.17 Facility and Process Plan Review.

A. The person-in-charge shall ensure that properly prepared plans and specifications are submitted to the Department:

(1) Before:

(a) A food processing plant is:

(i) Constructed;

(ii) Remodeled; or

(iii) Materially altered;

(b) An existing building or structure is converted or remodeled for use as a food processing plant; or

(c) A food process is added or modified so that:

(i) A plant or plant facilities require modification; and

(ii) Process critical control points are added;

(2) That include the following information:

(a) A scale drawing in horizontal view that shows the:

(i) Layout and arrangement of work areas;

(ii) Location of food equipment including exhaust ventilation hoods; and

(iii) Location of plumbing and plumbing fixtures such as water lines, sewer lines, hand sinks, toilets, utility sinks, utensil washing sinks, floor drains, floor sinks, and hose stations;

(b) Specifications for the:

(i) Construction materials for the building and interior finishes;

(ii) Disposal of sewage;

(iii) Provision of potable water;

(iv) Ventilation of the plant and individual areas within the plant;

(v) Methods and facilities for waste storage and disposal; and

(vi) Lighting;

(c) Manufacturer and model number of equipment and facilities;

(d) Written standard operating procedures for:

(i) Processing a food;

(ii) Worker and plant sanitation; and

(iii) A scheduled process when required;

(e) When required by COMAR 10.15.01, 10.15.02, 10.15.07, 10.15.10, or 10.15.12 or this chapter, a HACCP plan; and

(f) Any other information that may be required by the Department for the proper review of the plans and specifications.

B. The person-in-charge may not construct a new food processing plant, remodel an existing food processing plant, or manufacture a food using a new or modified process before receiving written approval of the plans and specifications from the Department.

C. The Department shall:

(1) Review the plans and specifications to ensure compliance with the applicable regulations;

(2) Inform the submitter in writing:

(a) Of additional information that may be required; and

(b) Following the review, whether the plans and specifications are approved or denied; and

(3) If the plans are denied, provide the submitter with information on how to appeal the decision, as set forth in the State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.

D. The person-in-charge shall ensure that before a new or remodeled food processing plant is operated:

(1) An inspection by the Department is:

(a) Scheduled; and

(b) Completed;

(2) The Department has issued written approval for the use of the new or remodeled plant; and

(3) For a new plant, a food processing license is obtained.

E. The approving authority shall:

(1) Conduct a priority assessment of the facility based on the information obtained pursuant to §B of this regulation; and

(2) Classify a food processing plant as a:

(a) High priority facility if the food processing plant manufactures food;

(b) Moderate priority facility if the food processing plant is a food warehouse that stores and distributes potentially hazardous food; or

(c) Low priority facility if the food processing plant is a food warehouse that stores and distributes only non-potentially hazardous food.