A. A person who is licensed to operate a food service facility may manufacture food for sale or distribution as provided in §§B, C, and E of this regulation.
B. The person-in-charge shall ensure that before a food is manufactured in a food service facility:
(1) Plans for the manufacturing:
(a) Are submitted to the Department;
(b) Are approved in writing by the Department based on a review that indicates compliance with this regulation;
(i) A list of foods proposed for manufacture;
(ii) The proposed processing procedures for a food;
(iii) Specifications for equipment items to be used for manufacture;
(iv) Packaging and labeling information;
(v) Methods of shipment;
(vi) Procedures for maintaining potentially hazardous food as set forth in Regulation .06B(7)(14) of this chapter; and
(vii) An HACCP plan in accordance with Regulation .34 of this chapter; and
(2) The facilities and equipment proposed for use in manufacturing are:
(a) Inspected by the Department; and
(b) Approved in writing by the Department based on a review that indicates compliance with this chapter.
C. A person licensed only to operate a food service facility may not manufacture the following foods:
(1) Low-acid canned foods as defined in 21 CFR §113.3(n);
(2) Acidified foods as defined in 21 CFR §114.3(b);
(3) Hermetically sealed and ready-to-eat potentially hazardous foods that a hazard analysis indicates are associated with the outgrowth of Clostridium botulinum or Listeria monocytogenes, such as:
(a) Smoked fish; or
(b) Pasteurized crabmeat;
(4) Bottled water; or
(5) Soft drinks.
D. The approving authority shall routinely inspect the food manufacturing conducted in the food service facility:
(1) During inspections of the retail food service facility; and
(2) At a frequency set forth in Regulation .30 of this chapter.
E. The person-in-charge shall ensure that:
(1) All manufactured food is labeled in accordance with Regulation .12 of this chapter; and
(2) Records are:
(a) Made to allow the trace-back of distributed or sold food to the food service facility that manufactured the food;
(b) Made to identify the immediate source of the food and food ingredients stored and processed at the facility;
(c) For shell eggs, made to provide the information required in COMAR 15.04.01.03A(2)(a)(e);
(d) Made to identify the initial distribution of the food to facilitate the segregation of food that may have become adulterated or otherwise unfit for human consumption; and
(e) Maintained at the facility for at least:
(i) 2 years for a shelf stable or preserved food; and
(ii) 1 year for a fresh food.