1. PURPOSE
   1. This notice informs inspection program personnel (IPP) that, On May 1, 2024, FSIS published the final determination, Salmonella in Not Ready-To-Eat Breaded Stuffed Chicken Products (89 FR 35033), which states that not ready-to-eat (NRTE) breaded stuffed chicken products that contain Salmonella at levels of 1 Colony Forming Unit per gram (hereinafter, “1 CFU/g”) or higher are adulterated within the meaning of the Poultry Products Inspection Act (PPIA). The determination is not effective until May 1, 2025.
   2. This notice provides instructions to IPP at all establishments that produce NRTE breaded stuffed chicken products to update the Public Health Information System (PHIS) profile by May 31, 2024. This notice also instructs supervisory personnel to verify that the establishment's PHIS profile information is complete and accurate by May 31, 2024.
2. BACKGROUND
   1. From 1998 to 2021, public health officials investigated 14 salmonellosis outbreaks attributed to consumption of NRTE breaded stuffed chicken products that may appear ready-to-eat (RTE) to consumers. Five of the outbreaks led to a recall of FSIS-regulated products, and in some cases, a public health alert. In response to these outbreaks, manufacturers of these products took steps to improve their labeling to ensure that the consumer is aware that the product is raw, and that these products should not be microwaved because of the increased likelihood that the product will be undercooked. In 2015, in response to an additional outbreak, industry also took steps to revalidate the cooking instructions for these products.
   2. From April through August 2021, state public health officials, the Centers for Disease Control and Prevention (CDC), and FSIS investigated a multistate outbreak of Salmonella illnesses linked to NRTE breaded stuffed chicken products. The outbreak included 36 cases from 11 states. The establishment recalled 59,251 pounds of frozen product (RC-028-2021).
   3. Specifically, the final determination:
      1. Concludes that NRTE breaded stuffed chicken products that contain Salmonella at levels of 1 CFU/g or higher are adulterated within the meaning of the PPIA;
      2. Defines “NRTE breaded stuffed chicken products” as those NRTE products that are both breaded and stuffed, contain raw chicken components (e.g., comminuted chicken breast meat, trim, skin, or whole chicken breast meat), and where the finished product is heat-treated only to set the batter or breading on the exterior of the product;
      3. Notifies industry that FSIS intends to develop and implement routine sampling and verification testing for Salmonella on the raw chicken source materials used to produce NRTE breaded stuffed chicken and that such components and associated lots that test positive for 1 CFU/g or greater of Salmonella must be diverted for other uses or destroyed; and
      4. Requires all establishments that produce NRTE breaded stuffed chicken products to reassess and, if needed, revalidate their HACCP plans by the effective date of the final determination.
   4. FSIS has added a new feature to PHIS to enable IPP to identify those establishments that produce NRTE breaded stuffed chicken products. The PHIS update also improves the specificity for IPP to select the PHIS product fields that best align with NRTE breaded stuffed chicken products and how establishments classify them in their food safety system.
   5. The PHIS update improves the accuracy of identifying establishment production and will be used for policy development, which will include FSIS verification sampling.
3. NRTE BREADED STUFFED CHICKEN PRODUCTS
   1. IPP are to be aware that FSIS' final determination only pertains to those products that meet the definition of NRTE breaded stuffed chicken products, i.e., NRTE products that are both breaded and stuffed, contain raw chicken components, and are heat-treated only to set the batter or breading on the exterior of the product.
   2. IPP are to be aware that there are numerous examples of NRTE breaded stuffed chicken products (such as those in Figure 1) that include—but are not limited to—breaded, pre-browned chicken cordon bleu, chicken Kiev, and chicken stuffed with broccoli and cheese.
      
      Figure 1. Examples of NRTE breaded stuffed chicken products.
      
      
      
   3. IPP are to be aware that NRTE breaded stuffed chicken products DO NOT include stuffed products that are not breaded (e.g., turducken, whole stuffed chickens, or chicken thighs stuffed with stuffing and almonds). NRTE breaded stuffed chicken products also DO NOT include breaded and par-fried products that are not stuffed (e.g., chicken nuggets, chicken tenders). The product typically is stuffed with ingredients such as a raw vegetable, butter, cheese, or meat, such as ham.
   4. IPP are to be aware that NRTE breaded stuffed chicken products DO NOT include ready-to-eat (RTE) products. IPP are to verify RTE breaded stuffed chicken products in accordance with the inspection activities applicable to the RTE Hazard Analysis Critical Control Points (HACCP) category corresponding to the operations used to make the finished product RTE. For example, a fully cooked, but not shelf stable, frozen breaded stuffed chicken product would be added to the establishment profile under the HACCP processing category and verified by IPP under the PHIS Fully-Cooked, Not-Shelf-Stable HACCP inspection verification task and the RTEPROD sampling verification task (See FSIS Directive 10,240.3FSIS Directive 10,240.3, FSIS Ready-to-Eat Sampling Programs).
4. SAMPLING PROGRAM AND HACCP REASSESSMENT
   1. IPP are to be aware that FSIS will implement its sampling and verification testing program for Salmonella in NRTE breaded stuffed chicken products on or after May 1, 2025. Before this date, FSIS will issue instructions and update training for IPP on how to collect samples.
   2. IPP are to be aware that all establishments that produce NRTE breaded stuffed chicken products must reassess their HACCP plans before the effective date. Establishments can reassess as part of their annual reassessment if their annual reassessment occurs before the effective date. Establishments that make changes to their production process as a result of their reassessment will need to re-validate their HACCP plans before the effective date. IPP are to verify that these establishments have adequately reassessed and completed their reassessment and revalidation before May 1, 2025.
5. AWARENESS MEETING WITH ESTABLISHMENT MANAGEMENT
   1. During the next weekly meeting, and prior to IPP implementing any updates to the PHIS Profile, IPP are to inform establishment management of the publication of the final determination, the issuance of this notice, and that IPP will be updating the establishment's PHIS profile.
   2. The inspector-in-charge is to make establishment management aware of this notice by providing a web link or printed copy and review the notice during the awareness meeting.
   3. IPP are to document the awareness meeting in a memorandum of interview as described in FSIS Directive 5010.1, Food Safety Related Topics for Discussion During Weekly Meetings with Establishment Management, Section IV.
6. IPP RESPONSIBILITIES FOR UPDATING PRODUCTS IN THE ESTABLISHMENT PROFILE
   1. IPP at all establishments that produce NRTE breaded stuffed chicken products are to initiate a directed “Update Establishment Profile” task and schedule it on the task calendar.
   2. IPP are to follow the instructions in FSIS Directive 5300.1, Managing the Establishment Profile in the Public Health Information System - Revision 1, to access the establishment's profile and add or edit products.
   3. IPP are to update all applicable products that meet the definition of NRTE breaded stuffed chicken products using the HACCP Categories in Appendix 1. Examples of modified establishment profiles can be found in Appendix 2.
   4. Per FSIS Directive 5300.1, IPP are to enter or update one product group entry in the profile at a time. If IPP enter or update multiple product groups at the same time, PHIS will not apply the intended use field correctly, which will affect sampling assignments. IPP are to make sure they do not create duplicative product groups if they choose to create a new product group instead of updating an old one. To delete a product group entry, select the trashcan icon to delete the entry.
   5. After IPP have followed the instructions in this notice to initiate and perform a directed “Update Establishment Profile” task, they are to mark the directed task as complete. IPP are to keep the information in the establishment profile up-to-date and accurate, as directed in Chapter I, Part IX of FSIS Directive 5300.1.
7. SUPERVISOR RESPONSIBILITIES
   1. All field supervisors are to ensure IPP in all establishments producing NRTE breaded stuffed chicken products complete the task as described in Section VI above. Supervisory personnel refer to any Office of Field Operations (OFO) personnel who supervise IPP conducting offline verification activities.
   2. Supervisors are to ensure that IPP have accurately updated the PHIS profile in the chicken establishments listed under the HACCP Categories in Appendix 1 and verify that the task “Update Establishment Profile” has been completed. Supervisors are to promptly follow-up with IPP for the tasks that have not been performed to ensure completion by May 31, 2024.
8. DATA ANALYSIS
   The FSIS Office of Planning, Analysis, and Risk Management will analyze the PHIS update results. Results from the update may be used to inform future sampling programs.
9. 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 Sampling as the Inquiry Type.

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