(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
(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
(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,
(A) Time/temperature controlled for safety foods must
be maintained at an internal temperature of 41 degrees Fahrenheit
(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
(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
(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
(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
(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
(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
(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
(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
(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
(ii) have a food safety plan that contains the information
specified under 21 Code of Federal Regulations §117.135 a(1)-c(3);