FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services
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CFSAN/Retail Food Safety Team
DRAFT: February 28, 1998; DRAFT: April 24, 2001; DRAFT: June 28, 2001; DRAFT: April 2003; DRAFT: January 2005; DRAFT: December 2007

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Draft Voluntary National
Retail Food Regulatory Program Standards


standard 2
trained regulatory staff

This Standard applies to the essential elements of a training program for regulatory staff.

Requirement Summary

The regulatory retail food program inspection staff (Food Safety Inspection Officers - FSIO) shall have the knowledge, skills, and ability to adequately perform their required duties. The following is a schematic of a 5-step training and standardization process to achieve the required level of competency.

Step 1 - Completion of curriculum courses designated as “Pre” in Appendix B-1 prior to conducting any independent routine inspections.

Step 2 - Completion of a minimum of 25 joint field training inspections,

AND

successful completion of the jurisdiction’s FSIO Assessment of Training Needs (ATN) similar to the process developed by the Conference for Food Protection. The Assessment of Training Needs Guide and Forms can be access from the CFP web site at http://www.foodprotect.org/pdf/GuideConductingAssessmentTrainingNe.pdf.

Step 3 - Completion of a minimum of 25 independent inspections

AND

remaining course curriculum (designated as “post” courses) outlined in Appendix B-1.

Step 4 - Completion of a standardization process similar to the FDA standardization procedures.

Step 5 - Completion of 20 contact hours of continuing food safety education every 36 months after the initial training is completed.

Description of Requirement

Ninety percent (90 %) of the regulatory retail food program inspection staff (Food Safety Inspection Officers - FSIO) shall have successfully completed the required elements of the 5-step training and standardization process:

Step 1 - Pre-Inspection Curriculum

Prior to conducting any type of independent field inspections in retail food establishments, the FSIO must satisfactorily complete training in pre-requisite courses designated with a “Pre” in Appendix B-1, for the following curriculum areas:

  1. Prevailing statutes, regulations, ordinances (specific laws and regulations to be addressed by each jurisdiction);
  2. Public Health Principles;
  3. Food Microbiology; and
  4. Communication Skills

There are two options for demonstrating successful completion of these pre-requisite (“Pre) courses.

OPTION 1:

Successful completion of the FDA ORA U pre-requisite courses/exercises/examinations identified as “Pre” in Appendix B-1

AND

training on the jurisdiction’s prevailing statutes; regulations and/or ordinances.

NOTE: The estimated contact time for completion of the FDA ORA U pre-requisite (“Pre”) courses is 42 hours.

OPTION 2:

Successful completion of courses deemed by the regulatory jurisdiction’s food program supervisor or training officer to be equivalent to the FDA ORA U pre-requisite (“Pre”) courses,

AND

training on the jurisdiction’s prevailing statutes, regulations and/or ordinances,

AND

successful passing of one of the four written examination options (described later in this Standard) for determining whether a FSIO has a basic level of food safety knowledge.

A course is deemed equivalent if it can be demonstrated that it covers at least 80% of the learning objectives of the comparable ORA U course AND verification of successful completion is provided. The learning objectives for each of the listed ORA U courses are available from the web site link at:


note: While certificates issued by course sponsors are the ideal proof of attendance, other official documentation can serve as satisfactory verification of attendance. The key to a document’s acceptability is that someone with responsibility, such as a trainer/food program manager who has first-hand knowledge of employee attendance at the session, keeps the records according to an established protocol. An established protocol can include such items as:
  • Logs/records that are completed based on sign-in sheets; or
  • Information validated from the certificate at the time-of-issuance; or
  • A college transcript with a passing grade or other indication of successful completion of the course; or
  • Automated attendance records, such as those currently kept by some professional associations and state agencies, or
  • Other accurate verification of actual attendance.

Regulatory retail food inspection staff submitting documentation of courses equivalent to the FDA ORA U courses – OPTION 2 – must also demonstrate a basic level of food safety knowledge by successfully passing one examination from the four written examination categories specified herein.

  1. The Certified Food Safety Professional examination offered by the National Environmental Health Association; or
  2. A state sponsored food safety examination that is based on the current version of the FDA Food Code (and supplement) and is developed using methods that are psychometrically valid and reliable; or
  3. A food manager certification examination provided by an ANSI/CFP accredited certification organization; or
  4. A Registered Environmental Health Specialist or Registered Sanitarian examination offered by the National Environmental Health Association or a State Registration Board.
note: Within the context of this Standard, the written examinations are part of a training process; NOT a standardization/certification process. The examinations listed are NOT to be considered equivalent to each other. They are to be considered as training tools and have been incorporated as part of the Standard because each instrument will provide a method of assessing whether a FSIO has attained a basic level of food safety knowledge. Any jurisdiction has the option and latitude to mandate a particular examination based on the laws and rules of that jurisdiction.

Step 2 - Initial Field Training and Experience

The regulatory staff conducting inspections of retail food establishments must conduct a minimum of 25 joint field inspections with a trainer or the jurisdiction’s designated staff member, who has successfully completed all training elements required by this Standard. The 25 joint field inspections are to be comprised of both “demonstration” (trainer led) and “training” (trainee led) inspections and include a variety of retail food establishment types available within the jurisdiction.

Demonstration inspections are those in which the jurisdiction’s trainer and/or designated staff person takes the lead and the candidate observes the inspection process. Training inspections are those in which the candidate takes the lead and their inspection performance is assessed and critiqued by the trainer. The jurisdiction’s trainer is responsible for determining the appropriate combination of demonstration and training inspections based on the candidate’s food safety knowledge and performance during the joint field inspections.

As part of the 25 joint field inspections, the jurisdiction’s trainer will conduct an Assessment of Training Needs (ATN) on those joint inspections performed as “training” inspections where the candidate takes the lead using a process and forms similar to the ones presented in The Guide to Conducting ATN. The ATN is designed not only to assess a Food Safety Inspection Officer’s readiness to conduct independent inspections, but also to provide valuable feedback on the jurisdiction’s food safety training process.

note: The ATN provides structure to the FSIO performance assessment. The performance assessment is part of a training process that provides both candidate and assessor feedback on specific knowledge, skills and abilities that are important elements of effective retail food, restaurant, and institutional foodservice inspections.
  • The ATN is NOT intended to be used for certification or licensure purposes.
  • Regulatory jurisdictions are NOT to use the ATN for administrative purposes including but not limited to, job classifications, promotions, or disciplinary actions up to and including termination.

FSIOs must successfully complete the ATN prior to conducting independent inspections and re-inspections of retail food establishments in risk categories 2, 3, and 4 as presented in Appendix B-3 (taken from Annex 5, Table 1 of the 2005 FDA Food Code) need to provide web site for this info. The jurisdiction’s trainer/food program manager can make a determination as to the FSIO’s readiness to conduct independent inspections of risk category 1 establishments as defined in Appendix B-3 at any time during the training process.

note: The criterion for conducting a minimum of 25 joint field training inspections is intended for new employees or employees new to the food safety program. In order to accommodate an experienced FSIO, the supervisor/training officer can include a signed statement or affidavit in the employee’s training file explaining the background or experience that justifies a waiver of this requirement. In lieu of the 25 joint field inspections, an ATN of experienced FSIOs must be conducted to determine any areas in need of improvement. An individual corrective action plan should be developed outlining how any training deficiencies will be corrected and the date when correction will be achieved.

Step 3 - Independent Inspections and Completion of ALL Curriculum Elements

Within 18 months of hire or assignment to the regulatory retail food program, Food Safety Inspection Officers must complete a minimum of 25 independent inspections of retail food, restaurant, and/or institutional foodservice establishments.

  • If the jurisdiction’s establishment inventory contains a sufficient number of facilities, the FSIO must complete 25 independent inspections of food establishments in risk categories 3 and 4 as described in Appendix B-3.
  • For those jurisdictions that have a limited number of establishments which would meet the risk category 3 and/or 4 criteria, the FSIO must complete 25 independent inspections in food establishments that are representative of the highest risk categories within their assigned geographic region or training area.

In addition, all coursework identified in Appendix B-1, for the following six curricula areas, must be completed within this 18 month time frame.

  1. Prevailing statutes, regulations, ordinances (all courses for this element are part of the pre-requisite curriculum outlined in Step 1);
  2. Public health principles (all courses for this element are part of the pre-requisite curriculum outlined in Step 1);
  3. Communication skills (Step 1);
  4. Food microbiology (some of the courses for this element are part of the pre-requisite curriculum outlined in Step 1);
  5. Epidemiology; and
  6. HACCP.

All courses for each of the curriculum areas must be successfully completed within 18 months of hire or assignment to the regulatory retail food program in order for FSIOs to be eligible for the Field Standardization Assessment.

note: The estimated contact time for completion of the FDA ORA U “post” courses is 16 hours. The term “post” refers to those courses in Appendix B-1 that were not included as part of the pre-requisite coursework. This includes all the courses in Appendix B-1 that do not have the designation “Pre” associated with them. All courses in Appendix B-1 must be successfully completed prior to conducting field standardizations.

As with the pre-requisite inspection courses, the coursework pertaining to the above six curriculum areas can be successfully achieved by completing the ORA U courses/exercises/exams listed under each curriculum area OR by completing courses, deemed by the regulatory jurisdiction’s food program supervisor or training officer to be equivalent to the comparable FDA ORA U courses. A course is deemed equivalent if it can be demonstrated that it covers at least 80% of the learning objectives of the comparable ORA U course AND verification of successful completion can be provided. The learning objectives for each of the listed ORA U courses are available from the FDA web site: http://www.fda.gov/ora/training/

Step 4 – Food Safety Inspection Officer – Field Standardization

Within 18 months of employment or assignment to the retail food program, staff conducting inspections of retail food establishments must satisfactorily complete four joint inspections with a “training standard” using a process similar to the ‘FDA Standardization Procedures.’ The standardization procedures shall determine the inspector’s ability to apply the knowledge and skills obtained from the training curriculum, and address the five following performance areas:

  1. Risk-based inspections focusing on the factors that contribute to foodborne illness;
  2. Good Retail Practices;
  3. Application of HACCP;
  4. Inspection equipment; and
  5. Communication.
note: The field standardization criteria described in Step 4 is intended to provide a jurisdiction the flexibility to use their own regulation or ordinance. In addition, the reference to using standardization procedures similar to the FDA Procedures for Standardization of Retail Food Inspection Training Officers, is intended to allow the jurisdiction the option to develop its own written protocol to ensure that personnel are trained and prepared to competently conduct inspections. Any written standardization protocol must include the five performance areas outlined above in Step 4.

It should be noted that it is possible and highly beneficial to use the FDA Food Code, standardization forms and procedures even when a jurisdiction has adopted modifications to the Food Code. Usually regulatory differences can be noted and discussed during the exercises, thereby enhancing the knowledge and understanding of the candidate. The scoring and assessment tools presented in the FDA standardization procedures can be used without modification regardless of the Food Code enforced in a jurisdiction. The scoring and assessment tools are, however, specifically tied to the standardization inspection form and other assessment forms that are a part of the FDA procedures for standardizations.

FDA’s standardization procedures are based on a minimum of 8 inspection. However to meet Standard #2, a minimum of 4 standardization inspections must be conducted.

Jurisdictions that modify the limits of the standardization process by reducing the minimum number of inspections from 8 to 4 are cautioned that a redesign of the scoring assessment of the candidate’s performance on the field inspections is required. This sometimes proves to be a very difficult task. A jurisdiction must consider both the food safety expertise of its staff, as well as the availability of personnel versed in statistical analysis before it decides to modify the minimum number of standardization inspections. The jurisdiction’s standardization procedures need to reflect a credible process and the scoring assessment should facilitate consistent evaluation of all candidates.

The five performance areas target the behavioral elements of an inspection. The behavioral elements of an inspection are defined as the manner, approach and focus which targets the most important public health risk factors, and communicates vital information about the inspection in a way that can be received, understood and acted upon by management. The goal of standardization is to assess not only technical knowledge but also an inspector’s ability to apply his or her knowledge in a way that ensures the time and resources spent within a facility offer maximum benefit to both the regulatory agency and the consuming public. Any customized standardization procedure must continue to meet these stated targets and goals.

Continuing standardization (re-standardization) shall be maintained by performing four joint inspections with the "training standard" every three years.

Should a jurisdiction fall short of having 90% of its retail food program inspection staff successfully complete the Program Standard #2 criteria within the 18 month time frame, a written protocol must be established to provide a remedy so that the Standard can be met. This protocol would include a corrective action plan outlining how the situation will be corrected and the date when the correction will be achieved.

Step 5 – Continuing Education and Training

A FSIO must accumulate 20 contact hours of continuing education in food safety every 36 months after the initial training (18 months) is completed. Within the scope of this standard, the goal of continuing education and training is to enhance the FSIO’s knowledge, skills, and ability to perform retail food and foodservice inspections. The objective is to build upon the FSIO’s knowledge base. Repeated coursework should be avoided unless justification is provided to, and approved by, the food program manager and/or training officer.

Training on any changes in the regulatory agency’s prevailing statutes, laws and/or ordinances must be included as part of the continuing education (CE) hours within six months of the regulatory change. Documentation of the regulatory change date and date of training must be included as part of the individual’s training record.

The candidate qualifies for one contact hour of continuing education for each clock hour of participation in any of the following nine activities that are related specifically to food safety or food inspectional work:

  1. Attendance at FDA Regional seminars / technical conferences;
  2. Professional symposiums / college courses;
  3. Food-related training provided by government agencies (e.g., USDA, State, local); and
  4. Food safety related conferences and workshops;
  5. Distance learning opportunities that pertain to food safety, such as:
    • WEB based or online training courses (e.g., additional food safety courses offered though ORA U, industry associations, universities); and
    • Satellite Broadcasts.

A maximum of ten (10) contact hours may be accrued from the following activities:

  1. Presentations at professional conferences;
  2. Providing classroom and/or field training to newly hired FSIOs, or being a course instructor in food safety;
  3. Publishing an original article in a peer-reviewed professional or trade association journal/periodical.

Contact hours for a specified presentation, course, or training activity will be recognized only one time within a 3-year continuing education period.

note: Time needed to prepare an original presentation, course, or article may be included as part of the continuing education hours. If the FSIO delivers a presentation or course that has been previously prepared, only the actual time of the presentation may be considered for continuing education credit.

A maximum of four (4) contact hours may be accrued for:

  1. Reading technical publications related to food safety.

Documentation must accompany each activity submitted for continuing education credit. Examples of acceptable documentation include:

  • certificates of completion indicating the course date(s) and number of hours attended or CE credits granted,
  • transcripts from a college or university; or
  • a letter from the administrator of the continuing education program attended.
  • a copy of the peer-reviewed article or presentation made at a professional conference.
  • documentation to verify technical publications related to food safety have been read including completion of self-assessment quizzes that accompany journal articles, written summaries of key points/findings presented in technical publications, and/or written book reports.
note: The key to a document’s acceptability is that someone with responsibility, such as a training officer or supervisor, who has first-hand knowledge of employee’s continuing education activities, keeps the records according to an established protocol similar to that presented in Step 1 for assessing equivalent courses.

Outcome

The desired outcome of this Standard is a trained regulatory staff with the skills and knowledge necessary to conduct quality inspections.

Documentation

The quality records needed for this standard include:

  1. Certificates or proof of attendance from the successful completion of all the course elements identified in the Program Standard curriculum (Steps 1 and 3);
  2. Documentation of field inspection reports for twenty-five each joint and independent inspections (Steps 2 and 3);
  3. Certificates or other documentation of successful completion of a field training process based on an Assessment of Training Needs;
  4. Certificates or other records showing proof of satisfactory standardization (Step 4);
  5. Contact hour certificates or other records for continuing education (Step 5);
  6. Signed documentation from the regulatory jurisdiction’s food program supervisor or training officer that food inspection personnel attended and successful completed the training and education steps outlined in this Standard.
  7. Date of hire records or assignment to the retail food program; and
  8. Summary record of employees’ compliance with the Standard.

The Standard 2, Program Self-Assessment and Verification Audit Form is designed to document the findings from the self-assessment and the verification audit process for Standard 2.

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