HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP)

  Section 1. When a HACCP Plan is Required.

  (a) Before engaging in an activity that requires a HACCP plan, a license applicant or license holder shall submit to the regulatory authority for approval a properly prepared HACCP plan as specified under Chapter 10, Section 2, and the relevant provisions of this Rule if:

    (i) Submission of a HACCP plan is required according to law;

    (ii) A variance is required as specified under Chapter 3, Sections 41(d)(iv), 62, or Chapter 6, Section 18 (b); or

    (iii) The regulatory authority determines that a food preparation or processing method requires a variance based on a plan submittal specified under Chapter 2, Section 7, an inspection finding, or a variance request.

  (b) A license applicant or license holder shall have a properly prepared HACCP plan as specified under Chapter 3, Section 63.

  Section 2. Contents of a HACCP Plan.

  (a) For an establishment or processing plant that is required under Chapter 10, Section 1, to have a HACCP plan, the plan and specification shall indicate:

    (i) A categorization of the types of potentially hazardous foods that are specified in the menu such as soups and sauces, salads, and bulk, solid foods such as meat roasts, or other foods that are specified by the regulatory authority;

    (ii) A flow diagram by specific food or category type identifying critical control points and providing information on the following:

      (A) Ingredients, materials, and equipment used in the preparation of that food; and

      (B) Formulations, or recipes that delineate methods and procedural control measures that address the food safety concerns involved;

    (iii) Food employee and supervisory training plan that addresses the food safety issues of concern;

    (iv) A statement of standard operating procedures for the plan under consideration including clearly identifying:

      (A) Each critical control point;

      (B) The critical limits for critical control point;

      (C) The method and frequency for monitoring and controlling each critical control point by the food employee designated by the person in charge;

      (D) The method and frequency for the person in charge to routinely verify that the food employee is following standard operating procedures and monitoring critical control points;

      (E) Action to be taken by the person in charge if the critical limits for each critical control point are not met;

      (F) Records to be maintained by the person in charge to demonstrate that the HACCP plan is properly operated and managed; and

  (v) Additional scientific data or other information, as required by the regulatory authority, supporting the determination that food safety is not compromised by the proposal.

  Section 3. Trade Secrets.

  (a) The regulatory authority shall treat as confidential in accordance with law information that meets criteria specified in law for a trade secret and is contained on inspection report forms and in the plans and specifications submitted as specified under Chapter 2, Section 7, and Chapter 10, Section 2.

  Section 4. HACCP Plans Required in Official Meat and Poultry Establishments.

  (a) Every official establishment shall have a written HACCP plan as specified in 9 CFR 417 Hazard Analysis and Critical Control Point (HACCP) Systems.