureus is a bacterial pathogen that causes nausea, vomiting, and abdominal cramping with or without diarrhea. The Centers for Disease Control and Prevention (CDC) estimates over 240,000 illnesses annually in the U.S. are attributed to S. aureus (Scallan et al., 2011). S. aureus causes illness when the bacteria grows to high levels in food and one or more heat-stable enterotoxins are produced (Kadariya et al., 2014). Various types of foods serve as the optimum vehicle for S. aureus. The pathogen has been identified in meat products, such as fermented salami and brine-injected hams. In the 1980s, S. aureus enterotoxin outbreaks were frequently attributed to hams. Continued outbreaks at hotels, restaurants and institutions as documented in the National Outbreak Reporting System (NORS)^4 highlight that S. aureus is still a concern in hams particularly when prepared in these settings. For example, between 2013 to 2018, at least six S. aureus enterotoxin outbreaks at hotels, restaurants and institutions were reported in NORS in which ham was the suspected food vehicle. S. aureus can contaminate raw meat and poultry from the animal hide, skin, or tissue during slaughter. After slaughter and cooking, RTE meat or poultry products can be contaminated with S. aureus from handling by individuals carrying the organism. This pathogen is the main food safety concern during long heating come-up-times (CUT) (that is the amount of time product temperature is between 50 to 130°F while heating). S. aureus can be present on the raw meat or poultry and grow to high enough levels to produce a toxin in the food. Growth occurs from 45 to 118°F, but effectively begins at 60˚F, especially in raw meats where the growth of other bacteria is inhibited by nitrite or salt. The critical level for human illness is 5-Log or higher which allows enterotoxin production (Kadariya et al., 2014). The toxin is not destroyed by the critical operating parameters described in this cooking guideline.
FSIS recommends limiting the growth of S. aureus during processing to 2-Log or less. Normal levels of S. aureus in raw meat are usually 2-Log (Doyle and Buchanan, 2013; IFT, 2003; Waldroup, 1996). Limiting growth to 2-Log or less allows for a margin of safety before S. aureus would produce toxins. Conditions that allow 3-Log growth are considered a public health concern because they would result in a total of 5-Log S. aureus in the product which is considered the minimum critical level for human illness (Kadariya et al., 2014).
To limit S. aureus growth, some establishments formulate products with antimicrobials such as phosphate or lactate. But the most common practice is to limit the amount of time products spend in the temperature range where S. aureus grows the fastest (i.e., 50 to 130°F). This guideline identifies CUT as a critical operating parameter to ensure lethality by cooking when applying the time-temperature tables (see FSIS Critical Operating Parameters for Cooking on page 23 ). FSIS is aware that establishments preparing some products ( e.g., ham or beef brisket) may not be able to follow FSIS’s Come-Up-Time Option because of the thermodynamics of the heating process. Therefore, FSIS identified long CUT as a Scientific Gap since support does not exist for many common processes (page 48 ). This gap supports the use of any of FSIS’s applicable time-temperature combinations (pages 35 , 37 , 38 ) and relative humidity,
(^4) https://www.cdc.gov/nors/index.html
assure the absence of other pathogens since the establishment was unable to follow the critical operational parameters in its scientific support. In addition, depending on the type of deviation, other pathogens may also be of concern (e.g., C. perfringens and C. botulinum ). For more information see Attachment A2. Cooking Deviations, page 66.
How to Control Salmonella
Establishments must ensure the target Log reduction of Salmonella and other vegetative pathogens is achieved throughout the product. To ensure vegetative pathogens, including Salmonella , are killed on the interior of the product, the endpoint time-temperature combination the product achieves is a critical operating parameter. Most often, the target temperatures used during cooking reported in scientific support documents and this guideline are the internal temperatures that the product should reach. FSIS has found that some establishments use the recommendations established for internal product temperature to set critical limits for the oven temperature. However, setting the oven temperature to the temperature identified in the FSIS time-temperature tables is not appropriate because doing so does not ensure that the product will reach the same target internal temperature.
In addition to the product temperature, the amount of time the product is held at this temperature (also known as the dwell time) is also critical to ensuring that adequate lethality is achieved. If the product is held at the target temperature for less time than specified in the time-temperature tables in this guideline, then adequate lethality may not be achieved.
To ensure a process achieves the target Log reductions of Salmonella on the surface of the product, moisture during cooking is a critical factor. Moisture ( e.g. , relative humidity) around a product during cooking promotes lethality on the product surface in two ways:
- Moist cooking reduces surface evaporation from the product during heating (evaporative cooling). Producing products under conditions of high moisture early in the cooking process reduces evaporative cooling allowing product surfaces to reach higher temperatures resulting in a greater reduction in microorganisms; and
- Moist cooking keeps the product surface (and any pathogens) wet which prevents product drying. Product drying reduces the water activity and concentrates solutes ( e.g., sugar and salt). Research has demonstrated that bacteria can become more heat tolerant as their moisture levels decrease, and increased concentrations of solutes, especially salt, increase the heat resistance of bacteria (Buege et al., (2006), Boles et al., (2004), and Sindelar et al., (2016)). Therefore, drying of the product surface before pathogens are destroyed will increase pathogen heat resistance and allow the pathogens to survive the heating process.
By incorporating moisture ( e.g., relative humidity) to minimize evaporation and the loss of surface moisture from the product, the D values (time at a constant temperature necessary to destroy 90% or 1-Log of the target organism) that are the basis for the
time-temperature combinations, will remain valid (Goepfert, 1970; Goodfellow and Brown, 1978). If evaporation, drying, or an increase in solute concentration is likely to occur, the times and temperatures in scientific studies and supporting documentation are not likely to be sufficient to provide the required lethality.
How does Moisture Ensure Bacteria on the Surface are Killed During Cooking? During cooking, achieving a high oven temperature and internal product temperature alone are not enough to ensure the final product is free of harmful bacteria. Establishments need to make sure that cooking is done in a moist environment to ensure lethality. When relative humidity is low, oven air is dry, and a process called evaporative cooling increases, which is something we do not want. Evaporative cooling is the same thing that allows humans to keep cool by sweating. When you get too hot, you produce sweat, and when that sweat evaporates, it cools you down. Evaporation equals cooling.
Just like on a person’s skin, evaporative cooling cools down the surface of meat and poultry during cooking. Although the oven is hot, because the surface of the product is cooling down, that moisture evaporation can actually prevent the surface of the product from becoming hot enough to kill off harmful bacteria. We can reduce evaporative cooling by keeping the humidity in the oven high. That way the moisture in the product does not evaporate as quickly, keeping the meat’s surface moist and hot and resulting in an adequate bacterial kill. Why does this work?
Imagine that you are in New Mexico or Nevada where it is really hot, but dry. If you’re outside, you’re more likely to sweat and that sweat will cool you down, so you don’t feel as hot. Now imagine you’re in Florida where it is not only really hot, but also humid. If you’re outside where it is humid, your skin’s surface will stay sweaty and hot, your sweat will not evaporate, and you will not cool down. Since the air is already saturated, or full of moisture (humid), there is less evaporation from your body and, therefore, less cooling. The way humidity keeps you hot in Florida is the same way moisture keeps meat and poultry products hot, too.
When you get too hot…
…you produce sweat.
When that sweat evaporates…
…it cools you down.
Evaporation
Cooling
VS.
Desert
Dry Heat = Cooling Down
Tropical
More Humidity = Less Cooling
An establishment should identify the performance standard or specific Log reduction target its process is designed to achieve in its HACCP plan or supporting documentation. If it does not, and FSIS cannot determine the pathogen reduction level the process achieves, FSIS may determine the establishment lacks support for its decisions related to Salmonella control (9 CFR 417.5(a)(1)). In addition, according to 9 CFR 417.2(c)(3), establishments must design their critical limits for Critical Control Points (CCPs) to meet all applicable performance standards and targets.
NOTE: If an establishment uses the time-temperature tables provided in this guideline or cooks beef patties according to 9 CFR 318.23, it does not need to indicate the specific Log reduction that its process achieves. It would be sufficient for the establishment to indicate that it uses time-temperature combinations from one of these documents as these regulations were designed to achieve a 5-log reduction in Salmonella and other pathogens including STEC.
Establishments are also required to validate that their HACCP system works as intended to address these hazards (9 CFR 417.4(a)). For more information on validation see the HACCP Systems Validation Guideline.
Key Question
Question: When a RTE meat food product is a mixture of meat and poultry such that the product has a meat legend, and the establishment is following this cooking guideline, does the RTE meat food product need to comply with the regulatory requirement found in 9 CFR 381.150(a)(1)?
Question: If a RTE meat food product has any amount of poultry in it, does it automatically have to meet the poultry Log reduction in the FSIS Time-Temperature Tables?
Answer: Yes to both questions.
RTE meat or poultry food products consisting of any combination of meat and poultry must meet the poultry lethality performance standard in 9 CFR 381.150(a)(1). Under the published final rule "Performance Standards for the Production of Certain Meat and Poultry Products," cooked product with any amount of poultry needs to meet the lethality requirements for the production of fully cooked poultry products (9 CFR 381.150(a)(1)) which stipulate a 7-Log Salmonella reduction or an alternative lethality that achieves an equivalent probability that no viable Salmonella organisms remain in the finished product. This provision is based on the FSIS national microbiological "baseline" survey of raw whole and ground meat and poultry products, which found higher levels of Salmonella in poultry than in meat (USDA 1994, 1996a-f). Consequently, FSIS established a higher lethality performance standard for RTE poultry products than for meat (based on highest "worst case" levels).
Alternative Lethality
An alternative lethality is a treatment that achieves a different (often lower) Log reduction than what is prescribed in the regulations but still achieves an equivalent probability that no viable Salmonella cells remain in the finished product, as well as ensures the reduction of other pathogens and their toxins or toxic metabolites (e.g., from S. aureus ) necessary to prevent adulteration. Establishments may use alternative lethality treatments to meet the performance standards (9 CFR 318.17(a)(1) and 9 CFR 381.150(a)(1)). When using an alternative lethality treatment ( e.g., at least a 5-Log reduction of Salmonella ), the establishment must validate its HACCP system to ensure that no viable Salmonella organisms (that is no organisms capable of causing human illness) remain in the finished product. Risk assessments have demonstrated that achieving a 5-Log reduction of Salmonella (instead of a 6.5-Log reduction) in cooked meat and poultry products that are not shelf stable is less protective of public health (Refer to text box: How is Alternative 5-Log Lethality Related to Risk of Foodborne Illness? page 57 ). Therefore, to use these lower targets, the establishment must provide additional support for its process as described in Attachment A1. Customized Processes and Alternative Lethality Support: Supporting an Alternative Lethality Target (e.g., 5-Log) on page 55. In contrast, risk assessments have shown that for shelf-stable meat and poultry products, a 5-Log reduction of Sa lmonella ( 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 shelf-stable products (9 CFR 417.5(a)(1) and 9 CFR 417.4(a)(1)).
Monitoring, Calibration, and Recordkeeping
The establishment’s cooking procedures should be designed to ensure all products in a batch or lot achieve lethality, and the monitoring procedures should be designed to detect a deviation when it occurs. To achieve these goals, establishments should carefully consider the selection of the critical limit, as well as the design of their monitoring procedures. Lessons learned from several recalls attributed, in part, to insufficient monitoring procedures are shared on page 22.
Selection of the critical limit
Establishments producing cooked meat and poultry products should have sufficient monitoring equipment, including recording devices, to assure that the time, temperature, and relative humidity operating parameters of their processes are being met. With any monitoring equipment, the establishment should take the normal variation of the monitoring equipment into account when designing the critical limits. For example, if a minimum internal temperature of 165°F is necessary to destroy pathogens in a product and the thermometer has an accuracy of ± 1°F (plus or minus one degree), then the critical limit should be set no lower than 166°F. The written reasoning and equipment specification materials should be kept as part of the establishment’s supporting documentation for its HACCP plan and the selection of its critical limit (9 CFR 417.5(a)(2)). All supporting documents and data from the recording devices must be made available to FSIS employees upon request (9 CFR 417.5).
