Regulation .07 Food Protection, Processes, and Controls.
Regulation .07 Food Protection, Processes, and Controls.LinkCopy Citation
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.