U.S. Food and Drug Administration
Center for Food Safety & Applied Nutrition
Industry Affairs Staff Booklet
February 1994

 

    CURRENT GOOD MANUFACTURING

               PRACTICE IN MANUFACTURING, PACKING,

      OR HOLDING HUMAN FOOD

 

         21 CFR Part 110

 

This is an unofficial compiliation of the Current Good

Manufacturing Practice (CGMP) regulations.  The regulations are

current through February, 1994.  The CGMP regulations are issued

under Title 21, Code of Federal Regulations, Part 110 (21 CFR 110).

Amendments to the regulations appear in the Federal Register.

Infomation concerning subscribing to the Federal Register appears

in the last paragraph of this page.

 

Related Subjects

 

The CGMP regulations in this booklet are general regulations that

apply to all foods.  Specific CGMP regulations apply to certain

categories of food, as listed below:

 

     1.  Quality control procuedures for assuring the nutrient

     content of infant formulas (21 CFR 106).

 

     2.  CGMP regulations for thermally processed low-acid foods in

     hermeticcally-sealed (air-tight) containers (21 CFR 113), and

     for acidified foods (21 CFR 114).

 

     3.  CGMP regulations for bottled water (21 CFR 129).

 

The regulations for the categories of foods llisted above are

contained in Title 21, Code of Federal Regulations, Parts 100 to

169 (21 CFR 100 - 169).  Information concerning purchase of 21 CFR

100 - 169 appears in the last paragraph of this page.

 

Federal Register

 

Changes in FDA regulations are published in the Federal Register.

The Federal Register is published Monday through Friday by the

Government Printing Office.  Individual issues or subscriptions are

available in paper form or in microfiche form.

 

How to Order

 

You may subscribe to the Federal Register or order 21 CFR 100-169

by submitting the current cost by check or money order to:

SUPERINTENDENT OF DOCUMENTS, U.S. GOVERNMENT PRINTING OFFICE,

WASHINGTON, D.C. 20402, or by telephoning the Governement Printing

Office at 202-783-3238 to charge on Visa (copyrighted) or Mastercard

(copyrighted).

 

 

          PART 110 - CURRENT GOOD MANUFACTURING PRACTICE

        IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD

 

 

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 Control

 

110.80 Processes and controls.

110.93 Warehousing and distribution.

 

 

Subpart F - [Reserved]

 

 

Subpart G - Defect Action Levels

 

Note: Subpart G - Defect Action Levels is not included in this

reprint.

 

 

Subpart A - General Provisions

 

110.3 Definitions.

 

The definitions and interpretations of terms in section 201 of the

Federal Food, Drug, and Cosmetic Act (the Act) are applicable to

such terms when used in this part. The following definitions shall

also apply:

(a) "Acid foods or acidified foods" means foods that have an

equilibrium pH of 4.6 or below.

(b) "Adequate" means that which is needed to accomplish the

intended purpose in keeping with good public health practice.

(c) "Batter" means a semifluid substance, usually composed of flour

and other ingredients, into which principal components of food are

dipped or with which they are coated, or which may be used directly

to form bakery foods.

(d) "Blanching," except for tree nuts and peanuts, means a

prepackaging heat treatment of foodstuffs for a sufficient time and

at a sufficient temperature to partially or completely inactivate

the naturally occurring enzymes and to effect other physical or

biochemical changes in the food.

(e) "Critical control point" means a point in a food process where

there is a high probability that improper control may cause, allow,

or contribute to a hazard or to filth in the final food or

decomposition of the final food.

(f) "Food" means food as defined in section 201(f) of the act and

includes raw materials and ingredients.

(g) "Food-contact surfaces" are those surfaces that contact human

food and those surfaces from which drainage onto the food or onto

surfaces that contact the food ordinarily occurs during the normal

course of operations. "Food-contact surfaces" includes utensils and

food-contact surfaces of equipment.

(h) "Lot" means the food produced during a period of time indicated

by a specific code.

(i) "Microorganisms" means yeasts molds, bacteria, and viruses and

includes, but is not limited to, species having public health

significance. The term "undesirable microorganisms" includes those

microorganisms that are of public health significance, that subject

food to decomposition, that indicate that food is contaminated with

filth, or that otherwise may cause food to be adulterated within

the meaning of the act. Occasionally in these regulations, FDA used

the adjective "microbial" instead of using an adjectival phrase

containing the word microorganism.

(j) "Pest" refers to any objectionable animals or insects

including, but not limited to, birds, rodents, flies, and larvae.

(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.

(I) "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.

 

110.5 Current good manufacturing practice.

 

(a) The criteria and definitions in this part shall apply in

determining whether a food is adulterated (1) within the meaning of

section 402(a)(3) of the act in that the food has been manufactured

under such conditions that it is unfit for food, or ( 2 ) within

the meaning of section 402(a)(4) of the act in that the food has

been prepared, packed, or held under insanitary conditions whereby

it may have become contaminated with filth, or whereby it may have

been rendered injurious to health. The criteria and definitions in

this part also apply in determining whether a food is in violation

of section 361 of the Public Health Service Act (42 U.S.C. 264).

(b) Food covered by specific current good manufacturing practice

regulations also is subject to the requirements of those

regulations.

 

110.10 Personnel.

 

The plant management shall take all reasonable measures and

precautions to ensure the following:

(a) Disease control. Any person who, by medical examination or

supervisory observation, is shown to have, or appears to have, an

illness, open lesion, including boils, sores, or infected wounds,

or any other abnormal source of microbial contamination by which

there is a reasonable possibility of food, food-contact surfaces,

or food packaging materials becoming contaminated, shall be

excluded from any operations which may be expected to result in

such contamination until the condition is corrected. Personnel

shall be instructed to report such health conditions to their

supervisors.

(b) Cleanliness. All persons working in direct contact with food,

food-contact surfaces, and food-packaging materials shall conform

to hygienic practices while on duty to the extent necessary to

protect against contamination of food. The methods for maintaining

cleanliness include, but are not limited to:

(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 as 4 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) (l) 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:

(l) 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 operation.

 

(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. (l) 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:

(l) 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.

 

Subpart C-Equipment

 

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 D - [Reserved]

 

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 operation 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.

(l) 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, 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 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, 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 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 45x F (7.2x C) or below as

appropriate for the particular food involved.

(ii) Maintaining frozen foods in a frozen state.

(iii) Maintaining hot foods at 140x F (60x 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.

 

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.

 

 

CFSAN/Industry Activities Staff Booklet:  February 1994

Hypertext updated by j3b 01/17/1997