(a) When plans are required. A permit applicant or permit holder shall submit to the regulatory authority properly prepared plans and specifications for review and approval before:

1. (1) The construction of a retail food establishment; ^Pf
2. (2) The conversion of an existing structure for use as a retail food establishment; ^Pf or
3. (3) The remodeling of a retail food establishment or a change of type of retail food establishment or food operation as specified under 20 CAR § 197-302(d)(3) if the regulatory authority determines that plans and specifications are necessary to ensure compliance with this subchapter. ^Pf

(b) Contents of the plans and specifications. The plans and specifications for a retail food establishment, including a retail food establishment specified under subsection (c) of this section, shall include, as required by the regulatory authority based on the type of operation, type of food preparation, and foods prepared, the following information to demonstrate conformance with this subchapter provisions:

1. (1) Intended menu;
2. (2) Anticipated volume of food to be stored, prepared, and sold or served;
3. (3) Proposed layout, mechanical schematics, construction materials, and finish schedules;
4. (4) Proposed equipment types, locations, dimensions, performance capacities, and installation specifications;
5. (5) Evidence that standard procedures that ensure compliance with the requirements of this subchapter are developed or are being developed; and
6. (6) Other information that may be required by the regulatory authority for the proper review of the proposed construction, conversion or modification, and procedures for operating a retail food establishment.

(c) When an HACCP plan is required.

1. (1) Before engaging in an activity that requires an HACCP plan, a permit applicant or permit holder shall submit to the regulatory authority for approval a properly prepared HACCP plan as specified under subsection (d) of this section and the relevant provisions of this subchapter if:

   1. (A) Submission of an HACCP plan is required according to law;
   2. (B) A variance is required as specified under 20 CAR § 192-401(a)(4)(C), 20 CAR § 192-502, or 20 CAR § 193-204(j)(2); or
   3. (C) The regulatory authority determines that a food preparation or processing method requires a variance based on a plan submittal specified under subsection (b) of this section, an inspectional finding, or a variance request.
2. (2) Before engaging in reduced oxygen packaging without a variance as specified under 20 CAR § 192-502, a permit applicant or permit holder shall submit a properly prepared HACCP plan to the regulatory authority.

(d) Contents of an HACCP plan. For a retail food establishment that is required under subsection (c) of this section to have an HACCP plan, the plan and specifications shall indicate:

1. (1) A categorization of the types of time/temperature control for safety foods that are specified in the menu such as soups and sauces, salads, and bulk, solid foods such as meat roasts, or of other foods that are specified by the regulatory authority; ^Pf

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

   1. (A) Ingredients, materials, and equipment used in the preparation of that food; ^Pf and
   2. (B) Formulations or recipes that delineate methods and procedural control measures that address the food safety concerns involved; ^Pf
3. (3) Food employee and supervisory training plan that addresses the food safety issues of concern; ^Pf

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

   1. (A) Each critical control point; ^Pf
   2. (B) The critical limits for each critical control point; ^Pf
   3. (C) The method and frequency for monitoring and controlling each critical control point;
   4. (D) The food employee designated by the person in charge; ^Pf
   5. (E) 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; ^Pf
   6. (F) Action to be taken by the person in charge if the critical limits for each critical control point are not met; ^Pf and
   7. (G) Records to be maintained by the person in charge to demonstrate that the HACCP plan is properly operated and managed; ^Pf and
5. (5) Additional scientific data or other information, as required by the regulatory authority, supporting the determination that food safety is not compromised by the proposal. ^Pf