NOTE: DO NOT IMPLEMENT THIS DIRECTIVE IN EGG PRODUCTS ESTABLISHMENTS UNTIL OCTOBER 29, 2021.

CHAPTER I - GENERAL

1. PURPOSE
   1. This directive provides comprehensive instructions to inspection program personnel (IPP) on how they are to protect the public health by properly verifying an establishment's compliance with the pathogen reduction, sanitation, and the Hazard Analysis and Critical Control Point (HACCP) regulations. This directive is being revised to add minor clarifications and incorporate instructions to IPP assigned to egg products establishments related to the implementation of Sanitation Standard Operating Procedures (Sanitation SOPs) and Sanitation Performance Standards (SPS) that become effective on October 29, 2021 (85 FR 68640) and the revised regulations under the Rules of Practice. This directive also provides comprehensive direction for IPP to verify compliance with sanitation regulations in official import inspection establishments and egg products establishments and for taking enforcement actions. This directive provides documentation procedures under the Public Health Information System (PHIS).
      
      NOTE: In this directive, the term IPP refers to Consumer Safety Inspectors and Public Health Veterinarians.
   2. IPP stationed at official import and egg products establishments are to refer only to the chapters of this directive as they relate to SPS, Sanitation SOPs, and documentation/enforcement. IPP at egg products establishments that have not voluntarily opted in early to HACCP or official import establishments are NOT to perform the verification activities in Chapter III- HACCP or Chapter IV- Pathogen Reduction Activities. The following chapters are applicable to inspection procedures at official import and egg products establishments:
      • Chapter I - General
      • Chapter II - Sanitation
      • Chapter V - Documentation and Enforcement
      • Chapter VI - Rules of Practice
      NOTE: FSIS has offered the option for egg products establishments to implement HACCP requirements before October 29, 2022. Chapter III- HACCP does apply in egg products establishments that have been approved by the District Office to opt-in early to implement HACCP requirements in 9 CFR part 417.
   3. IPP are to note that in PHIS and throughout this directive, they will see the term "establishment" used for egg products plants.
      
      KEY POINTS:
      • Provides IPP instructions for verification of SPS, Sanitation SOP, and HACCP regulatory requirements in PHIS.
      • Defines and outlines the components of an establishment HACCP system.
      • Adds instructions for IPP at official import establishments and egg products establishments to verify Sanitation SOPs and SPS requirements.
      • Provides IPP instructions for documentation of HACCP system verification results.
2. CANCELATION
   FSIS Directive 5000.1, Rev. 5, Verifying an Establishments Food Safety System, 04/04/2017
3. BACKGROUND
   1. Section 608 of the Federal Meat Inspection Act (FMIA), Section 456 of the Poultry Products Inspection Act (PPIA), and Section 1035 of the Egg Products Inspection Act (EPIA) authorize the Secretary to require establishments to be maintained and operated in such a sanitary manner to prevent adulterated products from entering commerce.
   2. Based on the authority of the FMIA, PPIA, and EPIA, FSIS applies the official mark of inspection to products that Agency IPP find are not adulterated. To produce unadulterated product, establishments are to implement a food safety system that includes assessing what food safety hazards are reasonably likely to occur in the establishment's production process, maintaining conditions to produce a safe product, and maintaining controls necessary to prevent the development of hazards during the operation of the establishment.
   3. To achieve these results, the establishment needs to have a validated food safety system. The food safety system that the regulations require is HACCP. A HACCP system consists of the following components:
      1. A flow chart describing the steps in each process and product flow;
      2. The hazard analysis with its supporting documentation; and
      3. The HACCP plans the establishment implements to control food safety hazards identified as reasonably likely to occur.
   4. The regulations also require that the establishment maintain Sanitation SOPs and meet the SPS requirements. Sanitation SOPs are a prerequisite to the HACCP plan, and the establishment may use Sanitation SOPs to support decisions in the hazard analysis that certain hazards are not reasonably likely to occur. Establishments may also maintain other prerequisite programs to support decisions in their hazard analysis.
4. COMMUNICATING WITH ESTABLISHMENT MANAGEMENT
   1. When IPP rotate into an assignment, or when IPP are newly assigned to an establishment, they are to review the establishment's history, which is reflected in the establishment's home page in PHIS. If the IPP have questions or concerns about the establishment's history, they are to consult with the Frontline Supervisor (FLS). IPP are to be familiar with the following elements of the establishment history:
      1. PHIS records of recent noncompliances including the corrective and preventive measures that the establishment provided to address the noncompliances;
      2. The results of any recent or ongoing FSIS verification sampling activities from the PHIS establishment home page;
      3. The findings and outcomes from the most recent Food Safety Assessment conducted at the establishment; and
      4. If an enforcement action has been deferred, or if a suspension has been held in abeyance at the establishment, the Agency's expectations, as described in the verification plan, and the results of the Agency's findings from verifying the effectiveness of the corrective and preventive measures that were proffered by the establishment. IPP are also to become familiar with the conditions that led the Agency to bring the enforcement action that has been deferred or resulted in the suspension that is in abeyance.
5. ENTRANCE MEETING
   1. When IPP rotate into an assignment or conduct an inspection at an establishment for the first time, they are to:
      1. Review the establishment's Sanitation SOPs, HACCP plan, and prerequisite programs;
      2. Review the establishment profile in PHIS to become familiar with the information in the profile. As IPP become familiar with the establishment operations, they are to update the PHIS establishment profile appropriately;
      3. Have an entrance meeting (at the first weekly meeting) with the establishment management to familiarize themselves with the establishment and inquire about the specific operations of that establishment. Also, if the IPP have questions based on their review of the programs, they are to ask these questions at the meeting; and
      4. Take notes at the entrance meeting and document the notes in a Memorandum of Interview (MOI) and provide a copy to the establishment.
   2. IPP are to ask establishment management about the location of the applicable records and the local arrangements for FSIS personnel to access and review the records. Establishments are required to provide access to records needed by IPP to perform their duties. However, IPP are to review the necessary records in the location specified by establishment management. IPP are not to maintain any copies of the establishment's written programs or data from such programs in the inspection office.
   3. IPP are to ask about any previously agreed upon notification (i.e. when IPP notify plant management to allow the establishment sufficient time to hold product) when Agency sampling is performed at the establishment. IPP need to know this information so that an establishment can properly control sampled product pending FSIS test results.
   4. In addition to the MOI, PHIS has a separate 'Meeting Agenda' feature that allows IPP to document notes or concerns for meetings with establishment management. IPP may use this feature to generate an agenda for the weekly meeting. This feature will help ensure that all appropriate issues are covered and documented.
6. Weekly meeting
   1. IPP are to have weekly meetings with establishment 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 establishment management when requested. In addition, establishment 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 establishment employees.
   2. On a periodic basis, about once a month as scheduled using the PHIS 'Update Establishment Profile' task, IPP are to ask establishment 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 establishment 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 establishment profile in PHIS as necessary to ensure that it accurately reflects establishment's operations and programs. See FSIS Directive 5300.1, Managing the Establishment Profile in the Public Health Information System for instructions on maintaining the establishment profile.
   3. IPP are to take notes at the weekly meetings and may document the notes in a 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 establishment management with a copy of the MOI. If after the establishment receives their copy of the MOI, it objects to anything written in the MOI, IPP are to follow the instructions in FSIS Directive 5010.1. IPP are toattach any documents provided by the establishment in the weekly meeting and reference the attachment in the MOI.
7. GENERAL PHIS VERIFICATION THOUGHT PROCESS
   1. When conducting any of the verification activities in this directive, IPP are to follow the thought process:
      1. Gather all available information;
      2. Assess the significance and meaning of the information gathered;
      3. Determine whether the information supports a finding of regulatory compliance; and
      4. Put it all together and document "findings," in PHIS.
   2. To gather all available information, IPP need to be aware that each verification task in this directive requires that they verify that the establishment complies with certain regulatory requirements. When IPP perform each verification task, they are to begin by collecting information that will help them determine whether the establishment is meeting the applicable regulatory requirements. In order to gather the appropriate information, IPP are to do the following:
      1. Review establishment programs and supporting documentation;
      2. Review establishment records documenting implementation of its programs;
      3. Observe establishment employees implementing the establishment's programs and procedures;
      4. Observe the conditions in the establishment; and
      5. Observe product and occasionally take measurements as specified in the establishment programs.
   3. To assess the significance and meaning of the information gathered, IPP are to consider what each piece of information, either taken separately or with other findings, says about how the food safety system is functioning to ensure that products are safe and wholesome (not adulterated). IPP are also to consider information 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 establishment getting worse over time?
      2. Are the same or similar problems occurring repeatedly or consistently occurring on a seasonal basis?
      3. Is the establishment responding effectively and in a timely manner to problems that do arise?
   4. To determine whether the information supports a finding of regulatory compliance, IPP are to decide, based on all the available information, whether one of the following findings emerges from the evidence:
      1. That the establishment is not maintaining sanitary conditions;
      2. That the establishment has produced or shipped adulterated products;
      3. That the establishment's food safety system is not effectively controlling the relevant food safety hazard; and
      4. That the establishment is not meeting the requirements in one or more regulations.
   5. If IPP are uncertain whether the information supports a particular determination, they are to discuss the issue with their immediate supervisor. IPP in slaughter establishments are to consult with a Public Health Veterinarian (PHV) or Supervisory Consumer Safety Inspector (SCSI) assigned to the establishment if they are uncertain about whether the available information supports a particular determination. PHVs are to consult with the FLS as necessary. IPP in processing and import establishments are to consult with the FLS.
   6. To put it all together, it is important that IPP consider each piece of information in the context of the food safety system. For example, IPP may identify several minor concerns regarding the hazard analysis. Each one, by itself, may not be sufficient to determine noncompliance, but considered together in the context of the establishment's total system, the concerns may indicate that there is a potential systemic problem. Thus, each finding should be evaluated for what it shows regarding the effectiveness of the food safety system and the potential for developing product adulteration. At the end of the process, IPP are to document their findings in PHIS.
   7. The following questions will help IPP to consider the significance of each finding for the food safety system:
      1. Is this piece of information part of a pattern?
         
         EXAMPLE: If the establishment skipped a measurement for a prerequisite program, is this an isolated incident, or does the establishment regularly fail to implement prerequisite procedures in its food safety system?
      2. Is there other information to indicate that the system is working or is not working?
         
         EXAMPLE: An establishment's prerequisite program for received products requires that they come with certificates of analysis (COA) from suppliers, as well as periodic testing of incoming product. If the establishment failed to receive a COA for a particular product, how did the establishment respond in its decisions on whether to use the product?
      3. Does the information seem to agree with the other available information about the food safety system?
         
         EXAMPLE: The establishment uses a prerequisite program to support that a hazard is not reasonably likely to occur in incoming products, and the records associated with the incoming products appear to show that the particular hazard is being prevented. The establishment's testing of finished product for the hazard finds positive results.
      4. Do these results support each other, or is there an apparent contradiction?
      In the above example, if the establishment is finding positive results for pathogens, what has it identified as the cause if it has determined that the hazard is not reasonably likely to occur?
   8. When IPP document noncompliance related to the hazard analysis, supporting documentation, and prerequisite programs, they are to describe why the findings led them to a determination of noncompliance.
   9. Many establishments have developed unique and complicated food safety systems. FSIS understands that IPP will not always be able to determine the significance of their findings. When IPP have concerns about the establishment's hazard analysis but are unable to determine whether their findings constitute noncompliance, they should discuss their concerns with their supervisor.
   10. The safety of meat and poultry products depends on establishments developing and implementing effective food safety systems. IPP are in the best position to identify concerns about the effectiveness of an establishment's food safety system because they are familiar with the daily operations and actual conditions in the establishment. By identifying concerns about the hazard analysis, supporting documentation, or prerequisite programs, IPP are acting to protect the public health by preventing products that present a risk from entering commerce.
   11. If IPP have concerns that there are systemic problems with the establishment's food safety system, or that there is reason to believe that product may have become adulterated, IPP are to bring these issues to the attention of their supervisor immediately.
8. 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 duties are performed in accordance with prescribed inspection methods and procedures addressed in this directive.
   2. FSIS supervisory personnel are to engage in discussion with IPP about their findings related to the establishment's HACCP system. Supervisors are to assist IPP with concerns raised about establishment documentation and prerequisite programs that support decisions in the hazard analysis and assist IPP in making supportable decisions about whether the establishment documentation meets the requirements of 9 CFR 417.5(a)(1).
   3. Supervisors are to discuss how establishment testing results and other data that may not explicitly be part of the establishment's critical control points (CCP) or prerequisite programs might influence IPP's thought process regarding the effectiveness of an establishment's HACCP system. Supervisors are to assist IPP in considering an establishment's hazard analysis, prerequisite programs, HACCP plans, Sanitation SOPs, and other programs in an integrated way and discuss ways in which findings in one area may impact other parts of a particular establishment's HACCP system.
   4. Supervisory personnel are to ensure that IPP are correctly applying the inspection methodology, are making informed decisions, are properly documenting findings, and are taking the appropriate enforcement actions as instructed in this directive.
   5. Supervisory personnel should refer to the current version of the FSIS Guide for Conducting In-Plant Performance System (IPPS) Assessments for additional guidance and instructions.

CHAPTER II - SANITATION

PART I - INTRODUCTION

PART II - SPS

1. VERIFYING SPS REQUIREMENTS ARE MET UNDER PHIS
2. GENERAL SPS REGULATIONS
3. GROUNDS AND PEST CONTROL
4. CONSTRUCTION
5. LIGHTING
6. VENTILATION
7. PLUMBING AND SEWAGE
8. WATER SUPPLY AND WATER, ICE, AND SOLUTION REUSE
   • WATER SUPPLY AND USE
   • REUSE OF WATER, ICE, AND SOLUTIONS FOR RTE PRODUCT
   • REUSE OF WATER, ICE, AND SOLUTIONS FOR RAW PRODUCT
9. DRESSING ROOMS AND LAVATORIES
10. EQUIPMENT AND UTENSILS
11. SANITARY OPERATIONS
12. EMPLOYEE HYGIENE

PART III SANITATION SOPs

1. SANITATION SOPs
2. VERIFYING SANITATION SOP REGULATORY REQUIREMENTS IN PHIS
3. SANITATION SOP OPERATIONAL AND PRE-OPERATIONAL VERIFICATION TASKS
4. SELECTING EQUIPMENT AND AREAS FOR PRE-OPERATIONAL SANITATION SOP VERIFICATION
5. IMPLEMENTATION AND MONITORING OF SANITATION SOPs
6. MAINTENANCE OF SANITATION SOPs
7. SANITATION SOP CORRECTIVE ACTIONS
8. SANITATION SOP RECORDKEEPING

CHAPTER III - HACCP

PART I - INTRODUCTION

1. GENERAL
2. HAZARD ANALYSIS
3. IPP VERIFY HACCP REGULATORY REQUIREMENTS

PART II - VERIFYING HACCP IN PHIS

1. GENERAL - PERFORMING THE HACCP VERIFICATION TASK
2. VERIFYING IMPLEMENTATION OF THE HACCP PLAN
3. IPP VERIFICATION OF HACCP IMPLEMENTATION

CHAPTER IV - PATHOGEN REDUCTION ACTIVITIES

1. TESTING FOR GENERIC E. coli
2. SAMPLE COLLECTION
3. SAMPLING FREQUENCY
4. SAMPLE ANALYSIS
5. RECORDING OF TEST RESULTS
6. EVALUATION OF RESULTS

CHAPTER V - DOCUMENTATION AND ENFORCEMENT

1. DOCUMENTING VERIFICATION RESULTS IN PHIS
2. DOCUMENTING NONCOMPLIANCE
3. DOCUMENTATION OF SPS VERIFICATION RESULTS
4. DOCUMENTATION OF SANITATION SOP VERIFICATION RESULTS
5. DOCUMENTING HACCP VERIFICATION RESULTS
6. DOCUMENTING GENERIC E. coli VERIFICATION RESULTS
7. TRENDS OF NONCOMPLIANCE

CHAPTER VI - RULES OF PRACTICE

1. ENFORCEMENT ACTIONS
2. REGULATORY CONTROL ACTION
3. WITHHOLDING ACTIONS AND SUSPENSIONS (PRIOR NOTIFICATION NOT NECESSARY)
4. WITHHOLDING ACTION OR A SUSPENSION ACTION (PRIOR NOTIFICATION GIVEN)
5. NOIE
6. ABEYANCE
7. VERIFICATION PLANS
8. DATA ANALYSIS
9. QUESTIONS
   Refer questions regarding this directive to your supervisor or if 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 HACCP inquiry type for general HACCP questions, HACCP Deviation & HACCP Validation for questions about pathogen modeling or product dispositions after a critical limit deviation and HACCP validation, or 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 5000.1 Revision 6, please download the PDF version.