# COMAR Title 10 — Maryland Department of Health

## Subtitle 15 — Food

### Chapter 04 — Food and Drink Processing and Transportation

#### Regulation .07 Food Protection, Processes, and Controls.

*COMAR 10.15.04.07*

The person-in-charge shall ensure that:

A. All food and food ingredients processed in a food processing plant:

  (1) Are from an approved source;

  (2) Are GRAS;

  (3) If applicable, conform to a standard of identity, as defined in 21 CFR Part 130;

  (4) Comply with FDA regulations for poisonous or deleterious substances; and

  (5) Are identified and held in a manner that prevents allergen cross-contact if the food and food ingredients are an allergen or contain an allergen;

B. When ice is used in contact with food, it shall be:

  (1) Made from potable water; and

  (2) Manufactured and stored in accordance with this chapter;

C. Compressed air or other gasses mechanically introduced into food do not contaminate the food with unlawful indirect food additives;

D. Raw materials and other ingredients:

  (1) Are inspected at receipt to ensure that they are acceptable for use; and

  (2) Are washed or cleaned as necessary to remove soil or other contamination;

E. Food is processed and stored under conditions and control procedures that prevent and protect from:

  (1) Contamination; and

  (2) Allergen cross-contact;

F. The potential for contamination and allergen cross-contact is reduced by:

  (1) Food safety controls;

  (2) Operating practices; and

  (3) Separation of operations by:

    (a) Location;

    (b) Time; or

    (c) Effective design;

G. Food is processed and stored at temperatures that:

  (1) Minimize the potential for the growth of microorganisms; and

  (2) Prevent adulteration;

H. The thermal processing of food eliminates or reduces the number of pathogens in the food so that the food is safe for human consumption;

I. The cooling of foods is conducted using methods that:

  (1) Minimize the potential for the growth of microorganisms; and

  (2) Prevent adulteration;

J. Foods that require temperature control for safety are maintained at the temperature:

  (1) 38°F or less for foods with a non-proteolytic Clostridium botulinum potential hazard;

  (2) 40°F or less;

  (3) 45°F or less for molluscan shellfish or shell eggs;

  (4) 135°F or higher; or

  (5) As otherwise approved by the Department;

K. Food that relies principally on the control of aw for preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level;

L. Food that relies principally on the control of pH for preventing the growth of undesirable microorganisms shall be monitored and maintained at a pH of 4.6 or below;

M. Adequate measures are taken to protect against the inclusion of metal or other extraneous material in food;

N. Frozen food remains frozen when stored or removed from refrigeration in order to be segregated, organized, or moved;

O. Frozen foods are thawed in a manner that prevents contamination;

P. Any food, raw material, or ingredient that is adulterated is not offered to human beings and is:

  (1) Rejected upon receipt;

  (2) Treated or processed to eliminate the contamination;

  (3) Destroyed in a manner that protects against the contamination and allergen cross-contact of other food;

  (4) Stored only in a designated area that is:

    (a) Separated from all other food and food process operations; and

    (b) Conspicuously marked with the intended disposition;

  (5) Reconditioned using a method that is safe and effective;

  (6) Reexamined following reconditioning and subsequently found not to be adulterated;

  (7) Not mixed with another lot of food that is not adulterated; and

  (8) If detained by the Department:

    (a) Reconditioned; or

    (b) Destroyed in a manner approved by the Department;

Q. A facility that only stores unexposed packaged foods that require time and temperature control to significantly minimize or prevent pathogens:

  (1) Establishes and implements temperature controls that significantly minimize or prevent the growth of, or toxin production by, pathogens;

  (2) Monitors the temperature controls with adequate frequency;

  (3) Takes appropriate corrective actions if there is a loss of temperature control that may impact the safety of the food;

  (4) Establishes and maintains affirmative or exception records that document implementation of temperature controls, calibration, or accuracy checks of temperature monitoring and recording devices, and corrective actions;

  (5) Reviews records of monitoring and corrective actions taken to correct a problem with the control of temperature within:

    (a) 7 working days after the records are created; or

    (b) A reasonable time frame; and

  (6) Reviews records of calibration or accuracy checks within a reasonable time frame after the records are created;

R. Written standard operating procedures are:

  (1) Available to employees in a format they understand;

  (2) Implemented; and

  (3) Reflective of current manufacturing procedures;

S. When the Department requires a scheduled process, the scheduled process is:

  (1) Established by a process authority;

  (2) Used to manufacture the target food;

  (3) Not changed without approval of the process authority;

  (4) Documented by:

    (a) Production records; and

    (b) Process deviation records; and

  (5) Verified by:

    (a) Production records review;

    (b) Equipment calibration; or

    (c) Laboratory testing;

T. Records that document compliance with this regulation are maintained in accordance with Regulation .06 of this chapter;

U. Human food by-products for use or distribution as animal food without additional manufacturing or processing are:

  (1) Accurately identified when stored;

  (2) Stored under conditions that protect against contamination; and

  (3) Labeled or accompanied by a label identifying the by-product by the common or usual name when distributed;

V. Finished product testing for chemicals, microbes, or extraneous materials is conducted when necessary to identify failures to protect ready to eat food from contamination or allergen cross-contact; and

W. Environmental testing for chemicals or microbes is conducted when necessary to identify failures to protect ready to eat food from contamination or allergen cross-contact.