[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR110.80]
[Page 226-229]
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 110_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,
PACKING, OR HOLDING HUMAN FOOD--Table of Contents
Subpart E_Production and Process Controls
Sec. 110.80 Processes and controls.
All operations in the receiving, inspecting, transporting,
segregating, preparing, manufacturing, packaging, and storing of food
shall be conducted in accordance with adequate sanitation
[[Page 227]]
principles. Appropriate quality control operations shall be employed to
ensure that food is suitable for human consumption and that food-
packaging materials are safe and suitable. Overall sanitation of the
plant shall be under the supervision of one or more competent
individuals assigned responsibility for this function. All reasonable
precautions shall be taken to ensure that production procedures do not
contribute contamination from any source. Chemical, microbial, or
extraneous-material testing procedures shall be used where necessary to
identify sanitation failures or possible food contamination. All food
that has become contaminated to the extent that it is adulterated within
the meaning of the act shall be rejected, or if permissible, treated or
processed to eliminate the contamination.
(a) Raw materials and other ingredients. (1) Raw materials and other
ingredients shall be inspected and segregated or otherwise handled as
necessary to ascertain that they are clean and suitable for processing
into food and shall be stored under conditions that will protect against
contamination and minimize deterioration. Raw materials shall be washed
or cleaned as necessary to remove soil or other contamination. Water
used for washing, rinsing, or conveying food shall be safe and of
adequate sanitary quality. Water may be reused for washing, rinsing, or
conveying food if it does not increase the level of contamination of the
food. Containers and carriers of raw materials should be inspected on
receipt to ensure that their condition has not contributed to the
contamination or deterioration of food.
(2) Raw materials and other ingredients shall either not contain
levels of microorganisms that may produce food poisoning or other
disease in humans, or they shall be pasteurized or otherwise treated
during manufacturing operations so that they no longer contain levels
that would cause the product to be adulterated within the meaning of the
act. Compliance with this requirement may be verified by any effective
means, including purchasing raw materials and other ingredients under a
supplier's guarantee or certification.
(3) Raw materials and other ingredients susceptible to contamination
with aflatoxin or other natural toxins shall comply with current Food
and Drug Administration regulations and action levels for poisonous or
deleterious substances before these materials or ingredients are
incorporated into finished food. Compliance with this requirement may be
accomplished by purchasing raw materials and other ingredients under a
supplier's guarantee or certification, or may be verified by analyzing
these materials and ingredients for aflatoxins and other natural toxins.
(4) Raw materials, other ingredients, and rework susceptible to
contamination with pests, undesirable microorganisms, or extraneous
material shall comply with applicable Food and Drug Administration
regulations and defect action levels for natural or unavoidable defects
if a manufacturer wishes to use the materials in manufacturing food.
Compliance with this requirement may be verified by any effective means,
including purchasing the materials under a supplier's guarantee or
certification, or examination of these materials for contamination.
(5) Raw materials, other ingredients, and rework shall be held in
bulk, or in containers designed and constructed so as to protect against
contamination and shall be held at such temperature and relative
humidity and in such a manner as to prevent the food from becoming
adulterated within the meaning of the act. Material scheduled for rework
shall be identified as such.
(6) Frozen raw materials and other ingredients shall be kept frozen.
If thawing is required prior to use, it shall be done in a manner that
prevents the raw materials and other ingredients from becoming
adulterated within the meaning of the act.
(7) Liquid or dry raw materials and other ingredients received and
stored in bulk form shall be held in a manner that protects against
contamination.
(b) Manufacturing operations. (1) Equipment and utensils and
finished food containers shall be maintained in an acceptable condition
through appropriate cleaning and sanitizing, as necessary. Insofar as
necessary, equipment
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shall be taken apart for thorough cleaning.
(2) All food manufacturing, including packaging and storage, shall
be conducted under such conditions and controls as are necessary to
minimize the potential for the growth of microorganisms, or for the
contamination of food. One way to comply with this requirement is
careful monitoring of physical factors such as time, temperature,
humidity, aw, pH, pressure, flow rate, and manufacturing
operations such as freezing, dehydration, heat processing,
acidification, and refrigeration to ensure that mechanical breakdowns,
time delays, temperature fluctuations, and other factors do not
contribute to the decomposition or contamination of food.
(3) Food that can support the rapid growth of undesirable
microorganisms, particularly those of public health significance, shall
be held in a manner that prevents the food from becoming adulterated
within the meaning of the act. Compliance with this requirement may be
accomplished by any effective means, including:
(i) Maintaining refrigerated foods at 45 [deg]F (7.2 [deg]C) or
below as appropriate for the particular food involved.
(ii) Maintaining frozen foods in a frozen state.
(iii) Maintaining hot foods at 140 [deg]F (60 [deg]C) or above.
(iv) Heat treating acid or acidified foods to destroy mesophilic
microorganisms when those foods are to be held in hermetically sealed
containers at ambient temperatures.
(4) Measures such as sterilizing, irradiating, pasteurizing,
freezing, refrigerating, controlling pH or controlling aw
that are taken to destroy or prevent the growth of undesirable
microorganisms, particularly those of public health significance, shall
be adequate under the conditions of manufacture, handling, and
distribution to prevent food from being adulterated within the meaning
of the act.
(5) Work-in-process shall be handled in a manner that protects
against contamination.
(6) Effective measures shall be taken to protect finished food from
contamination by raw materials, other ingredients, or refuse. When raw
materials, other ingredients, or refuse are unprotected, they shall not
be handled simultaneously in a receiving, loading, or shipping area if
that handling could result in contaminated food. Food transported by
conveyor shall be protected against contamination as necessary.
(7) Equipment, containers, and utensils used to convey, hold, or
store raw materials, work-in-process, rework, or food shall be
constructed, handled, and maintained during manufacturing or storage in
a manner that protects against contamination.
(8) Effective measures shall be taken to protect against the
inclusion of metal or other extraneous material in food. Compliance with
this requirement may be accomplished by using sieves, traps, magnets,
electronic metal detectors, or other suitable effective means.
(9) Food, raw materials, and other ingredients that are adulterated
within the meaning of the act shall be disposed of in a manner that
protects against the contamination of other food. If the adulterated
food is capable of being reconditioned, it shall be reconditioned using
a method that has been proven to be effective or it shall be reexamined
and found not to be adulterated within the meaning of the act before
being incorporated into other food.
(10) Mechanical manufacturing steps such as washing, peeling,
trimming, cutting, sorting and inspecting, mashing, dewatering, cooling,
shredding, extruding, drying, whipping, defatting, and forming shall be
performed so as to protect food against contamination. Compliance with
this requirement may be accomplished by providing adequate physical
protection of food from contaminants that may drip, drain, or be drawn
into the food. Protection may be provided by adequate cleaning and
sanitizing of all food-contact surfaces, and by using time and
temperature controls at and between each manufacturing step.
(11) Heat blanching, when required in the preparation of food,
should be effected 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
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passing it to subsequent manufacturing without delay. Thermophilic
growth and contamination in blanchers should be minimized by the use of
adequate operating temperatures and by periodic cleaning. Where the
blanched food is washed prior to filling, water used shall be safe and
of adequate sanitary quality.
(12) Batters, breading, sauces, gravies, dressings, and other
similar preparations shall be treated or maintained in such a manner
that they are protected against contamination. Compliance with this
requirement may be accomplished by any effective means, including one or
more of the following:
(i) Using ingredients free of contamination.
(ii) Employing adequate heat processes where applicable.
(iii) Using adequate time and temperature controls.
(iv) Providing adequate physical protection of components from
contaminants that may drip, drain, or be drawn into them.
(v) Cooling to an adequate temperature during manufacturing.
(vi) Disposing of batters at appropriate intervals to protect
against the growth of microorganisms.
(13) Filling, assembling, packaging, and other operations shall be
performed in such a way that the food is protected against
contamination. Compliance with this requirement may be accomplished by
any effective means, including:
(i) Use of a quality control operation in which the critical control
points are identified and controlled during manufacturing.
(ii) Adequate cleaning and sanitizing of all food-contact surfaces
and food containers.
(iii) Using materials for food containers and food- packaging
materials that are safe and suitable, as defined in Sec. 130.3(d) of
this chapter.
(iv) Providing physical protection from contamination, particularly
airborne contamination.
(v) Using sanitary handling procedures.
(14) Food such as, but not limited to, dry mixes, nuts, intermediate
moisture food, and dehydrated food, that relies on the control of
aw for preventing the growth of undesirable microorganisms
shall be processed to and maintained at a safe moisture level.
Compliance with this requirement may be accomplished by any effective
means, including employment of one or more of the following practices:
(i) Monitoring the aw of food.
(ii) Controlling the soluble solids-water ratio in finished food.
(iii) Protecting finished food from moisture pickup, by use of a
moisture barrier or by other means, so that the aw of the
food does not increase to an unsafe level.
(15) Food such as, but not limited to, acid and acidified 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. Compliance with this requirement may be accomplished by
any effective means, including employment of one or more of the
following practices:
(i) Monitoring the pH of raw materials, food in process, and
finished food.
(ii) Controlling the amount of acid or acidified food added to low-
acid food.
(16) When ice is used in contact with food, it shall be made from
water that is safe and of adequate sanitary quality, and shall be used
only if it has been manufactured in accordance with current good
manufacturing practice as outlined in this part.
(17) Food-manufacturing areas and equipment used for manufacturing
human food should not be used to manufacture nonhuman food-grade animal
feed or inedible products, unless there is no reasonable possibility for
the contamination of the human food.
[51 FR 24475, June 19, 1986, as amended at 65 FR 56479, Sept. 19, 2000]