.07 Processing Practices.

A. The person-in-charge shall ensure that:

(1) Food is processed using procedures, sanitary practices, and process controls that produce only safe and wholesome food;

(2) When required by the Department in accordance with §B of this regulation:

(a) A scheduled process is used to manufacture a food; and

(b) Except as set forth in §A(3) of this regulation, a scheduled process or shelf life approved by the Department is not changed;

(3) Before manufacturing a food or using a new food manufacturing process or shelf life, plans are:

(a) Submitted to the Department; and

(b) Approved by the Department based on a review that shows compliance with 21 CFR Part 110 and this chapter;

(4) Foods are manufactured as set forth in written processing standard operating procedures that:

(a) Are available to employees in a form they understand; and

(b) Ensure the proper and safe manufacture of food;

(5) Production aids and adjuvant substances comply with 21 CFR Part 178;

(6) Steam that contacts food is free from deleterious or harmful matter that might adulterate food;

(7) Heating and cooling media that are in close contact with food such as those in plate heat exchangers are:

(a) Food, food grade, or GRAS; or

(b) Through equipment design, provided a minimal chance of contacting food;

(8) Processing, labeling, storing, and transporting food and design of, operating, and maintaining the food processing plant and the facilities and equipment associated with the food processing plant are in compliance with this chapter and with the requirements set forth in the documents incorporated by reference in Regulation .03 of this chapter;

(9) Pressurized air in contact with food, such as in pneumatic transfer systems, is filtered to exclude contaminants from the food; and

(10) The reclamation or rehabilitation of adulterated and misbranded food that has been detained by the Department is completed in accordance with a written plan approved by the Department based on a review that indicates the food will conform to this chapter after the food is reclaimed or rehabilitated.

B. The Department may require that a scheduled process, laboratory analysis, or shelf life study be completed by a process authority for a food based on:

(1) Inherent hazards or risks associated with a food;

(2) Requirements for a scheduled process required in COMAR 10.15.01 and 10.15.02 and this chapter;

(3) Previous scientific research; or

(4) A need to:

(a) Determine whether a food is potentially hazardous;

(b) Identify critical factors;

(c) Verify a food's shelf life; or

(d) Standardize a food process.