Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 229 - FOOD AND DRUG
Subchapter N - CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
Section 229.222 - Production and Process Controls
Universal Citation: 25 TX Admin Code ยง 229.222
Current through Reg. 49, No. 38; September 20, 2024
(a) General.
(1) All operations in the
manufacturing, processing, packing, and holding of food (including operations
directed to receiving, inspections, transporting, and segregating) must be
conducted in accordance with adequate sanitation principles.
(2) Quality control operations must be
employed to ensure that food is suitable for human consumption and that
food-packaging materials are safe and suitable.
(3) Overall sanitation of the plant must be
under the supervision of one or more competent individuals assigned
responsibility for this function.
(4) Adequate precautions must be taken to
ensure that production procedures do not contribute to allergen cross-contact
and to contamination from any source.
(5) Chemical, microbial, or
extraneous-material testing procedures must be used where necessary to identify
sanitation failures or possible allergen cross-contact and food
contamination.
(6) All food that
has become contaminated to the extent that it is adulterated must be rejected,
treated or processed to eliminate the contamination.
(b) Raw materials and other ingredients.
(1) Food, including raw ingredients and
finished product, must be obtained from an approved source.
(2) Raw materials and other ingredients must
be inspected and segregated or otherwise handled as necessary to ascertain that
they are clean and suitable for processing into food and must be stored under
conditions that will protect against allergen cross-contact and against
contamination and minimize deterioration. Raw materials must be washed or
cleaned as necessary to remove soil or other contamination. Water used for
washing, rinsing, or conveying food must be safe and of adequate sanitary
quality. Water may be reused for washing, rinsing, or conveying food if it does
not cause allergen cross-contact or increase the level of contamination of the
food.
(3) Raw materials and other
ingredients must either: not contain levels of microorganisms that may render
the food injurious to the health of humans; or they must be pasteurized or
otherwise treated during manufacturing operations so that they no longer
contain levels that would cause the product to be adulterated.
(4) Raw materials and other ingredients
susceptible to contamination with aflatoxin or other natural toxins must comply
with current Food and Drug Administration regulations for poisonous or
deleterious substances before these materials or ingredients are incorporated
into finished food.
(5) Raw
materials, other ingredients, and rework susceptible to contamination with
pests, undesirable microorganisms, or extraneous material must comply with
applicable Food and Drug Administration regulations for natural or unavoidable
defects if a manufacturer wishes to use the materials in manufacturing
food.
(6) Raw materials, other
ingredients, and rework must be held in bulk, or in containers designed and
constructed so as to protect against allergen cross-contact and against
contamination and must be held at a temperature and relative humidity and in
such a manner as to prevent the food from becoming adulterated. Material
scheduled for rework must be identified as such.
(7) Frozen raw materials and other frozen
ingredients must be kept frozen. If thawing is required prior to use, it must
be done in a manner that prevents the raw materials and other ingredients from
becoming adulterated.
(8) Liquid or
dry raw materials and other ingredients received and stored in bulk form must
be held in a manner that protects allergen cross-contact and against
contamination.
(9) Raw materials
and other ingredients that are food allergens, and rework that contains food
allergens, must be identified and held in a manner that prevents allergen
cross-contact.
(c) Manufacturing operations.
(1) Equipment and
utensils and finished food containers must be maintained in an adequate
condition through appropriate cleaning and sanitizing, as necessary. In so far
as necessary, equipment must be taken apart for thorough cleaning.
(2) All food manufacturing, processing,
packaging, packing and holding must be conducted under such conditions and
controls as are necessary to minimize the potential for the growth of
microorganisms, allergen cross-contact, contamination of food, and
deterioration of food.
(3) Food
that can support the rapid growth of undesirable microorganisms must be held at
temperatures that will prevent the food from becoming adulterated during
manufacturing, processing, packing, and holding.
(A) Time/temperature controlled for safety
foods must be maintained at an internal temperature of 41 degrees Fahrenheit or
below.
(B) Frozen foods must be
kept frozen at all times.
(C) Shell
eggs, after initial packing, must be transported and stored at the lower of 45
degrees Fahrenheit or as required by The United States Department of
Agriculture.
(D) The temperature of
molluscan shellfish from the harvester through the original shellfish dealer
must be maintained in accordance with 25 TAC §§
241.57-
241.60 of
this title (relating to Molluscan Shellfish). Raw molluscan shellfish must be
adequately iced or refrigerated at 45 degrees Fahrenheit or less during all
subsequent distribution, storage, processing, and sale.
(E) Hot foods must be maintained at an
internal temperature of 135 degrees Fahrenheit (60 degrees Celsius) or
above.
(F) Seafood intended for
wholesale distribution must comply with temperature requirements specified in
21 Code of Federal Regulations Part 123.
(G) Milk received directly from a facility
under the jurisdiction of the Pasteurized Milk Ordinance must be received at an
internal temperature of 45 degrees F or below. Further storage and
transportation of the milk must be maintained at an internal 41 degrees or
below.
(4) Measures such
as sterilizing, irradiating, pasteurizing, cooking, freezing, refrigerating,
controlling pH or controlling aw that are taken to
destroy or prevent the growth of undesirable microorganisms must be adequate
under the conditions of manufacture, handling, and distribution to prevent food
from being adulterated.
(5)
Work-in-process and rework must be handled in a manner that protects against
allergen cross-contact, contamination, and the growth of undesirable
microorganisms.
(6) Effective
measures must be taken to protect finished food from allergen cross-contact and
from contamination by raw materials, other ingredients, or refuse. When raw
materials, other ingredients, or refuse are unprotected, they must not be
handled simultaneously in a receiving, loading, or shipping area if that
handling could result in allergen cross-contact or contaminated food. Food
transported by conveyor must be protected against contamination.
(7) Equipment, containers, and utensils used
to convey, hold, or store raw materials, work-in-process, rework, or other food
must be constructed, handled, and maintained during manufacturing, processing,
packing, and holding in a manner that protects against allergen cross-contact
and against contamination.
(8)
Adequate measures must be taken to protect against the inclusion of metal or
other extraneous material in food.
(9) Food, raw materials, and other
ingredients that are adulterated:
(A) Must be
disposed of in a manner that protects against the contamination of other food;
or
(B) If the adulterated food is
capable of being reconditioned, it must be:
(i) reconditioned using a method that has
been proven to be effective; or
(ii) reconditioned and reexamined and
subsequently found not to be adulterated before being incorporated into other
food.
(10)
Steps such as washing, peeling, trimming, cutting, sorting and inspecting,
mashing, dewatering, cooling, shredding, extruding, drying, whipping,
defatting, and forming must be performed so as to protect food against allergen
cross-contact and against contamination. Food must be protected from
contaminants that may drip, drain, or be drawn into the food.
(11) Heat blanching, when required in the
preparation of food capable of supporting microbial growth, must be affected by
heating the food to the required temperature, holding it at this temperature
for the required time, and then either rapidly cooling the food or passing it
to subsequent manufacturing without delay. Growth and contamination by
thermophilic microorganisms in blanchers must be minimized by the use of
adequate operating temperatures and by periodic cleaning and
sanitizing.
(12) Batters, breading,
sauces, gravies, dressings, dipping solutions, and other similar preparations
that are held and used repeatedly over time must be treated or maintained in
such a manner that they are protected against allergen cross-contact and
against contamination, and minimizing the potential for the growth of
undesirable microorganisms.
(13)
Filling, assembling, packaging, and other operations must be performed in such
a way that the food is protected against allergen cross-contact, contamination,
and the growth of undesirable microorganisms.
(14) Food such as, dry mixes, nuts,
intermediate moisture food, and dehydrated food, that relies on the control of
aw for preventing the growth of undesirable
microorganisms must be processed to and maintained at a safe moisture
level.
(15) Food such as acid and
acidified food, that relies principally on the control of pH for preventing the
growth of undesirable microorganisms, must be monitored and maintained at a pH
of 4.6 or below. Acid or acidified foods must be heat treated to destroy
mesophilic microorganisms when those foods are to be held in hermetically
sealed containers at ambient temperatures.
(16) Modified Atmosphere Packaging.
Manufacturers using Modified Atmosphere Packaging:
(A) Except for a facility that is subject to
21 Code of Federal Regulations Part 117, Subchapter C Hazard Analysis and
Risk-Based Preventive Controls or the product being produced is subject to 21
Code of Federal Regulations Part 123, Fish and Fishery Products, a facility
that packages a Time/Temperature Control for Safety (TCS) food using a modified
atmosphere packaging method shall control the growth and toxin formation of
Clostridium botulinum and the growth of Listeria
monocytogenes.
(B) a
facility that packages TCS food using a modified atmosphere packaging method
must implement a food safety plan that contains the information specified under
21 Code of Federal Regulations §117.135 a(1)-c(3) and that:
(i) identifies the food to be
packaged;
(ii) except as specified
under subparagraphs (C) and (D) of this paragraph, requires that the packaged
food shall be maintained at 5 degrees Celsius (41 degrees Fahrenheit) or less
and meet at least one of the following criteria:
(I) has an aw of 0.91
or less;
(II) has a pH of 4.6 or
less;
(III) is a meat or poultry
product cured at a food processing plant regulated by the USDA or the
department using substances specified in 9 Code of Federal Regulations
§424.21, use of food ingredients and sources of radiation, and is received
in an intact package; or
(IV) is a
food with a high level of competing organisms such as raw meat, raw poultry, or
raw vegetables;
(iii)
describes how the packages shall be prominently and conspicuously labeled on
the principal display panel in bold type on a contrasting background, with
instructions to:
(I) maintain the food at 5
degrees Celsius (41 degrees Fahrenheit) or below; and
(II) discard the food if within 30 calendar
days of its packaging it is not served for on-premises consumption, or consumed
if served or sold for off-premises consumption;
(iv) limits the refrigerated shelf life to no
more than 30 calendar days from packaging to consumption, except the time the
product is maintained frozen, or the original manufacturer's "sell by" or "use
by" date, whichever occurs first;
(C) a facility that packages TCS food using a
modified atmosphere packaging method must ensure individuals performing
modified atmosphere packaging have the appropriate training and documentation
as required by §
229.212
of this title (relating to Qualifications of Individuals Who Manufacture,
Process, Pack, or Hold Food).
(D)
Except for fish that is frozen before, during, and after packaging, a facility
may not package fish using a modified atmosphere packaging method unless the
product is subject to 21 Code of Federal Regulations Part 123, Fish and Fishery
Products;
(E) Cheese. A facility
that packages cheese using a Modified Atmosphere Packaging method must:
(i) limit the cheeses packaged to those that
are commercially manufactured in a food processing plant with no ingredients
added in a facility other than the original food processing plant and that meet
the Standards of Identity as specified in 21 Code of Federal Regulations
§133.150, Hard cheeses, 21 Code of Federal Regulations §133.169
Pasteurized process cheese or 21 Code of Federal Regulations §133.187
Semisoft cheeses;
(ii) have a food
safety plan that contains the information specified under 21 Code of Federal
Regulations §117.135 a(1)-c(3); and
(iii) label the package on the principal
display panel with a "use by" date that does not exceed 30 days from its
packaging or the original manufacturer's sell by date, or "use by" date,
whichever occurs first.
(F) A facility using a Modified Atmosphere
Packaging method for TCS Foods, intended to be frozen after packaging other
than those specified in subparagraph (B)(ii)(I)-(IV) of this paragraph must:
(i) implement a food safety plan that
contains the information specified under 21 Code of Federal Regulations
§117.135 a(1)-c(3);
(ii)
immediately freeze the product following packaging:
(iii) label the product Keep Frozen;
and
(iv) provide instructions for
safe handling after thawing.
(G) Foods other than those specified in
subparagraphs (B)(ii), (D), (E) (F) of this paragraph may be packaged utilizing
modified atmosphere packaging if the facility complies with 21 Code of Federal
Regulations Part 117, Subchapter C, Hazard Analysis and Risk Based Preventive
Controls.
(17) Unshelled
pecans intended to be consumed raw must be thoroughly cleaned to remove foreign
matter before cracking. After cleaning, unshelled pecans must be
sanitized.
(18) When ice is used in
contact with food, it must be made from water that is safe and of adequate
sanitary quality in accordance with §
229.220
of this title (relating to Sanitary Facilities and Controls) and must be used
only if it has been manufactured in accordance with current good manufacturing
practice as outlined in this subchapter.
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