1. PURPOSE
   This notice cancels FSIS Notice 25-21 and provides updated instructions for District Office (DO) personnel and inspection program personnel (IPP) to update plant information in the Public Health Information System (PHIS) for egg products plants Sanitation Standard Operating Procedures (Sanitation SOPs) and Sanitation Performance Standards (SPS) (9 CFR part 416). The notice is being reissued to also provide updated instructions to IPP on how to update PHIS for egg products plants that have requested and been approved for early implementation of the Hazard Analysis and Critical Control Point (HACCP) requirements (9 CFR part 417)and when updating the Establishment Profile product groups for egg product plants to ensure that accurate product groups are selected in the Establishment Profile.  IPP are to note that in PHIS they will see the term "establishment" used for egg product plants.
2.  BACKGROUND
   1. On October 29, 2020, FSIS published a final rule to modernize egg products inspection: Egg Products Inspection Regulations (85 FR 68640).  The rule has staggered effective dates.  Most provisions became effective on December 28, 2020.  Provisions related to the implementation of Sanitation SOPs will become effective on October 29, 2021, while provisions related to the implementation of HACCP systems will become effective on October 31, 2022.  Plants that produce egg substitutes or freeze-dried egg products will be regulated by FSIS on October 30, 2023. 
   2. The final rule requires all egg products plants to meet the requirements of 9 CFR 416 (Sanitation SOPs and Sanitation Performance Standards) by October 29, 2021.  As of that date, PHIS will assign the applicable sanitation inspection tasks to all egg products plants for IPP to verify the new requirements. 
   3. In the final rule, FSIS offered the option for egg products plants to implement HACCP requirements before the effective dates of the rule changes.  The PHIS changes made through the instructions below will prompt PHIS to assign the appropriate inspection tasks to those plants, so IPP can document verification of HACCP requirements.
3. DO RESPONSIBILITIES
   Egg products plants must contact the DO if they are interested in early implementation of HACCP requirements.  Once 9 CFR part 416 requirements become effective, the DO can approve plant requests for early implementation of the HACCP requirements.  When the DO approves an egg products plant for early implementation of HACCP requirements, the DO personnel in the Grant Curator role are to communicate the approval to either the Frontline Supervisor (FLS) or Consumer Safety Inspector (CSI) assigned to that egg products plant.  The DO personnel are to follow the procedures from the PHIS User Guide included as Attachment 1 to enter the HACCP processing categories information into the applicable field on the grant of inspection page.  All of the information on the grant page must also be completed because it is necessary for PHIS to generate the appropriate tasks.  The FLS or CSI is to review the plant grant information in PHIS with the appropriate HACCP processing categories, so the products produced are identified correctly.
4. IPP RESPONSIBILITIES FOR VERIFYING THE SANITATION COMPONENT OF AN ESTABLISHMENT'S FOOD SAFETY SYSTEM
   Beginning on October 30, 2021, IPP are to follow the instructions in FSIS Directive 5000.1, Verifying an Establishment's Food Safety System (insert link), to verify an egg products plant's compliance with the Sanitation SOP and other sanitation requirements of 9 CFR 416.  IPP are to follow instructions in FSIS Directive 5030.1, Inspection Methodology Utilizing the Public Health Information System for Verification of Regulatory Compliance in Egg Products Plants, to verify an egg products plant's compliance with the food safety requirements. 
5. IPP RESPONSIBILITIES FOR ENTERING HACCP SYSTEM INFORMATION TO UPDATE PROFILE INFORMATION
   1. When the DO has notified IPP that a plant has been approved to implement HACCP requirements, IPP are to follow the instructions below to record HACCP information and product information for all products produced by the plant using Table 1 (below). 
   2. When entering HACCP information to update plant profile information into PHIS, IPP are to:
      1. Gather information in parts B3 and B4 below from the plant on its HACCP system, including the hazard analysis and HACCP plan; and
      2. Select generic options from drop-down lists in PHIS that best describe the plant's products and HACCP system. 
         
         NOTE:  FSIS does not require plants to identify any of their HACCP systems information or other documentation using the list of PHIS categories.
      3. Hazard Analysis and HACCP Plan Information:  In the HACCP menu of the Establishment Profile, select Add Hazard Analysis to access the hazard analysis information fields in PHIS.  IPP must enter the hazard analysis information before PHIS allows users to enter the HACCP plan and product information.  IPP are to complete only the following information in PHIS for the plant's hazard analysis and HACCP plan:
         1. Name the HACCP plan or hazard analysis in the Document Name text box.  If the plant does not title their hazard analysis and associated HACCP plan, identify it using a name that other FSIS personnel can use to identify the plan easily (e.g., Heat Treated Shelf-Stable Dried Whole Egg HACCP Plan);
         2. In the Date section, enter the most recent date of the HACCP plan or hazard analysis;
         3. In the HACCP Processing Category section, select one or more HACCP processing categories for each HACCP plan or hazard analysis based on the processing steps performed at the egg products plant.  FSIS defines HACCP processing categories (9 CFR 417.2) based on food science principles.  Attachment 2 of this notice describes the HACCP processing categories applicable for egg products plants; and
         4. Enter a brief description of the lot definition in the Lot Definition text box.
      4. See Attachment 1 for more detailed instructions on how to add HACCP information to the Establishment Profile.
6. IPP RESPONSIBILITIES FOR UPDATING PROFILE INFORMATION ON PRODUCT INFORMATION
   1. IPP are to follow the instructions described in Chapter II, Part VII of FSIS Directive 5030.2 , Managing the Establishment Profile in the Public Health Information System for Egg Products Inspection, for the "Update Establishment Profile" inspection task when updating the product groups and product volume information. 
   2. IPP are to click on the "Products" menu of the Establishment Profile and complete finished product category, product group, and volume information for each of the plant's product types.  Table 1 below contains a list of product groups available in PHIS for egg products plants as they relate to the HACCP processing category and finished product categories.  IPP are to enter all product groups that apply to a specific plant's operations by checking the appropriate boxes.  Additional information on processing categories is found in Attachment 2.

      TABLE 1:  PHIS Product Category List (Egg Products Plants)
      HACCP Processing Category	Finished Product Category	Product Group Category	Production Volumes Categories (by Product Groups)
      Raw Non-Intact	Raw non-intact egg products	Unpasteurized (bulk or packaged)	Whole eggs or Yolks (<2% added ingredients) Egg Yolk (with or without ingredients) Whole eggs with added yolks (with >2% salt or sugar) Egg whites (w/wo added ingredients) Egg products (blends of whole egg, egg whites, and/or yolks w/wo added ingredients) Spray-dried egg whites (w/wo added ingredients) Pan-dried egg whites
      Fully Cooked - Not Shelf Stable	RTE fully cooked egg products	Pasteurized (bulk or packaged)	Whole eggs or yolks (<2% added ingredients) Egg Yolk (with or without added ingredients) Egg products (blends of whole egg, egg whites, and/or yolks) Whole eggs with added yolks (w >2% added salt or sugar) Whole egg or yolks (w/ >2% salt or sugar) Egg whites (w/wo added ingredients)
      	RTE egg product fully cooked w/o subsequent exposure to environment
      Heat Treated - Shelf Stable	RTE dried egg products	Pasteurized Dried Egg Products	Whole eggs or yolks (w/wo added ingredients) Egg yolk (with or without added ingredients) Egg products (blends of whole egg, egg whites, and/or yolks Whole eggs w/ added Yolks (w >2% salt or sugar) Spray-Dried Egg Whites (w/wo added ingredients) Whole Eggs or Yolks (<2% added ingredients) Pan Dried Egg Whites

   3. IPP are to ensure that any production data in the obsolete product groups listed under the Eggs/Egg Products category as referenced in FSIS Directive 5030.2, Section VII, are transferred to the appropriate product group listed in Table 1 above.  IPP are to select the product group entry in the profile that corresponds to a HACCP processing category in Attachment 2. IPP are to then select the appropriate volume category based on the average daily volume for the product group.
   4. IPP are to select the trashcan icon to delete obsolete product groups under the Eggs/Egg Products category for plants that will be implementing both Sanitation SOPs, SPS, and HACCP requirements.  In egg products plants that will only implement the Sanitation SOPs and SPS requirements, IPP are to verify and ensure the product groups under the Eggs/Egg Products category as per Table 1 of  FSIS Directive 5030.2 are being used and maintained.
   5. IPP are to enter or update each product group that corresponds to a product the plant produces for shipment.
   6. IPP are to enter the average daily volume (in pounds) on the "Volumes" tab in the Products menu of the Establishment Profile for each HACCP category that corresponds to the product groups added.     
   7. IPP are to also enter in the number of days of production in the No. of days production text box by typing the actual number of days in a month the plant produces the specific product.  IPP are to leave this text box blank for plants that elect to implement Sanitation SOPs and SPS requirements only.
7. IPP RESPONSIBILITIES FOR SELECTING NEW PHIS TASKS
   1. Approximately 24 hours after the profile changes described above have been made, when a plant implements the HACCP requirements, IPP are to review the Establishment Profile Inspection Tasks menu to verify that the following inspection tasks appear in the Inspection Tasks page of the profile:
      1. Sanitation SOPs:
         1. Sanitation Performance Standards (SPS) verification task
         2. Pre-Op SSOP Review and Observation task
         3. Pre-Op SSOP Record Review task
         4. Operational SSOP Review and Observation task
         5. Operational SSOP Record Review task
      2. HACCP - One or more of the following tasks corresponding to the HACCP information recorded in the profile:
         1. Raw Non-Intact HACCP task
         2. Fully Cooked-Not Shelf Stable HACCP task
         3. Heat Treated-Shelf Stable HACCP task
         4. Hazard Analysis Verification (HAV) task
      3. Other requirement or administrative:
         1. Other Inspection Requirements task
         2. Meeting with Establishment Management task
         3. Review Establishment Data task
         4. Update Establishment Profile task
         5. Monthly Volume Reporting Egg Products task
         6. Food Defense tasks
         7. Labeling tasks (e.g., General Labeling, Labeling - Product Standards, and Labeling - Net Weights tasks)
   2.  IPP are to verify that the inspection tasks identified under Part VII, Section A, subsection 1 and 3 appear on the Inspection Task page of the profile for plants that have not opted-in early to implement the HACCP requirements.
   3. IPP are to refer to FSIS Directive 13,000.1, Scheduling In-Plant Inspection Tasks in PHIS for additional information about managing inspection tasks in PHIS. 
8. EARLY IMPLEMENTATION OF HACCP REQUIREMENTS
   When an egg products plant opts in early to implement the HACCP requirements included in the final rule prior to the applicable effective dates, IPP are to follow the instructions in FSIS Directive 5000.1,   Verifying an Establishment's Food Safety System (insert link) to verify an egg products plant's compliance with those requirements. 
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 General Inspection Policy for the inquiry type.

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