10.15.04.08

.08 Process Control, Monitoring, and Record Keeping.

A. The Department may require a processor to conduct a process hazard analysis, establish and monitor critical control points, and provide verification based on:

(1) The requirements in COMAR 10.15.01, 10.15.02, 10.15.07, 10.15.10, and 10.15.12 and this chapter; and

(2) Potential hazards associated with a food.

B. While complying with §A of this regulation, the person-in-charge shall ensure that:

(1) Each processing operation, such as receiving, holding, thermal processing, chilling, freezing, packaging, storing, transportation, and labeling is evaluated to determine whether the operation is a critical control point;

(2) A processing operation that is a critical control point is:

(a) Controlled to prevent a hazard; and

(b) Monitored to verify control; and

(3) A record is made that:

(a) Documents compliance with the requirements of this regulation;

(b) Identifies the immediate previous source of the food and food ingredients stored and processed in the plant and provides the following:

(i) The name, address, and telephone number of the immediate previous source;

(ii) The type of food or food ingredient received, including brand name and specific variety;

(iii) A lot code number or other identifier, if available;

(iv) The date the food or food ingredient was received; and

(v) The name, address, and phone number of the transporter of the food or food ingredient from the immediate previous source to the food processing plant;

(c) For shell eggs, provides the information required in COMAR 15.04.01.03A(2)(a)—(e);

(d) Identifies the initial distribution of the food to facilitate, when necessary, the segregation of food that may have become adulterated or otherwise unfit for human consumption and provides the following:

(i) The name, address, and telephone number of the immediate subsequent recipient of the food released;

(ii) The type of food released, including brand name and specific variety;

(iii) A lot code number or other identifier, if available;

(iv) The date the food was released; and

(v) The name, address, and phone number of the transporter of the food to the immediate subsequent recipient of the food;

(e) After the control, observation, or monitoring is done, is maintained at the plant for:

(i) At least 2 years for a shelf stable or preserved food; or

(ii) At least 1 year for a fresh food; and

(f) Is available for inspection by the Department.