Current information on Current Good Manufacturing Practices (CGMPs).
(This document also available in PDF and Spanish)
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR110.3]
[Page 215-216]
TITLE 21--FOOD AND DRUGS
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 A--General Provisions
Sec. 110.3 Definitions.
The definitions and interpretations of terms in section 201 of the
Federal Food, Drug, and Cosmetic Act (the act) are applicable to such
terms when used in this part. The following definitions shall also
apply:
(a) Acid foods or acidified foods means foods that have an
equilibrium pH of 4.6 or below.
(b) Adequate means that which is needed to accomplish the intended
purpose in keeping with good public health practice.
(c) Batter means a semifluid substance, usually composed of flour
and other ingredients, into which principal components of food are
dipped or with which they are coated, or which may be used directly to
form bakery foods.
(d) Blanching, except for tree nuts and peanuts, means a
prepackaging heat treatment of foodstuffs for a sufficient time and at a
sufficient temperature to partially or completely inactivate the
naturally occurring enzymes and to effect other physical or biochemical
changes in the food.
(e) Critical control point means a point in a food process where
there is a high probability that improper control may cause, allow, or
contribute to a hazard or to filth in the final food or decomposition of
the final food.
(f) Food means food as defined in section 201(f) of the act and
includes raw materials and ingredients.
(g) Food-contact surfaces are those surfaces that contact human food
and those surfaces from which drainage onto the food or onto surfaces
that contact the food ordinarily occurs during the normal course of
operations. ``Food-contact surfaces'' includes utensils and food-contact
surfaces of equipment.
(h) Lot means the food produced during a period of time indicated by
a specific code.
(i) Microorganisms means yeasts, molds, bacteria, and viruses and
includes, but is not limited to, species having public health
significance. The term ``undesirable microorganisms'' includes those
microorganisms that are of public health significance, that subject food
to decomposition, that indicate that food is contaminated with filth, or
that otherwise may cause food to be adulterated within the meaning of
the act. Occasionally in these regulations, FDA used the adjective
``microbial'' instead of using an adjectival phrase containing the word
microorganism.
(j) Pest refers to any objectionable animals or insects including,
but not limited to, birds, rodents, flies, and larvae.
[[Page 216]]
(k) Plant means the building or facility or parts thereof, used for
or in connection with the manufacturing, packaging, labeling, or holding
of human food.
(l) Quality control operation means a planned and systematic
procedure for taking all actions necessary to prevent food from being
adulterated within the meaning of the act.
(m) Rework means clean, unadulterated food that has been removed
from processing for reasons other than insanitary conditions or that has
been successfully reconditioned by reprocessing and that is suitable for
use as food.
(n) Safe-moisture level is a level of moisture low enough to prevent
the growth of undesirable microorganisms in the finished product under
the intended conditions of manufacturing, storage, and distribution. The
maximum safe moisture level for a food is based on its water activity
(aw). An aw will be considered safe for a food if
adequate data are available that demonstrate that the food at or below
the given aw will not support the growth of undesirable
microorganisms.
(o) Sanitize means to adequately treat food-contact surfaces by a
process that is effective in destroying vegetative cells of
microorganisms of public health significance, and in substantially
reducing numbers of other undesirable microorganisms, but without
adversely affecting the product or its safety for the consumer.
(p) Shall is used to state mandatory requirements.
(q) Should is used to state recommended or advisory procedures or
identify recommended equipment.
(r) Water activity (aw) is a measure of the free moisture
in a food and is the quotient of the water vapor pressure of the
substance divided by the vapor pressure of pure water at the same
temperature.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR110.5]
[Page 216]
TITLE 21--FOOD AND DRUGS
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 A--General Provisions
Sec. 110.5 Current good manufacturing practice.
(a) The criteria and definitions in this part shall apply in
determining whether a food is adulterated (1) within the meaning of
section 402(a)(3) of the act in that the food has been manufactured
under such conditions that it is unfit for food; or (2) within the
meaning of section 402(a)(4) of the act in that the food has been
prepared, packed, or held under insanitary conditions whereby it may
have become contaminated with filth, or whereby it may have been
rendered injurious to health. The criteria and definitions in this part
also apply in determining whether a food is in violation of section 361
of the Public Health Service Act (42 U.S.C. 264).
(b) Food covered by specific current good manufacturing practice
regulations also is subject to the requirements of those regulations.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR110.10]
[Page 216-217]
TITLE 21--FOOD AND DRUGS
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 A--General Provisions
Sec. 110.10 Personnel.
The plant management shall take all reasonable measures and
precautions to ensure the following:
(a) Disease control. Any person who, by medical examination or
supervisory observation, is shown to have, or appears to have, an
illness, open lesion, including boils, sores, or infected wounds, or any
other abnormal source of microbial contamination by which there is a
reasonable possibility of food, food-contact surfaces, or food-packaging
materials becoming contaminated, shall be excluded from any operations
which may be expected to result in such contamination until the
condition is corrected. Personnel shall be instructed to report such
health conditions to their supervisors.
(b) Cleanliness. All persons working in direct contact with food,
food-contact surfaces, and food-packaging materials shall conform to
hygienic practices while on duty to the extent necessary to protect
against contamination of food. The methods for maintaining cleanliness
include, but are not limited to:
(1) Wearing outer garments suitable to the operation in a manner
that protects against the contamination of food, food-contact surfaces,
or food-packaging materials.
(2) Maintaining adequate personal cleanliness.
(3) Washing hands thoroughly (and sanitizing if necessary to protect
against contamination with undesirable microorganisms) in an adequate
hand-washing facility before starting work, after each absence from the
work
[[Page 217]]
station, and at any other time when the hands may have become soiled or
contaminated.
(4) Removing all unsecured jewelry and other objects that might fall
into food, equipment, or containers, and removing hand jewelry that
cannot be adequately sanitized during periods in which food is
manipulated by hand. If such hand jewelry cannot be removed, it may be
covered by material which can be maintained in an intact, clean, and
sanitary condition and which effectively protects against the
contamination by these objects of the food, food-contact surfaces, or
food-packaging materials.
(5) Maintaining gloves, if they are used in food handling, in an
intact, clean, and sanitary condition. The gloves should be of an
impermeable material.
(6) Wearing, where appropriate, in an effective manner, hair nets,
headbands, caps, beard covers, or other effective hair restraints.
(7) Storing clothing or other personal belongings in areas other
than where food is exposed or where equipment or utensils are washed.
(8) Confining the following to areas other than where food may be
exposed or where equipment or utensils are washed: eating food, chewing
gum, drinking beverages, or using tobacco.
(9) Taking any other necessary precautions to protect against
contamination of food, food-contact surfaces, or food-packaging
materials with microorganisms or foreign substances including, but not
limited to, perspiration, hair, cosmetics, tobacco, chemicals, and
medicines applied to the skin.
(c) Education and training. Personnel responsible for identifying
sanitation failures or food contamination should have a background of
education or experience, or a combination thereof, to provide a level of
competency necessary for production of clean and safe food. Food
handlers and supervisors should receive appropriate training in proper
food handling techniques and food-protection principles and should be
informed of the danger of poor personal hygiene and insanitary
practices.
(d) Supervision. Responsibility for assuring compliance by all
personnel with all requirements of this part shall be clearly assigned
to competent supervisory personnel.
[51 FR 24475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR110.19]
[Page 217]
TITLE 21--FOOD AND DRUGS
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 A--General Provisions
Sec. 110.19 Exclusions.
(a) The following operations are not subject to this part:
Establishments engaged solely in the harvesting, storage, or
distribution of one or more ``raw agricultural commodities,'' as defined
in section 201(r) of the act, which are ordinarily cleaned, prepared,
treated, or otherwise processed before being marketed to the consuming
public.
(b) FDA, however, will issue special regulations if it is necessary
to cover these excluded operations.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR110.20]
[Page 217-218]
TITLE 21--FOOD AND DRUGS
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 B--Buildings and Facilities
Sec. 110.20 Plant and grounds.
(a) Grounds. The grounds about a food plant under the control of the
operator shall be kept in a condition that will protect against the
contamination of food. The methods for adequate maintenance of grounds
include, but are not limited to:
(1) Properly storing equipment, removing litter and waste, and
cutting weeds or grass within the immediate vicinity of the plant
buildings or structures that may constitute an attractant, breeding
place, or harborage for pests.
(2) Maintaining roads, yards, and parking lots so that they do not
constitute a source of contamination in areas where food is exposed.
(3) Adequately draining areas that may contribute contamination to
food by seepage, foot-borne filth, or providing a breeding place for
pests.
(4) Operating systems for waste treatment and disposal in an
adequate manner so that they do not constitute a source of contamination
in areas where food is exposed.
If the plant grounds are bordered by grounds not under the operator's
control and not maintained in the manner described in paragraph (a) (1)
through (3) of this section, care shall be exercised in the plant by
inspection, extermination, or other means to exclude pests, dirt, and
filth that may be a source of food contamination.
[[Page 218]]
(b) Plant construction and design. Plant buildings and structures
shall be suitable in size, construction, and design to facilitate
maintenance and sanitary operations for food-manufacturing purposes. The
plant and facilities shall:
(1) Provide sufficient space for such placement of equipment and
storage of materials as is necessary for the maintenance of sanitary
operations and the production of safe food.
(2) Permit the taking of proper precautions to reduce the potential
for contamination of food, food-contact surfaces, or food-packaging
materials with microorganisms, chemicals, filth, or other extraneous
material. The potential for contamination may be reduced by adequate
food safety controls and operating practices or effective design,
including the separation of operations in which contamination is likely
to occur, by one or more of the following means: location, time,
partition, air flow, enclosed systems, or other effective means.
(3) Permit the taking of proper precautions to protect food in
outdoor bulk fermentation vessels by any effective means, including:
(i) Using protective coverings.
(ii) Controlling areas over and around the vessels to eliminate
harborages for pests.
(iii) Checking on a regular basis for pests and pest infestation.
(iv) Skimming the fermentation vessels, as necessary.
(4) Be constructed in such a manner that floors, walls, and ceilings
may be adequately cleaned and kept clean and kept in good repair; that
drip or condensate from fixtures, ducts and pipes does not contaminate
food, food-contact surfaces, or food-packaging materials; and that
aisles or working spaces are provided between equipment and walls and
are adequately unobstructed and of adequate width to permit employees to
perform their duties and to protect against contaminating food or food-
contact surfaces with clothing or personal contact.
(5) Provide adequate lighting in hand-washing areas, dressing and
locker rooms, and toilet rooms and in all areas where food is examined,
processed, or stored and where equipment or utensils are cleaned; and
provide safety-type light bulbs, fixtures, skylights, or other glass
suspended over exposed food in any step of preparation or otherwise
protect against food contamination in case of glass breakage.
(6) Provide adequate ventilation or control equipment to minimize
odors and vapors (including steam and noxious fumes) in areas where they
may contaminate food; and locate and operate fans and other air-blowing
equipment in a manner that minimizes the potential for contaminating
food, food-packaging materials, and food-contact surfaces.
(7) Provide, where necessary, adequate screening or other protection
against pests.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR110.35]
[Page 218-219]
TITLE 21--FOOD AND DRUGS
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 B--Buildings and Facilities
Sec. 110.35 Sanitary operations.
(a) General maintenance. Buildings, fixtures, and other physical
facilities of the plant shall be maintained in a sanitary condition and
shall be kept in repair sufficient to prevent food from becoming
adulterated within the meaning of the act. Cleaning and sanitizing of
utensils and equipment shall be conducted in a manner that protects
against contamination of food, food-contact surfaces, or food-packaging
materials.
(b) Substances used in cleaning and sanitizing; storage of toxic
materials. (1) Cleaning compounds and sanitizing agents used in cleaning
and sanitizing procedures shall be free from undesirable microorganisms
and shall be safe and adequate under the conditions of use. Compliance
with this requirement may be verified by any effective means including
purchase of these substances under a supplier's guarantee or
certification, or examination of these substances for contamination.
Only the following toxic materials may be used or stored in a plant
where food is processed or exposed:
(i) Those required to maintain clean and sanitary conditions;
(ii) Those necessary for use in laboratory testing procedures;
(iii) Those necessary for plant and equipment maintenance and
operation; and
(iv) Those necessary for use in the plant's operations.
[[Page 219]]
(2) Toxic cleaning compounds, sanitizing agents, and pesticide
chemicals shall be identified, held, and stored in a manner that
protects against contamination of food, food-contact surfaces, or food-
packaging materials. All relevant regulations promulgated by other
Federal, State, and local government agencies for the application, use,
or holding of these products should be followed.
(c) Pest control. No pests shall be allowed in any area of a food
plant. Guard or guide dogs may be allowed in some areas of a plant if
the presence of the dogs is unlikely to result in contamination of food,
food-contact surfaces, or food-packaging materials. Effective measures
shall be taken to exclude pests from the processing areas and to protect
against the contamination of food on the premises by pests. The use of
insecticides or rodenticides is permitted only under precautions and
restrictions that will protect against the contamination of food, food-
contact surfaces, and food-packaging materials.
(d) Sanitation of food-contact surfaces. All food-contact surfaces,
including utensils and food-contact surfaces of equipment, shall be
cleaned as frequently as necessary to protect against contamination of
food.
(1) Food-contact surfaces used for manufacturing or holding low-
moisture food shall be in a dry, sanitary condition at the time of use.
When the surfaces are wet-cleaned, they shall, when necessary, be
sanitized and thoroughly dried before subsequent use.
(2) In wet processing, when cleaning is necessary to protect against
the introduction of microorganisms into food, all food-contact surfaces
shall be cleaned and sanitized before use and after any interruption
during which the food-contact surfaces may have become contaminated.
Where equipment and utensils are used in a continuous production
operation, the utensils and food-contact surfaces of the equipment shall
be cleaned and sanitized as necessary.
(3) Non-food-contact surfaces of equipment used in the operation of
food plants should be cleaned as frequently as necessary to protect
against contamination of food.
(4) Single-service articles (such as utensils intended for one-time
use, paper cups, and paper towels) should be stored in appropriate
containers and shall be handled, dispensed, used, and disposed of in a
manner that protects against contamination of food or food-contact
surfaces.
(5) Sanitizing agents shall be adequate and safe under conditions of
use. Any facility, procedure, or machine is acceptable for cleaning and
sanitizing equipment and utensils if it is established that the
facility, procedure, or machine will routinely render equipment and
utensils clean and provide adequate cleaning and sanitizing treatment.
(e) Storage and handling of cleaned portable equipment and utensils.
Cleaned and sanitized portable equipment with food-contact surfaces and
utensils should be stored in a location and manner that protects food-
contact surfaces from contamination.
[51 FR 24475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR110.37]
[Page 219-220]
TITLE 21--FOOD AND DRUGS
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 B--Buildings and Facilities
Sec. 110.37 Sanitary facilities and controls.
Each plant shall be equipped with adequate sanitary facilities and
accommodations including, but not limited to:
(a) Water supply. The water supply shall be sufficient for the
operations intended and shall be derived from an adequate source. Any
water that contacts food or food-contact surfaces shall be safe and of
adequate sanitary quality. Running water at a suitable temperature, and
under pressure as needed, shall be provided in all areas where required
for the processing of food, for the cleaning of equipment, utensils, and
food-packaging materials, or for employee sanitary facilities.
(b) Plumbing. Plumbing shall be of adequate size and design and
adequately installed and maintained to:
(1) Carry sufficient quantities of water to required locations
throughout the plant.
(2) Properly convey sewage and liquid disposable waste from the
plant.
(3) Avoid constituting a source of contamination to food, water
supplies, equipment, or utensils or creating an unsanitary condition.
[[Page 220]]
(4) Provide adequate floor drainage in all areas where floors are
subject to flooding-type cleaning or where normal operations release or
discharge water or other liquid waste on the floor.
(5) Provide that there is not backflow from, or cross-connection
between, piping systems that discharge waste water or sewage and piping
systems that carry water for food or food manufacturing.
(c) Sewage disposal. Sewage disposal shall be made into an adequate
sewerage system or disposed of through other adequate means.
(d) Toilet facilities. Each plant shall provide its employees with
adequate, readily accessible toilet facilities. Compliance with this
requirement may be accomplished by:
(1) Maintaining the facilities in a sanitary condition.
(2) Keeping the facilities in good repair at all times.
(3) Providing self-closing doors.
(4) Providing doors that do not open into areas where food is
exposed to airborne contamination, except where alternate means have
been taken to protect against such contamination (such as double doors
or positive air-flow systems).
(e) Hand-washing facilities. Hand-washing facilities shall be
adequate and convenient and be furnished with running water at a
suitable temperature. Compliance with this requirement may be
accomplished by providing:
(1) Hand-washing and, where appropriate, hand-sanitizing facilities
at each location in the plant where good sanitary practices require
employees to wash and/or sanitize their hands.
(2) Effective hand-cleaning and sanitizing preparations.
(3) Sanitary towel service or suitable drying devices.
(4) Devices or fixtures, such as water control valves, so designed
and constructed to protect against recontamination of clean, sanitized
hands.
(5) Readily understandable signs directing employees handling
unproteced food, unprotected food-packaging materials, of food-contact
surfaces to wash and, where appropriate, sanitize their hands before
they start work, after each absence from post of duty, and when their
hands may have become soiled or contaminated. These signs may be posted
in the processing room(s) and in all other areas where employees may
handle such food, materials, or surfaces.
(6) Refuse receptacles that are constructed and maintained in a
manner that protects against contamination of food.
(f) Rubbish and offal disposal. Rubbish and any offal shall be so
conveyed, stored, and disposed of as to minimize the development of
odor, minimize the potential for the waste becoming an attractant and
harborage or breeding place for pests, and protect against contamination
of food, food-contact surfaces, water supplies, and ground surfaces.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR110.40]
[Page 220-221]
TITLE 21--FOOD AND DRUGS
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 C--Equipment
Sec. 110.40 Equipment and utensils.
(a) All plant equipment and utensils shall be so designed and of
such material and workmanship as to be adequately cleanable, and shall
be properly maintained. The design, construction, and use of equipment
and utensils shall preclude the adulteration of food with lubricants,
fuel, metal fragments, contaminated water, or any other contaminants.
All equipment should be so installed and maintained as to facilitate the
cleaning of the equipment and of all adjacent spaces. Food-contact
surfaces shall be corrosion-resistant when in contact with food. They
shall be made of nontoxic materials and designed to withstand the
environment of their intended use and the action of food, and, if
applicable, cleaning compounds and sanitizing agents. Food-contact
surfaces shall be maintained to protect food from being contaminated by
any source, including unlawful indirect food additives.
(b) Seams on food-contact surfaces shall be smoothly bonded or
maintained so as to minimize accumulation of food particles, dirt, and
organic matter and thus minimize the opportunity for growth of
microorganisms.
(c) Equipment that is in the manufacturing or food-handling area and
that does not come into contact with food shall be so constructed that
it can be kept in a clean condition.
[[Page 221]]
(d) Holding, conveying, and manufacturing systems, including
gravimetric, pneumatic, closed, and automated systems, shall be of a
design and construction that enables them to be maintained in an
appropriate sanitary condition.
(e) Each freezer and cold storage compartment used to store and hold
food capable of supporting growth of microorganisms shall be fitted with
an indicating thermometer, temperature-measuring device, or temperature-
recording device so installed as to show the temperature accurately
within the compartment, and should be fitted with an automatic control
for regulating temperature or with an automatic alarm system to indicate
a significant temperature change in a manual operation.
(f) Instruments and controls used for measuring, regulating, or
recording temperatures, pH, acidity, water activity, or other conditions
that control or prevent the growth of undesirable microorganisms in food
shall be accurate and adequately maintained, and adequate in number for
their designated uses.
(g) Compressed air or other gases mechanically introduced into food
or used to clean food-contact surfaces or equipment shall be treated in
such a way that food is not contaminated with unlawful indirect food
additives.
Subpart D [Reserved]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR110.80]
[Page 221-224]
TITLE 21--FOOD AND DRUGS
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 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
[[Page 222]]
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 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
[[Page 223]]
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 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
[[Page 224]]
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]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR110.93]
[Page 224]
TITLE 21--FOOD AND DRUGS
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. 110.93 Warehousing and distribution.
Storage and transportation of finished food shall be under
conditions that will protect food against physical, chemical, and
microbial contamination as well as against deterioration of the food and
the container.
Subpart F [Reserved]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR110.110]
[Page 224]
TITLE 21--FOOD AND DRUGS
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 G--Defect Action Levels
Sec. 110.110 Natural or unavoidable defects in food for human use that present no health hazard.
(a) Some foods, even when produced under current good manufacturing
practice, contain natural or unavoidable defects that at low levels are
not hazardous to health. The Food and Drug Administration establishes
maximum levels for these defects in foods produced under current good
manufacturing practice and uses these levels in deciding whether to
recommend regulatory action.
(b) Defect action levels are established for foods whenever it is
necessary and feasible to do so. These levels are subject to change upon
the development of new technology or the availability of new
information.
(c) Compliance with defect action levels does not excuse violation
of the requirement in section 402(a)(4) of the act that food not be
prepared, packed, or held under unsanitary conditions or the
requirements in this part that food manufacturers, distributors, and
holders shall observe current good manufacturing practice. Evidence
indicating that such a violation exists causes the food to be
adulterated within the meaning of the act, even though the amounts of
natural or unavoidable defects are lower than the currently established
defect action levels. The manufacturer, distributor, and holder of food
shall at all times utilize quality control operations that reduce
natural or unavoidable defects to the lowest level currently feasible.
(d) The mixing of a food containing defects above the current defect
action level with another lot of food is not permitted and renders the
final food adulterated within the meaning of the act, regardless of the
defect level of the final food.
(e) A compilation of the current defect action levels for natural or
unavoidable defects in food for human use that present no health hazard
may be obtained upon request from the Center for Food Safety and Applied
Nutrition (HFS-565), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740.
[51 FR 24475, June 19, 1986, as amended at 61 FR 14480, Apr. 2, 1996; 66
FR 56035, Nov. 6, 2001]