Appendix — United States v. Park

Supreme Court brief1975

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APPENDIX A

VOLUNTARY

INDUSTRY SANITATION

GUIDELINES FOR

FOOD DISTRIBUTION

CENTERS AND

WAREHOUSES

Mui

Sponsored by:

ASSOCIATION OF INSTITUTIONAL DISTRIBUTORS

COOPERATIVE FOOD DISTRIBUTORS OF AMERICA

GROCERY MANUFACTURERS OF"AMERICA

INTERNATIONAL FOODSERVICE DISTRIBUTORS ASSOCIATION

INTERNATIONAL FOODSERVICE MANUFACTURERS ASSOCIATION

NATIONAL-AMERICAN WHOLESALE GROCERS’ ASSOCIATION

NATIONAL ASSOCIATION OF FOOD CHAINS

I. ForEworp

These guidelines were prepared for receiving, handling,

storage, and shipping of food and food products con-

tained in retail and/or shipping containers at food dis-

tribution centers and food warehouse establishments,

referred to as ‘‘food warehouses’’ throughout these guide-

lines. The term ‘‘food(s)’’ in these guidelines means foods

and food products which are contained in retail and/or

shipping containers, but includes items such as fresh

produce received unpackaged or in partially open packages,

which are subject to various specific additional portions

of the guidelines.

The purpose of these guidelines is to promote receiving,

handling, storage, and shipping of food and related items

at such establishments in a manner that will assure the

continued delivery of safe, sanitary, and wholesome foods

to consumers.

It is further intended that conscientious adherence to

the letter and spirit of these guidelines will not only

minimize the chance of noncompliance with applicable

governmental requirements for food sanitation, but will

improve and maintain the overall effectiveness and quality

of the practices by which foods are brought to the

American consumer.

In this context, it is essential that management, including

those directly responsible for any food warehousing

activity, make provision for persons employed in a food

handling capacity to receive the degree of training,

emphasis, and support commensurate with their job re-

sponsibilities and with ensuring the effective implementa-

tion of the provisions of this document.

These guidelines, of necessity, are neither exclusive nor

all inclusive; they are, however, intended to assist manage-

ment and food warehouse operators in developing and

maintaining facilities, methods, practices, and controls for

the receiving, handling, storage, and shipping of foods at

the food warehouse establishment in a manner that pro-

tects the public health.

They are designed to deal with exposed or otherwise

uncovered foods only to the extent that such foods are

exposed or uncovered during receiving, handling, storage,

and shipping in the food warehouse establishment.

They are not designed to cover food manufacturing,

processing, or packaging areas and related equipment,

practices, and procedures which are subject to regulations

and/or guidelines specifically developed for those types |

of operations.

If food warehousing and food manufacturing, processing,

or packaging operations are maintained in the same

establishment, neither type of operation should interfere

with the compliance with any good sanitation practices,

guidelines, or regulations applicable to the other type or

types of operations.

Il. Bumpines anp Grounps

A. Maintain Grounds Around Warehouses in a

Sanitary Manner :

e Maintain the grounds around food warehouse buildings

under the control of the operator in a well-drained condi-

tion, and free from conditions likely to lead to contami-

nation of foods in the food warehouse, leaving the food

warehouse, or being delivered to the food warehouse.

¢ Keep grounds clean and free of discarded equipment,

lumber, litter, waste, refuse, and uncut weeds or grasses

within the immediate vicinity of the food warehouse which

may provide breeding places or harborages for rodents,

insects and other pests.

e Locate outside waste disposal containers on properly

drained areas, clean them as needed, and keep them covered

between use.

e Maintain and surface driveways, truck aprons, and

rail sidings at receiving and shipping areas and parking

areas to facilitate good drainage and to minimize dust and

dirt being blown or tracked into the food warehouse.

_Maintain them in a clean, well-drained condition.

e If the food warehouse buildings are closely bordered

by grounds not under the operator’s control, exercise

special care in the food warehouse, by inspection, extermi-

nation, or other means, to exclude and control pests, dirt,

and other potential contaminants originating from such

non-controlled grounds.

B: Maintain and Operate Food Warehouse Buildings

and Structures in a Sanitary Manner:

e Provide floors and interior walls which are adequately

cleanable and keep them clean and in good repair.

e Suspend fixtures, ducts, and pipes which are over

working areas so as to prevent drip or condensate from

contaminating food or food packages.

e Maintain adequate separation by location or other

effective means for those operations which may cause con-

tamination of foods with undesirable chemicals, filth, or

other éxtraneous material.

e Provide adequate lighting to areas where food is

received, stored, held or assembled for delivery, in order :

to facilitate handling, processing, and examination of mer-

chandise and to permit adequate inspection, clean-up, and

repair of the buildings and their structures.

e Provide adequate lighting in hand washing areas,

dressing and locker rooms (if present), and toilet rooms.

e Employ appropriate special efforts to maintain sani-

tation whenever necessitated by unique features of

structure or design.

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e In a food warehouse utilizing light bulbs, light fixtures,

skylights or other glass over exposed food, such as produce

items in mesh bags, ete., use safety type bulbs or shielded

fixtures to prevent food contamination in case of breakage.

Ill. Fixtures anp EQuiIPpMENT

e Provide food warehouse equipment which is suitable

as used and maintained, and is of design, material, and

workmanship which permits it to be adequately cleaned

and properly maintained by the methods used at the

establishment.

e Use and maintain the equipment so as to prevent the

adulteration of foods with lubricants, fuel, metal fragments,

contaminated water, or any other contaminants.

e Install and maintain equipment in a manner which

will facilitate its cleaning and the cleaning of adjacent

spaces. .

IV. Sanitary Faci.ities

Provide the food warehouse with adequate sanitary

facilities and accommodations:

A. Water Supply:

e From an adequate source, provide a water supply

which is sufficient for the food warehouse operations.

~B. Sewage:

e Dispose of sewage into an adequate sewerage system

or through other appropriate means.

C. Plumbing:

e Install and maintain plumbing of adequate capacity

and design and in accordance with applicable governmental

sanitation requirements, if any, so as to provide sufficient

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quantities of water to required locations throughout the

food warehouse, and to properly convey sewage and

liquid disposable waste from the food warehouse.

D. Toilet Facilities:

e Provide toilet facilities which are adequate, kept in

good repair, conveniently located, well-ventilated, and in

compliance with applicable governmental sanitation re-

quirements, if any.

e Provide them with self-closing doors and with walls,

ceilings, and floors which are tight fitting and of a material

which can be easily cleaned and kept in good repair; and

maintain them in a clean condition.

e Furnish toilet rooms with toilet tissue, and post signs

instructing employees to wash their hands with soap or

detergent before returning to work.

e If toilet rooms are located near areas in the food ware-

house where exposed foods, such as produce items in mesh

bags, might be subjected to airborne contamination, pro-

vide them with self-closing doors which do not open directly

into such areas.

E. Hand Washing Facilities:

e Provide adequate hand washing facilities in the toilet

rooms or in places convenient to the toilet rooms for hand

washing after use of the toilets.

e Furnish such facilities. with hot and cold running

water, hand-cleansing soaps or detergents, sanitary towels,

or other suitable drying devices.

e Provide adequate receptacles, with covers, for disposal

of hand-drying articles or waste material.

e Maintain the washing facilities and the surrounding

areas in a clean condition.

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F. Dressing and Locker Areas:

e If dressing and locker areas are present, provide them

with adequate ventilation and lighting, and maintain them

in a clean and orderly condition.

e If lockers are present, provide them with sufficient

ventilation to keep them dry for the retardation of mold

and odors and maintain them in a clean condition, free from

trash, food scraps, or litter which serve as insect or rodent

attractants. Keep the tops of such lockers clean, and do

not use them as surfaces for the storage of materials.

G. Eating Areas:

e If there are eating areas in the food warehouse, en-

close them adequately or locate them in areas away from

operations. Provide adequate space, light, and ventilation

in such areas. Clean eating areas regularly, and provide

them with a sufficient number of covered receptacles for

disposal of meal trash. Clean such trash receptacles regu-

larly and do not permit them to become insect or rodent

attractants.

e Clean and inspect vending machines and surrounding

areas at regular and frequent intervals to detect and cor-

rect conditions of insanitation which may exist in or around

such machines.

e If drinking fountains are provided, locate them con

veniently and clean them regularly.

V. Sanirary OPERATIONS

A. Keep Buildings and Equipment Sanitary:

e Maintain buildings, fixtures, equipment, and other

physical facilities of the food warehouse in good repair

and in a sanitary condition.

e Conduct cleaning operations in such a manner as to

minimize the danger of contamination. For cleaning and

sanitizing procedures, utilize detergents, sanitizers and

other supplies which are safe and effective for their in-

tended uses.

e Exclusive of packaged products held for distribution,

store and use in the food warehouse only such toxic mater-

ials as are required for necessary activities, such as for

maintaining sanitary and pest free conditions, for use in

laboratory testing procedures, or for food warehouse and

equipment maintenance and operation. Identify and use

such products only in such manner and under such condi-

tions as will be safe for the intended use.

e Use pesticides only under such precautions and re-

strictions as will prevent the contamination of food and

food packaging materials.

B. Rubbish:

e Convey, store, and dispose of rubbish in a manner

which will minimize the development of odor, prevent

waste from becoming an attractant and harborage or

breeding place for vermin, and prevent contamination of

warehoused food, food containers, ground surfaces, and

water supplies.

C. Pest Control Programs:

» Establish and maintain positive control programs de-

signed to exclude and eliminate pests from the food ware-

house and to deny them harborage, in order to protect

against the contamination of foods in or on the premises

by animals, birds, and vermin (including, but not limited

to, rodents and insects).

e Keep trained security dogs*out of actual storage areas

to avoid excreta contamination of foods stored at floor

level. Keep cats out ofthe food warehouse.

e Implement these programs as an integral part of the

construction, maintenance, operational, and personnel

programs described elsewhere in the guidelines.

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VI. Procepurges anp CoNnTROLS

Conduct operations in the receiving, inspecting, trans-

porting, handling, segregating, recouping, and storing of

foods in accordance with appropriate sanitation principles.

Implement overall sanitation under the supervision of an

individual assigned responsibility for’ this function.

Take reasonable precautions, including the following, to

assure that food warehouse procedures do not. contribute

to contamination of foods by harmful chemicals, objection-

able odors, or other objectionable materials.

A. Incoming Product Shipments:

The integrity of the food warehouse sanitation pro-

gram requires that the materials, including foods and their

packaging, which are received into the warehouse do not |

expose the food warehouse to contamination by reason of

infestation by insects, birds, rodents, or other vermin, or

by iutroduction of filth or other contaminants. It is often

useful, when practicable, to work with suppliers and ship-

pers in advance to establish guidelines for acceptance, re-

jection, and where appropriate, reconditioning of particular

product, taking into consideration factors such as the na-

ture, method of shipment, and ownership of ‘the product,

in order to facilitate the effective implementation of these

programs. ,

1. Within a reasonable time after the arrival of a car

or truck, and before product is unloaded, the product

should be inspected to the extent permitted by the loading

of the vehicle for evidence of damage or of insect or rodent

infestation, objectionable odor, or other form of contamin-

ation.

Where an adequate inspection has not been ‘possible

prior to unloading, further inspect such product during and

immediately after unloading. ”

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a 2. If damaged product has been accepted, keep it sepa:

ate from other product, and recondition or otherwise,

; handle it as necesary in a manner which will not expose

foods or the food warehouse ” contamination or infesta-

tion.

‘

| 8. If the inspection reveals evidence of infestation or

‘contamination:

° Determine whether the condition is only ‘‘suspect,’’

_or is superficial (such as surface infestation of flying in-

sects which may be on, but have not penetrated, soiled, or

eompromised the integrity of the packaging) and might be

fully correctable by fumigation or other means.

¢ In each such.case, remove the product from the food

warehouse area, utilizing the vehicle in which it arrived, if

feasible, after closing and sealing it.

e In case of contamination, if rejection is appropriate

(based on the origin and ownership of the product),

_. promptly notify the carrier and shipper of the time, place,

and circumstances of the rejection.

e After removal from the food warehouse because of

suspect and/or superficial conditions, concentrated efforts

can be made to further evaluate the actual condition of

the product, and to recondition it, when possible.

4. Give special attention to product which has prev-

‘jiously been rejected, or has otherwise been removed from

the food warehouse because of suspect and/or superficial

conditions, when it is subsequently received again, to agsure

reinspection. —

5. In the event of serious question, or of failure to

agree with the shipper or carrier, as appropriate, as to

condition or reconditioning, consider requesting evaluation

.of the suspect or rejected product by appropriate federal,

state, or local authorities.

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B. Store Product Properly:

e Place foods received into the food warehouse for

handling or storage in a manner which will facilitate clean-

ing and the implementation of insect, rodent, and other

sanitary controls and will maintain product wholesomeness.

C. Proper Stock Rotation:

e Adopt and implement effective procedures to provide

stock rotation appropriate to the particular food.

D. Contaminated or Damaged Foods:

e Unless promptly and adequately repaired or cor-

rected at or near the point of detection, promptly separate

foods which are identified as being damaged or are other-

wise suspect from other foods for further inspection,

sorting, and disposition.

e Promptly destrédy ‘or remove from the food warehouse

product determined to present a hazard of contamination to

foods in the food warehouse.

E. Hazardous Non-Food Products:

¢ Handle and store non-food products which present

hazards of contamination to foods stored in the same food

warehouse by reason of undesirable odors, toxicity of con-

tents, or otherwise, in a manner which will keep them from

contaminating the foods.

¢ Take special measures to safeguard from damage and

infestation those foods which are particularly susceptible

to such risks.

F. Avoid Damage to Packaging:

e Exercise care in moving, handling and storing product

to avoid damage to packaging which would affect the

contents of food packages, would cause spillage, or would

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otherwise contribute to the creation of insanitary

conditions.

G. Shipping:

e Prior to loading with foods, inspect rail car and truck

and trailer interiors for general cleanliness and for freedom

from moisture; from foreign materials which would cause

product contamination (such as broken glass, oil, toxic

chemicals, ete.) or damage to packaging ‘and contents

(such as boards, nails, harmful protrusions, ete.) ; and from

wall, floor, or ceiling defects that could contribute to

insanitary conditions.

e Clean, repair, or reject them as necessary to protect

foods before loading.

e Exercise care in loading foods to avoid spillage or

damage to packaging and contents.

e Maintain docks, rail sidings, truck bays, and driveways

free from accumulations of debris and spillage.

H. Warehouse Temperatures:

e Maintain warehouse temperatures (particularly for _

refrigerated and frozen food storage areas) which are in”

compliance with applicable governmental temperature

requirements, if any, for maintaining the wholesomeness

of the particular foods received and held in such areas.

I. Housekeeping, Sanitation and Inspection:

e Establish a regularly scheduled program of general

housekeeping, sanitation, and inspection to maintain

floors, walls, fixtures, equipment, and other physical

facilities in a state of sanitation sufficient to protect foods

from contamination or adulteration, and to prevent waste

from becoming an attractant and harborage or breeding

place for vermin.

e In addition, develop and implement an effective pro-

gram and procedure for timely cleanup of any debris and

spillage resulting from accidents or other unscheduled

occurrences. ;

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J. Pest Control Measures:

e Implement pest control measures designed to prevent

the entrance of pests, to deny them harborage, and to

detect and eliminate them, with such schedules, instruc-

tions, and procedures, and by such trained and qualified

personnel or professional representatives as may be nec-

essary, based on the nature of the foods and other products

handled, the structure and condition of the building and

equipment, and the surroundings and environment of the

warehouse.

e Monitor traps-and bait stations, whether inside or

outside of buildings, on a regular basis. Use covered

interior bait stations designed, located, or protected to

prevent spillage. Where appropriate, use bait stations

constructed of moistureproof material.

K. Pesticides:

e Use only pesticides with labels showing USDA or

EPA registration numbers, and only for the uses specified

in the labeling.

e Have them applied only by responsible personnel in

accordance with the manufacturer’s labeling instructions

and in a manner which prevents contamination of foods.

While not in use, clearly mark and store pesticides in a

secure place apart from foods.

L. Audit Food Warehouse Sanitation Programs:

e Establish programs internally and/or through outside

consultants for effectively auditing the food warehouse

sanitation program.

VII. PrersonnEL

A. Employee Practices:

e Prohibit employees affected by disease in a communi-

cable form, while carriers of such disease, or while afflicted

with boils, sores, infected wounds, or other abnormal

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sources of bacterial infection, from working in the food

warehouse in capacities in which there is a likelihood of

food becoming contaminated, or of disease being transmitted

to other persons.

¢ Prohibit clothing or other personal belongings from

being stored and food and beverages from being consumed

and tobacco from being used in areas where foods are

~ handled or stored.

e Instruct employees who are working in direct contact

with exposed or partially exposed foods, such as produce

items in mesh bags, etc., to maintain personal cleanliness

and to conform to hygienic practices to avoid contamination

of such foods with microorganisms or foreign substances

such as human hair, perspiration, cosmetics, tobacco,

chemicals, and medicants and, if gloves are used in

handling such foods, to use only gloves which are of an

impermeable material in handling: such foods, and to

maintain them in a clean and sanitary condition.

B. Management Responsibilities:

e Assign responsibility for the overall food warehouse

sanitation program and authority commensurate with this

responsibility to persons who, by education, training, and/

or experience are able to identify sanitation risks and

failures and food contamination hazards. .

e Instruct employees in the sanitation and hygienic

practices appropriate to their duties and the locations of

their work assignments within the food warehouse. In-

struct employees to report observations of infestations

(such as evidence of rodents, insects or harborages) or

construction defects permitting entry or harborage of

pests, or other developments of insanitary conditions.

e Exercise programs of follow-up and control to ensure

that your employees, consultants, and outside*services are

doing their jobs effectively.

15a

APPENDIX

This appendix to the Voluntary Industry Sanitation

Guidelines for Food Distribution Centers and Warehouses

has been prepared to assist the food warehouse operator in

implementation of Sections (I) through (VII) of the

Guidelines. Information in this appendix will require

adaptation for specific application to your operations.

Since no single document can provide all the information

necessary for every situation or specify the only methods

for compliance, develop your own appendix or company

guidelines to reflect your individual applications in the

general areas dealt with in the Guidelines and this ap-

pendix.

I. Foreworp

To ensure product wholesomeness and proper sanitation,

the food warehouse sanitation program must have the

commitment of top management, must be implemented by

operating supervision, artd must be supported by the en-

tire food warehouse staff. Preventive sanitation—the per-

formance of inspection, sanitation, building maintenance,

and pest control functions designed to prevent insanita-

tion in preference to correcting it—should be an important

goal of food warehouse management and of food ware-

house operations.

II. ORGANIZATION AND PROGRAMS

A program to ensure continued success in safeguarding

the wholesomeness of food and in providing good sanita-

tion will ordinarily include:

1. An organizational chart showing chain of authority

and responsibility.

2. A flow diagram of receiving, storage, and shipping

operations,

/ .

3. Regular maintenance schedules.

4. Regular sanitation programs.

5. Regular pest control programs.

6. An effective program of follow-up and control in-

cluding reports to responsible executive officer(s).

III. Cuecx Pornts anp AppiTionaL GuIDES

1. Grounds:

e Keep nearby grounds free of liquid or solid emissions

that could be sources of contamination.

e Prevent grounds from providing conditions for insect

or rodent harborage.

e Check paving, drainage, weed, and litter control regu-

larly.

e Stack materials which are stored in the open neatly and

away from buildings, and on racks above ground level

where feasible.

e ‘‘No-vegetation strips’? around exterior building .

walls and at property lines adjacent to properties con

taining potential harborages are helpful for discovering

and discouraging travel by rodents.

2. Buildings:

e Provide separate and sufficient space for placement of

equipment and storage of materials necessary for proper

operations.

e Separate activities that might cause contamination of

stored foods with chemicals, filth, or other harmful ma-

terial.

e Check structural conditions, pest barriers, repair of

windows, screens, and doors continuously.

17a

e Seal and clean floor wall junctions and fill holes and

cracks; a painted inspection strip is also recommended.

e Keep offices—including overhead offices—in the food

warehouse clean, and do not permit them to become attract-

ants or harborages for insects or vermin. Include them in

the pest control program.

e Check false ceilings for harborage of insects and

possibly rodents.

e Give basements, attics, elevators, and rail sidings, etc.,

special attention.

3. Sanitary Operations:

¢ Keep walls, ceilings and rafters free of soil, insect

webbing, mold, and similar materials.

e Do not leave unscreened doors and windows open un-

necessarily.

e Do not permit dust to accumulate.

e Keep floors free of product spillage, oil drippage, and

buildup in all areas.

e Provide proper trash and refuse storage and removal.

e Store tools and equipment properly.

e Clean and flush drains regularly.

e Maintain railfoad and truck courts free of debris, and

properly patrol them for pest control.

e Keep eating and break areas, locker rooms, etc. clean

and orderly. Vending machines are often overlooked:

keep them and the areas adjacent to them clean and

sanitary. Maintain equipment in a properly functioning

condition and do not permit it to serve as a source of

sanitation or harborage problems.

18a

4. Receiving and Inspection:

e Inspect the materials which are being received for

evidence of damage; insect, bird, rodent, or other vermin

infestation; and moisture, odor, or chemical contamination.

e Exclude contaminated materials, including product,

pallets, and slip sheets, from the building.

e If damaged merchandise is accepted, segregate it for

special handling.

e Make sure that incoming and outgoing vehicles are

free of conditions that could contaminate product—no

birds, rodents, insects, spillage, or objectionable odor

should be evident. :

e Code or mark foods received at the receiving point to

ensure proper stock rotation.

e To facilitate handling of rejected and suspect pro-

duct, it is often a good idea to develop procedures with in-

dividual shippers, carriers, and/or manufacturers for re-

inspections, returns, etc.

5. Storage:

e Store products in an orderly manner and so that date

codes are visible for proper rotation.

e Generally, it is desirable to stack foods on pallets or

racks (or on slip sheets, where a clamp truck operation is

utilized), and away from walls so as to allow for inspec-

tion aisles between stacks and walls. Painting inspection

aisles in a light color is often helpful in maintaining their

effectiveness. Where full inspection aisles are not pro-

vided, take special care (such as more frequent inspection,

rotation, and removal of product for cleaning) to ensure

sanitary, pest free conditions.

e Separate bagged and baled foods to provide visibility

between stacks.

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e Dispose of contaminated or infested merchandise, or

otherwise remove it from the food warehouse promptly.

e Promptly remove damaged merchandise and broken

containers from general food storage areas. Handle and

process salvageable merchandise separately in an area

isolated from general food storage; this area probably will

require extra sanitation and pest control attention.

e If salvage operations include the repackaging or other

manipulation of exposed foods (other than items such as

fresh produce received unpackaged or in partially open

packages), conduct such operations in compliance with the

food sanitation practices, guidelines, or regulations, such

as 21 CFR 128, which are applicable to handling exposed

foods.

e Do not intermingle chemicals, including pesticides, with

food or food products. Such products are best separated

by an aisleway.

6. Pest Control:

e Maintain written schedules, log activity, and monitor

traps and bait stations regularly.

e Use covered bait stations which are of such types and

so located as to reduce the danger of spoilage; and where |

appropriate, use moisture-proof bait stations.

e Keep the pesticides which are used in the food ware-

house securely, and separate from foods. Permit their

use only by properly trained personnel. Use only types

registered and approved by an appropriate government

agency for the intended use.

e Check especially for:

e rodent burrows in nearby grounds,

e activity at floor wall junctions and doorways, and

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e insect crawl marks in dust accumulation, especially

on overhead pipes, beams, window sills, around

flour, sugar, and pet food storage.

e Where feasible, seal load levelers at docks to prevent

trash accumulations and rodent harborage and entry; and

clean them frequently.

e Look for insect activity in folds of bagged foods.

e Use black light, supplemented with means for dis-

tinguishing other chemicals that fluoresce, to check for

rodent urine stains; and use flashlights to cheek for other

evidence of contamination.

7. Shipping:

e Make sure that transportation equipment into which

food warehouse food is loaded is maintained in a sanitary

condition comparable to that of the food warehouse.

e Make sure that rail cars, trailers and trucks ... are

free of birds, rodents and insects or contamination from

them,

. are free of odors, nails, splinters, oil, and grease,

. are free of accumulations of dirt or dunnage, and

. are in good repair and have no holes, cracks, or

crevices that -could provide entrances or harborages for

pests.

8. Follow-Up:

8 Exercise programs of follow-up and control to ensure

that your employees, consultants, and outside services are

doing their jobs effectively.

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Reprint oF Parr 128, Tite 21 or FeperaL REGULATIONS

Part 128—Iiuman Foops; Current Goop MANUFACTURING

PRACTICE (Sanrration) In MANvuFACTURE, PROCESSING,

Or Howpinc

See.

128.1 Definitions.

128.2 Current good manufacturing practice (sanitation).

128.3 Plant and grounds.

128.4 Equipment and utensils.

128.5 Sanitary facilities and controls.

128.6 Sanitary operations.

128.7 Processes and controls.

128.8 Personnel.

128.9 Exclusions.

128.10 Natural or unavoidable defects in food for

human use that present no health hazard.

Avurnority: The provisions of this Part 128 issued under

sees. 402(a)(4), 701(a), 52 Stat. 1046, 1055; 21 U.S.C.

342(a) (4), 371(a) unless otherwise noted.

Source: The provisions of this Part 128 appear at 34

FR 6977, Apr. 26, 1969, unless otherwise noted.

§ 128.1 Definitions.

The definitions and interpretations contained in section

' 201 of the Federal Food, Drug, and Cosmetic Act are

Asean ——

applicable to such terms when used in this part. The fol-

lowing definitions shall also apply:

(a ‘‘ Adequate’’ means that which is needed to accomplish

the intended purpose in keeping with good public health

practice.

(b) ‘‘Plant’’ means the building or buildings or parts

thereof, used for or in connection with the manufacturing,

processing, packaging, labeling, or holding of human food.

22a

by a process that is effective in destroying vegetative cells

of pathogenic bacteria and in substantially reducing other

micro-organisms. Such treatment shall not adversely

affect the product and shall be safe for the consumer.

§ 128.2 Current good manufacturing practice (sanitation).

The criteria in §$128.3 through 128.8 shall apply in

determining whether the facilities, methods, practices, and

controls used in the manufacture, processing, packing, or

holding food are in conformance with or are operated or

administered in conformity with good manufacturing

practices to assure that food for human consumption is

safe and has been prepared, packed, and held under sani-

tary conditions.

§ 128.3 Plant and grounds.

(a) Grounds. The grounds about a food plant under the

control of the operator shall be free from conditions which

may result in the contamination of food including, but not

limited to, the following:

(1) Improperly stored equipment, litter, waste, refuse,

and uncut weeds or grass within the immediate vicinity of

the plant buildings or structures that may constitute an -

attractant, breeding place, or harborage for rodents, in-

sects, and other pests. |

(2) Excessively dusty roads, yards, or parking lots

that may constitute a source of contamination in areas

where food is exposed.

(3) Inadequately drained areas that may contribute

contamination to food products through seepage or foot-

borne filth and by providing a breeding place for insects

or micro-organisms.

If the plant grounds are bordered by grounds not under

the operator’s control of the kind described in subpara-

a = as we Ss EP REE LOO ET ENR BSD BLT perro:

23a

graphs (1) through (3) of this paragraph, care must be

exercised in the plant by inspection, extermination, or other

means to effect exclusion of pests, dirt, and other 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-proce§sing purposes. The plant and facilities

shall:

(1) Provide sufficient space for such placement of

- equipment and storage of materials as is necessary for

sanitary operations and production of safe food. Floors,

walls, and ceilings in the plant shall be of such construction

as to be adequately cleanable and shall be kept clean and

in good repair. -Fixtures, ducts, and pipes shall not be

so suspended over working areas that drip or condensate

may contaminate foods, raw materials, or food-contact sur-

faces. Aisles or working spaces between equipment and

between equipment and walls shall be unobstructed and of

sufficient width to permit employees to perform their duties

without contaminaton of food or food-contact surfaces with

clothing or personal contact.

(2) Provide separation by partition, location, or other

effective means for those operations which may cause

contamination of food products with undesirable micro-

organisms, chemicals, filth, or other extraneous material.

(3) Provide adequate lighting to hand-washing areas,

dressing and locker rooms, and toilet rooms and to all.

areas where food or food ingredients are examined, proc-

essed, or stored and where equipment and utensils are

cleaned. Light bulbs, fixtures, skylights, or other glass

suspended over exposed food in any step of preparation

shall be of the safety type or otherwise protected to

prevent food contamination in case of breakage.

24a

(4) Provide adequate ventilation or control equipment

to minimize odors and noxious fumes or vapors (including

" steam) in areas where they may contaminate food. Such

ventilation or control equipment shall not create conditions

that may contribute to food contamination by airborne

contaminants.

(5) Provide, where necessary, effective screening or

other protection against birds, animals, and vermin

ecpioasintiae but not limited to, insects and rodents)

§ 128, 4 Equipment and utensils. .

(a) General. All plant equipment and utensils should

‘be (1) suitable for their intended use, (2) so designed and

of such material and workmanship as to be adequately

cleanable, and (3) properly maintained. The design,’

construction, and use of such equipment and utensils shall

' preclude the adulteration of food with lubricants, fuel,

metal fragments, contaminated water, or any other con-

~ taminants. All equipment should be so installed and

maintained as to facilitate the cleaning of the equipment

, and of\ all adjacent spaces.

(b) Use of polychlorinated biphenyls in food plants.

Polychlorinated biphenyls (PCB’s) represent a class of

toxic industrial chemicals manufactured and sold under a

variety of trade names, including: Aroclor (United States) ;

Phenoclor (France); Colphen (Germany); and Kanaclor

(Japan). PCB’s are highly stable, heat resistant, and

non-flammable chemicals. Industrial uses of PCB’s in-

clude, or did include in the past, their use as electrical

transformer and eapacitor fluids, heat transfer ‘fluids,

hydraulic fluids, and plasticizers, and in formulations of

lubricants, coatings, and inks. Their unique physical and

chemical properties and widespread, umeontrolled industrial

applications have caused PCB’s to be a persistent and

ubiquitous contaminant in the environment and causing

the contamination of certain foods. In addition, incidents

— 2 ow . ened SPOOL OL EL CLOT PME PIETY IT ASE EPR lS

25a

have occurred in which PCB’s have directly contaminated

animal feeds as a result of industrial accidents (leakage

or spillage of PCB fluids from plant equipment). These

‘accidents in turn cause the contamination of food intended

for human consumption (meat, milk, and eggs). Since

PCB’s are toxic chemicals, the PCB contamination of food

as a result of these accidents represents a hazard to human

health. It is therefore necessary to place certain re-

strictions on the industrial uses of PCB’s in the production,

handling, and storage of food. The following special pro-

visions are necessary to preclude accidental PCB contami-

nation of food:

(1) New equipment, utensils, and machinery for hand-

ling or processing food in or around a food plant shall not

contain PCB’s.

(2) On or before September 4, 1973, the management

of food plants shall:

(i) Have the heat exchange fluid used in existing

equipment or machinery for handling or processing food

sampled and tested to determine whether it contains PCB’s,

or verify the absence of PCB’s in such formulations by

other appropriate means. On or before Sept. 4, 1973, any

such fluid formulated with PCB’s must be replaced with a

heat exchange fluid that does not include PCB’s.

(ii) Eliminate from the food plant any PCB-containing

food-contact surfaces of equipment or utensils and any

PCB-containing lubricants for equipment or machinery

that is used for handling or processing food.

; (iii) Eliminate from the food plant any other PCB-

i containing materials wherever there is a reasonable ex-

pectation that such materials could cause food to become

contaminated with PCB’s either as a result of normal use

or as a result of accident, breakage, or other mishap.

(iv) The toxicity and other characteristics of fluids

selected as PCB replacements must be adequately de-

26a

termined so that the least potentially hazardous replace-

ment is used. In making this determination with respect

to a given fluid, consideration should be given to (a) its

toxicity; (b) the maximum quantity that could be spilled

onto a given quantity of food before it would be noticed,

taking into account its color and odor; (c) possible signal-

ing devices in the equipment to indicate a loss of fluid,

etc.; and (d) its environmental stability and tendency to

survive and be concentrated through the food chain.. The

judgment as to whether a replacement fluid is sufficiently

non-hazardous is to be made on an individual installation

and operation basis.

(3) For the purposes of this section, the provisions do

not apply to electrical transformers and condensers con-

taining PCB’s in sealed containers.

[38 rr 18012, July 6, 1973]

§ 128.5 Sanitary facilities and controls.

Fach plant shall be equipped with adequate sanitary fa-

cilities and accommodations including, but not limited to,

the following:

(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 foods or food-

contact surfaces shall be safe and of adequate sanitary

quality. Running water at a suitable temperature and un-

der pressure as needed shall be provided in all areas where

the processing of food, the cleaning of equipment utensils,

or containers, or employee sanitary facilities require.

(b) Sewage disposal. Sewage disposal shall be made

into an adequate sewerage system or disposed of through

other adequate means.

design and adequately installed and.maintained to:

27a

(1) Carry sufficient quantities of water to required

locations throughout the plant.

(2) Properly convey sewage and liquid disposable

waste from the plant.

(3) Not constitute a source of contamination to foods,

food products or ingredients, water supplies, equipment or

utensils or create an insanitary condition. g

(4) Provide adequate floor drainage in all areas where

floors are subject to flood-type cleaning or where formal

operations release or discharge water or other liquid waste

on the floor.

*(d) Toilet facilities. Each plant shall provide its em-

ployees with adequate toilet and associated hand-washing

facilities within the plant. Toilet rooms shall be furnished

with toilet tissue. The facilities shall be maintained in a

sanitary condition and kept in good repair at all times.

Doors to toilet rooms shall be self-closing and shall not open

directly into areas where food is exposed to airborne con-

tamination, except where alternate means have been taken

to prevent such contamination (such as double doors, posi-

tive air-flow systems, etc.). Signs shall be posted directing

employees to wash their hands with cleaning soap or de-

tergents after using toilet.

(e) Hand-washing facilities. Adequate and convenient

facilities for hand washing and, where appropriate, hand

sanitizing shall be provided at each location in the plant

where good sanitary practices require.employees to wash or

sanitize and dry their hands. Such facilities shall be

furnished with running water at a suitable temperature for

-hand washing, effective hand-cleaning and sanitizing pre-

parations, sanitary towel service or suitable drying devices,

and, where appropriate, easily cleanable waste receptacles.

(f) Rubbish and offal disposal. Rubbish and any offal

shall be so conveyed, stored, and disposed of as to minimize

the development of odor, prevent waste from becoming an

Weve. SUNN:

28a

attractant and harborage or breeding place for vermin,

and prevent contamination of food, food-contact surfaces,

ground surfaces, and water supplies.

§ 128.6 Sanitary operations.

(a) General maintenance. Buildings, fixtures, and other

physical facilities of the plant shall be kept in good repair

and shall be maintained in a sanitary condition. Cleaning

operations shall be conducted in such a manner as to min-

imize the danger of contamination of food and food-contact

surfaces. Detergents, sanitizers, and other supplies em-

ployed in cleaning and sanitizing procedures shall be free

of significant microbielogical contamination and shall be

safe and eftective for their intended uses. Only such toxic

materials as are required to maintain sanitary conditions,

for use in laboratory testing procedures, for plant and

equipment maintenance and operation, or in manufactufing

or processing operations shall be used or stored in the

plant. These materials shall be identified and used only in

such manner and under conditions as will be safe for their

intended uses. “

(b) Animal and vermin control. No animals or birds,

other than those essential as raw material, shall be al-

lowed in any area of a food plant. Effective measures shall

be taken to exclude pests from the processing areas and to

protect against the contamination of foods in or on the

premises by animals, birds, and vermin (including, but not

limited to, rodents and insects). The use of insecticides or

rodenticides is permitted only under such precautions and

restrictions as will prevent the contamination of food or

packaging materials with illegal residues.

and product-contact surfaces of equipment shall be cleaned

as frequently as necessary to prevent contamination of food

and food products. Nonproduct-contact surfaces of equip-

ment used in the operation of food plants should be cleaned

as frequently as necessary to minimize accumulation of

29a

dust, dirt, food particles, and other debris. Single-service

articles (such as utensils intended for one-time use, paper

cups, paper towels, Atc.) should be stored in appropriate

_eontainers and handled, dispensed, used, and disposed of

: in a manner that prevents contamination of food or food-

contact surfaces. Where necessary to prevent the introduc-

tion of undesirable microbiological organisms into food

products, all utensils and product-contact surfaces of equip-

ment 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 con-

taminated. Where such equipment and utensils are used

in a continuous production operation, the contact surfaces

of such equipment and utensils shall be cleaned and sani-

tized on a predetermined schedule using adequate methods

for cleaning and sanitizing. Sanitizing agents shall be ef-

fective and safe under conditions of use. Any facility, pro-

cedure, 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 rou-

tinely render equipment and utensils clean and provide

adequate sanitizing treatment. ~

(d) Storage and handling of cleaned portable equip-

ment and utensils. Cleaned and sanitized portable equip-

ment and utensils with product-contact surfaces should

be stored in such a location and manner that product-con-

tact surfaces are protected from splash, dust, and other

contamination.

§ 128.7 Processes and controls.

All operations in the receiving, inspecting, transporting,

packaging, segregating, preparing, processing, and storing

of food shall be conducted in accord with adequate sani-

tation principles. Overall sanitation of the plant shall be

under the supervision of an individual assigned responsi-

bility for this function. Al reasonable precautions, in-

cluding the following, shall b> taken to assure that produc-

Petree once:

30a

tion procedures do not contribute contamination such as

filth, harmful chemicals, undesirable micro-organisms, or

any other objectionable material to the processed product:

(a) Raw material and ingredients shall be inspected

and segregated .as necessary to assure that they are clean,

wholesome, and fit for processing into human food and shall

be stored under conditions that will protect against con-

tamination and minimize deterioration. Raw materials

shall be washed or cleaned as required to remove soil or

other contamination. Water used for washing, rinsing,

or conveying of food products shall be of adequate quality,

and water shall not be reused for washing, rinsing, or °

conveying products in a manner that may result in con-

tamination of food products.

(b) Containers and carriers of raw ingredients should

be inspected on receipt to assure that their condition has

not contributed to the contamination or deterioration of

the products.

it shall be made from potable water and shall be used only

if it has been manufactured in accordance with adequate

standards and stored, transported, and handled in a sani-

tary manner. :

(d) Food-processing areas and equipment used for

processing human food should not be used to process non-

human food-grade animal feed or inedible products unless

there is no reasonable possibility for the contamination of

the human food.

(e) Processing equipment shall be maintained in a

sanitary condition through frequent cleaning including

senitization where indicated. Insofar as necessary, equip-

ment shall be taken apart: for thorough cleaning.

(f) All food processing, including packaging and

storage, should be conducted under such conditions and con-

trols as are necessary to minimize the potential for unde-

sia mi a - REG SYRIA ae FR =

3la

sirable bacterial or other microbiological growth, toxin

formation, or deterioration or contamination of the proc-

essed product or ingredients. This may require careful

monitoring of such physical factors as time, temperature,

humidity, pressure, flow-rate and such processing opera-

tions as freezing, dehydration, heat processing, and re-

frigeration to assure that mechanical breakdowns, time

delays, temperature fluctuations, and other factors do not

contribute to the decomposition or contamination of the

processed products.

(g) Chemical, microbiological, or extraneous-material

testing procedures shall be utilized where necessary to iden-

tify sanitation failures or food contamination, and all foods

and ingredients that have become contaminated shall be

rejected or treated or processed to eliminate the contami-

nation where this may be properly accomplished.

(h) Packaging processes and materials shall not trans-

mit contaminants or objectionable substances to the prod-

ucts, shall conform to any applicable food additive regula-

tion (Part 121 of this chapter), and should provide ade-

quate protection from contamination.

(i) Meaningful coding of products sold or otherwise

distributed from a manufacturing, processing, packing, or

repacking activity should 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 2 years.

(j) Storage and transportation of finished products

should be under such conditions as will prevent contamina-

tion, including development of pathogenic or toxigenic

micro-organisms, and will protect against undesirable de-

terioration of the product and the container. *

32a

§ 128.8 Personnel.

The plant management shall take all reasonable measures

and precautions to assure the following:

(a) Disease control. No person affected by disease_in

a communicable form, or while a carrier of such disease,

or while affected with boils, sores, infected wounds, or

other abnormal sources of microbiological contamination,

shall work in a food plant in any capacity in which there is’

a reasonable possibility of food or food ingredients be=

coming contaminated by such person, or of disease being’

transmitted by such person to other individuals.

(b) Cleanliness. All persons, while working in direct

contact with food preparation, food ingredients, or surfaces

coming into contact therewith shall:

(1) Wear clean outer garments, maintain a high de-

gree of personal cleanliness, and conform to hygienic prac-

tices while on duty, to the extent necessary to prevent con-

tamination of food products.

(2) Wash their hands thoroughly (and sanitize if

necessary to prevent contamination by undesirable micro-

organism) 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.

(3) Remove all insecure jewelry and, during periods

where food is manipulated by hand, remove from hands

any jewelry that cannot be adequately sanitized.

(4) If gloves are used in food handling, maintain them

in an intact, clean, and sanitary condition. Such gloves

should be of an impermeable material except where their

usage would be inappropriate or incompatible with the

work involved. -

(5) Wear hair nets, headbands, caps, or other ef- .

fective hair restraints.

(6) Not store clothing or other personal belongings,

eat food or drink beverages, or use tobacco in any form in

33a

- areas where food or food ingredients are expose or in areas

used for washing equipment or utensils,

(7) Take any other necessary precautions to prevent

contamination of foods with micro-organisms or foreign

substances including, but not limited to perspiration, hair,

cosmetics, tobacco, chemicals, and medicants.

identifying sanitation failures or food contamination should

have a background of education, or experience, or a com-

bination thereof, to provide a level of competency neces-

sary for production of clean and safe food. Food handlers

and supervisors ‘should receive appropriate training in

proper food-handling techniques and food-protection prin-

ciples and should be cognizant of the danger of poor per-

sonal hygiene and insanitary practices.

(d) Supervision. Responsibility for assuring compli-

ance by all personnel with all requirements of this Part

128 shall be clearly assigned to competent supervisory

personnel.

§ 128.9 Exclusions.

The following operations are excluded from coverage

under these general regulations, however, the Commis-

sioner will issue special regulations when he believes it nec-

essary to cover these excluded operations: 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.

§ 128.10 Natural or unavoidable defects in food for

human use that present no health hazard.

(a) Some foods, even when produced under current

good manufacturing and/or processing practices, contain

natural or unavoidable defects at lower levels that are not

34a

hazardous to health. The Food and Drug Administration

establishes maximum levels for such defects in foods pro-

duced under good manufacturing and/or processing

practices and uses these levels for recommending regula-

tory actions.

(b) Defect action levels are established for products

whenever it is necessary and feas ble. Such levels are

subject to change upon the development of new technology

or the availability of new information.

cuse failure to observe either the requirement in section 402

(a) (4) of the Federal Food, Drug, and Cosmetic Act that

food may not be prepared, packed, or held under insanitary

conditions or the other requirements in this part that food

manufacturers must observe current good manufacturing

practices. Evidence obtained through factory inspection

though the amounts of natural or unavoidable defects are

lower than the currently established action levels. The

control procedures which will reduce natural or unavoid-

able defects to the lowest level currently. feasible.

(d) The mixing of a food containing defects above the

current defect action level with another lot of food is not

permitted and renders the final food unlawful regardless

of the defect level of the final food.

(e) Current action levels for natural and unavoidable>

defects in food for human use that present no health hazard

are as follows. (Lev@ls that have been adopted on a tem-

porary basis prior to publication as a regulation may be

obtained upon request at the Office of the Assistant Com-

missioner for Public Affairs, Food and Drug Administra-

tion, Room 15B-42, 5600 Fishers Lane, Rockville, Md.

20852.)

[38 F.R. 855, Jan. 5, 1973]

indicating such a violation renders the food unlawful, even —

manufacturer of food must at all times utilize quality .

abe

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.