Md. Code Regs. 10.15.04.07

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.15.04.07 - Food Protection, Processes, and Controls

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 a_w 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.

Md. Code Regs. 10.15.04.07

Regulations .07 adopted effective November 22, 2004 (31:23 Md. R. 1652)
Regulation .07B amended effective March 5, 2012 (39:4 Md. R. 337); adopted effective 51:15 Md. R. 708, eff. 8/5/2024.