# COMAR Title 10 — Maryland Department of Health

## Subtitle 15 — Food

### Chapter 03 — Food Service Facilities

#### Regulation .24 Food Manufacturing in Food Service Facilities.

*COMAR 10.15.03.24*

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)—(13) 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.