DO NOT IMPLEMENT THIS DIRECTIVE UNTIL OCTOBER 29, 2021.

CHAPTER I - GENERAL

1. PURPOSE
   
   This directive instructs inspection program personnel (IPP) how to verify that egg products plants are meeting the regulatory requirements of  9 CFR Part 590 and 9 CFR Part 500 (Rules of Practice). The directive is being revised to remove the previous instructions how to verify sanitation requirements in egg products plants. This change coincides with the implementation of Sanitation Performance Standards (SPS) and Sanitation Standard Operating Procedures (SSOP) requirements from 9 CFR Part 416 in egg products plants, as published in the final rule Egg Products Inspection Regulations (85 FR 68640). The Public Health Information System (PHIS) egg products task library (Attachment 2) is also being revised to remove obsolete PHIS inspection tasks.
   
   KEY POINTS:
   • Provides regulations and instructions to IPP for verification of PHIS General Labeling task and enforcement actions related to the implementation of 9 CFR part 500 (Rules of Practice) regulations in egg products plants
   • Provides instructions for completing Noncompliance Records (NRs), Meeting Agendas, Memorandums of Interview (MOIs), PHIS task library (Attachment 2), and other types of documentation within PHIS
   • Provides instructions on how IPP are to verify appropriate labeling and movement controls of egg products after the cancellation of FSIS Directive 5040.1, Uses of FSIS Form PY-200 Egg Products Inspection Certificate
2. CANCELLATION
   
   FSIS Directive 5030.1, Revision 2, Inspection Methodology Utilizing the Public Health Information System (PHIS) for the Verification of Regulatory Compliance in Egg Products Plants, 12/21/20
3. BACKGROUND
   1. FSIS conducts inspection activities at egg products plants as required under the Egg Products Inspection Act (EPIA).  FSIS egg products inspection regulations are in 9 CFR part 590.  Under the EPIA, an egg product is adulterated if, among other things, it has "been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health" (21 U.S.C. 1033(a)).  Under the EPIA, an egg product is misbranded if it is not labeled and packaged in accordance with FSIS regulations (21 U.S.C. 1033(l)). FSIS IPP verify that egg products plants meet the regulations to ensure that egg products are not  adulterated or misbranded.
   2. On October 29, 2020, FSIS published a final rule, Egg Products Inspection Regulations (85 FR 68640) .  The final 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 and imports of these products will be regulated by FSIS on October 30, 2023. 
   3. On October 29, 2021, egg products plants will be required to meet the sanitation requirements of 9 CFR Part 416.  IPP will follow the instructions in FSIS Directive 5000.1, Verifying an Establishment's Food Safety System to verify these sanitation requirements.
4. WEEKLY MEETINGS
   1. IPP are to have weekly meetings with plant management to discuss issues of concern.  The meetings may involve discussing individual noncompliance, developing trends of noncompliance, findings on the part of the IPP that show compliance but warrant discussion, or other topics that arise.  IPP may use PHIS Inspection Verification 'Meeting Agenda' feature to prepare the meeting agenda.  IPP are to share a copy of the meeting agenda with plant management when requested.  In addition, plant management may wish to share information or concerns at the weekly meetings.  See FSIS Directive 5010.1, Food Safety Related Topics for Discussion During Weekly Meetings with Establishment Management, for suggested topics for weekly meetings.
      
      NOTE:  IPP have access to an 'Inspection Notes' feature in PHIS that allows inspectors to capture information in between weekly meetings that can be included in the meeting agenda and used to create the MOI.  IPP are not to use the MOI as a means to document daily conversations with plant employees.
   2. On a periodic basis, about once a month as scheduled using the PHIS 'Update Establishment Profile' task, IPP are to ask plant management at the weekly meeting whether it has made any changes in the production process or other changes that could affect the safety of the product.  If IPP learn that plant management has made a change in its process, based on the nature of the change, IPP are to perform the appropriate verification activities outlined in this directive.  If IPP are unsure how to proceed, they are to contact their supervisor for guidance.  IPP are to update the applicable sections of the plant profile in PHIS as necessary to ensure that it accurately reflects the plant's operations and programs.  See FSIS Directive 5030.2, Managing the Establishment Profile in the Public Health Information System (PHIS) for Egg Products Inspection, for instructions on maintaining the plant profile.
   3. IPP are to take notes at the weekly meetings and may document the notes in an MOI generated from the meeting agenda feature in PHIS.  The MOI is to include the date of the meeting, who was at the meeting, and details about the specific topics discussed including answers to any questions asked during the meeting.  IPP are to provide plant management with a copy of the MOI.  If plant management objects to anything written in the MOI, IPP are to follow the instructions in FSIS Directive 5010.1.  IPP are to attach any documents provided by the plant in the weekly meeting and reference the attachment in the MOI. 
5. PHIS VERIFICATION METHODOLOGY
   1. FSIS Directive 13,000.1, Scheduling In-plant Inspection Tasks in the Public Health Information System (PHIS), contains instructions on how to schedule tasks and use the task calendar in PHIS.  In situations where IPP are unable to complete all tasks in a given month, they are to use the priority scale (See Attachment 1 - Task Priority List) to decide which tasks are more important to complete. 
   2. The Task Priority List (Attachment 1) ranks the various inspection and sampling procedures in order of priority, with 1 being the most important and 6 being least important.  IPP are to ensure that when tasks cannot be completed, they focus on performing the most important tasks.  In other words, if IPP are unable to complete all tasks, they are to drop the least important (priority 6) ones first.  IPP are to focus on accurately and thoroughly performing and completing higher priority tasks as instructed through this directive.
      
      NOTE:  IPP are to note that in PHIS they will see the term "establishment" used for egg product plants.
   3. IPP are to verify regulatory requirements in one or more areas of the plant.  IPP are to gather information regarding what they see occurring in the operation and use professional knowledge and good judgment when determining whether the plant has met the regulatory requirements.  IPP also are to assess all the information available in the plant and then make a determination as to whether the observed situation creates insanitary conditions or causes adulteration of product (9 CFR part 416 and 9 CFR 590.500-590.575), prevents FSIS from performing inspection (9 CFR 590.132), or violates other specific regulatory requirements.  When IPP determine that the plant has failed to meet the regulatory requirements, they are to evaluate what is known for a fact and then take appropriate action (9 CFR 590.426).
   4. IPP are to use the following thought process when performing verification duties:
      1. Gather all available information, including any relevant records generated by the plant;
      2. Observe plant conditions;
      3. Observe product and verify temperature measurements for applicable regulatory requirements;
      4. Assess the significance and meaning of the information gathered;
      5. Determine whether the information supports a finding of regulatory compliance; and
      6. Document findings in PHIS.  Refer to Chapter III, Section II of this directive.
   5. To assess the significance and meaning of the information gathered, IPP are to consider what each piece of information taken separately, or with other findings, means to ensure that products are not adulterated (9 CFR 590.420(c)).  IPP are to consider information that they have gathered in the context of past findings and to look for any patterns or trends in the findings.  IPP are to consider the following:
      1. Are conditions in the plant getting worse over time?
      2. Are the same or similar problems occurring repeatedly or consistently occurring on a seasonal basis?
      3. Is the plant responding effectively and in a timely manner to problems that do arise (9 CFR 590.504)?
   6. To determine whether the information supports a finding of regulatory noncompliance, IPP are to determine, based on all the available information, whether one of the following findings emerges from the evidence that the plant:
      1. Is not maintaining sanitary conditions (9 CFR part 416 and 9 CFR 590.504(a));
      2. Has produced or shipped adulterated product (9 CFR 590.504(b), (d)(2)); or
      3. Is not meeting other requirements.
      NOTE:  There can be conditions in the plant that are less than perfect but that would not represent noncompliance with the regulations because they are not creating insanitary conditions, adulterating product, or preventing FSIS personnel from performing inspection activities.
   7. When IPP document noncompliance, they are to describe why the findings led them to a determination of noncompliance.  If IPP are uncertain whether the information supports a particular determination, they are to discuss the issue with their immediate supervisor. 
   8. If IPP have concerns about circumstances that may indicate systemic problems, or there is reason to believe that product may have become adulterated, IPP are to bring these issues to the attention of their supervisor immediately.
6. SUPERVISORY RESPONSIBILITIES
   1. The supervisor plays a key role in ensuring that decisions made by IPP are consistent with FSIS statutory authority and Agency policy, and that they perform their duties in accordance with prescribed inspection methods and procedures addressed in this directive.
   2. Supervisory personnel are to ensure that IPP correctly apply inspection methodology, make informed decisions, properly document findings, and take appropriate enforcement actions, as instructed in this directive.

CHAPTER II - VERIFICATION REQUIREMENTS

1. FOOD SAFETY VERIFICATION REQUIREMENTS
   1. IPP are to verify food safety regulatory requirements by performing the Food Safety verification tasks that appear on the PHIS task list.  The Food Safety verification tasks will appear on the plant's inspection task list according to the specific Food Safety process categories (See FSIS Directive 5030.2, Managing the Plant Profile for Egg Products, Chapter II).
   2. When IPP verify that egg products plants meet food safety requirements, they are to evaluate the food safety procedures and associated activities observed in the plant.  IPP are to verify that the plant meets the applicable food safety regulatory requirements (9 CFR 590.500-590) to ensure that products are not adulterated.  In order to determine compliance, IPP should ask questions such as, but not limited to, the following: 
      1. Are dirty and leaker shell eggs being precluded from entering, and being broken in, the breaking room? (9 CFR 590.510(c));
      2. Have shell eggs that entered the breaking room with fecal, mold, or foreign material contamination on the shell contaminated the breaker cracker head or separator cups after transfer? (9 CFR 590.504(m) and 590.510(c));
      3. If the plant breaks checks and eggs with a portion of the shell missing, are they free of adhering dirt and foreign material and the shell membrane not ruptured?  (9 CFR 590.510(c)(1));
      4. If the plant breaks eggs damaged during candling or transfer that have a portion of the shell and shell membranes missing, are they clean, is the yolk unbroken, and are the contents of the egg contained within the shell (not extruding over the outside shell)?  (9 CFR 590.510(c)(2));
      5. Is the plant ensuring that eggs with meat or blood spots are being removed in an acceptable manner prior to breaking those eggs? (9 CFR 590.510(c)(3));
      6. Are liquid egg products meeting the minimum temperature and holding time requirements to achieve complete pasteurization throughout the entire pasteurization run? (9 CFR 590.570(b));
      7. Is the plant conducting Salmonella testing on liquid, frozen, or dried egg products? (9 CFR 590.580(b));
      8. Is the plant immediately notifying IPP of Salmonella positive test results? (9 CFR 590.580(c));
      9. Is the plant supplying the test results on all egg products analyzed for Salmonella? (9 CFR 590.580(c));
      10. Are the ingredients/substances added in the processing of egg products clean, approved for their intended use, at the correct concentration or percentage, and fit for human food? (9 CFR 590.504(j));
      11. Are ineligible eggs or eggs contaminated with feces or foreign material being removed and segregated from the eggs being broken such that they are not contaminating the egg products being produced? (9 CFR 590.504(b));
      12. During the final organoleptic examination of liquid, dried, and frozen egg products, are foreign material, any off-conditions, or unsatisfactory odors detected? (9 CFR 590.5 (Adulteration) and 590.504(b)); and
      13. Is the plant ensuring irradiated shell eggs used to produce pasteurized egg products are subject to heat or another lethality treatment sufficient to produce egg products that are edible without additional preparation to achieve food safety (9 CFR 590.590).
   3. Each Food Safety task has two components:  a recordkeeping component and a review and observation component.  IPP are to use either of these components, or a combination of the two, to verify regulatory compliance.  For example, IPP may review the recording charts (recordkeeping component) of the continuous pasteurizer recording device (paper chart or electronic) or observe the plant employee documenting the results (observation part of the review and observation component) on the recording chart (9 CFR 590.570(a) and (b)).  IPP can then calculate and verify the holding time and flow rate (review part of the review and observation component) to determine if the plant is in compliance with the time/temperature requirements for pasteurization for the product being produced.
   4. During the recordkeeping component of a verification task, IPP are to gather information by reviewing the required charts, data recording devices, or testing results associated with food safety, e.g., 9 CFR 590.570, 590.575, and 590.580, as well as any additional relevant records generated by the plant.
      
      NOTE:  Plants engaged in the transportation, shipment, production, and receipt of eggs and egg products are required to maintain records in accordance with 9 CFR 590.200 for a period of two (2) years.  Heat treatment records associated with dried whites shall be maintained for 1 year (9 CFR 590.575(d)). 
   5. During the review and observation component of a verification task, IPP are to gather information by:
      1. Making observations about whether the plant's continuous recording device is recording the actual time/temperature measurements as required by 9 CFR 590.570(a) and (b);
      2. Observing the plant employee taking other measurements; or
      3. Observing product or conditions within the plant.
   6. When IPP document a food safety verification task in PHIS, IPP are to select on the "Activity" tab Review and Observation, Recordkeeping, or Both as the verification (also referenced as components) activity when claiming a task.
   7. If an egg products plant chooses to implement the HACCP requirements (9 CFR part 417) included in the final rule prior to their implementation date, IPP are to use FSIS Directive 5000.1, Verifying an Establishment's Food Safety System, to verify an egg products plant's compliance with those requirements.
2. VERIFICATION OF THE NON-FOOD SAFETY CONSUMER PROTECTION REGULATORY REQUIREMENTS
   1. IPP are to verify that plants comply with regulatory requirements designed to protect the consumer in ways other than ensuring food safety.
   2. When PHIS schedules a routine non-food safety consumer protection task, IPP are to perform the appropriate verification task.  This task includes verifying that plants:
      1. Comply with labeling requirements ( 9 CFR 590.410-418412.1412.2;
      2. Implement preparation or processing procedures that comply with 9 CFR 590.500-590.590);
      3. Maintain records associated with product formulation, condition, and temperature (e.g., examining lots of frozen egg products) to show compliance with 9 CFR 590.200, 590.504(l), 590.536(b) and 590.539;
      4. Maintain the records of receipt of shell eggs and loads of domestic unpasteurized liquid egg products to comply with 9 CFR 590.200 and 590.424;
      5. Receive containers of inedible egg products for storage, processing, and reshipment maintain adequate segregation and inventory controls at all times (9 CFR 590.430(b));
      6. Ensure that all loss and inedible eggs or inedible egg products meet labeling and handling requirements (9 CFR 590.504(c)(1));
      7. Ship undenatured or inedible egg products from official egg products plant and meet the labeling, packaging, segregation, and inventory controls (9 CFR 590.504(c)(2));
      8. Use only food and color additives in the processing of egg products that are approved by the U.S. Food and Drug Administration(9 CFR 590.435);
      9. Label products containing ova in accordance with 9 CFR 590.411 (9 CFR 590.440); and
      10. Receive restricted shell eggs segregated and dispose of them in accordance with 9 CFR 590.720(a)(2),(a)(3), and (a)(4).
   3. IPP are to reinspect egg products brought into an official plant in such manner and at such times as may be deemed necessary to ensure compliance with regulations (9 CFR 590.424).
      
      NOTE:  Shell egg producers/packers shipping shell eggs destined for further processing at egg product plants are to comply with labeling and handling requirements in accordance with 9 CFR 590.720.  IPP are to verify that the egg products plant ensures these shell eggs are appropriately segregated, processed, and properly disposed of. 
   4. IPP are to perform a directed non-food safety consumer protection task when, during the performance of food safety verification activities, they observe conditions or activities that cause them to suspect that the plant is not meeting non-food safety regulatory requirements.  Similarly, if while performing a scheduled non-food consumer protection verification task IPP have food safety concerns, they are to perform the appropriate food safety task as an unscheduled task and take any necessary enforcement actions.  For example, if an inspector is performing final inspection of product to determine whether it meets the time/temperature requirements for frozen product (9 CFR 590.536(b)) and upon organoleptic examination determines that the product is off-condition or has an unsatisfactory odor (9 CFR 590.5 (Adulteration) and 590.504(b)), he or she is to perform the applicable food safety task directed as instructed in Chapter II of this directive to verify the applicable regulatory requirements and to determine whether the product is adulterated and document noncompliance if appropriate.
   5. IPP are to conduct a final condition examination of the finished product (9 CFR 590.504(l)).  IPP examine product to determine whether the product complies with regulatory requirements such as product standards (21 CFR part 160), regulatory minimum or maximum limits of ingredients or components (FSIS Directive 7120.1, Safe and Suitable Ingredients Used in the Production of Meat, Poultry and Egg Products), or whether product intended for freezing fails to meet the time and temperature requirements (9 CFR 590.536).  If IPP find that product exceeds any of the maximum limits, falls below the minimum requirements, or fails to meet any of the other non-food safety regulatory requirements, there is regulatory noncompliance.  For example, during the final condition inspection of a lot of frozen product, IPP do not need to conduct an examination of all containers of the lot but rather a smaller selected sample that represents the entire lot (e.g., a minimum of two containers).  If IPP observe any containers of the representative sampling size that fail to meet the time/temperature requirements for pasteurized egg products intended to be frozen (9 CFR 590.536(b)), it would mean that the entire lot is affected and thus fails to meet the regulatory time/temperature requirements.
      
      NOTE:  The applicable non-food safety tasks include:  General Labeling, Labeling - Product Standards, Labeling - Net Weights, and Other Inspection Requirements.
3. VERIFICATION ACTIVITIES UNDER GENERAL LABELING, PRODUCT STANDARDS/IDENTITY, AND NET WEIGHTS
   1. IPP are to select one or more products in current production and verify that the applicable labels, containers, portable tanks, bulk shipments of edible egg products and packaging material bearing USDA identification meet the requirements in 9 CFR 590.411-415. 
      
      NOTE:  Starting December 28, 2020, the Labeling and Policy Delivery Staff (LPDS) will no longer issue the PY-221 form nor provide an egg products approval number.  IPP are to be aware that plants are to comply with the label approval provisions of 9 CFR part 412.1 and are responsible for obtaining label approval by submitting those requests to LPDS and maintaining labeling records.  IPP are also to be aware that the plant is required to make these records available to IPP upon request to review and substantiate compliance with applicable labeling requirements as per 9 CFR part 412, 590.220, and 590.411.
   2. IPP are to review plant records and product labels and observe plant operations to verify that the product complies with the regulations by determining whether:
      1. The plant maintains records of product formulation and processing procedures, as prescribed in 9 CFR 590.410 through 412 (9 CFR 590.200(c)), to establish that the labels meet the applicable labeling requirements under 9 CFR 412.1(e) and have been submitted to, and approved by, LPDS;
      2. The product meets any applicable product standards of identity to ensure that the label is not false or misleading;
         
         NOTE:  9 CFR 590.411(c) includes, by reference, the requirements for specific standardized egg products under FDA regulations implementing the Federal Food, Drug, and Cosmetic Act, found in 21 CFR part 160.
      3. The net weight of the product is accurately reflected on its label (9 CFR 590.411(c));
      4. All ingredients have been added in amounts that come within the maximum or minimum level specified (e.g., color preservatives);
      5. Ingredients are accurately declared on the product label in order of descending proportions by weight;
      6. All required labeling features listed in 9 CFR 590.411(c) are displayed on the label (e.g., product name, ingredients statement, address line, lot number, net contents, official identification, plant number, and nutritional labeling, unless an exemption applies);
      7. Product formulations and processing procedures are documented to ensure that labels conform to the requirements (9 CFR 590.411(c));
      8. Labels of packages of egg products produced from shell eggs treated with ionizing radiation reflect that treatment in the ingredient statement on finished product labeling (9 CFR 590.410(a)(3));
      9. Containers, portable tanks, and bulk shipments of edible egg products meet the labeling requirements per 9 CFR 590.411 through 590.414 and bear the official identification shown in Figure 1 of 9 CFR 590.413; and
      10. Bulk shipments of unpasteurized egg products (including from Salmonella enteriditis (SE) positive flock sources shell eggs) or microbial pathogen-positive egg products meet the labeling requirements per 9 CFR 590.410(c). The label must be conspicuously located and printed and affixed on material that cannot be detached or effaced due to exposure to weather and bear the official identification per 9 CFR 590.415.   IPP are to also verify that such products:
          1. Are not released into consumer channels until subjected to pasteurization, heat treatment, or other method of treatment sufficient to produce egg products that are edible without additional preparation to achieve food safety; and
          2. After pasteurization or treatment, the product may bear the official inspection mark as shown in 9 CFR 590.413.
      NOTE:  The labeling requirements in 9 CFR 590.410(c) replace the requirement for the PY-200, Egg Products Inspection Certificate to accompany the shipment and the need to apply government seals.  Egg products plants may include a statement on the company's bill of lading for bulk shipments of unpasteurized egg products (e.g., tanker) that indicates the sourced shell eggs used were from SE positive flocks.  EXCEPTION:  When IPP receive a request (e.g., from plant management) for the certification of egg products for  school lunch or a commodity specification program, IPP are to verify that egg products are manufactured, processed, and produced in compliance with any applicable standard or specification and complete FSIS Form PY-200 certificate.  Certification of egg products for bacteriological, chemical, or physical characteristics requires laboratory testing.  All laboratory samples intended for certification are submitted under the Voluntary Egg Products Inspection Program (9 CFR part 592) to which the PY-200 certificate will accompany lab samples sent to the USDA/Agricultural Marketing Service, Science and Technology National Science Laboratory for analyses. 
   3. IPP are to verify the presence and accuracy of plant records (9 CFR part 412 and 590.411(c)) substantiating that each lot produced:
      1. Complies with applicable standards of identity or product identity;
      2. Contains ingredients, including non-egg ingredients, that are food grade;
      3. Meets egg solids requirements;
      4. Has batch records that correspond with the volume of packaged product produced; or
      5. Meets other requirements as indicated on the product label (e.g., special claims, shelf-life claims).
   4. IPP are to issue an NR when product does not comply with a non-food safety regulatory requirement and are to notify the plant orally of the finding.  IPP are to consider all relevant factors when determining the amount of affected product.  Factors IPP are to consider include such items as the plant's lot identification procedures, receiving records, and production records, as well as the average amount of product produced per shift or per production line.  When necessary, IPP are to consult with their supervisor for assistance in determining the amount of affected product.
   5. IPP are to take appropriate control actions (9 CFR 590.426), such as retention of product, rejection of equipment or facilities, stopping lines, or refusing to allow the processing of specifically identified product, if they determine that misbranded or adulterated product would enter commerce.  Additionally, FSIS may rescind or refuse approval of false or misleading marks, labels, or forms of any container for use with egg products.
   6. IPP are to issue an NR when they determine that the process is out of control, resulting in economically adulterated or misbranded product.  IPP are to associate (that is, link) the NRs when noncompliances are from the same cause, as described in Chapter III of this directive.
4. IPP RESPONSIBILITIES FOR IMPORTED UNPASTEURIZED LIQUID EGG PRODUCT RECEIVED AT AN OFFICIAL EGG PRODUCTS PLANT
   1. Personnel in Headquarters (i.e., Recall Management and Technical Analysis Division (RMTAD)) will send notification via e-mail to inform Frontline Supervisor (FLS) and in-plant inspection personnel information regarding incoming shipments of imported unpasteurized liquid egg products prior to arrival at the official egg products plant.
   2. After being notified by plant management that a shipment of imported unpasteurized liquid egg products has arrived at the official egg products plant, IPP are to log into PHIS under the Import Inspector Role to retrieve the lot information.
   3. Under the Import Inspector Role, IPP are to retrieve the lot information and verify the shipment information in the PHIS system by:
      1. Clicking on Find Import Shipments on the navigation menu. Doing so will open the Import Reinspection - Shipments page;
      2. Entering the certificate number from CFIA Form 2648 that accompanied the shipment in the certificate number box and click on the Search button; and
      3. Reviewing the list of shipments on the Import Reinspection - Shipments page, (categorized by the application number) and clicking on the arrow next to the application number (which is the number that is automatically generated in PHIS when the application was originally initiated in the system) that is associated with the certificate number that was entered. This action expands the application list to show the lots (Lot ID) associated with the inspection certificate. Note that the Lot status is shown as "Received" as illustrated on the screenshot below (Figure 3a).
   4. After the Lot status is shown as being "Received," IPP are to click the blue arrow icon next to the lot ID number (Figure 3a).  By executing this action, the Import Reinspection - Lot Manager page is presented which shows the inspection assignment, known as "Types of Inspections" (TOIs) to which the IPP will be conducting (See Figure 4). The TOIs that IPP will be performing are:  Certification, Label Verification, and Product Exam-3.
   5. Once the Import Reinspection - Lot Manager page is opened, IPP are to click on the "View Application" (See Figure 4) to access FSIS Form 9540-1, Import Inspection Application (See Figure 4a) which contains the imported shipment product information that was electronically submitted by HQ personnel.
      1. IPP are to close the application by clicking on the "X" located in the upper right-hand corner of the screen in order to return to the Import Reinspection - Lot Manager page.
   6. From the Import Reinspection - Lot Manager page, IPP are to access the assignments under the TOIs field (as shown in Figure 5) by conducting the following steps:
      
      NOTE:  IPP are to review the electronically submitted FSIS Forms 9540-1, Import Inspection Application, and also the hard copy of the foreign inspection certificate that accompanies the imported unpasteurized liquid egg products shipment, CFIA Form 2648, Certificate of Inspection for Processed Eggs (green form) to be able to complete the TOIs.
      1. Click on Certification link in the TOI field to record the results of the certification verification for the shipment of domestic and imported unpasteurized liquid egg products in accordance with 9 CFR 590.915;
         1. Inspector Certification TOI page - select either Pass or Fail as applicable for certification TOI;
         2. After verifying the certification accompanying the imported shipment of unpasteurized liquid egg products are in compliance with 9 CFR 590.915, IPP are to select "Pass" and enter any information related to the inspection of the lot under the "remarks" section; and
         3. Then click Complete button to finalize this action (Figure 5c).  As can be seen in Figure 5d it will show the status as "COMPLETE and Passed" for the certification box.
         4. If during the performance of the assigned TOIs, IPP discover that the imported egg products do not comply with the U.S. regulatory requirements, IPP are to immediately inform the DO through supervisory channels for guidance and disposition of the lot.
      2. IPP are to click on Label Verification linkin the TOI field to record the results of the label verification for the shipment of imported, unpasteurized liquid egg products.  IPP are to verify that the product meets the labeling requirements as outlined in 9 CFR 590.950 and 590.955 and matches the information provided in the CFIA Form 2648. IPP are to follow the same steps under Part E, section 1, subsections a through c as illustrated under Figure 5b and 5c.
         1. After IPP complete the action of indicating that the Label Verification has met the regulatory requirements, the Import Reinspection - Lot Manager page will show the status as "COMPLETE and Passed" as shown in Figure 6a.
      3. IPP are to Perform an organoleptic examination of the product received as per 9 CFR 590.424(b), 590.925(b), and 590.930(g), along with Section V (Sampling Plans and Defect Tables for Physical Inspections) of FSIS Directive 9900.2, Import Reinspection of Meat, Poultry, and Egg Products.  To enter the results in PHIS, IPP are to click on Product Exam-3 link which takes IPP to the Import Reinspection - Product Exam-3 page as shown in Figure 7a. 
         1. When IPP access the Product Exam-3 page as shown in Figure 7a, they are to complete the required fields.  IPP are to follow FSIS Directive 9900.2, Section V (Sampling Plans and Defects Tables for Physical Inspections), Table 1, when determining the sampling plan and defect criteria for a specific product when physical inspection has been assigned.  The associated sampling plan for egg products is SP5.  IPP are to follow the procedures as outlined in section XIX (Physical Inspection of Egg Products) of FSIS Directive 9900.2 to conduct reinspection of the imported product.
         2. While executing the Product Examination TOI, IPP are to refer to Attachment 1 (Sampling Defect Tables - Inspection) and use the sampling plan SP5 when a physical examination has been assigned for egg products.  As per Attachment 1, the corresponding sampling plan SP5 references the matching Defect criteria Product Examination-3 (PE3) which is delineated in Attachment 2, (Defect Classifications - PE3).
            
            NOTE:  Product examination is an organoleptic, physical type of inspection in which IPP look for defects such as extraneous materials (i.e., wood, glass, chemical, and insects) and off-condition odors (e.g., sour, moldy).  The defects are classified either as a public health (PH) concern or as other consumer protection (OCP) concern (i.e., quality).
         3. The egg products tanker that arrives at the plant is a bulk package, (i.e., the tanker is the immediate container and represents one sample unit).  When product is bulk packaged, in this case the egg products tanker, the sample unit to be collected for the organoleptic examination should weigh approximately 12 pounds or 1.5 gallons by volume.  The numbers that should be entered in the Product Exam-3 page under the mandatory fields (marked with asterisk*) are "12" in the 'Weight Sample' box and "1" in the 'Number of Units Taken' box.
         4. If IPP observe any PH or OCP defect (i.e., off-condition, chemical, or physical hazards, etc.) after examination of the product, then IPP are to enter "1" in the "Off-Condition" or "Other Chemical/Physical Hazard" box - Public Health Critical box in PHIS, following the defect criteria description under the Product Examination (PE3) table (Attachment 2 - Defect Classification).  IPP are to clearly and accurately describe the defects details in the "Remarks" section.  IPP are to refuse entry on the lot if a public health defect is determined and notify the DO and await instructions through supervisory channels.
            
            NOTE:  These descriptions are the official record of the defect and in the case of a failed TOI, they are used as the official description of the issue conveyed to the foreign government.
         5. After IPP initiate the action of indicating that the Product Exam - 3 has met the regulatory requirements, the Import Reinspection - Lot Manager page will confirm the status as "COMPLETE and Passed" as shown in Figure 7c.
      4. Once IPP have completed all three TOIs assignments, IPP are to click on Lot Reinspection linkunder the Pending Actions as shown in Figure 8 which will open the Import Reinspection - Complete Reinspection page.  After this page has been opened, IPP are to place checkmark in the Release Acceptable Units box and then click on Complete box to finalize this action (as shown in Figure 8a).
      5. If there are no impending imported lots that require inspection, IPP can either log out of PHIS by clicking on "Sign Out" or can switch user roles (e.g., Consumer Safety Inspector) to continue conducting and performing tasks in PHIS.

CHAPTER III - DOCUMENTATION

1. DOCUMENTING VERIFICATION RESULTS IN PHIS
   1. IPP are to use PHIS to document the results of their verification tasks, including findings of regulatory compliance and regulatory noncompliance.  For additional instructions on how to use PHIS to document inspection results, please refer to the PHIS User Guide and FSIS Directive 13,000.1.
   2. After IPP have completed a verification task, they are to record the results of the task by scheduling the task and recording the results in the task results page.  They are to make the appropriate entries regarding the task and their findings of regulatory compliance or noncompliance by checking appropriate boxes, making appropriate selections from lists, or typing in text as prompted by PHIS. 
   3. PHIS will prompt IPP to select the specific regulatory requirements that they verified during the inspection task from a list and record their finding of compliance or noncompliance for each one. 
   4. When IPP find noncompliance, they are to:
      1. Notify a representative of plant management as soon as possible (before documenting the findings);
      2. Document the noncompliance in PHIS, mark the noncompliance as "finalized" (see section II, below), print the NR, and present it to plant management.  Note that PHIS will allow IPP to document one or more instances of noncompliance as separate documents within a single NR.  IPP are to finalize each individual noncompliance and present it to plant management as soon as practical, if they have not finished the inspection task.  If IPP find subsequent noncompliances during the remainder of the inspection task, those may be documented separately;
      3. Verify that the plant takes necessary actions to return to compliance with the applicable regulations found noncompliant;
      4. When the plant has returned to compliance with all regulations with which it was found not to be in compliance as documented in the NR, IPP are to mark the NR and the associated inspection task as "completed";
      5. When IPP enter inspection results in PHIS, the system will allow IPP to enter information by selecting from appropriate choices wherever possible.  In some cases, the possible selections for these data fields will be reflected by the information entered in the PHIS plant profile; 
      6. If IPP observe that the available selections do not match the plant's operations, they are to review the plant profile and make any necessary updates.  IPP are to refer to FSIS Directive 5030.2 for information about the plant profile and instructions on how to update the profile.
2. DOCUMENTING NONCOMPLIANCE
   1. When IPP find noncompliance with one or more regulatory requirements, they are to complete the NR in the PHIS electronic format following the instructions below and in the PHIS User Guide. The date, NR number, inspection task, and plant number are automatically entered by PHIS.
      
      NOTE:  The instructions below coincide with the flow for PHIS and are not in order of the numbered blocks on the printed NR.
   2. If PHIS is not operational, IPP may complete and issue a paper copy of the NR (FSIS Form 5400-4).  However, once PHIS becomes operational again, IPP are to record the applicable procedure and results and document the NR in PHIS.
      
      NOTE:  Block 7 on the printed NR is associated with information added from the PHIS task "Activity" tab.
   3. Relevant Regulations - (Block 6 on printed NR) IPP are to select one or more of the regulatory citations offered on the noncompliance page in PHIS.  PHIS will offer the regulatory citations based on the earlier recording of the regulations verified on the task results page.  IPP are to verify that the regulatory citation includes all the specific regulations and requirements that the plant did not meet. If a particular regulatory citation is not available in PHIS, IPP are to type it in the description text block.  If IPP believe that the regulatory citation should be available for a particular inspection task, they are to submit the suggestion to the Policy Development Staff (PDS) through askFSIS.   
   4. Description of Noncompliance-IPP are to include the following elements in their description:
      1. A description of each noncompliance in clear, concise terms, including the problem, time of occurrence, location, and effect on the product, if any.  The description needs to clearly explain how the IPP's findings support the determination that the plant did not meet regulatory requirements. 
      2. An explanation of how IPP notified plant management of the noncompliance (e.g., written or oral).
      3. IPP are to review recent similar NRs and select one NR to associate to the new NR.  The selected NR number appears in block 6a of the printed NR.  When there is a developing trend of noncompliance, IPP are to include the number of the previous NR with the same cause and a description of how the NR derived from the same cause is included in the description block.  When applicable, IPP are to describe any unsuccessful further planned actions taken by the plant to address the noncompliances.  IPP may document the identified trend in the meeting agenda feature of PHIS for discussion at the next meeting with establishment management (refer to the PHIS User Guide for additional instructions on the meeting agenda and MOI features of PHIS).  IPP are to discuss developing trend of noncompliance with plant management at the weekly meeting (See Chapter I, Section IV, Weekly Meetings). 
   5. Affected Product Information-IPP are to record approximate weight and product name, lot number, or other information available to identify the specific amount of product affected by the noncompliance, if any. 
   6. Product adulteration-IPP are to use the product adulteration check box on the noncompliance page to indicate if the documented noncompliance resulted in any adulterated product being produced. 
   7. Retain Tags/Rejected Tags-If IPP took a regulatory control action (US Retained/Rejected tag) in response to the noncompliance, they are to enter the tag numbers.
   8.  Sample Form Number- If IPP  are documenting a NR because of a sample result, they are to enter the sample form number associated with the non-compliant or violative sample result.
      
      NOTE:  In most cases, it is not necessary to include references to the Acts or to quote the applicable regulation in full in the description of noncompliance.
   9. Example of information to be included in the description of noncompliance:
      • At approximately 0600 hours, after the plant's pre-operational inspection and before the start of production, I performed a pre-operational Sanitation verification procedure.  I observed the following instances of noncompliance:  Heavy organic matter of liquid egg residue from previous day's production located inside multiple pipes, inlet valves, and gaskets of the High Temperature Short Time (HTST) pasteurization system.  Because these surfaces are all actual or potential product contact surfaces, organic matter and product residue in these areas could cause product to become contaminated at the start of operations.  I applied U.S. "Rejected" tag # B 1469277 to the HTST pasteurization system.  A similar noncompliance was documented on NR 05 -13, dated February 13, 2013.  The preventive measures of including procedures for cleaning the HTST pasteurization system, pipes, valves, and gaskets in a manner that will prevent organic residue formation were not implemented or were ineffective in preventing recurrence.  (9 CFR 590.522(a))
   10. 'Either Addressed To or Other Addressed To is required' (Block 4. To (Name and Title) on printed NR)-- PHIS will provide a list of names from the PHIS Plant Profile Contact tab information to select from or enter the name and title of the responsible plant official, if not listed. IPP are to enter the name of the plant official responsible for responding to the NRs.
   11. Personnel Notified - Enter the names of the plant management personnel who were notified about the noncompliance.  IPP are to select one or more names from the list offered in PHIS.  If IPP notified someone other than one of the listed contacts, they are to enter that name in the field. 
   12. Signature of Inspection Program Employee -- IPP are to sign the paper NR form after the noncompliance has been finalized and printed.
   13. Plant Management Response -- On the printed NR, this block may be completed by the plant.
   14. Signature of Plant Management and Date -- If plant management responds in writing on block 12 or block 13, a plant official should sign and date the NR.
   15. Verification Signature of Inspection Program Employee and Date -- Once a plant has returned to compliance for all the regulatory noncompliances documented in the NR, IPP are to navigate to that NR in PHIS and designate it as completed.  IPP sign and date the paper NR.
       
       NOTE: The NR can only be marked completed after IPP have verified that the plant has brought itself into compliance with the regulatory requirement that was not met and resulted in the issuance of the NR.  
   16. The plant is not required to indicate its corrective and preventive measures on the NR, and IPP may need to verify corrective actions by direct observation and reviewing records prepared by the plant.
3. TRENDS OF NONCOMPLIANCE
   1. When IPP document a noncompliance and consider whether the noncompliance is associated with previous instances of noncompliances at that plant, they are to be aware that the word "Link" on the 'Noncompliance Record (NR) - Noncompliances' screen is used to associate noncompliances as described in this part. 
   2. IPP are to associate two or more NRs when they indicate an ongoing trend of related noncompliances or systemic problems with the plant's food safety system.  The following characteristics may help IPP to identify NRs that may be associated, but these factors, by themselves, do not justify associating the NRs:
      1. Two or more NRs have the same regulatory citation;
      2. Two or more NRs resulted from the same type of inspection task; or
      3. Two or more similar NRs occurred within a reasonably close period of time.
   3. IPP are to associate NRs when they demonstrate one or more of the following trends:
      1. One NR indicates that the plant's corrective actions for a previous NR were not implemented or did not prevent recurrence of the same noncompliance; or
         
         EXAMPLE: IPP documented noncompliance with 9 CFR 590.515(a)(4) this week at Plant A when they observed that the wash water for the shell egg washer was not changed approximately every 4 hours.  Upon reviewing the NR history prior to the weekly meeting, IPP noted another noncompliance with 9 CFR 590.515(a)(4) last week that also documented the same issue.  After reviewing the plant's proposed corrective actions from the previous noncompliance, IPP find that the plant did not implement its proposal to increase the frequency of changing wash water to every 3 hours.  IPP concluded that the plant failed to implement the corrective actions, resulting in the recurrence, so they associate the two NRs.
      2. Two or more NRs demonstrate repetitive failures of the same aspect of the plant's food safety operations. 
         
         EXAMPLE: IPP documented noncompliance with 9 CFR 590.510(c) this week at Plant C when they observed that the transfer room operator was allowing ineligible leakers and dirty eggs to enter the breaking room (9 CFR 590.5).  The plant determined that the employee monitoring the shell eggs exiting the washer had not been properly trained in how to identify and remove all ineligible shell eggs exiting the washer.  The preventive measure was to re-train the employee.  Upon reviewing the NR history in preparation for the weekly meeting, IPP noted a noncompliance with 9 CFR 590.510(c) from the previous week.  In that case, the breaking machine operator was not stopping the machine and removing the contents of broken shell eggs that were of inedible interior quality.  The plant had determined that that employee was also not properly trained to handle the equipment and re-trained the employee.  Even though these two noncompliances involved different employees at different locations in the plant, IPP decided to associate them because they both indicated that the plant had a loss of process control, and that the plant's employees had not been properly trained for their assigned duties.   
   4. When IPP determine that an NR is associated with one or more previous NRs, they are to record the association and briefly describe why they determined that the NRs were associated in the "Inspection Notes" feature of PHIS.  If IPP are uncertain whether particular noncompliances are associated, they are to request assistance from their supervisor. 
   5. The FLS is to ask the following questions regarding trends of noncompliance:
      1. Do the NRs indicate a trend of ongoing related noncompliances or systematic problems with the plant's food safety operations?
      2. How much time has elapsed between associated NRs?
      3. Are there NRs over the past three months that should have been associated with other NRs?
      4. Do the NRs establish that there is a persistent problem in the plant's approach to addressing noncompliances (e.g., the plant's procedures led to repeated noncompliances)?
   6. Based on the answers to these questions, the FLS is to determine whether IPP are correctly identifying and documenting any trends of noncompliance, and whether a comprehensive food safety assessment should be recommended.

CHAPTER IV - RULES OF PRACTICE

1. GENERAL INSTRUCTIONS
   1. IPP are to be aware that the FSIS Rules of Practice in 9 CFR part 500 apply to egg products plants.  These rules of practice authorize FSIS to take certain actions against products or plants under certain conditions.  FSIS actions under the rules of practice can include regulatory control actions, such as retaining potentially adulterated products, rejecting insanitary equipment, suspending inspection, or withdrawing a plant's grant of inspection.  IPP are to take regulatory control actions in accordance with 9 CFR 500.2 to prevent adulterated or misbranded products from entering commerce or to prevent adulteration of products by exposure to insanitary conditions.  When IPP believe that their findings may warrant additional administrative actions because of ongoing trends of noncompliance or other conditions described in 9 CFR part 500, they are to discuss their findings with the FLS.  The FLS will correlate with District Office personnel to determine if enforcement actions are appropriate in accordance with FSIS Directive 5100.3, Administrative Enforcement Action Decision-Making and Methodology.
   2. IPP are to refer to FSIS Directive 5000.1, Part V - Rules of Practice, as per 9 CFR part 500 for instructions regarding the various steps of enforcement actions.
2. DATA ANALYSIS  
   
   PHIS tracks inspection activities that are used to verify the plant's compliance with the egg products inspection regulations.  The Office of Planning, Analysis and Risk Management will create a PHIS report that tracks whether inspection activities have been completed.  This report will include identifying noncompliance by the type of activity. 
3. QUESTIONS
   
   Refer questions regarding this directive 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.

For Full Directive 5030.1 Revision 3, please download the PDF version.