Current through Register Vol. 49, No. 9, September, 2024
SECTION IV. DEFINITIONS
For the purpose of these Regulations, the following terms are
defined:
A. "Acid Food or Acidified
Food" means foods that have an equilibrium pH of 4.6 or below.
B. "Act" means Act 415 of 1953, the Arkansas
Food, Drug and Cosmetic Act.
C.
"Adequate" means that which is needed to accomplish the intended purpose in
keeping with good public health practice.
D. "Batter" means a semi-fluid 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.
E. "Blanching", except for tree nuts and
peanuts, means a pre-packaging heat treatment of food stuffs for a sufficient
time and at a sufficient temperature to partially or completely inactivate the
naturally occurring enzymes and to effect other physical or bio-chemical
changes in food.
F.
"Corrosion-resistant" means capable of maintaining original surface
characteristics under prolonged influence of the food to be contacted, the
normal use of cleaning compounds and bactericidal solutions, and other
conditions-of-use.
G. "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 filth in the final food or decomposition of the final food.
H. "Department" means the Arkansas Department
of Health and its duly designated representatives.
I. "Easily Cleanable" means that surfaces are
readily accessible and made of such materials and finish and so fabricated that
residue may be effectively removed by normal cleaning methods.
J. "Employee" means the permit holder, any
individual having supervisory or management duties and any other person working
in a food establishment.
K.
"Equipment" means stoves, ovens, ranges, hoods, slicers, mixers, meat blocks,
tables, counters, refrigerators, sinks, dishwashing machines, steam tables, and
similar items other than utensils, used in the operation of a food
establishment.
L. "Food" means any
raw, cooked, or processed edible substance, ice, beverage or ingredient used or
intended for use or for sale in whole or in part for human
consumption.
M. "Food Contact
Surfaces" means those surfaces of equipment and utensils with which food
normally comes in contact, and those surfaces from which food may contact
drain, drip, or splash back onto surfaces normally in contact with
food.
N. "Food Processing
Establishment" means a commercial establishment in which food is manufactured
or packaged for human consumption.
O. "Hazardous Substance" means any substance
or mixture of substances which is toxic, corrosive, an irritant, strong
sanitizer, flammable or which generates pressure through
decomposition.
P. "Imminent Public
Health Hazard" means a situation which creates a risk posing" a significant
threat to public health. Such hazards should not continue while a hearing or
other formal proceeding is pending.
Q. "Manufacture" means the process of
combining or purifying articles of food and packing same for sale to the
consumer, either by wholesale or retail. Any firm, person, or corporation who
represents itself as responsible for the purity and the proper labeling of any
article of food by placing or having placed its name and address on the label
of any food shall be deemed a manufacturer and shall be included within the
meaning of these rules.
R.
"Microorganism" 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.
S. "Non-Food-Contact
Surfaces" means surfaces of equipment not intended for contact with food, but
which are being exposed to splash or food debris or which otherwise require
frequent cleaning, shall be designed and fabricated to be smooth, washable,
free of unnecessary ledges, projections, or crevices, and readily accessible
for cleaning, and shall be of such material and in such repair as to be easily
maintained in a clean and sanitary condition.
T. "Operator" means any person, partnership,
corporation, association, cooperative or other business unit having the direct
and primary responsibility for the construction, maintenance and operation of a
food storage or food manufacturing plant or warehouse.
U. "Packaging" means any covering, wrapper,
or container in which a product is placed for retail or wholesale distribution,
either before or after sale, to a consumer. Packaging shall not be construed to
include the inner wrapper.
V.
"Perishable Foods" means any food of such type or in such condition or physical
state that it may spoil or otherwise become unfit for human
consumption.
W. "Person" means an
individual, corporation, business trust, estate, trust, partnership,
association, or any other public or private entity.
X. "Personnel" means all persons employed by
a food manufacturer, who do or may in any manner handle or come in contact with
the handling, storage, transporting, selling or distributing of food.
Y. "Pest" means any objectionable animal or
insect including, but not limited to, birds, rodents, flies and
larvae.
Z. "Plant" means the
building or facility or parts thereof, used for or in connection with the
manufacturing, packaging, labeling or holding of human food.
AA. "Potentially Hazardous Food" means any
food that consists in whole or in part of milk or milk products, eggs_, meat,
poultry, fish, shellfish, edible crustacean, or other ingredients, including
synthetic ingredients, in a form capable of supporting rapid and progressive
growth of infectious or toxigenic microorganisms. The term does not include
foods which have a pH level of 4.6 or below or a water activity (aw) value of
0.85 or less.
BB. "Processing"
means the preparing of a food in a manner which changes the food from its
original state.
CC. "Processor"
means any person processing food.
DD. "Quality Control Operation" means a
planned and systematic procedure for taking actions necessary to prevent food
from being adulterated.
EE.
"Reconditioning" means any appropriate process or procedure by which distressed
merchandise can be brought into compliance with the standards of the Department
for consumption or use by the public.
FF. "Refuse" means all garbage, trash, and
rubbish not intended for reuse as salvaged merchandise.
GG. "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.
HH.
"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.
II. "Safe
Temperatures" as applied to potentially hazardous food means food temperature
of 45 degrees F. or below or 140 degrees F. or above.
JJ. "Sale or Distribution" means the act of
selling or distributing, whether for compensation or not, and includes
delivery, holding or offering for sale, transfer, or other means of handling or
trafficking.
KK. "Sanitization"
means adequate treatment of surfaces by a process that is effective in
destroying vegetative cells of microorganisms of public health significance and
in substantially reducing the number of other microorganisms. Such treatment
shall not adversely affect the product and shall be safe to the
consumer.
LL. "Single-Service
Articles" means cups, containers, lids, closures, plates, knives, forks,
spoons, stirrers, paddles, straws, placemats, napkins, doilies, wrapping
materials, toothpicks and similar articles, intended to be discarded after one
use.
MM. "Utensil" means any
implement used in the storage, preparation, transportation or service of
food.
NN. "Vehicle" means any car,
truck, bus or other means by which food or distressed, salvageable or salvaged
merchandise is transported from one location to another.
OO. "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.
PP. "Wholesome" means
in sound condition, clean, free from adulteration and otherwise suitable for
human consumption.
SECTION VI. PLANT AND
GROUNDS.
A. Grounds.
The grounds about a 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 rodents, insects or other
pests.
(2) Maintaining roads,
yards, and parking lots, including dust and flying debris, 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 insects or microorganisms.
(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 piant 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-packing 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 vessels by any effective means, including:
(a) Using protective coverings.
(b) Controlling areas over and around the
vessels to eliminate harborages for pests.
(c) Checking on a regular basis for pests and
pest infestation.
(d) Skimming the
fermentation vessels, as necessary. ,
(4) Be constructed in such a manner that:
(a) the walls and ceilings in all food
processing areas, walk-in refrigeration units, dressing rooms, locker rooms,
equipment and utensil washing areas, and toilet rooms and vestibules shall be
durable, smooth, easily-cleanable, non absorbent and light colored and that the
floors in these areas shall be durable, smooth and non-absorbent.
(b) drip or condensate from fixtures, ducts
and pipes does not contaminate food, food-contact surfaces, or food-packing
materials.
(c) 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)
Provides complete partitioning and solid self-closing doors between the food
processing establishment and any directly attached room(s) used as living or
sleeping quarters.
(6) 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.
(7) Provide safety-type light bulbs or
protective shielding of artificial lighting fixtures or other glass located
over, by, or within food storage or preparation areas and facilities where
utensiis and equipment are cleaned or stored, or otherwise protect against food
contamination by broken glass.
(8)
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.
(9) Provide,
where necessary, adequate screening or other protection against
pests.
(10) Provide adequate
protection from contamination of food products, while being transported by
vehicles.
SECTION
VII. 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 operations 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.
Approved 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 that are required to maintain sanitary conditions may
be used or stored in a plant where food is processed or exposed:
(a) Those required to maintain clean and
sanitary conditions;
(b) Those
necessary for use in laboratory testing procedures;
(c) Those necessary for plant and equipment
maintenance and operation; and
(d)
Those necessary for use in the plant's operations.
C. Poisonous or Toxic Materials.
(1) Toxic cieaning compounds, sanitizing
agents, and pesticide chemicals shall be identified, held, stored and used in a
manner that protects against contamination of food, food contact surfaces, or
food-packaging materials.
(2)
Insecticides and rodenticides shall be stored or located as to be separated
physically from detergents, sanitizers, cleaning and drying agents, caustics,
acids, polishes and other chemicals.
(3) Containers of poisonous or toxic
materials shall be prominently and distinctly labeled according to law for easy
identification of contents.
(4)
Poisonous and toxic materials shall only be used in full compliance with the
manufacturer's labeling.
D. Pest control.
No pests or animals 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-packing 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.
E. Cleaning and sanitization of food-contact
and non-food-contact surfaces.
All food-contact surfaces of equipment and utensils and
non-food-contact surfaces of equipment shall be cleaned and sanitized 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 and sanitized as
frequently as necessary to protect against contamination of food.
(4) Single-service articles 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) Where necessary to
prevent the introduction of undesirable microbiological organisms into food
products, at! utensils and food-contact surfaces of equipment used in the plant
shall be cleaned and sanitized prior to such use and following any interruption
during which such utensils and contact surfaces may have become contaminated.
Where such equipment and utensils are used in a continuous production
operation, the contact surfaces of such equipment and utensils shall be cleaned
and sanitized on a predetermined schedule using adequate methods for cleaning
and sanitizing.
(6) Sanitizing
agents shall be approved, effective and safe under conditions of use, and used
only in accordance with the manufacturer's labeling instructions.
(7) Sterilization for multi-use beverage
containers must be accomplished prior to refilling by soaking with a 3 percent
alkali solution of which not less than 60 percent is caustic for a period of
not less than five minutes at a temperature of not less than 130° F., then
thoroughly rinsed until freed from alkali.
(8) Any facility, procedure, machine, or
device may be acceptable for cleaning and sanitizing equipment and utensils if
it is established that such facility, procedure, machine, or device will
routinely render equipment and utensils clean and provide adequate sanitizing
treatment.
F. 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.
SECTION VIII. 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 in compliance with
applicable water supply regulations adopted by the State Board of Health. Any
water that contacts food or food-contact surfaces shall be safe and of adequate
sanitary quality. Hot and cold running water under pressure 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 installed in accordance with the Arkansas
State Plumbing Code and shall be adequately designed, 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
insanitary condition.
(4) Provide
adequate floor drainage in ail 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 no backflow from, or cross-connection between, piping systems
that discharge waste water or sewage and piping systems that carry potable
water for food or food manufacturing or for equipment and utensil
cleaning.
C. Sewage
disposal.
Sewage disposal shall be made into an adequate and approved
sewerage system which is in compliance with applicable wastewater disposal
regulations adopted by the State Board of Health.
D. Toilet facilities.
The plant shall be provided with adequate and conveniently
located toilets, installed in accordance with the Arkansas State Plumbing Code.
The toilet facilities shall be kept clean and in good repair. The toilet
room(s) shall be completely enclosed, well lighted, mechanically ventilated to
the outside, and equipped with a tight fitting, solid, self closing
door.
E. Hand-washing
facilities.
Hand-washing facilities shall be provided in each separate food
preparation or food processing area, and shall meet the following
requirements:
(1) Be located within
each separate food preparation or food processing area so as to permit the
convenient and expeditious usage by all employees working within that
area.
(2) Be provided with hot and
cold water under pressure.
(3) Be
provided with effective hand-cleaning and sanitizing preparations.
(4) Be provided with sanitary towel service
or suitable drying devices.
(5)
Devices or fixtures, such as water control valves, shall be so designed and
constructed as to protect against re-contamination of clean, sanitized
hands.
(6) Provide signs directing
employees handling unprotected food, unprotected food-packaging materials, or
food-contact surfaces to wash and where appropriate, sanitize their hands
before they start to work, after each absence from post of duty, after using
the toilet and whenever their hands may have become soiled or contaminated.
These signs should be posted in the processing room(s) and in the toilet
facilities.
(7) Provide refuse
receptacles that are constructed and maintained in a manner that protects
against contamination of food, equipment or hands.
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.
SECTION
IX. EQUIPMENT AND UTENSILS.
A.
Design, fabrication, installation and maintenance.
Ali 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 a!! adjacent spaces. Food-contact surfaces shall be corrosion-resistant
and shall be made of non-toxic 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.
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. Non-food contact equipment.
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.
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 approved sanitary
condition.
E. Thermometers.
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 to within
±3° F. inside the compartment, and shall be fitted with an automatic
control for regulating temperature or with an automatic alarm system to
indicate a significant temperature change during manual operation.
F. Instruments and controls.
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.
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.
SECTION X. PROCESSES
AND CONTROLS.
A. General sanitation
requirements.
All operations in the receiving, inspecting, transporting,
segregating, preparing, manufacturing, packaging, processing 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.
B. 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 shall be safe and of potable quality. Water shall
not be reused for washing, rinsing or conveying if it increases the level of
contamination of the food. Containers and carriers of raw materials shall 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 be 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 approved 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, pesticides or herbicides, shall comply with current
Federal Food and Drug Administration regulations, guidelines, and action levels
for poisonous or deleterious substances before these materials or ingredients
are incorporated into finished food. Compliance with this requirement may be
verified by any approved means, including purchasing raw materials and other
ingredients under a supplier's guarantee or certification.
(4) Raw materials, other ingredients and
rework susceptible to contamination with pests, undesirable microorganisms or
extraneous material shall comply with applicable Federal Food and Drug
Administration regulations, guidelines, 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
approved means, including purchasing raw materials and other ingredients under
a supplier's guarantee or certification.
(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.
C. 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. This may include careful monitoring or 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.
Compliance with this requirement may be accomplished by any effective means,
including:
(a) Maintaining refrigerated foods
at 45 degrees F. (7.2 degrees C) or below or appropriate for the particular
food involved.
(b) Maintaining
frozen foods in a frozen state.
(c)
Maintaining hot foods at 140 degrees F. (60 degrees C) or above.
(d) 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 metai 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 shall be disposed 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 re-examined and found not to be
adulterated before being incorporated into other food.
(10) Mechanical manufacturing steps such as
washing, peeling, trimming, cutting, sorting and inspecting, mashing,
de-watering, cooling, shredding, extruding, drying, whipping, de-fatting 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 to 45o F. or below or passing it to subsequent
manufacturing without delay. Thermophilic growth and contamination in bianchers
should be minimized by the use of adequate operating temperatures and by
periodic cleaning. Where the blanched food is washed prior to filling, water
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 the
following:
(a) Using ingredients free of
contamination.
(b) Employing
adequate heat processes where applicable.
(c) Using adequate time and temperature
controls.
(d) Providing adequate
physical protection of components from contaminants that may drip, drain or be
drawn into them.
(e) Cooling to an
adequate temperature during manufacturing.
(f) 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
approved means, including:
(a) Use of a
quality control operation in which the critical control points are identified
and controlled during manufacturing.
(b) Adequate cleaning and sanitizing of all
food-contact surfaces and food containers.
(c) Using materials for food containers and
food-packaging materials that are safe and suitable.
(d) Providing physical protection from
contamination, particularly airborne contamination.
(e) 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 shail be processed to and maintained at a safe
moisture level. Compliance with this requirement may be accomplished by an
effective means, including employment of one or more of the following practices
as appropriate:
(a) Monitoring the pH of raw
materials, food in process and finished food.
(b) Controlling the soluble solids-water
ratio in finished food.
(c)
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 an effective means, including employment of
one or more of the following practices as appropriate:
(a) Monitoring the aw of raw materials, food
in process, and finished food.
(b)
Controlling the amount of acid or acidified food added to low-fat
food.
(16) When ice is
used in contact with food, it shall be made from water from a source in
compliance with applicable water supply regulations adopted by the State Board
of Health and shall be used only if it has been manufactured in accordance with
current good manufacturing practice as outlined in these regulations, and
provisions shall be made for drainage of water produced by melting
ice.
(17) Food-manufacturing areas
and equipment used for manufacturing human food shall not be used to
manufacture non-human food-grade animal feed or inedible products, unless there
is no reasonable possibility for the contamination of the human food.
(18) Food manufacturing shall not be
performed in place of human residence nor shall manufacturing areas open
directly into rooms occupied as residence or sleeping quarters.
(20) Meaningful coding of products sold or
otherwise distributed from a manufacturing, processing, packing, or repacking
activity shall be utilized to enable positive lot identification to facilitate,
where necessary, the segregation of specific food lots that may have become
contaminated or otherwise unfit for their intended use. Records should be
retained for a period of time that exceeds the shelf life of the product,
except that they need not be retained more than two years.
