10.15.03.24

.24 Food Manufacturing in Food Service Facilities.

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;

(c) Include:

(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.