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Home=20
Page > Executive=20
Branch > Code of=20
Federal Regulations > Electronic Code of Federal =
Regulations
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e-CFR=20
Data is current as of August 17, 2010
Title 21:=20
Food and Drugs
Browse=20
Previous | Browse=20
Next
PART 110=97CURRENT GOOD MANUFACTURING PRACTICE IN =
MANUFACTURING,=20
PACKING, OR HOLDING HUMAN FOOD
Section Contents
Subpart=20
A=97General Provisions
=A7 110.3 &nbs=
p; Definitions.
=A7 110.5 &nbs=
p; Current=20
good manufacturing practice.
=A7 110.10 &nb=
sp; Personnel.
=A7 110.19 &nb=
sp; Exclusions.
Subpart=20
B=97Buildings and Facilities
=A7 110.20 &nb=
sp; Plant=20
and grounds.
=A7 110.35 &nb=
sp; Sanitary=20
operations.
=A7 110.37 &nb=
sp; Sanitary=20
facilities and controls.
Subpart=20
C=97Equipment
=A7 110.40 &nb=
sp; Equipment=20
and utensils.
Subpart=20
D [Reserved]
Subpart=20
E=97Production and Process =
Controls
=A7 110.80 &nb=
sp; Processes=20
and controls.
=A7 110.93 &nb=
sp; Warehousing=20
and distribution.
Subpart=20
F [Reserved]
Subpart=20
G=97Defect Action Levels
=A7 110.110 &n=
bsp; Natural=20
or unavoidable defects in food for human use that present no =
health=20
hazard.
Authority: 21 U.S.C. 342, =
371, 374; 42=20
U.S.C. 264.
Source: 51 FR 24475, June =
19, 1986,=20
unless otherwise noted.
Subpart A=97General Provisions=20
top
=A7 110.3 Definitions.=20
top
The definitions and interpretations of terms in section 201 of =
the=20
Federal Food, Drug, and Cosmetic Act (the act) are applicable to =
such=20
terms when used in this part. The following definitions shall also =
apply:
(a) Acid foods or acidified foods means foods that have =
an=20
equilibrium pH of 4.6 or below.
(b) Adequate means that which is needed to accomplish =
the=20
intended purpose in keeping with good public health practice.
(c) Batter means a semifluid substance, usually composed =
of=20
flour and other ingredients, into which principal components of =
food are=20
dipped or with which they are coated, or which may be used =
directly to=20
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=20
sufficient temperature to partially or completely inactivate the =
naturally=20
occurring enzymes and to effect other physical or biochemical =
changes in=20
the food.
(e) Critical control point means a point in a food =
process where=20
there is a high probability that improper control may cause, =
allow, or=20
contribute to a hazard or to filth in the final food or =
decomposition of=20
the final food.
(f) Food means food as defined in section 201(f) of the =
act and=20
includes raw materials and ingredients.
(g) Food-contact surfaces are those surfaces that =
contact human=20
food and those surfaces from which drainage onto the food or onto =
surfaces=20
that contact the food ordinarily occurs during the normal course =
of=20
operations. =93Food-contact surfaces=94 includes utensils and =
food-contact=20
surfaces of equipment.
(h) Lot means the food produced during a period of time=20
indicated by a specific code.
(i) Microorganisms means yeasts, molds, bacteria, and =
viruses=20
and includes, but is not limited to, species having public health=20
significance. The term =93undesirable microorganisms=94 includes =
those=20
microorganisms that are of public health significance, that =
subject food=20
to decomposition, that indicate that food is contaminated with =
filth, or=20
that otherwise may cause food to be adulterated within the meaning =
of the=20
act. Occasionally in these regulations, FDA used the adjective =
=93microbial=94=20
instead of using an adjectival phrase containing the word=20
microorganism.
(j) Pest refers to any objectionable animals or insects=20
including, but not limited to, birds, rodents, flies, and =
larvae.
(k) Plant means the building or facility or parts =
thereof, used=20
for or in connection with the manufacturing, packaging, labeling, =
or=20
holding of human food.
(l) Quality control operation means a planned and =
systematic=20
procedure for taking all actions necessary to prevent food from =
being=20
adulterated within the meaning of the act.
(m) Rework means clean, unadulterated food that has been =
removed=20
from processing for reasons other than insanitary conditions or =
that has=20
been successfully reconditioned by reprocessing and that is =
suitable for=20
use as food.
(n) Safe-moisture level is a level of moisture low =
enough to=20
prevent the growth of undesirable microorganisms in the finished =
product=20
under the intended conditions of manufacturing, storage, and =
distribution.=20
The maximum safe moisture level for a food is based on its water =
activity=20
(aw). An awwill be considered safe for a =
food if=20
adequate data are available that demonstrate that the food at or =
below the=20
given awwill not support the growth of undesirable=20
microorganisms.
(o) Sanitize means to adequately treat food-contact =
surfaces by=20
a process that is effective in destroying vegetative cells of=20
microorganisms of public health significance, and in substantially =
reducing numbers of other undesirable microorganisms, but without=20
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=20
or identify recommended equipment.
(r) Water activity (aw) is a measure of the =
free=20
moisture in a food and is the quotient of the water vapor pressure =
of the=20
substance divided by the vapor pressure of pure water at the same=20
temperature.
=A7 110.5 Current good manufacturing=20
practice.=20
top
(a) The criteria and definitions in this part shall apply in=20
determining whether a food is adulterated (1) within the meaning =
of=20
section 402(a)(3) of the act in that the food has been =
manufactured under=20
such conditions that it is unfit for food; or (2) within the =
meaning of=20
section 402(a)(4) of the act in that the food has been prepared, =
packed,=20
or held under insanitary conditions whereby it may have become=20
contaminated with filth, or whereby it may have been rendered =
injurious to=20
health. The criteria and definitions in this part also apply in=20
determining whether a food is in violation of section 361 of the =
Public=20
Health Service Act (42 U.S.C. 264).
(b) Food covered by specific current good manufacturing =
practice=20
regulations also is subject to the requirements of those=20
regulations.
=A7 110.10 Personnel.=20
top
The plant management shall take all reasonable measures and =
precautions=20
to ensure the following:
(a) Disease control. Any person who, by medical =
examination or=20
supervisory observation, is shown to have, or appears to have, an =
illness,=20
open lesion, including boils, sores, or infected wounds, or any =
other=20
abnormal source of microbial contamination by which there is a =
reasonable=20
possibility of food, food-contact surfaces, or food-packaging =
materials=20
becoming contaminated, shall be excluded from any operations which =
may be=20
expected to result in such contamination until the condition is =
corrected.=20
Personnel shall be instructed to report such health conditions to =
their=20
supervisors.
(b) Cleanliness. All persons working in direct contact =
with=20
food, food-contact surfaces, and food-packaging materials shall =
conform to=20
hygienic practices while on duty to the extent necessary to =
protect=20
against contamination of food. The methods for maintaining =
cleanliness=20
include, but are not limited to:
(1) Wearing outer garments suitable to the operation in a =
manner that=20
protects against the contamination of food, food-contact surfaces, =
or=20
food-packaging materials.
(2) Maintaining adequate personal cleanliness.
(3) Washing hands thoroughly (and sanitizing if necessary to =
protect=20
against contamination with undesirable microorganisms) in an =
adequate=20
hand-washing facility before starting work, after each absence =
from the=20
work station, and at any other time when the hands may have become =
soiled=20
or contaminated.
(4) Removing all unsecured jewelry and other objects that might =
fall=20
into food, equipment, or containers, and removing hand jewelry =
that cannot=20
be adequately sanitized during periods in which food is =
manipulated by=20
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=20
these objects of the food, food-contact surfaces, or =
food-packaging=20
materials.
(5) Maintaining gloves, if they are used in food handling, in =
an=20
intact, clean, and sanitary condition. The gloves should be of an=20
impermeable material.
(6) Wearing, where appropriate, in an effective manner, hair =
nets,=20
headbands, caps, beard covers, or other effective hair =
restraints.
(7) Storing clothing or other personal belongings in areas =
other than=20
where food is exposed or where equipment or utensils are =
washed.
(8) Confining the following to areas other than where food may =
be=20
exposed or where equipment or utensils are washed: eating food, =
chewing=20
gum, drinking beverages, or using tobacco.
(9) Taking any other necessary precautions to protect against=20
contamination of food, food-contact surfaces, or food-packaging =
materials=20
with microorganisms or foreign substances including, but not =
limited to,=20
perspiration, hair, cosmetics, tobacco, chemicals, and medicines =
applied=20
to the skin.
(c) Education and training. Personnel responsible for=20
identifying sanitation failures or food contamination should have =
a=20
background of education or experience, or a combination thereof, =
to=20
provide a level of competency necessary for production of clean =
and safe=20
food. Food handlers and supervisors should receive appropriate =
training in=20
proper food handling techniques and food-protection principles and =
should=20
be informed of the danger of poor personal hygiene and insanitary=20
practices.
(d) Supervision. Responsibility for assuring compliance =
by all=20
personnel with all requirements of this part shall be clearly =
assigned to=20
competent supervisory personnel.
[51 FR 24475, June 19, 1986, as amended at 54 FR 24892, June =
12,=20
1989]
=A7 110.19 Exclusions.=20
top
(a) The following operations are not subject to this part:=20
Establishments engaged solely in the harvesting, storage, or =
distribution=20
of one or more =93raw agricultural commodities,=94 as defined in =
section=20
201(r) of the act, which are ordinarily cleaned, prepared, =
treated, or=20
otherwise processed before being marketed to the consuming =
public.
(b) FDA, however, will issue special regulations if it is =
necessary to=20
cover these excluded operations.
Subpart B=97Buildings and Facilities=20
top
=A7 110.20 Plant and grounds.=20
top
(a) Grounds. The grounds about a food plant under the =
control of=20
the operator shall be kept in a condition that will protect =
against the=20
contamination of food. The methods for adequate maintenance of =
grounds=20
include, but are not limited to:
(1) Properly storing equipment, removing litter and waste, and =
cutting=20
weeds or grass within the immediate vicinity of the plant =
buildings or=20
structures that may constitute an attractant, breeding place, or =
harborage=20
for pests.
(2) Maintaining roads, yards, and parking lots so that they do =
not=20
constitute a source of contamination in areas where food is =
exposed.
(3) Adequately draining areas that may contribute contamination =
to food=20
by seepage, foot-borne filth, or providing a breeding place for =
pests.
(4) Operating systems for waste treatment and disposal in an =
adequate=20
manner so that they do not constitute a source of contamination in =
areas=20
where food is exposed.
If the plant grounds are bordered by grounds not under the =
operator's=20
control and not maintained in the manner described in paragraph =
(a) (1)=20
through (3) of this section, care shall be exercised in the plant =
by=20
inspection, extermination, or other means to exclude pests, dirt, =
and=20
filth that may be a source of food contamination.
(b) Plant construction and design. Plant buildings and=20
structures shall be suitable in size, construction, and design to=20
facilitate maintenance and sanitary operations for =
food-manufacturing=20
purposes. The plant and facilities shall:
(1) Provide sufficient space for such placement of equipment =
and=20
storage of materials as is necessary for the maintenance of =
sanitary=20
operations and the production of safe food.
(2) Permit the taking of proper precautions to reduce the =
potential for=20
contamination of food, food-contact surfaces, or food-packaging =
materials=20
with microorganisms, chemicals, filth, or other extraneous =
material. The=20
potential for contamination may be reduced by adequate food safety =
controls and operating practices or effective design, including =
the=20
separation of operations in which contamination is likely to =
occur, by one=20
or more of the following means: location, time, partition, air =
flow,=20
enclosed systems, or other effective means.
(3) Permit the taking of proper precautions to protect food in =
outdoor=20
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=20
may be adequately cleaned and kept clean and kept in good repair; =
that=20
drip or condensate from fixtures, ducts and pipes does not =
contaminate=20
food, food-contact surfaces, or food-packaging materials; and that =
aisles=20
or working spaces are provided between equipment and walls and are =
adequately unobstructed and of adequate width to permit employees =
to=20
perform their duties and to protect against contaminating food or=20
food-contact surfaces with clothing or personal contact.
(5) Provide adequate lighting in hand-washing areas, dressing =
and=20
locker rooms, and toilet rooms and in all areas where food is =
examined,=20
processed, or stored and where equipment or utensils are cleaned; =
and=20
provide safety-type light bulbs, fixtures, skylights, or other =
glass=20
suspended over exposed food in any step of preparation or =
otherwise=20
protect against food contamination in case of glass breakage.
(6) Provide adequate ventilation or control equipment to =
minimize odors=20
and vapors (including steam and noxious fumes) in areas where they =
may=20
contaminate food; and locate and operate fans and other =
air-blowing=20
equipment in a manner that minimizes the potential for =
contaminating food,=20
food-packaging materials, and food-contact surfaces.
(7) Provide, where necessary, adequate screening or other =
protection=20
against pests.
=A7 110.35 Sanitary =
operations.=20
top
(a) General maintenance. Buildings, fixtures, and other =
physical=20
facilities of the plant shall be maintained in a sanitary =
condition and=20
shall be kept in repair sufficient to prevent food from becoming=20
adulterated within the meaning of the act. Cleaning and sanitizing =
of=20
utensils and equipment shall be conducted in a manner that =
protects=20
against contamination of food, food-contact surfaces, or =
food-packaging=20
materials.
(b) Substances used in cleaning and sanitizing; storage of =
toxic=20
materials. (1) Cleaning compounds and sanitizing agents used =
in=20
cleaning and sanitizing procedures shall be free from undesirable=20
microorganisms and shall be safe and adequate under the conditions =
of use.=20
Compliance with this requirement may be verified by any effective =
means=20
including purchase of these substances under a supplier's =
guarantee or=20
certification, or examination of these substances for =
contamination. Only=20
the following toxic materials may be used or stored in a plant =
where food=20
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=20
operation; and
(iv) Those necessary for use in the plant's operations.
(2) Toxic cleaning compounds, sanitizing agents, and pesticide=20
chemicals shall be identified, held, and stored in a manner that =
protects=20
against contamination of food, food-contact surfaces, or =
food-packaging=20
materials. All relevant regulations promulgated by other Federal, =
State,=20
and local government agencies for the application, use, or holding =
of=20
these products should be followed.
(c) Pest control. No pests shall be allowed in any area =
of a=20
food plant. Guard or guide dogs may be allowed in some areas of a =
plant if=20
the presence of the dogs is unlikely to result in contamination of =
food,=20
food-contact surfaces, or food-packaging materials. Effective =
measures=20
shall be taken to exclude pests from the processing areas and to =
protect=20
against the contamination of food on the premises by pests. The =
use of=20
insecticides or rodenticides is permitted only under precautions =
and=20
restrictions that will protect against the contamination of food,=20
food-contact surfaces, and food-packaging materials.
(d) Sanitation of food-contact surfaces. All =
food-contact=20
surfaces, including utensils and food-contact surfaces of =
equipment, shall=20
be cleaned as frequently as necessary to protect against =
contamination of=20
food.
(1) Food-contact surfaces used for manufacturing or holding=20
low-moisture food shall be in a dry, sanitary condition at the =
time of=20
use. When the surfaces are wet-cleaned, they shall, when =
necessary, be=20
sanitized and thoroughly dried before subsequent use.
(2) In wet processing, when cleaning is necessary to protect =
against=20
the introduction of microorganisms into food, all food-contact =
surfaces=20
shall be cleaned and sanitized before use and after any =
interruption=20
during which the food-contact surfaces may have become =
contaminated. Where=20
equipment and utensils are used in a continuous production =
operation, the=20
utensils and food-contact surfaces of the equipment shall be =
cleaned and=20
sanitized as necessary.
(3) Non-food-contact surfaces of equipment used in the =
operation of=20
food plants should be cleaned as frequently as necessary to =
protect=20
against contamination of food.
(4) Single-service articles (such as utensils intended for =
one-time=20
use, paper cups, and paper towels) should be stored in appropriate =
containers and shall be handled, dispensed, used, and disposed of =
in a=20
manner that protects against contamination of food or food-contact =
surfaces.
(5) Sanitizing agents shall be adequate and safe under =
conditions of=20
use. Any facility, procedure, or machine is acceptable for =
cleaning and=20
sanitizing equipment and utensils if it is established that the =
facility,=20
procedure, or machine will routinely render equipment and utensils =
clean=20
and provide adequate cleaning and sanitizing treatment.
(e) Storage and handling of cleaned portable equipment and =
utensils.=20
Cleaned and sanitized portable equipment with food-contact =
surfaces=20
and utensils should be stored in a location and manner that =
protects=20
food-contact surfaces from contamination.
[51 FR 24475, June 19, 1986, as amended at 54 FR 24892, June =
12,=20
1989]
=A7 110.37 Sanitary facilities and=20
controls.=20
top
Each plant shall be equipped with adequate sanitary facilities =
and=20
accommodations including, but not limited to:
(a) Water supply. The water supply shall be sufficient =
for the=20
operations intended and shall be derived from an adequate source. =
Any=20
water that contacts food or food-contact surfaces shall be safe =
and of=20
adequate sanitary quality. Running water at a suitable =
temperature, and=20
under pressure as needed, shall be provided in all areas where =
required=20
for the processing of food, for the cleaning of equipment, =
utensils, and=20
food-packaging materials, or for employee sanitary facilities.
(b) Plumbing. Plumbing shall be of adequate size and =
design and=20
adequately installed and maintained to:
(1) Carry sufficient quantities of water to required locations=20
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=20
subject to flooding-type cleaning or where normal operations =
release or=20
discharge water or other liquid waste on the floor.
(5) Provide that there is not backflow from, or =
cross-connection=20
between, piping systems that discharge waste water or sewage and =
piping=20
systems that carry water for food or food manufacturing.
(c) Sewage disposal. Sewage disposal shall be made into =
an=20
adequate sewerage system or disposed of through other adequate =
means.
(d) Toilet facilities. Each plant shall provide its =
employees=20
with adequate, readily accessible toilet facilities. Compliance =
with this=20
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=20
to airborne contamination, except where alternate means have been =
taken to=20
protect against such contamination (such as double doors or =
positive=20
air-flow systems).
(e) Hand-washing facilities. Hand-washing facilities =
shall be=20
adequate and convenient and be furnished with running water at a =
suitable=20
temperature. Compliance with this requirement may be accomplished =
by=20
providing:
(1) Hand-washing and, where appropriate, hand-sanitizing =
facilities at=20
each location in the plant where good sanitary practices require =
employees=20
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=20
constructed to protect against recontamination of clean, sanitized =
hands.
(5) Readily understandable signs directing employees handling=20
unproteced food, unprotected food-packaging materials, of =
food-contact=20
surfaces to wash and, where appropriate, sanitize their hands =
before they=20
start work, after each absence from post of duty, and when their =
hands may=20
have become soiled or contaminated. These signs may be posted in =
the=20
processing room(s) and in all other areas where employees may =
handle such=20
food, materials, or surfaces.
(6) Refuse receptacles that are constructed and maintained in a =
manner=20
that protects against contamination of food.
(f) Rubbish and offal disposal. Rubbish and any offal =
shall be=20
so conveyed, stored, and disposed of as to minimize the =
development of=20
odor, minimize the potential for the waste becoming an attractant =
and=20
harborage or breeding place for pests, and protect against =
contamination=20
of food, food-contact surfaces, water supplies, and ground =
surfaces.
Subpart C=97Equipment=20
top
=A7 110.40 Equipment and =
utensils.=20
top
(a) All plant equipment and utensils shall be so designed and =
of such=20
material and workmanship as to be adequately cleanable, and shall =
be=20
properly maintained. The design, construction, and use of =
equipment and=20
utensils shall preclude the adulteration of food with lubricants, =
fuel,=20
metal fragments, contaminated water, or any other contaminants. =
All=20
equipment should be so installed and maintained as to facilitate =
the=20
cleaning of the equipment and of all adjacent spaces. Food-contact =
surfaces shall be corrosion-resistant when in contact with food. =
They=20
shall be made of nontoxic materials and designed to withstand the=20
environment of their intended use and the action of food, and, if=20
applicable, cleaning compounds and sanitizing agents. Food-contact =
surfaces shall be maintained to protect food from being =
contaminated by=20
any source, including unlawful indirect food additives.
(b) Seams on food-contact surfaces shall be smoothly bonded or=20
maintained so as to minimize accumulation of food particles, dirt, =
and=20
organic matter and thus minimize the opportunity for growth of=20
microorganisms.
(c) Equipment that is in the manufacturing or food-handling =
area and=20
that does not come into contact with food shall be so constructed =
that it=20
can be kept in a clean condition.
(d) Holding, conveying, and manufacturing systems, including=20
gravimetric, pneumatic, closed, and automated systems, shall be of =
a=20
design and construction that enables them to be maintained in an=20
appropriate sanitary condition.
(e) Each freezer and cold storage compartment used to store and =
hold=20
food capable of supporting growth of microorganisms shall be =
fitted with=20
an indicating thermometer, temperature-measuring device, or=20
temperature-recording device so installed as to show the =
temperature=20
accurately within the compartment, and should be fitted with an =
automatic=20
control for regulating temperature or with an automatic alarm =
system to=20
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=20
that control or prevent the growth of undesirable microorganisms =
in food=20
shall be accurate and adequately maintained, and adequate in =
number for=20
their designated uses.
(g) Compressed air or other gases mechanically introduced into =
food or=20
used to clean food-contact surfaces or equipment shall be treated =
in such=20
a way that food is not contaminated with unlawful indirect food=20
additives.
Subpart D [Reserved]=20
top
Subpart E=97Production and Process Controls=20
top
=A7 110.80 Processes and =
controls.=20
top
All operations in the receiving, inspecting, transporting, =
segregating,=20
preparing, manufacturing, packaging, and storing of food shall be=20
conducted in accordance with adequate sanitation principles. =
Appropriate=20
quality control operations shall be employed to ensure that food =
is=20
suitable for human consumption and that food-packaging materials =
are safe=20
and suitable. Overall sanitation of the plant shall be under the=20
supervision of one or more competent individuals assigned =
responsibility=20
for this function. All reasonable precautions shall be taken to =
ensure=20
that production procedures do not contribute contamination from =
any=20
source. Chemical, microbial, or extraneous-material testing =
procedures=20
shall be used where necessary to identify sanitation failures or =
possible=20
food contamination. All food that has become contaminated to the =
extent=20
that it is adulterated within the meaning of the act shall be =
rejected, or=20
if permissible, treated or processed to eliminate the =
contamination.
(a) Raw materials and other ingredients. (1) Raw =
materials and=20
other ingredients shall be inspected and segregated or otherwise =
handled=20
as necessary to ascertain that they are clean and suitable for =
processing=20
into food and shall be stored under conditions that will protect =
against=20
contamination and minimize deterioration. Raw materials shall be =
washed or=20
cleaned as necessary to remove soil or other contamination. Water =
used for=20
washing, rinsing, or conveying food shall be safe and of adequate =
sanitary=20
quality. Water may be reused for washing, rinsing, or conveying =
food if it=20
does not increase the level of contamination of the food. =
Containers and=20
carriers of raw materials should be inspected on receipt to ensure =
that=20
their condition has not contributed to the contamination or =
deterioration=20
of food.
(2) Raw materials and other ingredients shall either not =
contain levels=20
of microorganisms that may produce food poisoning or other disease =
in=20
humans, or they shall be pasteurized or otherwise treated during=20
manufacturing operations so that they no longer contain levels =
that would=20
cause the product to be adulterated within the meaning of the act. =
Compliance with this requirement may be verified by any effective =
means,=20
including purchasing raw materials and other ingredients under a=20
supplier's guarantee or certification.
(3) Raw materials and other ingredients susceptible to =
contamination=20
with aflatoxin or other natural toxins shall comply with current =
Food and=20
Drug Administration regulations and action levels for poisonous or =
deleterious substances before these materials or ingredients are=20
incorporated into finished food. Compliance with this requirement =
may be=20
accomplished by purchasing raw materials and other ingredients =
under a=20
supplier's guarantee or certification, or may be verified by =
analyzing=20
these materials and ingredients for aflatoxins and other natural=20
toxins.
(4) Raw materials, other ingredients, and rework susceptible to =
contamination with pests, undesirable microorganisms, or =
extraneous=20
material shall comply with applicable Food and Drug Administration =
regulations and defect action levels for natural or unavoidable =
defects if=20
a manufacturer wishes to use the materials in manufacturing food.=20
Compliance with this requirement may be verified by any effective =
means,=20
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,=20
or in containers designed and constructed so as to protect against =
contamination and shall be held at such temperature and relative =
humidity=20
and in such a manner as to prevent the food from becoming =
adulterated=20
within the meaning of the act. Material scheduled for rework shall =
be=20
identified as such.
(6) Frozen raw materials and other ingredients shall be kept =
frozen. If=20
thawing is required prior to use, it shall be done in a manner =
that=20
prevents the raw materials and other ingredients from becoming =
adulterated=20
within the meaning of the act.
(7) Liquid or dry raw materials and other ingredients received =
and=20
stored in bulk form shall be held in a manner that protects =
against=20
contamination.
(b) Manufacturing operations. (1) Equipment and utensils =
and=20
finished food containers shall be maintained in an acceptable =
condition=20
through appropriate cleaning and sanitizing, as necessary. Insofar =
as=20
necessary, equipment shall be taken apart for thorough =
cleaning.
(2) All food manufacturing, including packaging and storage, =
shall be=20
conducted under such conditions and controls as are necessary to =
minimize=20
the potential for the growth of microorganisms, or for the =
contamination=20
of food. One way to comply with this requirement is careful =
monitoring of=20
physical factors such as time, temperature, humidity, =
aw, pH,=20
pressure, flow rate, and manufacturing operations such as =
freezing,=20
dehydration, heat processing, acidification, and refrigeration to =
ensure=20
that mechanical breakdowns, time delays, temperature fluctuations, =
and=20
other factors do not contribute to the decomposition or =
contamination of=20
food.
(3) Food that can support the rapid growth of undesirable=20
microorganisms, particularly those of public health significance, =
shall be=20
held in a manner that prevents the food from becoming adulterated =
within=20
the meaning of the act. Compliance with this requirement may be=20
accomplished by any effective means, including:
(i) Maintaining refrigerated foods at 45 =B0F (7.2 =B0C) or =
below as=20
appropriate for the particular food involved.
(ii) Maintaining frozen foods in a frozen state.
(iii) Maintaining hot foods at 140 =B0F (60 =B0C) or above.
(iv) Heat treating acid or acidified foods to destroy =
mesophilic=20
microorganisms when those foods are to be held in hermetically =
sealed=20
containers at ambient temperatures.
(4) Measures such as sterilizing, irradiating, pasteurizing, =
freezing,=20
refrigerating, controlling pH or controlling awthat are =
taken=20
to destroy or prevent the growth of undesirable microorganisms,=20
particularly those of public health significance, shall be =
adequate under=20
the conditions of manufacture, handling, and distribution to =
prevent food=20
from being adulterated within the meaning of the act.
(5) Work-in-process shall be handled in a manner that protects =
against=20
contamination.
(6) Effective measures shall be taken to protect finished food =
from=20
contamination by raw materials, other ingredients, or refuse. When =
raw=20
materials, other ingredients, or refuse are unprotected, they =
shall not be=20
handled simultaneously in a receiving, loading, or shipping area =
if that=20
handling could result in contaminated food. Food transported by =
conveyor=20
shall be protected against contamination as necessary.
(7) Equipment, containers, and utensils used to convey, hold, =
or store=20
raw materials, work-in-process, rework, or food shall be =
constructed,=20
handled, and maintained during manufacturing or storage in a =
manner that=20
protects against contamination.
(8) Effective measures shall be taken to protect against the =
inclusion=20
of metal or other extraneous material in food. Compliance with =
this=20
requirement may be accomplished by using sieves, traps, magnets,=20
electronic metal detectors, or other suitable effective means.
(9) Food, raw materials, and other ingredients that are =
adulterated=20
within the meaning of the act shall be disposed of in a manner =
that=20
protects against the contamination of other food. If the =
adulterated food=20
is capable of being reconditioned, it shall be reconditioned using =
a=20
method that has been proven to be effective or it shall be =
reexamined and=20
found not to be adulterated within the meaning of the act before =
being=20
incorporated into other food.
(10) Mechanical manufacturing steps such as washing, peeling, =
trimming,=20
cutting, sorting and inspecting, mashing, dewatering, cooling, =
shredding,=20
extruding, drying, whipping, defatting, and forming shall be =
performed so=20
as to protect food against contamination. Compliance with this =
requirement=20
may be accomplished by providing adequate physical protection of =
food from=20
contaminants that may drip, drain, or be drawn into the food. =
Protection=20
may be provided by adequate cleaning and sanitizing of all =
food-contact=20
surfaces, and by using time and temperature controls at and =
between each=20
manufacturing step.
(11) Heat blanching, when required in the preparation of food, =
should=20
be effected by heating the food to the required temperature, =
holding it at=20
this temperature for the required time, and then either rapidly =
cooling=20
the food or passing it to subsequent manufacturing without delay.=20
Thermophilic growth and contamination in blanchers should be =
minimized by=20
the use of adequate operating temperatures and by periodic =
cleaning. Where=20
the blanched food is washed prior to filling, water used shall be =
safe and=20
of adequate sanitary quality.
(12) Batters, breading, sauces, gravies, dressings, and other =
similar=20
preparations shall be treated or maintained in such a manner that =
they are=20
protected against contamination. Compliance with this requirement =
may be=20
accomplished by any effective means, including one or more of the=20
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=20
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=20
the growth of microorganisms.
(13) Filling, assembling, packaging, and other operations shall =
be=20
performed in such a way that the food is protected against =
contamination.=20
Compliance with this requirement may be accomplished by any =
effective=20
means, including:
(i) Use of a quality control operation in which the critical =
control=20
points are identified and controlled during manufacturing.
(ii) Adequate cleaning and sanitizing of all food-contact =
surfaces and=20
food containers.
(iii) Using materials for food containers and food- packaging =
materials=20
that are safe and suitable, as defined in =A7130.3(d) of this =
chapter.
(iv) Providing physical protection from contamination, =
particularly=20
airborne contamination.
(v) Using sanitary handling procedures.
(14) Food such as, but not limited to, dry mixes, nuts, =
intermediate=20
moisture food, and dehydrated food, that relies on the control of=20
awfor preventing the growth of undesirable =
microorganisms shall=20
be processed to and maintained at a safe moisture level. =
Compliance with=20
this requirement may be accomplished by any effective means, =
including=20
employment of one or more of the following practices:
(i) Monitoring the awof food.
(ii) Controlling the soluble solids-water ratio in finished =
food.
(iii) Protecting finished food from moisture pickup, by use of =
a=20
moisture barrier or by other means, so that the awof =
the food=20
does not increase to an unsafe level.
(15) Food such as, but not limited to, acid and acidified food, =
that=20
relies principally on the control of pH for preventing the growth =
of=20
undesirable microorganisms shall be monitored and maintained at a =
pH of=20
4.6 or below. Compliance with this requirement may be accomplished =
by any=20
effective means, including employment of one or more of the =
following=20
practices:
(i) Monitoring the pH of raw materials, food in process, and =
finished=20
food.
(ii) Controlling the amount of acid or acidified food added to =
low-acid=20
food.
(16) When ice is used in contact with food, it shall be made =
from water=20
that is safe and of adequate sanitary quality, and shall be used =
only if=20
it has been manufactured in accordance with current good =
manufacturing=20
practice as outlined in this part.
(17) Food-manufacturing areas and equipment used for =
manufacturing=20
human food should not be used to manufacture nonhuman food-grade =
animal=20
feed or inedible products, unless there is no reasonable =
possibility for=20
the contamination of the human food.
[51 FR 24475, June 19, 1986, as amended at 65 FR 56479, Sept. =
19,=20
2000]
=A7 110.93 Warehousing and=20
distribution.=20
top
Storage and transportation of finished food shall be under =
conditions=20
that will protect food against physical, chemical, and microbial=20
contamination as well as against deterioration of the food and the =
container.
Subpart F [Reserved]=20
top
Subpart G=97Defect Action Levels=20
top
=A7 110.110 Natural or unavoidable =
defects in food=20
for human use that present no health hazard.=20
top
(a) Some foods, even when produced under current good =
manufacturing=20
practice, contain natural or unavoidable defects that at low =
levels are=20
not hazardous to health. The Food and Drug Administration =
establishes=20
maximum levels for these defects in foods produced under current =
good=20
manufacturing practice and uses these levels in deciding whether =
to=20
recommend regulatory action.
(b) Defect action levels are established for foods whenever it =
is=20
necessary and feasible to do so. These levels are subject to =
change upon=20
the development of new technology or the availability of new=20
information.
(c) Compliance with defect action levels does not excuse =
violation of=20
the requirement in section 402(a)(4) of the act that food not be =
prepared,=20
packed, or held under unsanitary conditions or the requirements in =
this=20
part that food manufacturers, distributors, and holders shall =
observe=20
current good manufacturing practice. Evidence indicating that such =
a=20
violation exists causes the food to be adulterated within the =
meaning of=20
the act, even though the amounts of natural or unavoidable defects =
are=20
lower than the currently established defect action levels. The=20
manufacturer, distributor, and holder of food shall at all times =
utilize=20
quality control operations that reduce natural or unavoidable =
defects to=20
the lowest level currently feasible.
(d) The mixing of a food containing defects above the current =
defect=20
action level with another lot of food is not permitted and renders =
the=20
final food adulterated within the meaning of the act, regardless =
of the=20
defect level of the final food.
(e) A compilation of the current defect action levels for =
natural or=20
unavoidable defects in food for human use that present no health =
hazard=20
may be obtained upon request from the Center for Food Safety and =
Applied=20
Nutrition (HFS=96565), Food and Drug Administration, 5100 Paint =
Branch=20
Pkwy., College Park, MD 20740.
[51 FR 24475, June 19, 1986, as amended at 61 FR 14480, Apr. 2, =
1996;=20
66 FR 56035, Nov. 6, 2001]
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