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U.S. Department of Health and Human Services

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FDA Food Code 2009: Annex 3 - Public Health Reasons / Administrative Guidelines - Chapter 8, Compliance and Enforcement

 

Public Health Reasons / Administrative Guidelines for:


Chapter 8 Compliance and Enforcement

Construction Inspection and Approval

8-201.12 Contents of the Plans and Specifications.
8-203.10 Preoperational Inspections.

In conjunction with the Conference for Food Protection Plan Review committee, FDA has participated in developing a document that is intended to assist regulators in reviewing food establishment plans, and industry in understanding what is expected in the plan review process. For several years, this FDA/CFP Food Establishment Plan Review Guide - 2000 has been used in the FDA State Training Team Plan Review courses.

At the plan review stage, the regulatory authority may be dealing with an agent of the permit applicant who is seeking a building permit and who is not in a position to discuss plans for safely conducting the food operation. Nonetheless, the plan review step presents a unique opportunity to lay a foundation that enables the proposed operation to proactively sustain compliance with the Code over time. Standard operating procedures (SOPs) are a part of that foundation and ideally are developed in tandem with designing the facility. Consequently, as an integral part of the plan review process, discussion needs to occur about such procedures and their scope.

SOPs need to be developed by the time of the preoperational inspection and put into effect when the food operation begins. It is recommended that such procedures be written, available for reference by the person in charge, conveyed to the appropriate employees, and available for review by the regulatory authority during inspections. Operating procedures should include definitive practices and expectations that ensure that:

  1. (1) The transmission of foodborne disease is prevented by managing job applicants and food employees as specified under Subpart 2-201,

     
  2. (2) Food is received from approved sources as specified under § 3-201.11,

     
  3. (3) Food is managed so that the safety and integrity of the food from the time of delivery to the establishment throughout its storage, preparation, and transportation to the point of sale or service to the consumer is protected,

     
  4. (4) Potentially hazardous (time/temperature control for safety) food is maintained, including freezing, cold holding, cooking, hot holding, cooling, reheating, and serving in conformance with the temperature and time requirements specified under Parts 3-4 and 3-5,

     
  5. (5) Warewashing is effective, including assurance that the chemical solutions and exposure times necessary for cleaning and sanitizing utensils and food-contact surfaces of equipment are provided as specified under Parts 4-6 and 4-7, and

     
  6. (6) Records that are specified under §§ 3-203.11, 3-203.12, and 5-205.13 are retained for inspection.

During the plan review stage, the regulatory authority and a management representative of the proposed food establishment should discuss available training options that may be used to train food employees and the person in charge regarding food safety as it relates to their assigned duties. By the time of the preoperational inspection, operating procedures for training should include definitive practices and expectations of how the management of the proposed food establishment plans to comply with ¶ 2-103.11(L) of this Code which requires the person in charge to assure that food employees are properly trained in food safety as it relates to their assigned duties.

8-402.10 Competency of Inspectors.

Regulatory agencies are encouraged to use Standard #2 of the draft FDA's Recommended National Retail Food Regulatory Program Standards to ensure employees who inspect food establishments are properly trained. Regulatory inspectors are also encouraged to seek food safety certification through a nationally recognized and accredited program.

8-501.20 Restriction or Exclusion of Food Employee, or Summary Suspension of Permit.

See discussion in Annex 3, § 2-201.12.