Sec. 10.15.04.14. Unit Processing Operations — Processing Food for Safety and Shelf Life

The person-in-charge shall ensure that:

A. Food pathogens are excluded or eliminated from food before offering the food for human consumption;

B. The thermal processing of food:

(1) Eliminates or reduces the number of pathogens in the food so that the food is safe for human consumption;

(2) Achieves the necessary reduction in spoilage organisms for a stated or desired shelf life under normal conditions of storage and distribution; and

(3) For a commercially sterile product, produces the condition set forth in Regulation .02B(5) of this chapter;

C. The cooling of potentially hazardous foods:

(1) Uses methods that prevent food contamination; and

(2) Steadily cools hot foods:

(a) From 135°F to 70°F within 2 hours and from 70°F to 41°F within an additional 4 hours; or

(b) By using other cooling time and temperature relationships in a scheduled process;

D. Except as provided in §§E and F of this regulation, a potentially hazardous food is maintained at temperatures set forth in Regulation .06C of this chapter during processing;

E. Except for a food with a non-proteolytic Clostridium botulinum potential hazard and as provided in §F of this regulation, when it is necessary for a period of time during preparation or processing to keep a potentially hazardous food at ambient temperatures that may result in the food's internal temperatures not complying with the requirements set forth in Regulation .06C of this chapter:

(1) The cumulative time that the food is kept at ambient temperatures:

(a) Is minimized;

(b) If the food is a raw food that:

(i) Will not be fully thermally processed following the time the food is kept at ambient temperatures, does not exceed a verifiable period of 2 hours; or

(ii) Will be fully thermally processed following the exposure to ambient room temperatures, does not exceed a verifiable period of 4 hours; and

(c) If the food is a cooked food, does not exceed a verifiable period of 2 hours;

(2) The food is rapidly returned to and maintained at the temperatures set forth in Regulation .06C of this chapter;

(3) The food is discarded if the maximum allowed time of exposure to ambient room temperatures set forth in §E(1)(b) and (c) of this regulation is exceeded; and

(4) A hazard analysis of the food and food process is completed;

F. A scheduled process is used if:

(1) Time and food temperature relationships during food processing are other than the times and temperatures specified in this chapter; and

(2) A food with a non-proteolytic Clostridium botulinum potential hazard is kept at temperatures other than the temperatures specified in Regulation .06C and D of this chapter;

G. Canning is done in accordance with COMAR 10.15.01;

H. Crab meat is processed in accordance with COMAR 10.15.02;

I. Shellfish is processed is in accordance with COMAR 10.15.07;

J. Seafood is processed and handled in accordance with COMAR 10.15.10;

K. Juice is processed in accordance with COMAR 10.15.12;

L. A shelf life study of food:

(1) Mimics the normal conditions of storage and use; and

(2) Is performed by a process authority;

M. When the Department requires a scheduled process pursuant to Regulation .07B of this chapter, the scheduled process is:

(1) Established by a process authority;

(2) Used to manufacture the target food;

(3) Documented by:

(a) Production records; and

(b) Process deviation records; and

(4) Verified by techniques such as:

(a) Production records review;

(b) Equipment calibration; and

(c) Laboratory testing;

N. A potentially hazardous food that is placed in a vending machine is removed from the vending machine and not offered for human consumption:

(1) Within 3 days of the food's manufacture when no shelf life study is performed for the food;

(2) Before the expiration of its determined shelf life when a shelf life study is performed for the food; and

(3) If the vending machine fails to maintain food temperatures as set forth in Regulation .06C and D of this chapter;

O. Records that document compliance with §§K and L of this regulation are:

(1) Maintained; and

(2) Available for inspection by the Department;

P. A potentially hazardous bakery product, such as a pumpkin pie containing unpasteurized shell eggs, that is not maintained at the temperatures set forth in Regulation .06C of this chapter while on display for retail sale is:

(1) Manufactured in a licensed food processing plant;

(2) Thermally processed to:

(a) Eliminate Salmonella Enteritidis; and

(b) Raise the internal temperature of the food to at least 180°F;

(3) Packaged to:

(a) Protect the food; and

(b) Maintain aerobic conditions within the packaging;

(4) Allowed a maximum shelf life:

(a) Determined by a shelf life study;

(b) Not to exceed 3 days after the day of manufacture; and

(c) That is clearly and prominently displayed on the container label; and

(5) Labeled as set forth in Regulation .16A(2)(h); and

Q. Thermometers used to monitor temperatures at critical control points are calibrated annually using:

(1) A thermometer with an accuracy certified by the National Institute of Standards and Technology;

(2) An ice bath for thermometers used to monitor cold temperatures; or

(3) A boiling water bath for thermometers used to monitor hot temperatures.