Md. Code Regs. 10.15.04.07 - [Effective until 8/5/2024] Processing Practices
A. The
person-in-charge shall ensure that:
(1) Food
is processed using procedures, sanitary practices, and process controls that
produce only safe and wholesome food;
(2) When required by the Department in
accordance with §B of this regulation:
(a) A scheduled process is used to
manufacture a food; and
(b) Except
as set forth in §A(3) of this regulation, a scheduled process or shelf
life approved by the Department is not changed;
(3) Before manufacturing a food or using a
new food manufacturing process or shelf life, plans are:
(a) Submitted to the Department;
and
(b) Approved by the Department
based on a review that shows compliance with 21 CFR Part 110 and this
chapter;
(4) Foods are
manufactured as set forth in written processing standard operating procedures
that:
(a) Are available to employees in a
form they understand; and
(b)
Ensure the proper and safe manufacture of food;
(5) Production aids and adjuvant substances
comply with 21 CFR Part 178 ;
(6)
Steam that contacts food is free from deleterious or harmful matter that might
adulterate food;
(7) Heating and
cooling media that are in close contact with food such as those in plate heat
exchangers are:
(a) Food, food grade, or
GRAS; or
(b) Through equipment
design, provided a minimal chance of contacting food;
(8) Processing, labeling, storing, and
transporting food and design of, operating, and maintaining the food processing
plant and the facilities and equipment associated with the food processing
plant are in compliance with this chapter and with the requirements set forth
in the documents incorporated by reference in Regulation .03 of this
chapter;
(9) Pressurized air in
contact with food, such as in pneumatic transfer systems, is filtered to
exclude contaminants from the food; and
(10) The reclamation or rehabilitation of
adulterated and misbranded food that has been detained by the Department is
completed in accordance with a written plan approved by the Department based on
a review that indicates the food will conform to this chapter after the food is
reclaimed or rehabilitated.
B. The Department may require that a
scheduled process, laboratory analysis, or shelf life study be completed by a
process authority for a food based on:
(1)
Inherent hazards or risks associated with a food;
(3) Previous scientific research;
or
(4) A need to:
(a) Determine whether a food is potentially
hazardous;
(b) Identify critical
factors;
(c) Verify a food's shelf
life; or
(d) Standardize a food
process.
Notes
Regulation .07B amended effective March 5, 2012 (39:4 Md. R. 337)
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