Regulation .24 Food Manufacturing in Food Service Facilities.
Regulation .24 Food Manufacturing in Food Service Facilities.LinkCopy Citation
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.