I.  PURPOSE

This notice provides instructions for inspection program personnel (IPP) to notify establishments that revised versions of FSIS Cooking Guideline for Meat and Poultry Products (Revised Appendix A) (see Appendix A) and FSIS Stabilization Guideline for Meat and Poultry Products (Revised Appendix B) (see Appendix B) are now available.  This notice also provides instructions for IPP to notify establishments that the Agency is providing establishments that use the 1999 and 2017 versions of these guidelines as scientific support for their Hazard Analysis and Critical Control Point (HACCP) System until December 14, 2022 to begin using the 2021 guidelines or identify alternative support for their cooking and stabilization processes, making changes to their HACCP system as needed.  FSIS is not issuing instructions for new verification activities.  IPP are to continue to verify validation requirements following the instructions in FSIS Directive 5000.6, Performance of the Hazard Analysis Verification (HAV) Task and FSIS Directive 7111.1, Verification Procedures for Lethality and Stabilization, until further notice.  This notice also provides instructions for Enforcement, Investigation, and Analysis Officers (EIAOs) when performing Food Safety Assessments (FSAs) in establishments using FSIS’s Appendix A or B as scientific support. 

II.  BACKGROUND

A.  FSIS issued revisions of its cooking (lethality) and stabilization (cooling and hot-holding) guidance in 2017, referred to as Appendices A and B.  The guidelines were originally issued in 1999. The revisions considered new and emerging technologies, processes, and science while ensuring that the guidance results in safe food production, when applied correctly. 

B.  In 2021, FSIS revised these guidelines in response to comments.  In addition, the guidelines have been revised to include recommendations from previous versions and new updates based on up-to-date science.  The guidelines were also renamed and include other changes to improve readability.  The revised guidelines were announced in the Federal Register  86 FR 71007 and are now available online: 

1. FSIS Cooking Guideline for Meat and Poultry Products (Revised Appendix A).
2. FSIS Stabilization Guideline for Meat and Poultry Products (Revised Appendix B).

III.  IPP RESPONSIBILITIES

1. If an establishment uses a cooking or stabilization process for meat and poultry products (either fully cooked or partially heat-treated), IPP are to make establishment management aware of these revised guidance documents at the next weekly meeting.
2. IPP are to be aware these documents are guidance, not requirements. IPP are to make compliance determinations based on the regulatory requirements.
3. IPP are to inform establishment management that:
   1. The 2021 Cooking and Stabilization Guidelines are available on the FSIS website at the links provided in Section II.B. of this notice. 
   2. The new guidelines provide the following information:
      1. FSIS Cooking Guideline for Meat and Poultry Products (Revised Appendix A) provides information for complying with Agency regulatory requirements in 9 CFR 318.17(a)(1), 9 CFR 318.23, 381.150(a)(1), and 9 CFR part 417 associated with safe production of ready-to-eat (RTE) products with respect to the destruction of Salmonella and other pathogens using cooking. 
      2. FSIS Stabilization Guideline for Meat and Poultry Products (Revised Appendix B) provides information on complying with the Agency regulatory requirements in 9 CFR 318.17(a)(2), 9 CFR 318.23(c)(1), 9 CFR 381.150(a)(2), 9 CFR 381.150(b), and 9 CFR part 417 associated with safe production of heat-treated ready-to-eat (RTE) and not-ready-to-eat (NRTE) meat and poultry products with respect to preventing or limiting the growth of spore-forming bacteria (Clostridium perfringens and Clostridium botulinum) and other pathogens. 
   3. The FSIS Cooking Guideline (Revised Appendix A) includes a summary of Changes from the Previous Versions.  IPP are to be aware that a summary of changes from previous versions of the FSIS Cooking Guideline are also included in Attachment 1.
   4. The FSIS Stabilization Guideline (Revised Appendix B) includes a summary of Changes from the Previous Versions.  IPP are to be aware that a summary of changes from previous versions of the FSIS Cooking Guideline are also included in Attachment 2 of this notice.  
   5. The 2021 guidelines include recommendations from older cooking and stabilization guidance for products and processes considered “Scientific gaps”.  “Scientific gaps” are common cooking and stabilization processes for which establishments have used Appendix A and B as support in the past, even though these processes cannot achieve the critical operating parameters included in the revised guidelines. These are also processes for which there is no evidence of imminent food safety concerns resulting from the continued application of the older recommendations to these processes. 
   6. Establishments may continue to use the 1999 and 2017 versions of these guidelines until December 14, 2022, at which time those versions will be considered no longer adequate scientific support for the HACCP system because they are out of date. 
   7. FSIS is providing establishments that use the 1999 and 2017 versions of these guidelines as scientific support for their HACCP System until December 14, 2022 to:
      1. Begin using the 2021 guidelines or identify alternative support for their cooking and stabilization processes, making changes to their HACCP system as needed (9 CFR 417.5(a)(1)); and
      2. Gather any needed in-plant validation data for changes made to their HACCP system (9 CFR 417.4(a)(1)). 

   D.  IPP are to continue to verify that establishments are following all of the critical operating parameters in their supporting documentation.

   1. Until December 14, 2022, IPP are not to issue a noncompliance record (NR) solely because the establishment uses the 1999 or 2017 versions of the Cooking Guideline (Appendix A) or Stabilization Guideline (Appendix B) as scientific support for its process.  
   2. If IPP find that the establishment has not followed all of the critical operational parameters in  its scientific support, they are to issue an NR for not supporting the decisions in the hazard analysis (9 CFR 417.5 (a)(1)), as instructed in FSIS Directive 7111.1, Section VI.B.1. 

   E.  FSIS will provide further instructions to IPP before the implementation date (December 14, 2022).  These instructions will describe the verification procedures IPP are to follow in relation to the revised 2021 guidelines, including verification procedures for processes within a defined scientific gap.

   IV.  EIAO RESPONSIBILITIES

   A.  EIAOs are to review and familiarize themselves with the information in the 2021 Cooking and Stabilization guidelines because they represent the most current scientific research and critical operating parameters related to cooking (lethality) and stabilization (cooling). 

   B.  During an FSA, as instructed in FSIS Directive 5100.1, Enforcement, Investigations, and Analysis Officer Comprehensive Food Safety Assessment Methodology, Chapter V, Section VI, EIAOs are to evaluate whether the establishment has adequate scientific support for the design of its HACCP system (e.g., critical control point, prerequisite program, or other program design), and whether in-plant validation data demonstrate that the establishment can implement its system as designed.

   C.  Until further notice, if an establishment is using the 1999 or 2017 versions of the Cooking Guideline (Appendix A) or Stabilization Guideline (Appendix B), the EIAO is to note this fact in the FSA.  However, EIAOs are not to use this information as the only reason for recommending the issuance of an NR or an enforcement action until December 14, 2022.

   D.  When performing outreach activities, EIAOs are to make establishment management aware of the 2021 Cooking and Stabilization guidelines.  EIAOs are to provide technical assistance as part of the compliance assistance resources they provide according to the instructions in FSIS Directive 5100.1.

   E.  FSIS will provide further instructions to EIAOs prior to the implementation date (December 14, 2022).  These instructions will describe the verification procedures EIAOs are to follow in relation to the 2021 Cooking and Stabilization guidelines, including verification procedures for processes within a defined scientific gap.

   V.  QUESTIONS

   Refer questions regarding this notice to your supervisor or as needed to the Office of Policy and Program Development through askFSIS or by telephone at 1-800-233-3935. When submitting a question, complete the web form and select HACCP Deviation & Validation as the Inquiry Type.

   NOTE:  Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting questions.

    

   Assistant Administrator
   Office of Policy and Program Development

See PDF for additional information

Attachment 1:

• Changes from the Previous Versions of “FSIS Cooking Guideline for Meat and Poultry Products (Revised Appendix A)”

Attachment 2:

• Changes from the Previous Versions of “FSIS Stabilization Guideline for Meat and Poultry Products (Revised Appendix B)”