Current through Register Vol. 51, No. 19, September 20, 2024
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.
