We are pleased that Dr. Michael Fisher has joined the FTCLDF website as a regular contributor. Dr. Fisher is a retired United States Department of Agriculture (USDA) Food Safety and Inspection Services (FSIS) veterinarian, bringing decades of experience enforcing FSIS regulations during the slaughter and processing of animals for which the USDA provides inspection services. Dr. Fisher is thrilled to bring you his expertise and guidance to help you navigate regulatory compliance. His goal is for small, USDA-inspected meat processors to succeed and to understand how to best maintain compliance and reduce regulatory issues.
This month we consider a hazard analysis for a product in the Fully Cooked, Not Shelf Stable processing category. What is Fully Cooked, Not Shelf Stable? If you do not know, you cannot conduct a hazard analysis.
- The Code of Federal Regulations (CFR) defines “product” to include any livestock or poultry carcass, part thereof, meat by-product, meat food product, or poultry food product capable of use as human food.[1]
- It is FSIS inspection policy that a fully cooked product is further processed using a full lethality heat process step[2] that achieves the 9 CFR 318.23(b) or 9 CFR 381.150(a) performance standard.
- It is FSIS inspection policy that a product is not shelf stable if it is perishable and cannot be safely stored at room temperature.[3]
What separates a fully cooked, not shelf stable product from all other products is the application of heat plus a shelf stable status.
Now that we have identified a fully cooked, not shelf stable product, we need a 9 CFR 417.2(a)(2) flow chart describing the process steps and product flow for preparing the product. The diagram to the left is such a flow chart. Remember, a process is a series of steps conducted to an end, and a step is a unique activity that can encompass multiple actions. Our end is a fully cooked, not shelf stable product.
Grounds, facilities, equipment, utensils, chemicals, non-meat ingredients, and employees are potential sources of food safety hazards and common to all process steps. Maintaining 9 CFR 416 compliance prevents insanitary conditions and ensures that product is not adulterated by grounds, facilities, equipment, utensils, chemicals, non-meat ingredients, and employees. Therefore, a 9 CFR 417.1 preventive measure is not required to control a potential food safety hazard originating from grounds, facilities, equipment, utensils, chemicals, non-meat ingredients, and employees because it is already controlled by another regulatory performance standard. So, our hazard analysis makes no determination about a food safety hazard with regard to grounds, facilities, equipment, utensils, and employees during the Fully Cooked, Not Shelf Stable process.
Receive Raw Meat: Raw meat or poultry are potential sources of a food safety hazard. A federally inspected, fully cooked, not shelf stable product must be prepared from federally inspected product. 9 CFR 318.1(a) and 9 CFR 381.145(a) require that such product be “prepared only in an official establishment and previously inspected and passed by a Program employee” to ensure they are not adulterated. The mark of inspection means that FSIS verified that the producing establishment followed the Hazard Analysis Critical Control Point (HACCP) process it determined is necessary to produce safe product.[4] USDA’s FSIS Office of Investigation Enforcement and Audit (OIEA) Compliance and Investigations Division conducts surveillance of all products in commerce to assure that such products are not adulterated. An establishment that maintains 9 CFR 318.1(a) and 9 CFR 381.145(a) and 9 CFR 416 compliance is sufficiently assured that product received is not adulterated. Therefore, our hazard analysis makes no determination that a food safety hazard is reasonably likely to occur during this process step.
Prepare Meat Block: Preparing the meat block can involve cutting, grinding, mixing, injecting, or stuffing. I choose to capture these activities within a single process step. An official establishment may/may not choose the same.
Fully cooked, not shelf stable products may or may not contain ingredients. Ingredients are potential sources of food safety hazards. 9 CFR 318.6(a) requires that ingredients not result in the product being adulterated. Non-meat and -poultry ingredients are regulated by the Food and Drug Administration. FSIS accepts a guaranty by the ingredient supplier that the ingredient is safe for the intended use within the meaning of the Federal Food, Drug, and Cosmetic Act. A prudent establishment maintains such guaranty and 9 CFR 318.6(a) and 9 CFR 416 compliance. No food safety hazard reasonably likely to occur carries over from the previous process step. Therefore, our hazard analysis makes no determination that a food safety hazard is reasonably likely to occur during this process step.
Fully Cooked, Not Shelf Stable: The only method to transform the meat block into a fully cooked, not shelf stable product is to apply full lethality heat process. A prudent establishment maintains 9 CFR 416 compliance when applying a full lethality heat process. No food safety hazard reasonably likely to occur carries over from the previous process step. No new ingredients are introduced at this process step. Therefore, our hazard analysis makes no determination that a food safety hazard is reasonably likely to occur during this process step.
A process step applying a full lethality heat process is a critical control point only if a food safety hazard reasonably likely to occur can be prevented, eliminated, or reduced to acceptable levels at the process step. In our hazard analysis, no food safety hazard reasonably likely to occur exists to be prevented, eliminated, or reduced to acceptable levels; therefore, the fully cooked, not shelf stable process step is not a critical control point.[5]
The Fully Cooked, Not Shelf Stable process step is a control point: for misbranding. Fully cooked, not shelf stable products are ready-to-eat. The 9 CFR 430.1 standard of identify for ready-to-eat product is a “product that is in a form that is edible without additional preparation to achieve food safety.” The heat treatment, which is compatible with an adequate 9 CFR 318.17(a)(1) lethality treatment for Salmonella and eliminates any biological food safety hazard, ensures that the fully cooked not shelf stable products meet the ready-to-eat standard of identity.
Cool: A prudent establishment maintains 9 CFR 416 compliance when applying a cool process. No food safety hazard reasonably likely to occur carries over from the previous process step. It is FSIS policy that “Spores of … Clostridium perfringens, and other spore-forming bacteria can survive cooking and, in fact, thrive in the warm product following cooking.”[6] Spores not destroyed by heat can develop into vegetative cells and produce Clostridium perfringens enterotoxin, a biological food safety hazard in fully cooked, not shelf stable meat products. Therefore, the hazard analysis determines that a biological food safety hazard is reasonably likely to occur in fully cooked, not shelf stable, ready-to-eat products during the Cool Process Step in the absence of a 9 CFR 417.1 preventive measure. The Cool Process Step is a step in the process where a control can be applied that prevents a biological food safety hazard, the production of Clostridium perfringens enterotoxin.
Package/Storage/Ship: Packaging, storage, and shipping are activities common to all processing categories, regardless of the product prepared. I choose to capture them within a single process step. An official establishment may/may not choose the same.
9 CFR 317.24 or 9 CFR 381.144 and 9 CFR 325.1(c) or 9 CFR 381,190(c) require that packaging materials and transport methods, respectfully, not result in product being adulterated. A prudent establishment maintains 9 CFR 317.24 or 9 CFR 381.144 and 9 CFR 325.1(c) or 9 CFR 381,190(c) and 9 CFR 416 compliance. No food safety hazard reasonably likely to occur carries over from the previous process step. Therefore, our hazard analysis makes no determination that a food safety hazard is reasonably likely to occur during this process step.
Hazard Analysis Complete! Key to conducting any hazard analysis is the realization that a hazard analysis rests on a foundation of sanitation. Absent that foundation, conducing a hazard analysis is a waste of time because without sanitation, product that is not adulterated cannot be produced. The above hazard analysis is moot if the establishment fails to start the process with meat or poultry that is adulterated and fails to comply with all applicable sanitation requirements.
Footnotes
[1] 9 CFR 301.2 and 9 CFR 381.1
[2] USDA, FSIS. (2019) FSIS Product Categorization (Guideline ID: FSIS-GD-2019-0010). https://www.fsis.usda.gov/guidelines/2019-0010
[3] USDA, FSIS. (2019) What does “shelf stable” mean? (Knowledge Article). https://ask.usda.gov
[4] Paul Kiecker, Acting FSIS Administrator (official communication, April 12, 2018)
[5] Lynda Lilyestrom, Philadelphia District Manager. Compliance with Consent Decision and Order FMIA Docket No. 14-0180 (official correspondence, July 19, 2019)
[6] Performance Standards for the Production of Certain Meat and Poultry Products: Final Rule. 64 Fed. Reg. 732 (January 6, 1999)
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