Standardization of Retail Food Safety Officers - Chapter 1
FDA Procedures for Standardization of Retail Food Safety Inspection Officers
Under the authority of the Public Health Service Act as amended, the U.S. Food and Drug Administration (FDA) has a responsibility to provide assistance to state and local retail food protection programs [42 USC 243]. FDA provides assistance to federal agency retail food protection programs under authority of the Economy Act [31 USC 1535]. Assistance provided to federal, state, and local governmental bodies is also pursuant to FDA's authorities and responsibilities under the Federal Food, Drug, and Cosmetic Act [21 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 and foodservice establishments. Providing the model FDA Food Code and model code interpretations and opinions is the mechanism through which FDA, as a lead federal food protection 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 ensure greater uniformity, FDA recommends that regulatory jurisdictions adopt the model FDA Food Code as law or regulation.
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 of retail food inspection personnel. This process provides regulatory personnel with 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 of Retail Food Safety Inspection 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 and Critical Control Point (HACCP).
It is critical that food safety personnel become standardized through this process to ensure that retail foods are safe, unadulterated, and honestly presented throughout the United States. A certificate of standardization as an FDA standardized food safety inspection officer is issued to all candidates who successfully complete the standardization process.
The purpose of the FDA standardization procedure is to promote uniformity of regulatory retail food inspections among federal, state, local and tribal agencies. In addition, it is used to reduce the risk of foodborne illness based on a science-based interpretation of the Food Code and effective principles to achieve compliance. The application of the standardization procedure will ensure that the Candidate recognizes foodborne illness risk factors, Food Code interventions, and good retail practices. The procedure will confirm that the Candidate can achieve practical and immediate correction of Out of Compliance (OOC) foodborne illness risk factors during the inspection, can effectively communicate with the establishment's staff, can understand and apply HACCP principles and use necessary inspection equipment in a risk-based, real-time regulatory inspection.
This procedure is not intended to provide basic training to individual candidates but rather is intended to confirm a high level of knowledge, understanding and application of food safety principles.
The Candidate shall meet all the requirements of the procedure in order to be standardized 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 findings of the inspection as well as achieve corrective action and compliance. A template for a risk-based standardization inspection can be found in Annex 6.
The template (Annex 6-2) provides a list of recommended inspection activities for both standardization candidates and regulatory inspectors. Both types of inspection should contain aspects of evaluation/auditing and education/training for short term and long term correction of violations. The primary focus of either type of inspection should be on provisions of the Food Code that directly eliminate, prevent or reduce to an acceptable level, hazards associated with foodborne illness or injury or on provisions that support or facilitate them. The 2009 Food Code designates these provisions as Priority and Priority Foundation Items, respectively. Earlier versions of the Food Code referred to critical and non-critical items.
candidates who are successful in achieving standardization by FDA are expected to use the procedure to train or standardize other inspectors within their regulatory agency in a manner that is consistent with routine regulatory inspections.
The procedures in this manual describe the process used by the FDA standard standardizing qualified food safety inspection personnel in retail food establishment inspection techniques based on the FDA Food Code. Successful completion of the process results in standardization as a FDA standardized food safety inspection officer.
The standardization process encompasses both auditing the performance of the Candidate and training to improve the performance of the Candidate. The FDA standard evaluates the applicant's understanding and application of the Food Code provisions during inspections of food establishments. In addition, the FDA standard evaluates the inspection technique used by the applicant, and he or she imparts knowledge during the standardization exercise to assist the Candidate with becoming more proficient in the understanding and application of the FOOD CODE and risk-based inspection technique. The standard will discuss, explain and correct interpretations and marking of the inspection report after each inspection. The standard may also take the opportunity through "teaching moments" during the inspection to point out examples that illustrate new Code provisions, interpretations or industry changes.
The procedures used in the standardization process are intended as a template for a regulatory inspection conducted by federal, state, local and tribal governing bodies that directly regulate food establishments at the retail level. The process of questioning to clarify procedures and methods helps understanding of operations before and after the inspection and is especially useful during foodborne outbreak investigations.
1-201 Applicability and Terms Defined
- Terms defined in this document appear in small caps and are defined in (B) below. These definitions apply in the interpretation and application of this procedure.
- "applicant" means an employee of FDA, state, or other regulatory authority who applies for standardization or re-standardization and is recommended to the FDA for standardization or re-standardization by the person's supervisor.
- "candidate"means a regulatory officer whose duties include the inspection of retail food and foodservice establishments, may also include standardization of other Food Safety Inspection Officers, and is:
- An applicant who successfully completes the eligibility requirements for initial standardization, or
- An FDA standardized food safety inspection officer who is applying for re-standardization.
- "certificate" means the official document issued by FDA to a standardized food safety inspection officer.
- "critical control point (CCP)"means a point or procedure in a specific food system where loss of control may result in an unacceptable health risk.
- "critical limit (CL) "means 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.
- "foodborne illness risk factors" means improper practices or procedures which are most frequently identified by epidemiologic investigation as a cause of foodborne illness or injury at the retail level:
- Improper holding temperatures;
- Inadequate cooking;
- Contaminated equipment;
- Unsafe source; and
- Poor personal hygiene.
- "good retail practices (GRP)" means the 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 and are not addressed by the food code interventions or foodborne illness risk factors.
- "interstate certified shellfish shippers list (ICSSL)" means an FDA publication of shellfish dealers, domestic and foreign, who have been certified by a state or foreign authority as meeting the public health control measures specified in the National Shellfish Sanitation Program (NSSP).
- "food code interventions" means the preventive measures identified in the FDA Food Code to protect consumer health:
- Management's demonstration of knowledge;
- Employee health controls;
- Controlling hands as a vehicle of contamination;
- Time/temperature parameters for controlling pathogens; and
- Consumer advisory.
- "risk-based inspection" a food establishment inspection approach that utilizes the technical skills and attributes identified in the five performance areas, foodborne illness risk factors and food code interventions, Good Retail Practices, Application of haccp, Inspection Equipment, and Communication as specified in Subpart 3-102 with particular emphasis on food code interventions and foodborne illness risk factors.
- "risk control plan (RCP)" means 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 illness risk factors. The plan delineates necessary records, responsible personnel, what needs to be controlled, and how it will be controlled
- "standard" means a person employed by FDA who is responsible for standardizing a candidate. This person shall be standardized by the National by the National standard or designee from FDA's Center for Food Safety and Applied Nutrition (CFSAN). The standard represents the FDA position on all issues during the standardization process.
- "standardization"means the process whereby a candidate demonstrates the knowledge and skills to satisfy requirements for a standardized food safety inspection officer as stated in this procedure
- "standardized food safety inspection officer"means a person who has been standardized by FDA and has successfully met all requirements for standardization.