U. S. Department of Health and Human Services
Public Health Service
Food and Drug Administration

Cover Memo
Contents
Expanded Contents

COVER MEMO TO BE TRANSMITTED WITH THE STANDARDIZATION AND CERTIFICATION PROCEDURES
issued May 13, 1999
updated May 2000
updated January 2003

To:
FDA Retail Food Specialists
Candidates for Standardization and Certification
Other Users of these Procedures

From:
Retail Food Steering Committee

Subject:
FDA Procedures for Standardization and Certification of Retail Food Inspection / Training Officers

Development

We are pleased to provide these Procedures which are the result of the collective efforts over the last few years by various working groups within FDA, in consultation with the states, through the Conference for Food Protection and cooperative field application. This document has undergone many revisions and trial approaches to strike a balanced mix of the various aspects of Standardization and Certification. It focuses on preventive practices that are reflective of the Food Code interventions and that address Risk Factors known to contribute to foodborne illness, and encourages a voluntary HACCP-based response from industry to observed deficiencies.

Living Document

We believe this is a procedure that integrates the assessment of an individual's knowledge, skills, and abilities in a manageable number of inspections while preserving the quality and integrity of the process. At the same time, we continue to learn from our experiences in applying it and remain open to improving these Procedures based on your experiences and feedback.

Perspective of Procedures as Written

As they are written, the Procedures address the situation wherein an FDA Standard is assessing a CANDIDATE who is not employed by FDA. For example, Subparagraph 3-301(C) mentions but does not require recording citations (i.e., identifying the codified provision that relates to each observed violation). Since jurisdiction's codification systems (numeric or alphanumeric) are usually different from the system in the FDA Food Code, the utility of that practice would be minimal in an FDA-to-jurisdiction field exercise. However, within a jurisdiction where the same Code is in use, the practice could be useful in reinforcing diligence in ensuring that violations listed during inspections are, in fact, soundly based in regulation.

Use of Procedures

We invite and encourage jurisdictions to use these Procedures in their internal Standardization and Certifications and to add dimensions that promote uniformity such as citing codified provisions, as discussed above. With a few language changes, the document can be custom-tailored to fit individual jurisdictions and serve as their procedures. As with other documents provided as guidance for applying regulatory requirements in the retail sector, these Procedures are in the "public domain" and we encourage their duplication and use.

Significant Changes

As mentioned earlier, this document sets forth a condensed and targeted process. It also contains some significant departures, which we believe to be improvements, from the historical process. One of particular note is the fact that the design of the inspection report form evokes an active and comprehensive recording of conditions. That is, it requires the Candidate to seek out an observation regarding all Code provisions or categories of Code provisions and to record the status rather than to rely on a more passive method of citing only observed violative conditions.

We thank you for your input to date, look forward to using these Procedures with your Candidates, and encourage your assistance in improving this document as we continue to work together towards uniformity in how we go about achieving our mutual goal of FOOD safety at the retail level. FDA's Division of Federal/State Relations will be the central receiving point for your comments:

Division of Federal/State Relations
Office of Regulatory Affairs, FDA
5600 Fishers Lane (HFC-150)
Rockville, MD 20857
Phone: 301-443-6200 Fax: 301-443-2143

Parts

1. INTRODUCTION
2. DEFINITIONS

1-101 Background.

Under the authority of the Public Health Service Act as amended, the FDA has a responsibility to provide assistance to state and local retail FOOD protection programs [42 USC 243]. The FDA provides assistance to federal agency retail FOOD protection programs under authority of the Economy Act [31 USC 1535]. Assistance provided to state, local, and federal governmental bodies is also pursuant to FDA's authorities and responsibilities under the Federal Food, Drug, and Cosmetic Act [1 USC 301].

Historically, FDA has met this responsibility by offering a variety of training opportunities and technical assistance based on model codes addressing recommended sanitation and FOOD safety criteria for retail FOOD ESTABLISHMENTS. Providing model FOOD codes and model code interpretations and opinions, is the mechanism through which FDA, as a lead federal FOOD control agency, promotes uniform implementation of national FOOD regulatory policy among federal, state, tribal, and local agencies that have primary responsibility for retail FOOD safety oversight or regulation. To assure greater uniformity, FDA recommends that regulatory jurisdictions adopt the model Food Code as law or regulation.

1-102 Introduction.

The main goal of a national FOOD safety program is the reduction and prevention of foodborne illness. To that end, FDA provides several pathways, one of which is the STANDARDIZATION and CERTIFICATION of retail food inspection personnel. This process provides regulatory personnel the opportunity to subject their knowledge and skills related to the Code's provisions to a uniform system of measurement. The process and criteria for demonstrating proficiency in the required performance areas are described in the FDA Procedures for STANDARDIZATION and CERTIFICATION of Retail Food Inspection / Training Officers.

The procedures are based on the FDA Food Code and are updated to reflect current Food Code provisions and to include a more refined focus on foodborne illness RISK FACTORS, FOOD CODE INTERVENTIONS, and application of the PRINCIPLES of HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP).

It is critical that FOOD safety personnel become STANDARDIZED and subsequently CERTIFIED through this process to ensure that retail FOODs are safe, unadulterated, and honestly presented at retail throughout the United States. CERTIFICATION as an FDA-CERTIFIED INSPECTION / TRAINING OFFICER is issued to all CANDIDATES who successfully complete the STANDARDIZATION process.

1-103 Purpose.

Through the application of the procedure, the CANDIDATE will demonstrate knowledge and expertise in the understanding, application, and interpretation of FOOD CODE INTERVENTIONS, foodborne illness RISK FACTORS, and HACCP PRINCIPLES; and in the use of essential inspection equipment; and will exhibit necessary communication skills in conducting a FOOD ESTABLISHMENT inspection. This procedure is not intended to provide basic training to individual CANDIDATES.

The CANDIDATE shall meet all the requirements of the procedure, in order to be CERTIFIED by FDA. Chapter 2 of the procedure describes the qualifications required of the CANDIDATE; Chapter 3 describes the field requirements; and Chapter 4 describes the communication requirements to convey the purpose and the findings of the inspection.

CANDIDATES who are successful in achieving CERTIFICATION by FDA are expected to use the procedure to train or STANDARDIZE other inspectors within their regulatory agency.

1-104 Scope.

The procedures describe the process used by the FDA STANDARD in certifying qualified FOOD safety inspection personnel in retail FOOD ESTABLISHMENT inspection technique, based on the FDA Food Code, and leading to CERTIFICATION as an FDA-CERTIFIED INSPECTION / TRAINING OFFICER. They are also intended as a model process for states, tribes, territorial governments, local municipalities, and other governing bodies that directly regulate FOOD ESTABLISHMENTS and have FOOD safety regulatory responsibilities at retail.

1-105 Identifying Applicants.

Each state REGULATORY AUTHORITY for retail FOOD ESTABLISHMENTS, as broadly defined by the FDA Food Code, is encouraged to select at least 1 individual to be STANDARDIZED and CERTIFIED by FDA as the FDA-CERTIFIED INSPECTION / TRAINING OFFICER. The FDA-CERTIFIED INSPECTION / TRAINING OFFICER may also be CERTIFIED as a retail PROGRAM EVALUATION OFFICER by completing additional training and performance requirements. A separate procedural document will be developed for FDA CERTIFICATION of PROGRAM EVALUATION OFFICERS.

Table of Contents

1. All terms appearing throughout this document in SMALL CAPS refer to defined terms in the 1999 FDA Food Code and this document. The following definitions apply in the interpretation and application of this Procedure.

2. Terms Defined:

   1. "Applicant" means an EMPLOYEE of the FDA, state, or other REGULATORY AUTHORITY who applies for CERTIFICATION or reCERTIFICATION and is recommended to the FDA for CERTIFICATION or reCERTIFICATION by the person's supervisor.

   2. "Candidate" means:

      1. An APPLICANT who successfully completes the eligibility requirements for initial CERTIFICATION; or

      2. An FDA-CERTIFIED INSPECTION / TRAINING OFFICER who is applying for reCERTIFICATION.

   3. "Certificate" means the official document issued by FDA to a "CERTIFIED INSPECTION / TRAINING OFFICER."

   4. "CERTIFICATION" means the process by which the STANDARD verifies that a CANDIDATE meets the requirements set out in the STANDARDIZATION and CERTIFICATION procedures for INSPECTION / TRAINING OFFICERS.

   5. "Certified Inspection / Training Officer" means a person who has been issued a CERTIFICATE by the FDA, stating that the CANDIDATE has successfully met all requirements for CERTIFICATION.

   6. "Certified Program Evaluation Officer" means a person who has been CERTIFIED as an INSPECTION / TRAINING OFFICER and has also met the additional requirements for an FDA-CERTIFIED PROGRAM EVALUATION OFFICER, such as program evaluation.

   7. "Complex food preparation" means a process wherein multiple food processes are involved in the preparation of a retail food item, i.e., food is stored, prepared, cooked, cooled, reheated, hot held, and served.

   8. "CCP" means "CRITICAL CONTROL POINT," a point or procedure in a specific FOOD system where loss of control may result in an unacceptable health risk.

   9. "CL" means "CRITICAL LIMIT," the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a CRITICAL CONTROL POINT to minimize the risk that the identified FOOD safety hazard may occur.

   10. "FOOD CODE INTERVENTIONS" means the following set of new preventive measures that were introduced beginning with the 1993 Food Code. The INTERVENTIONS are:

       1. Demonstration of Knowledge;

       2. EMPLOYEE Health;

       3. Hands as a Vehicle of Contamination (also a RISK FACTOR);

       4. Time -Temperature Relationships (also a RISK FACTOR); and

       5. Consumer Advisory.

   11. "GRP" means "GOOD RETAIL PRACTICES," which are preventive measures that include practices and procedures which effectively control the introduction of pathogens, chemicals, and physical objects into FOOD. GOOD RETAIL PRACTICES are prerequisites to instituting a HACCP PLAN or RISK CONTROL PLAN.

   12. "HACCP" means "HAZARD ANALYSIS CRITICAL CONTROL POINT."

   13. "HACCP plan" means a written document that delineates the formal procedures for following the HAZARD ANALYSIS CRITICAL CONTROL POINT PRINCIPLES developed by the National Advisory Committee on Microbiological Criteria for Foods.

   14. "HACCP PRINCIPLES" means the 7 PRINCIPLES of the Hazard Analysis and Critical Control Point System which:

       1. Were adopted March 20, 1992 and amended 8/14/97, by the National Advisory Committee for the Microbiological Criteria for Foods; and

       2. Are the following:

          1. Conduct a HAZARD analysis;

          2. Identify the CCPs in the process;

          3. Establish CRITICAL LIMITS for preventive measures associated with each identified CCP;

          4. Establish CCP monitoring requirements;

          5. Establish corrective action to be taken when monitoring indicates that there is a deviation from the established critical limit;

          6. Establish procedures for verification that the HACCP system is working correctly; and

          7. Establish effective recordkeeping procedures that document the HACCP system.

   15. "HSP" means "HIGHLY SUSCEPTIBLE POPULATION," a group of persons who are more likely than other populations to experience foodborne disease because they are immunocompromised or older adults and in a facility that provides health care or assisted living services, such as a hospital or nursing home; or preschool age children in a facility that provides custodial care, such as a day care center.

   16. "NSSP" means "National Shellfish Sanitation Program,"which is a cooperative state-FDA-industry program for the sanitary control of shellfish that are shipped in interstate commerce.

   17. "Person in charge" means the individual present at a FOOD ESTABLISHMENT who is responsible for the operation at the time of the inspection.

   18. "PHF" means Potentially Hazardous Food.

       1. "Potentially hazardous food" means a FOOD that is natural or synthetic and that requires temperature control because it is in a form capable of supporting:

          1. The rapid and progressive growth of infectious or toxigenic microorganisms;

          2. The growth and toxin production of Clostridium botulinum; or

          3. In raw shell eggs, the growth of Salmonella Enteritidis.

       2. "Potentially hazardous food" includes an animal FOOD (a FOOD of animal origin) that is raw or heat-treated; a FOOD of plant origin that is heat-treated or consists of raw seed sprouts; cut melons; and garlic-in-oil mixtures that are not modified in a way that results in mixtures that do not support growth as specified under Subparagraph (a) of this definition.

       3. "Potentially hazardous food" does not include:

          1. An air-cooled hard-boiled egg with shell intact;

          2. A FOOD with an a_w value of 0.85 or less;

          3. A FOOD with a pH level of 4.6 or below when measured at 24°C (75°F);

          4. A FOOD, in an unopened hermetically sealed container, that is commercially processed to achieve and maintain commercial sterility under conditions of nonrefrigerated storage and distribution;

          5. A FOOD for which laboratory evidence demonstrates that the rapid and progressive growth of infectious or toxigenic microorganisms or the growth of S. Enteritidis in eggs or C. botulinum can not occur, such as a FOOD that has an a_w and a pH that are above the level specified under Subparagraphs (c)(ii) and (iii) of this definition and that may contain a preservative, other barrier to the growth of microorganisms, or a combination of barriers that inhibit the growth of microorganisms; or

          6. A FOOD that does not support the growth of microorganisms as specified under Subparagraph (a) of this definition even though the FOOD may contain an infectious or toxigenic microorganism or chemical or physical contaminant at a level sufficient to cause illness.

   19. "Regulatory Authority;" means the state or federal enforcement body or authorized representative having jurisdiction over FOOD ESTABLISHMENTS.

   20. "Risk-based inspection;" means a FOOD ESTABLISHMENT inspection approach focused on identifying significant behaviors and practices inherent to the FOOD ESTABLISHMENT operations with particular emphasis on the FOOD CODE INTERVENTIONS and RISK FACTORS.

   21. "RCP" means Risk Control Plan which is a mutually agreed upon written plan (between the CANDIDATE and the management of the FOOD ESTABLISHMENT) that describes a management system for control of foodborne disease RISK FACTORS. The plan delineates necessary records, responsible personnel, what needs to be controlled, and how it will be controlled.

   22. Risk Factors.

       1. "Risk factors" means improper practices or procedures, which have been identified by the centers for Disease Control and Prevention (CDC), through epidemiological data as the most prevalent contributing factors of foodborne illness or injury.

       2. "Risk factors" includes:

          1. poor personal hygiene;

          2. FOOD from unsafe source;

          3. inadequate cooking;

          4. improper holding temperatures; and

          5. contaminated EQUIPMENT.

   23. "RTE" means Ready-to-Eat Food.

       1. "Ready-to-eat-FOOD" means FOOD that is in a form that is edible without washing, cooking, or additional preparation by the FOOD ESTABLISHMENT or the consumer and that is reasonably expected to be consumed in that form.

       2. "Ready-to-eat-food" includes:

          1. POTENTIALLY HAZARDOUS FOOD that is unPACKAGED and cooked to the temperature and time required for the specific FOOD under Subpart 3-401 of the Food Code;

          2. Raw, washed, cut fruits and vegetables;

          3. Whole, raw fruits and vegetables that are presented for consumption without the need for further washing, such as at a buffet; and

          4. Other FOOD presented for consumption for which further washing or cooking is not required and from which rinds, peels, husks, or shells are removed.

   24. "Standard" means a person employed by FDA who is responsible for certifying a CANDIDATE. This person shall be CERTIFIED by the FDA center for Food Safety and Applied Nutrition (CFSAN). The STANDARD represents the FDA position on all issues during the CERTIFICATION process.

   25. "Standardization" means the process whereby a CANDIDATE demonstrates the knowledge and skills to satisfy CERTIFICATION requirements.

Table of Contents

Parts

2-1 PREREQUISITE TRAINING AND EXPERIENCE

2-101 Objective.

This chapter explains the prerequisite training and experience requirements for CANDIDATES to qualify for FDA CERTIFICATION. In order for FDA to engage in the process of field inspections for the purpose of STANDARDIZATION and CERTIFICATION, the CANDIDATE must qualify by fulfilling the training and experience requirements specified in this chapter. These eligibility requirements only apply to first time APPLICANTs for FDA STANDARDIZATION and CERTIFICATION. Once CERTIFIED, CANDIDATES for reCERTIFICATION only need to meet the CERTIFICATION maintenance requirements (see Section 3-403).

2-102 Eligibility.

1. APPLICANTS for initial FDA CERTIFICATION must:

   1. Be routinely engaged in retail FOOD protection program work;

   2. Have job responsibility for conducting FOOD safety training and/or STANDARDIZATION of other regulatory personnel;

   3. Have successfully completed within the preceding 2 years at least 20 contact hours of training in the application of FOOD science and related studies such as microbiology, epidemiology, regulations, plan review or HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP) PRINCIPLES; and

   4. Have fulfilled one or more of the following prerequisites:

      1. At least 1 year of full time experience in retail FOOD ESTABLISHMENT inspections within the past 3 years, or

      2. At least one hundred retail FOOD ESTABLISHMENT inspections performed within the past 3 years, such as enforcement, training, or consultation inspections.

2. When an APPLICANT's supervisor submits the CERTIFICATION Nomination form (Annex 1) to FDA, the APPLICANT shall provide documentation of having fulfilled the above eligibility requirements. The APPLICANT'S line supervisor must sign and date the nomination form. The completed nomination forms should be submitted to the appropriate FDA office.

3. APPLICANTS who do not meet eligibility requirements may later request CERTIFICATION, after completing the unmet requirements.

Table of Contents

Parts

3-1 SCOPE
3-2 INSPECTION EQUIPMENT REQUIREMENTS
3-3 INSPECTIONS
3-4 FDA CERTIFICATION
3-5 CERTIFICATION RENEWAL
3-6 TERMINATION OF FIELD EXERCISE
      OR CERTIFICATION SUSPENSION OR REVOCATION
3-7 APPEALS

3-101 Objective.

This chapter explains the field requirements leading to FDA CERTIFICATION.

3-102 Performance Areas.

The following areas of performance shall be addressed by the CANDIDATE during the retail FOOD ESTABLISHMENT inspections and evaluated by the STANDARD:

1. Good Retail Practices:

   The CANDIDATE shall demonstrate knowledge of current FDA Food Code provisions related to GOOD RETAIL PRACTICES and the ability to interpret and apply them.

2. Risk-Based Inspection:

   The CANDIDATE shall demonstrate knowledge of current FDA Food Code provisions related to FOOD CODE INTERVENTIONS and RISK FACTORS which are most frequently associated with foodborne illness or injury.

3. Application of HACCP:

   The CANDIDATE shall demonstrate the ability to verify compliance with an existing HACCP PLAN. In the absence of a HACCP PLAN, the CANDIDATE shall demonstrate the ability to apply all 7 HACCP PRINCIPLES to the inspection process.

4. Inspection Equipment:

   The CANDIDATE shall be equipped and familiar with inspection equipment essential to each FOOD ESTABLISHMENT inspection. During the inspection, the CANDIDATE shall demonstrate knowledge of proper use of essential inspection equipment.

5. Communication:

   The CANDIDATE shall demonstrate the ability to effectively communicate with the PERSON IN CHARGE and explain significant inspection findings to the PERSON IN CHARGE at the conclusion of the inspection.

3-103 Methodology.

1. Initial CERTIFICATION:

   The FDA STANDARD and the CANDIDATE shall conduct 8 joint field inspections of retail FOOD ESTABLISHMENTS (including at least 1 with a HACCP PLAN) selected by the STANDARD. The FOOD ESTABLISHMENTS selected for inspection during CERTIFICATION should be in risk category 3, 4, or 5 as described in the Food Code, Annex 4. All 8 inspections for initial CERTIFICATION should be completed within a reasonable period of time, not to exceed 12 months.

2. ReCERTIFICATION:

   The FDA STANDARD and the CANDIDATE will conduct 6 joint field inspections of retail FOOD ESTABLISHMENTS (including at least 1 with a HACCP PLAN) selected by the STANDARD. The FOOD ESTABLISHMENTS selected for inspection during reCERTIFICATION should be in risk category 3, 4, or 5 as described in the Food Code, Annex 4. All 6 inspections for reCERTIFICATION should be completed within a reasonable period of time, not to exceed 3 years.

3. Options of the STANDARD:

   The STANDARD has the option of adjusting the time period, type of facility selected, and methodology for inspection at any time to enhance the effectiveness of the CERTIFICATION process.

4. Performance Evaluation Methods:

   The performance of the CANDIDATE shall be evaluated by the FDA STANDARD using the methods outlined in the following table:

Table of Contents

3-201 Equipment Use.

Specific inspection equipment is required to effectively and accurately conduct an inspection and evaluate RISK FACTORS that contribute to foodborne illness in retail FOOD operations. The CANDIDATE shall be evaluated on the proper use of the inspection equipment during all inspections (refer to Subpart 3-302 (C)). Even though some equipment is listed as optional, it may be essential for some FOOD ESTABLISHMENT inspections, depending on the circumstances (Food Code, Annex 4).

3-202 Equipment List.

1. The following is a list of the essential equipment recommended to evaluate a retail FOOD operation:

   1. Necessary inspection forms and administrative materials;

   2. Lab coat or equivalent protection to cover street clothes;

   3. Head cover: baseball cap, hair net, or equivalent;

   4. Thermocouple TEMPERATURE MEASURING DEVICE;

   5. Maximum registering thermometer or temperature-sensitive tapes for verifying hot water WAREWASHER final rinse temperature;

   6. Chemical test kit for different chemical SANITIZER types;

   7. Flashlight; and

   8. Alcohol swabs.

2. The following is a list of optional equipment recommended to evaluate a retail operation:

   1. Light meter;

   2. Pressure guage;

   3. Measuring tape;

   4. Time-temperature data logger;

   5. pH meter

   6. Water activity meter; and

   7. Camera.

Table of Contents

3-301 Field Exercise.

1. CANDIDATE Inspection Duties:

   During all joint field RETAIL FOOD ESTABLISHMENT inspections, the CANDIDATE shall take the lead. The CANDIDATE shall make introductions and determine who the PERSON IN CHARGE is at the beginning of each inspection.

   The CANDIDATE shall record all observations and inspection data collected during the inspection. For the purpose of tracking temperature patterns, it is recommended that the CANDIDATE perform a preliminary survey of FOOD temperatures early in each inspection.

   At various times during the field exercise the CANDIDATE shall be directed to perform specific tasks, such as explaining code requirements, citing code provisions, calibrating inspection equipment, and preparing flow charts or reviewing HACCP records to demonstrate proficiency in each area.

2. Performance Areas:

   During the inspection, the STANDARD shall observe and evaluate the CANDIDATE, based on the CANDIDATE's interpretation and application of FDA Food Code provisions. Five performance areas are included in the evaluation:

   1. GOOD RETAIL PRACTICES;

   2. RISK-BASED INSPECTION;

   3. Application of HACCP PRINCIPLES;

   4. Inspection equipment; and

   5. Communications.

3. Determining Code Citations:

   It is recommended that when the STANDARD and the CANDIDATE are employed by the same agency, i.e., using the same set of codified provisions, each cite the appropriate code provision corresponding to each violation observed. For this section only, scoring is not used and does not impact the outcome of the CANDIDATE's performance.

4. Comparison of Findings:

   Following each joint FOOD ESTABLISHMENT inspection, the CANDIDATES shall compare their findings with the STANDARD, and the differences shall be thoroughly discussed before proceeding to the next inspection (See Annex 2). The STANDARD shall retain the CANDIDATE's inspection reports, flow charts, and RISK CONTROL PLAN to document satisfactory completion of CERTIFICATION requirements (See Annexes 2 and 3).

   At the conclusion of the field exercise, the STANDARD shall tabulate and review the CANDIDATE's inspection results and other observations to determine if the CANDIDATE has successfully completed the requirements for CERTIFICATION (See Annex 5).

3-302 Performance Criteria.

To be CERTIFIED by FDA, a CANDIDATE shall meet the following criteria for each performance area:

1. Risk-Based Inspection and Good Retail Practices:

   1. Inspection Report:
      At the conclusion of each inspection the CANDIDATE shall complete the FDA STANDARDIZATION Inspection Report (Annex 2, Section 1), based on observations and data collected during the inspection. The CANDIDATE shall determine which items on the inspection report form were in or out of compliance, not observed, and/or not applicable based on the observations.

   2. Candidate Scoring:
      The STANDARD shall grade each FDA STANDARDIZATION Inspection Report (Annex 2, Section 1), by circling each incorrectly marked item and discussing these items with the CANDIDATE after each inspection.

      The STANDARD may mark an item "S" to reflect a disagreement in a case where the CANDIDATE has the opportunity to make an observation or take a measurement and fails to do so, and intervention by the STANDARD would alert the CANDIDATE to the missed opportunity. A scoring of "S" should be used in instances such as when an opportunity to take a cooked hamburger temperature is available, but the CANDIDATE does not take the temperature and subsequently marks 5.1(B) as NO. The STANDARD's scoring of an item as "S" represents a disagreement between the CANDIDATE and the STANDARD.

      At the conclusion of each inspection, the STANDARD shall determine the number of disagreements on items and record that number in the chart provided in Annex 5. At the completion of the final inspection, the STANDARD shall total the number of disagreements for all FOOD ESTABLISHMENTS inspected.

      1. To satisfy the "RISK-BASED inspection" performance area, the CANDIDATE shall not disagree with the STANDARD on more than 11 items in any one ESTABLISHMENT in this section of the STANDARDIZATION Inspection Report and have an average score of at least 90%.

      2. To satisfy the "GOOD RETAIL PRACTICES" performance area, the CANDIDATE shall not disagree with the STANDARD on more than 5 items in any one ESTABLISHMENT in this section of the STANDARDIZATION Inspection Report and have an average score of at least 85%.

2. Application of HACCP Principles:

   During the FOOD ESTABLISHMENT inspections, the CANDIDATE shall demonstrate the proper inspection approach for FOOD ESTABLISHMENTS with preexisting HACCP PLANS and those without HACCP PLANS. Each CANDIDATE shall demonstrate an understanding of HACCP by:

   1. Flow Charts: (Required for initial CERTIFICATIONS; optional for reCERTIFICATIONS)

      1. Preparing Process Flow Charts:
         During the joint inspections, the STANDARD shall select a total of 3 food preparation processes for the CANDIDATE to describe on a flow chart to include

         1. Process 1 - "No Cook Step"

         2. Process 2 - "Same Day Service"

         3. Process 3 - "COMPLEX FOOD PREPARATION"

         The CANDIDATE shall develop each flow chart using information gained through actual observations of OPERATIONAL STEPS during an inspection. Information gained through discussions with the PERSON IN CHARGE and/or food workers should be used to substitute for a lack of observations OPERATIONAL STEPS are not occurring during the inspection. On each flow chart, the CANDIDATE shall identify the HAZARDS, CCPs, and CLs. The CANDIDATE shall indicate the CLs as stated by the FDA Food Code and by the establishment, if differing from those of the Food Code. In addition, the CANDIDATE shall also indicate to the STANDARD any CCPs which the establishment did not control.

      2. Requirements:
         The STANDARD shall grade the 3 flow charts based on the correct identification of HAZARDS, CCPs, and CLs. To satisfy this requirement, the 3 flow charts may contain no more than 2 errors or omissions. The FDA Retail HACCP Guide: "Managing Food Safety, A HAACP Principles Guide for Operators of Food Service, Retail Food Stores, and Other Food Establishments at the Retail Level", and the current edition of the FDA Food Code will be the reference documents for this exercise.

   2. Risk Control Plan: (Required for both initial CERTIFICATIONS and reCERTIFICATIONS)

      1. Developing a RISK CONTROL PLAN:
         During at least 1 of the joint inspections, the STANDARD will select a CCP that the CANDIDATE has determined is not in compliance with CLs set by the Food Code. The CANDIDATE shall complete Annex 3-1, Chart 1, in order to demonstrate a clear understanding of the observation, process, hazard, critical limits, and corrective actions that are being targeted for a risk control plan. The CANDIDATE shall develop a mock RISK CONTROL PLAN with the PERSON IN CHARGE. The RISK CONTROL PLAN should stress simple control measures that can be integrated into the daily routine of the FOOD ESTABLISHMENT. The plan should be brief and address the following points:

         1. What HAZARD needs to be controlled;

         2. How the HAZARD will be controlled;

         3. Who is responsible for control; and

         4. What monitoring, record keeping, and corrective actions are required.

      2. Requirements:
         To satisfy the requirements, all 4 points shall be addressed in the RISK CONTROL PLAN. The CANDIDATE is not required to ask the PERSON IN CHARGE to commit to implementation of the RISK CONTROL PLAN (Annex 3, Section1).

   3. HACCP PLANS: (Required for both initial CERTIFICATIONS and reCERTIFICATIONS)

      1. Verification of HACCP PLANS:
         During the joint inspections, the CANDIDATE shall select at least 1 FOOD ESTABLISHMENT to inspect that has implemented a HACCP PLAN. The CANDIDATE shall demonstrate the ability to verify that the HACCP PLAN is implemented by reviewing the FOOD ESTABLISHMENT's monitoring procedures and record keeping; verifying that CLs are met, and by substantiating that corrective actions are taken when the CLs are not met. The STANDARD shall select at least 1 CCP for the CANDIDATE to verify.

         1. The CANDIDATE shall review the records for the selected CCPs for 3 specific twenty-four hour periods, which shall include records for the current day, if possible, and 2 additional days selected at random. Based on this review, the CANDIDATE shall make the following determinations regarding monitoring, record keeping, and the performance of corrective action for a total of 9 HACCP PLAN record answers (Annex 4, Chart #2):

         2. Required monitoring was performed on the 3 selected dates;

         3. Accurate and consistent records appear for the selected dates; and

         4. Corrective action was documented in accordance with the plan when CLs were not met on each of the 3 selected dates (CANDIDATE shall select the 3 days of records through discussions with the FOOD ESTABLISHMENT management).

      2. HACCP Principles (For initial CERTIFICATION only):
         The CANDIDATE shall orally communicate to the STANDARD the HACCP PRINCIPLES and how they would apply to the FOOD ESTABLISHMENT's operation.

      3. Requirement
         The CANDIDATE shall record the determination under "Records" on the FDA STANDARDIZATION Inspection Report (Annex 2, Section 1, #14); and document findings on the HACCP PLAN Verification Summary Chart (Annex 4, Section 2, Chart #2). To satisfy this requirement, the CANDIDATE and the STANDARD shall be in agreement in at least 8 out of the 9 HACCP PLAN record answers on the HACCP PLAN Verification Summary Chart.

3. Inspection Equipment:

   The CANDIDATE shall have essential equipment (listed in 3-202) available for use during each inspection and shall demonstrate knowledge of necessary equipment to conduct a FOOD ESTABLISHMENT inspection. The CANDIDATE shall know how to properly use and maintain the equipment. Specifically, the CANDIDATE shall demonstrate that the temperature measuring device is accurate at 0:C (32:F) and 100:C 212:F).

4. Communications:

   In accordance with Chapter 4 of this procedure, the CANDIDATE shall take the lead in communicating with industry personnel during each of the inspections in 3 areas:

   1. Introduction;

   2. PERSON IN CHARGE Interview; and

   3. Exit Conference.

   During the inspections, the CANDIDATE shall demonstrate by example the concepts of FOOD safety such as washing hands at the appropriate place and time and wearing the proper inspection apparel. The STANDARD shall observe and evaluate the CANDIDATE by focusing attention on communication skills that relay to the PERSON IN CHARGE, the compliance status and any observations, concerns, and alternatives for compliance. Satisfactory performance is achieved if this information is conveyed in a way that is understood, accepted, and acted upon.

3-303 Assessment - Level of Agreement with Perfomance Criteria.

1. Chart 3 in Annex 5 can be used to tally the number of disagreements on the items between the STANDARD and the CANDIDATE in the "RISK-BASED inspection" and "GOOD RETAIL PRACTICES" sections of the STANDARDIZATION Inspection Report.

2. Criteria for Success:

   1. To achieve CERTIFICATION, the CANDIDATE shall meet minimum requirements for the 3 Performance Areas described in 3-302 (A) and (B). The CANDIDATE may receive "Needs Improvement" classification in the Equipment and Communications Performance Areas and still be CERTIFIED.

   2. When one or both of these Performance Areas is classified as needing improvement, the CANDIDATE and the CANDIDATE's supervisor shall be notified that the "Needs Improvement" area or areas must be satisfactorily addressed before reCERTIFICATION is granted. Prior to reCERTIFICATION, the CANDIDATE's supervisor must notify the STANDARD that the area or areas or concern have been addressed.

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3-401 CERTIFICATE Issuance.

Upon achieving the required level of agreement with the STANDARD, the CANDIDATE is awarded the certificate of an FDA-CERTIFIED INSPECTION/ TRAINING OFFICER. A certificate recognizing the accomplishment is forwarded to the CANDIDATE and notification is sent to the CANDIDATE's supervisor within sixty days.

3-402 CERTIFICATE Expiration.

CERTIFICATION is valid for a period of 3 years. The date that CERTIFICATION is issued and the date that it expires appear on the CERTIFICATE issued by the STANDARD.

3-403 CERTIFICATE Maintenance.

1. Official records of all CERTIFICATIONS in retail FOOD inspection shall be maintained by the STANDARD for at least 3 years.

2. CERTIFICATION shall be maintained in good standing for the 3-year period when the CERTIFIED person:

   1. Each year, attends the annual Retail Food Protection Seminar held in the CERTIFIED person's FDA region;

   2. Annually conducts and documents STANDARDIZATION exercises, in accordance with this document, with at least 5 other retail FOOD program inspection personnel; and

   3. Annually accomplishes and documents at least 1 of the following activities:

      1. Assists at least 5 retail FOOD ESTABLISHMENTS in the development of RISK CONTROL PLANS (RCP). The CERTIFIED INSPECTION/ TRAINING OFFICER shall submit a report describing the outcome of the RCP to the STANDARD, or

      2. Conducts or coordinates and documents to the STANDARD at least 5 training courses related to the retail FOOD protection program, or

      3. Performs and documents to the STANDARD any combination of training courses or RISK CONTROL PLANS that equals 5.

3. Upon written request by the CERTIFIED person, the requirements listed in Paragraph 3-403 (B) may be adjusted by the STANDARD due to special situations or circumstances.

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3-501 Requirements.

In order to renew a person's CERTIFICATION, the STANDARD and the CERTIFIED person shall conduct 6 CERTIFICATION inspections, as described in Part 3-3 and Chapter 4. A person's CERTIFICATION may not be extended beyond the expiration date unless the person successfully fulfills the criteria described in Part 3-3 and Chapter 4, and has complied with the CERTIFICATION maintenance criteria listed in Part 3-4.

3-502 Expired CERTIFICATE

If a person's CERTIFICATION expires and is not renewed, and the person subsequently reapplies for CERTIFICATION, the person shall apply in writing to the STANDARD for reCERTIFICATION giving reasons why the person is qualified and should be reCERTIFIED. The person shall submit a nomination form signed by the person's program supervisor. The STANDARD shall respond in writing to the program supervisor advising whether or not FDA will proceed with reCERTIFICATION and the conditions under which CERTIFICATION renewal may be accomplished.

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3-601 Termination of Field Exercise.

1. The STANDARD has the option to terminate the field exercise, at any time during the STANDARDIZATION procedure if the CANDIDATE is not properly prepared to achieve the required level of agreement.

2. The STANDARD shall notify the CANDIDATE and the CANDIDATE's supervisor in writing of the reasons for failure.

3. The STANDARD shall document the results of the field exercise, with the reasons for termination of the field exercise, following termination of the STANDARDIZATION procedure. This information shall be forwarded to the CANDIDATE's supervisor and a copy shall be placed in the FDA file. All evidence and conclusions reached by the Agency shall be documented in writing by the STANDARD and shall be kept for 3 years in accordance with the Freedom of Information Act.

3-602 CERTIFICATION Suspension or Revocation.

1. When a CERTIFIED person fails to fulfill the required maintenance activities described in Part 3-4, the STANDARD shall consult with the CERTIFIED person to fully examine the reasons for the failure.

2. Before suspension or revocation, the STANDARD shall consult with other appropriate personnel in the CERTIFIED person's agency and within FDA including: the center for Food Safety and Applied Nutrition (CFSAN), Office of Field Programs (OFP), Division of Cooperative Programs (DCP), Retail Food and Interstate Travel Team (RFITT), and the Office of Regulatory Affairs (ORA), Division of Federal-State Relations (DFSR).

3. The STANDARD, the RFITT, and the DFSR shall reach a decision as to whether:

   1. No action should be taken;

   2. A warning letter should be sent to the CERTIFIED person and the person's supervisor or agency;

   3. The CERTIFICATION should be suspended temporarily, with notice regarding conditions required for reinstatement; or

   4. The CERTIFICATION should be revoked.

4. The STANDARD shall notify the CERTIFIED person and the supervisor of the CERTIFIED person, in writing, of the Agency's decision.

5. All evidence and conclusions reached by the Agency shall be documented in writing by the STANDARD and shall be kept for 3 years in accordance with the Freedom of Information Act.

3-603 Request for ReCERTIFICATION after Termination, Suspension, or Revocation.

CANDIDATES may apply for another opportunity to become CERTIFIED when an unsuccessful field exercise is terminated by the STANDARD or a CERTIFICATION or suspension or revocation occurs. Before reapplying, CANDIDATES should improve their skills and areas of weakness.

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3-701 Appeals Board Members.

Representatives from the following organizations will comprise the STANDARDIZATION and CERTIFICATION Appeals Board (Appeals Board):

1. An FDA Regional Food Specialist (other than the involved STANDARD);

2. A Retail Food and Interstate Travel Team representative; and

3. A Division of Federal / State Relations representative.

3-702 Filing an Appeal.

The CANDIDATE, after being notified of the CANDIDATE's failure to successfully achieve CERTIFICATION or reCERTIFICATION, may appeal the decision. Should the CANDIDATE elect to submit an appeal, this action must be initiated within thirty days of the date of the written notification of the termination, suspension, or revocation.

3-703 Appeals Board Meeting.

Upon receipt of a CANDIDATE's appeal by the FDA, a meeting of the Appeals Board will be held to determine if the argument regarding the failed STANDARDIZATION process is worthy of being heard.

3-704 Hearings.

1. Preliminary Hearing:
   

   If the appeal is not convincing, the decision of the FDA STANDARD to terminate the field exercise will stand. Should the Appeals Board determine that the CANDIDATE's argument holds merit, the CANDIDATE and the FDA STANDARD shall be notified in writing that a hearing will be held, including a date and time for the hearing.

2. Hearing Procedure:

   At the hearing, the following procedure will be followed:

   1. The CANDIDATE will present the CANDIDATE's argument for reversing the STANDARD's decision;

   2. The Appeals Board will have the opportunity to question the action or conduct of the CANDIDATE and the STANDARD; and

   3. The Appeals Board will make a decision regarding the FDA STANDARD's decision; the Appeals Board decision will be either to let the decision stand or to consider conducting an additional CERTIFICATION exercise.

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Parts

4-1 Application

4-101 Objective.

Skillful communication is essential to the inspection process in order to effectuate needed changes by the PERSON IN CHARGE . This chapter highlights the importance of communication skills during an inspection. Activities and responsibilities involved in a retail FOOD inspection program require a person to speak and to listen effectively.

Many different types of communication skills and approaches are necessary and valuable during the inspection process. The CANDIDATE shall be required to take the lead in communicating with industry personnel during all inspections and the STANDARD shall evaluate the CANDIDATE's communication skills.

4-102 Introduction.

1. The CANDIDATE shall be required to make all introductions. A complete introduction consists of:

   1. Introducing all persons participating in the inspection;

   2. Presenting credentials or identification;

   3. Describing the purpose and flow of the inspection;

   4. Identifying and explaining to the PERSON IN CHARGE that it will be necessary to ask questions about the operation during the inspection; and

   5. Explaining that this is not intended as a regulatory inspection and that there will be no written report left at the end of the inspection; however, significant findings will be brought to the attention of the PERSON IN CHARGE.:

   In addition to verbal and written communication, the CANDIDATE shall also use the inspection process to communicate and demonstrate FOOD safety concepts by example. Activities such as proper handwashing, SANITIZING thermometers before probing FOODS, and wearing the proper inspection apparel should be used to reinforce spoken and written communications.

4-103 Interview with the PERSON IN CHARGE.

The CANDIDATE shall conduct a discussion with the PERSON IN CHARGE to determine:

1. If a HACCP PLAN exists, and if so, whether the PERSON IN CHARGE understands the PRINCIPLES of the HACCP PLAN and is ensuring that the EMPLOYEES are effectively using the plan;

2. What training is provided for EMPLOYEES and managers that is relevant to applying the FOOD CODE INTERVENTIONS and controlling foodborne illness RISK FACTORS;

3. What EMPLOYEE health policies are in effect; and

4. What POTENTIALLY HAZARDOUS FOODS are on the menu and what production activities are ongoing at the time of inspection.

4-104 Exit Conference.

At the exit conference, the CANDIDATE shall clearly:

1. Convey and discuss in detail with the PERSON IN CHARGE the inspection findings including:

   1. The compliance status of the FOOD ESTABLISHMENT describing each significant violative condition and, where appropriate, acceptable compliance alternatives,

   2. The response and plans of the PERSON IN CHARGE for correcting violations, including a RISK CONTROL PLAN, and

   3. Corrective actions observed during the inspection. Such proactive FOOD safety measures should be commended.

2. Explain the public health significance of the RISK FACTORS and FOOD CODE INTERVENTIONS, GRPs, and the CCPs which do not meet the CLs as established in the Food Code; and

3. Demonstrate the ability to discuss and resolve in a courteous and professional manner, issues that the PERSON IN CHARGE might not agree with or clearly understand.

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