21 CFR Part 110 - Current Good Manufacturing Practice In Manufacturing,
Packing, or Holding Human Food
Current as of 1 April 2005
Subpart A - General Provisions
§110.3 Definitions.
§110.5 Current good manufacturing practice.
§110.10 Personnel.
§110.19 Exclusions.
Subpart B - Buildings and Facilities
§110.20 Plant and grounds.
§110.35 Sanitary operations.
§110.37 Sanitary facilities and controls.
Subpart C - Equipment
§110.40 Equipment and utensils.
Subpart D [Reserved]
Subpart E - Production and Process Controls
§110.80 Processes and controls.
§110.93 Warehousing and distribution.
Subpart F [Reserved]
Subpart G - Defect Action Levels
§110.110 Natural or unavoidable defects in food
for human use that present no health hazard.
AUTHORITY: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264.
SOURCE: 51 FR 24475, June 19, 1986, unless otherwise
noted.
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.
(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.
(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.
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:
(l) 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
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]
§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.
Subpart B - Buildings and Facilities
§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.
(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.
§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.
(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]
§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.
(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
airflow systems).
(e) Hand-washing facilities. Handwashing 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
unprotected 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.
§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.
(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 E - Production and Process Controls
§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
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°F
(7.2°C) or below as appropriate for the
particular food involved.
(ii) Maintaining frozen foods in a frozen state.
(iii) Maintaining hot foods at 140° F
(60°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 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 § 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]
§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 G - Defect Action Levels
§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]
