United States

Department of

Agriculture

Agricultural

Marketing 

Service

Dairy 

Programs

General Specifications 

for Dairy Plants 

Approved for USDA 

Inspection and Grading 

Service

Effective June 29, 2012
1

Subpart B -- General Specifications for Dairy Plants Approved for USDA Inspection and 

Grading Service1

DEFINITIONS 

§ 58.100 OMB control numbers assigned pursuant to the Paperwork Reduction Act.

The following control number has been assigned to the information collection 

requirements in 7 CFR part 58, subpart B, by the Office of Management and Budget pursuant to 

the Paperwork Reduction Act of 1980, Pub. L. 96 - 511.

7 CFR section where requirements are described Current OMB 

control No.

58.139.........................................................................................................

58.148.........................................................................................................

58.322(g)....................................................................................................

58.441.........................................................................................................

0581-0110

0581-0110

0581-0110

0581-0110

§ 58.101 Meaning of words. 

 For the purpose of the regulations of this subpart, words in the singular form shall be 

deemed to impart the plural and vice versa, as the case may demand. Unless the context 

otherwise requires, the following terms shall have the following meaning: 

(a) Act. The applicable provisions of the Agricultural Marketing Act of 1946 (60 Stat. 

1087, as amended; (7 U.S.C. 1621 - 1627)), or any other Act of Congress conferring like 

authority. 

 (b) Administrator. The Administrator of the Agricultural Marketing Service or any other 

officer or employee of the Agricultural Marketing Service of the Department to whom there has 

aheretofore been delegated, or to whom there may hereafter be delegated the authority to act in 

his stead. 

 

1Compliance with these standards does not excuse failure to comply with the provisions 

of the Federal Food, Drug, and Cosmetic Act, Environmental Protection Act, or applicable laws 

and regulations of any State or Municipality. 

 (c) Approved laboratory. A laboratory in which the facilities and equipment used for 

official testing have been approved by the Administrator as being adequate to perform the 

necessary official tests in accordance with this part, and operates under a USDA surveillance 

program as set forth by the Administrator. 
2

 (d) Approved plant. One or more adjacent buildings, or parts thereof, comprising a single 

plant at one location in which the facilities and methods of operation therein have been surveyed 

and approved by the Administrator as suitable and adequate for inspection or grading service in 

accordance with the following: 

(1) Shall satisfactorily meet the specifications of this subpart as determined by the 

Administrator. 

(2) Receive dairy products only from plants, transfer stations, receiving stations and 

cream buying stations which satisfactorily comply with the applicable requirements of this 

subpart as determined by the Administrator. (Occasional shipments may be received from 

nonapproved plants provided the product is tested and meets the quality requirements for No. 2 

milk.) 

 (e) Sanitizing treatment. Subjection of a clean product contact surface to steam, hot 

water, hot air, or an acceptable sanitizing solution for the destruction of most human pathogens 

and other vegetative microorganisms to a level considered safe for product production. Such 

treatment shall not adversely affect the equipment, the milk or the milk product or the health of 

consumers. Sanitizing solutions shall comply with 21 CFR 178.1010. 

(f) Resident service. Inspection or grading service performed at a dairy manufacturing 

plant or grading station by an inspector or grader assigned to the plant or station on a continuous 

basis. 

 (g) Dairy products. Butter, cheese (whether natural or processed), skim milk, cream, 

whey or buttermilk (whether dry, evaporated, stabilized or condensed), frozen desserts and any 

other food product which is prepared or manufactured in whole or in part from any of the 

aforesaid products, as the Administrator may hereafter designate. 

 (h) Grader. Any employee of the Department authorized by the Administrator or any 

other person to whom a license has been issued by the Administrator to investigate and certify, in 

accordance with the Act and this part, to shippers of products and other interested parties, the 

class, quality, quantity, and condition of such products. 

(i) Inspector. Any employee of the Department authorized by the Administrator or any 

other person to whom a license has been issued by the Administrator to inspect and certify 

quality, quantity and condition of products, observe the manufacturing, processing, packaging 

and handling of dairy products, and to perform dairy plant surveys in accordance with the 

regulations of this part. 

 (j) Inspection or grading service. Means in accordance with this part, the act of (1) 

drawing samples of any product; (2) determining the class, grade, quality, composition, size, 

quantity, condition, or wholesomeness of any product by examining each unit or representative 

samples; (3) determining condition of product containers; (4) identifying any product or 

packaging material by means of official identification; (5) regrading or appeal grading of a 

previously graded product; (6) inspecting dairy plant facilities, equipment, and operations; such 

as, processing, manufacturing, packaging, repackaging, and quality control; (7) supervision of 

packaging inspected or graded product; (8) reinspection or appeal inspection; and (9) issuing an 

inspection or grading certificate or sampling, inspection, or other report related to any of the 
3

foregoing. 

 (k) Milk. The term ``milk'' shall include the following: 

(1) Milk is the lacteal secretion, practically free from colostrum, obtained by the complete 

milking of one or more healthy cows. The cows shall be located in a Modified Accredited Area, 

an Accredited Free State, or an Accredited Free Herd for tuberculosis as determined by the 

Department. In addition, the cows shall be located in States meeting Class B status or 

Certified-Free Herds or shall be involved in a milk ring testing program or blood testing program 

under the current USDA Brucellosis Eradication Uniform Methods and Rules. 

(2) Goat milk is the lacteal secretion, practically free from colostrum, obtained by the 

complete milking of one or more healthy goats. The goats shall be located in States meeting the 

current USDA Uniform Methods and Rules for Bovine Tuberculosis Eradication or an 

Accredited Free Goat Herd. Goat milk shall only be used to manufacture dairy products that are 

legally provided for in 21 CFR or recognized as non-standardized traditional products normally 

manufactured from goats milk. 

 (l) Official identification. Official identification is provided for use on product packed 

under USDA inspection. Any package label or packaging material which bears any official 

identification shall be used only in such manner as the Administrator may prescribe, and such 

official identification shall be of such form and contain such information as the Administrator 

may require. 

 (m) Official Methods of Analysis of the Association of Official Analytical Chemists. 

“Official Methods of Analysis of the Association of Official Analytical Chemists,” a publication 

of the Association of Official Analytical Chemists International, 481 North Frederick Avenue, 

Suite 500, Gaithersburg, MD 20877-2417. 

 (n) Pasteurization (Pasteurized). Pasteurization shall mean that every particle of product 

shall have been heated in properly operated equipment to one of the temperatures specified in the 

table and held continuously at or above that temperature for at least the specified time (or other 

time/temperature relationship equivalent thereto in microbial destruction): 

Fluid Products 

 Temperature Time

1450F (vat pasteurization)........................................................................... 30 minutes.

1610F (high temperature short time pasteurization).................................... 15 seconds.

1910F (higher heat shorter time pasteurization).......................................... 1.0 second.

1940F (higher heat shorter time pasteurization).......................................... 0.5 second.

2010F (higher heat shorter time pasteurization).......................................... 0.1 second.

2040F (higher heat shorter time pasteurization).......................................... .05 second.

2120F (higher heat shorter time pasteurization).......................................... .01 second. 
4

Products Having Dairy Ingredients With a Fat Content of 10 Percent or More, or Contain Added 

Sweeteners 

1500

F............................................................................................................. 30 minutes. 

1660F............................................................................................................. 15 seconds. 

Frozen Dessert Mix 

1550F............................................................................................................. 30 minutes. 

1750

F............................................................................................................. 25 seconds. 

Condensed Milk to Be Repasteurized 

1660F............................................................................................................. 15 seconds. 

 (o) Plant survey. An appraisal of a plant to determine the extent to which facilities, 

equipment, method of operation, and raw material being received are in accordance with the 

provisions of this part. The survey shall be used to determine suitability of the plant for USDA 

inspection or grading service. 

 (p) Plant status. The extent to which a plant complies with this subpart shall be 

determined under procedures as set forth by the Administrator. 

 (q) Producer. The person or persons who exercise control over the production of the milk 

delivered to a processing plant or receiving station and who receive payment for this product. 

 (r) Quality control. The inspection of the quality of the raw material and the conditions 

relative to the preparation of the product from its raw state through each step in the entire 

process. It includes the inspection of conditions under which the product is prepared, processed, 

manufactured, packed and stored. In addition, assistance and guidance is offered to improve the 

raw milk quality, processing methods, quality, stability, and packaging and handling of the 

finished product. 

 (s) Regulations. The term “regulations” means the provisions contained in this part. 

 (t) Shall. Expresses a provision that is mandatory. 

 (u) Should. Expresses recommended nonmandatory provisions which when followed 

would significantly aid in a quality improvement program. 

 (v) Standard Methods for the Examination of Dairy Products. “Standard Methods for the 

Examination of Dairy Products,” a publication of the American Public Health Association, 1015 
5

Fifteenth Street, N.W. Washington, D.C. 20005. 

 (w) 3-A Sanitary Standards and Accepted Practice. The latest standards for dairy 

equipment and accepted practices formulated by the 3-A Sanitary Standards Committees 

representing the International Association for Food Protection, the Food and Drug 

Administration, and the Dairy Industry Committee. Published by the International Association 

for Food Protection, 6200 Aurora Avenue, Suite 200 W, Des Moines, Iowa 50322-2863. 

 (x) USDA or Department. Means the United States Department of Agriculture. 

 (y) Receiving Station. Any place, premise, or establishment where milk or dairy products 

are received, collected or handled for transfer to a processing or manufacturing plant. 

 (z) Transfer station. Any place, premise, or establishment where milk or dairy products 

are transferred directly from one transport tank to another. 

 (aa) Corrosion-resistant. Those materials that maintain their original surface 

characteristics under prolonged influence of the product to be contacted, cleaning compounds 

and sanitizing solutions, and other conditions of the environment in which used. 

PURPOSE 

§ 58.122 Approved plants under USDA inspection and grading service. 

 (a) Adoption of certain sound practices at dairy plants will significantly aid the operators 

to manufacture more consistently, uniform high-quality stable dairy products. Only dairy 

products manufactured, processed and packaged in an approved plant may be graded or inspected 

and identified with official identification. The specifications established herein provide the basis 

for a quality maintenance program which may be effectively carried forward through official 

inspection, grading, and quality control service. 

 (b) USDA inspection and grading service is provided to dairy product manufacturing 

plants on a voluntary basis. The operator of any dairy plant desiring to have such a plant 

qualified as an approved plant under USDA inspection and grading service may request surveys 

of such plant, premises, equipment, facilities, methods of operation, and raw material to 

determine whether they are adequate to permit inspection and grading service. The cost of this 

survey shall be borne by the applicant. 
6

APPROVED PLANTS 

§ 58.123 Survey and approval. 

 Prior to the approval of a plant, a designated representative of the Administrator shall 

make a survey of the plant, premises, storage facilities, equipment and raw material, volume of 

raw material processed daily, and facilities for handling the products at the plant. The survey 

shall be made at least twice a year to determine whether the facilities, equipment, method of 

operation, and raw material being received are adequate and suitable for USDA inspection and 

grading service in accordance with the provisions of this part. To be eligible for approval a plant 

shall satisfactorily meet the specifications of this subpart as determined by the Administrator. 

§ 58.124 Denial or suspension of plant approval. 

 Plant approval may be denied or suspended if a determination is made by a designated 

representative of the Administrator that the plant is not performing satisfactorily in regard to; (a) 

the classification of milk, (b) proper segregation and disposal of unwholesome raw materials or 

finished product, (c) adequate facilities and condition of processing equipment, (d) sanitary 

conditions of plant and equipment, (e) control of insects, rodents and other vermin, (f) use of 

non-toxic product contact surfaces and prevention of adulteration of raw materials and products 

with chemicals or other foreign material, (g) proper operating procedures, (h) the maintenance of 

legal composition of finished products, (i) the manufacture of stable dairy products, of desirable 

keeping quality characteristics, (j) proper storage conditions for ingredients and dairy products, or 

(k) suitable and effective packaging methods and material. 

PREMISES, BUILDINGS, FACILITIES, EQUIPMENT AND UTENSILS

§ 58.125 Premises. 

 (a) The premises shall be kept in a clean and orderly condition, and shall be free from 

strong or foul odors, smoke, or excessive air pollution. Construction and maintenance of 

driveways and adjacent plant traffic areas should be of cement, asphalt, or similar material to 

keep dust and mud to a minimum. 

 (b) Surroundings. The immediate surroundings shall be free from refuse, rubbish, 

overgrown vegetation, and waste materials to prevent harborage of rodents, insects and other 

vermin. 

 (c) Drainage. A suitable drainage system shall be provided which will allow rapid 

drainage of all water from plant buildings and driveways, including surface water around the 

plant and on the premises and all such water shall be disposed of in such a manner as to prevent 

an environmental or health hazard. 
7

§ 58.126 Buildings. 

 The building or buildings shall be of sound construction and shall be kept in good repair 

to prevent the entrance or harboring of rodents, birds, insects, vermin, dogs, and cats. All service 

pipe openings through outside walls shall be effectively sealed around the opening or provided 

with tight metal collars. 

 (a) Outside doors, windows, openings, etc. All openings to the outer air including doors, 

windows, skylights and transoms shall be effectively protected or screened against the entrance 

of flies and other insects, rodents, birds, dust and dirt. All outside doors opening into processing 

rooms shall be in good condition and fit properly. All hinged, outside screen doors shall open 

outward. All doors and windows should be kept clean and in good repair. Outside conveyor 

openings and other special-type outside openings shall be effectively protected to prevent the 

entrance of flies and rodents, by the use of doors, screens, flaps, fans or tunnels. Outside 

openings for sanitary pipelines shall be covered when not in use. On new construction window 

sills should be slanted downward at approximately a 450

angle. 

 (b) Walls, ceilings, partitions and posts. The walls, ceilings, partitions, and posts of 

rooms in which milk, or dairy products are processed, manufactured, handled, packaged or stored 

(except dry storage of packaged finished products and supplies) or in which utensils are washed 

and stored, shall be smoothly finished with a suitable material of light color, which is 

substantially impervious to moisture and kept clean. They shall be refinished as often as 

necessary to maintain a neat, clean surface. For easier cleaning new construction should have 

rounded cove at the juncture of the wall and floor in all receiving, pasteurizing, manufacturing, 

packaging and storage rooms. 

 (c) Floors. The floors of all rooms in which milk, or dairy products are processed, 

manufactured, packaged or stored or in which utensils are washed shall be constructed of tile 

properly laid with impervious joint material, concrete, or other equally impervious material. The 

floors shall be smooth, kept in good repair, graded so that there will be no pools of standing 

water or milk products after flushing, and all openings to the drains shall be equipped with traps 

properly constructed and kept in good repair. On new construction, bell and standpipe type traps 

shall not be used. The plumbing shall be so installed as to prevent the back-up of sewage into 

the drain lines and to the floor of the plant. Cold storage rooms used for storage of product and 

starter rooms need not be provided with floor drains if the floor is sloped to drain to an exit. 

Sound, smooth, wood floors which can be kept clean, may be used in rooms where new 

containers and supplies and certain packaged finished products are stored. 

 (d) Lighting and ventilation. (1) Light shall be ample, natural or artificial, or both, of 

good quality and well distributed. All rooms in which dairy products are manufactured or 

packaged or where utensils are washed shall have at least 30 foot-candles of light intensity on all 

working surfaces. Rooms where dairy products are graded or examined for condition and quality 

shall have at least 50 foot-candles of light intensity on the working surface. Restrooms and 
8

locker rooms should have at least 30 foot-candles of light intensity. In all other rooms there shall 

be provided at least 5 foot-candles of light intensity when measured at a distance of 30 inches 

from the floor. Where contamination of product by broken glass is possible, light bulbs and 

fluorescent tubes shall be protected against breakage. 

(2) There shall be adequate heating, ventilation or air conditioning for all rooms and 

compartments to permit maintenance of sanitary conditions. Exhaust or inlet fans, vents, hoods 

or temperature and humidity control equipment shall be provided where and when needed, to 

minimize or control room temperatures, eliminate objectionable odors, and aid in prevention of 

moisture condensation and mold. Inlet fans should be provided with an adequate air filtering 

device to eliminate dirt and dust from the incoming air. Ventilation systems shall be cleaned 

periodically as needed and maintained in good repair. Exhaust outlets shall be screened or 

provided with self closing louvers to prevent the entrance of insects when not in use. 

 (e) Rooms and compartments. Rooms and compartments in which any raw material, 

packaging, ingredient supplies or dairy products are handled, manufactured, packaged or stored 

shall be so designed, constructed and maintained as to assure desirable room temperatures and 

clean and orderly operating conditions free from objectionable odors and vapors. Enclosed bulk 

milk receiving rooms, when present, shall be separated from the processing rooms by a wall. 

Rooms for receiving can milk shall be separated from the processing rooms by a partition or by 

suitable arrangement of equipment. Processing rooms shall be kept free from equipment and 

materials not regularly used. 

(1) Coolers and freezers. Coolers and freezers where dairy products are stored shall be 

clean, reasonably dry and maintained at the proper uniform temperature and humidity to 

adequately protect the product, and minimize the growth of mold. Adequate circulation of air 

shall be maintained at all times. They shall be free from rodents, insects, and pests. Shelves 

shall be kept clean and dry. Refrigeration units shall have provisions for collecting and disposing 

of condensate. 

(2) Supply room. The supply rooms or areas used for the storing of packaging materials; 

containers, and miscellaneous ingredients shall be kept clean, dry, orderly, free from insects, 

rodents, and mold, and maintained in good repair. Such items stored therein shall be adequately 

protected from dust, dirt, or other extraneous material and so arranged on racks, shelves or pallets 

to permit access to the supplies and cleaning and inspection of the room. Insecticides, 

rodenticides, cleaning compounds and other nonfood products shall be properly labeled and 

segregated, and stored in a separate room or cabinet away from milk, dairy products, ingredients 

or packaging supplies. 

(3) Boiler rooms, shop rooms and shop areas. The boiler, and shop rooms shall be 

separated from other rooms where milk, and dairy products are processed, manufactured, 

packaged, handled or stored. Shop rooms or areas should be kept orderly and reasonably free 

from dust and dirt. 

(4) Toilet and dressing rooms. Adequate toilet and dressing room facilities shall be 

conveniently located. 

(i) Toilet rooms shall not open directly into any room in which milk or dairy products are 

processed, manufactured, packaged or stored; doors shall be self-closing; ventilation shall be 
9

provided by mechanical means to the outer air; fixtures shall be kept clean and in good repair. 

(ii) All employees shall be furnished with a locker or other suitable facility and the 

lockers and dressing rooms shall be kept clean and orderly. Adequate handwashing facilities 

shall be provided. Legible signs shall be posted conspicuously in each toilet or dressing room 

directing employees to wash their hands before returning to work. 

(5) Laboratory. (i) Consistent with the size and type of plant and the volume of dairy 

products manufactured, an adequately equipped laboratory shall be maintained and properly 

staffed with qualified and trained personnel for quality control and analytical testing. The 

laboratory should be located reasonably close to the processing activity and be of sufficient size 

to perform tests necessary in evaluating the quality of raw and finished products. 

(ii) Approved laboratories shall be supervised by the USDA resident inspector in all 

aspects of official testing and in reporting results. Plant laboratory personnel in such plants may 

be authorized by USDA to perform official duties. The AMS Science and Technology Programs 

will provide independent auditing of laboratory analysis functions.

(iii) An approved central control laboratory serving more than one plant may be 

acceptable, if conveniently located to the dairy plants, and if samples and results can be 

transmitted without undue delay. 

(6) Starter facilities. Adequate facilities shall be provided for the handling of starter 

cultures. The facilities shall not be located near areas where contamination is likely to occur. 

(7) Grading and inspection room. When grading or inspection of product is performed 

the plants shall furnish a room or designated area specifically for this purpose. The room or area 

shall be suitably located, sufficient in size, well lighted (see § 58.126d), ventilated and the 

temperature shall be not less than 600F. It shall be kept clean and dry, free from foreign odors 

and reasonably free from disturbing elements which would interfere with proper concentration by 

the grader or inspector. The grading or inspection room or area shall be equipped with a table or 

desk and convenient facilities for washing hands. 

(8) Resident inspector's facilities. In resident plants, an office or space shall be provided 

for official purposes. The room or space should be conveniently located in or near the approved 

laboratory, adequate in size, and equipped with desk and a lockable storage supply cabinet, and 

clothes locker. It shall be well lighted, ventilated or air conditioned, and heated. Custodial 

service shall be furnished on a regular basis. 

(9) Lunch rooms and eating areas. When these areas are provided, they (i) shall be kept 

clean and orderly, (ii) should not open directly into any room in which milk or dairy products are 

processed, manufactured or packaged, and (iii) signs shall be posted directing employees to wash 

their hands before returning to work. 

§ 58.127 Facilities.

 (a) Water supply. There shall be an ample supply of both hot and cold water of safe and 

sanitary quality, with adequate facilities for its proper distribution throughout the plant, and 

protected against contamination. Water from other facilities, when officially approved, may be 

used for boiler feed water and condenser water provided that such water lines are completely 
10

separated from the water lines carrying the sanitary water supply, and the equipment is so 

constructed and controlled as to preclude contamination of product contact surfaces. There shall 

be no cross connection between potable water lines and non-potable water lines or between 

public and private water supplies. Bacteriological examinations shall be made of the plant's 

sanitary water supply taken at the plant at least twice a year, or as often as necessary to determine 

safety and suitability as related to product keeping quality for use in manufactured products shall 

be made by a USDA or State agency laboratory except for supplies that are regularly tested for 

purity and bacteriological quality, and approved by the local health officer. The results of all 

water tests shall be kept on file at the plant for which the test was performed. 

The location, construction, and operation of any well shall comply with regulations of the 

appropriate agency. 

 (b) Drinking-water facilities. Drinking-water facilities of a sanitary type shall be 

provided in the plant and should be conveniently located. 

 (c) Hand-washing facilities. Convenient hand-washing facilities shall be provided, 

including hot and cold running water, soap or other detergents, and sanitary single service towels 

or air driers. Such accommodations shall be located in or adjacent to toilet and dressing rooms 

and also at such other places in the plant as may be essential to the cleanliness of all personnel 

handling products. Vats for washing equipment or utensils shall not be used as hand-washing 

facilities. Containers shall be provided for used towels and other wastes. The containers may be 

metal or plastic, disposable or reusable and should have self-closing covers. 

 (d) Steam. Steam shall be supplied in sufficient volume and pressure for satisfactory 

operation of each applicable piece of equipment. Culinary steam used in direct contact with milk 

or dairy products shall be free from harmful substances or extraneous material and only those 

boiler water additives that meet the requirements of 21 CFR 173.310 shall be used, or a 

secondary steam generator shall be used in which soft water is converted to steam and no boiler 

compounds are used. Steam traps, strainers and condensate traps shall be used wherever 

applicable to insure a satisfactory and safe steam supply. Culinary steam shall comply with the 

3-A Accepted Practices for a Method of Producing Steam of Culinary Quality, number 609. This 

document is available from the International Association for Food Protection, 6200 Aurora 

Avenue, Suite 200 W, Des Moines, Iowa 50322-2863. 

 (e) Air under pressure. The method for supplying air under pressure, which comes in 

contact with milk or dairy products or any product contact surface, shall comply with the 3-A 

Accepted Practices for Supplying Air Under Pressure. 

 (f) Disposal of wastes. Dairy wastes shall be properly disposed of from the plant and 

premises consistent with requirements imposed by the Environmental Protection Act. The sewer 

system shall have sufficient slope and capacity to readily remove all waste from the various 

processing operations. Where a public sewer is not available, all wastes shall be properly 
11

disposed of so as not to contaminate milk equipment or to create a nuisance or public health 

hazard. Containers used for the collection and holding of wastes shall be constructed of metal, 

plastic, or other equally impervious material and kept covered with tight fitting lids. Waste shall 

be stored in an area or room in a manner to protect it from flies and vermin. Solid wastes shall 

be disposed of regularly and the containers cleaned before reuse. Accumulation of dry waste 

paper and cardboard shall be kept to a minimum and disposed of in a manner that is 

environmentally acceptable. 

§ 58.128 Equipment and utensils. 

 (a) General construction, repair and installation. The equipment and utensils used for 

the processing of milk and manufacture of dairy products shall be constructed to be readily 

demountable where necessary for cleaning and sanitizing. The product contact surfaces of all 

utensils and equipment such as holding tanks, pasteurizers, coolers, vats, agitators, pumps, 

sanitary piping and fittings or any specialized equipment shall be constructed of stainless steel, or 

other materials which under conditions of intended use are as equally corrosion resistant. 

Non-metallic parts other than glass having product contact surfaces shall comply with 3-A 

Sanitary Standards for Plastic or Rubber and Rubber-Like Materials. Equipment and utensils 

used for cleaning shall be in an acceptable condition, such as not rusty, pitted or corroded. All 

equipment and piping shall be designed and installed so as to be easily accessible for cleaning, 

and shall be kept in good repair, free from cracks and corroded surfaces. New or rearranged 

equipment, shall be set away from any wall or spaced in such a manner as to facilitate proper 

cleaning and to maintain good housekeeping. All parts or interior surfaces of equipment, pipes 

(except certain piping cleaned-in-place) or fittings, including valves and connections shall be 

accessible for inspection. Milk and dairy product pumps shall be of a sanitary type and easily 

dismantled for cleaning or shall be of specially approved construction to allow effective cleaning 

in place. 

All C.I.P. systems shall comply with the 3-A Accepted Practices for Permanently Installed 

Sanitary Product, Pipelines and Cleaning Systems. 

 (b) Weigh cans and receiving tanks. Weigh cans and receiving tanks shall comply with 

the 3-A Sanitary Standards for Weigh Cans and Receiving Tanks for Raw Milk and shall be 

easily accessible for cleaning both inside and outside and shall be elevated above the floor and 

protected sufficiently with the necessary covers or baffles to prevent contamination from splash, 

condensate and drippage. Where necessary to provide easy access for cleaning of floors and 

adjacent wall areas, the receiving tank shall be equipped with wheels or casters to allow easy 

removal. 

 (c) Can washers. Can washers shall have sufficient capacity and ability to discharge a 

clean dry can and cover and shall be kept properly timed in accordance with the instructions of 

the manufacturer. They should be equipped with proper temperature controls on the wash and 

rinse tanks and the following additional devices: Prerinse jet, wash tank solution feeder, can 
12

sanitizing attachment, forced air vapor exhaust, and removable air filter on drying chamber. The 

water and steam lines supplying the washer shall maintain a reasonably uniform pressure and if 

necessary be equipped with pressure regulating valves. The steam pressure to the can washer 

should be not less than 80 pounds, and the temperature of the wash and final rinse solution 

should be automatically controlled and not exceed 1400

F. 

 (d) Product storage tanks or vats. Storage tanks or vats shall be fully enclosed or tightly 

covered and well insulated. The entire interior surface, agitator and all appurtenances shall be 

accessible for thorough cleaning and inspection. Any opening at the top of the tank or vat 

including the entrance of the shaft shall be suitably protected against the entrance of dust, 

moisture, insects, oil or grease. The sight glasses, if used, shall be sound, clear, and in good 

repair. Vats which have hinged covers shall be easily cleaned and shall be so designed that 

moisture, or dust on the surface cannot enter the vat when the covers are raised. If the storage 

tanks or vats are equipped with air agitation, the system shall be of an approved type and properly 

installed in accordance with the 3-A Accepted Practices for Supplying Air Under Pressure. 

Storage tanks or vats intended to hold product for longer than approximately 8 hours shall be 

equipped with adequate refrigeration and/or have adequate insulation. New or replacement 

storage tanks or vats shall comply with the appropriate 3-A Sanitary Standards for Storage Tanks 

for Milk and Milk Products or Sanitary Standards for Silo-Type Storage Tanks for Milk and Milk 

Products and shall be equipped with thermometers in good operating order. 

 (e) Separators. All product contact surfaces of separators shall be free from rust and pits 

and insofar as practicable shall be of stainless steel or other equally noncorrosive metals. 

 (f) Coil or dome type batch pasteurizers. Coil or dome type batch pasteurizers shall be 

stainless steel lined and if the coil is not stainless steel or other equally noncorrosive metal it 

shall be properly tinned over the entire surface. Sanitary seal assemblies at the shaft ends of coil 

vats shall be of the removable type, except that existing equipment not provided with this type 

gland will be acceptable if the packing glands are maintained and operated without adverse 

effects. New or replacement units shall be provided with removable packing glands. Dome type 

pasteurizer agitators shall be stainless steel except that any non-metallic parts shall comply with 

3-A Sanitary Standards for Plastic or Rubber and Rubberlike Materials, as applicable. Each 

pasteurizer used for heating product at a temperature of 50F. or more above the minimum 

pasteurization temperature need not have the airspace heater. It shall be equipped with an 

airspace thermometer to insure a temperature at least 50

F. above that required for pasteurization 

of the product. There shall be adequate means of controlling the temperature of the heating 

medium, Batch pasteurizers shall have temperature indicating and recording devices. 

 (g) Short time pasteurizing systems. When pasteurization is intended or required, an 

approved timing pump or device, recorder-controller, automatic flow diversion valve and holding 

tube or its equivalent, if not a part of the existing equipment, shall be installed on all such 

equipment used for pasteurization, to assure complete pasteurization. The entire facility shall 

comply with the 3-A Accepted Practices for the Sanitary Construction, Installation, Testing and 
13

Operation of High Temperature Short Time Pasteurizers. After the unit has been tested 

according to the 3-A Accepted Practices, the timing pump or device and the recorder controller 

shall be sealed at the correct setting to assure pasteurization. The system should be rechecked 

semi-annually to assure continued compliance with the 3-A Accepted Practices. Sealing and 

rechecking of the unit shall be performed by the control authority having jurisdiction. When 

direct steam pasteurizers are used, the steam, prior to entering the product, shall be conducted 

through a steam strainer and a steam purifier equipped with a steam trap and only steam meeting 

the requirements for culinary steam shall be used. 

 (h) Thermometers and recorders--(1) Indicating thermometers. (i) Long stem indicating 

thermometers which are accurate within 0.50

F., plus or minus, for the applicable temperature 

range, shall be provided for checking the temperature of pasteurization and cooling of products in 

vats and checking the accuracy of recording thermometers. 

(ii) Short stem indicating thermometers, which are accurate within 0.50F., plus or minus, 

for the applicable temperature range, shall be installed in the proper stationary position in all 

pasteurizers. Storage tanks where temperature readings are required shall have thermometers 

which are accurate within 2.00

F., plus or minus. 

(iii) Air space indicating thermometers, where applicable, which are accurate within 

1.00

F., plus or minus, for the proper temperature range shall also be installed above the surface 

of the products pasteurized in vats, to make certain that the temperature of the foam and/or air 

above the products pasteurized also received the required minimum temperature treatment. 

(2) Recording thermometers. (i) Recording thermometers that are accurate within 10F., 

plus or minus, for the applicable temperature range, shall be used on each heat treating, 

pasteurizing or thermal processing unit to record the heating process. 

(ii) Additional use of recording thermometers accurate within 20F., plus or minus may be 

required where a record of temperature or time of cooling and holding is of significant 

importance. 

(iii) Recorder charts shall be marked to show date and plant identification, reading of the 

indicating thermometer at a particular referenced reading point on the recording chart, amount 

and name of product, product temperature at which the cut-in and cut-out function, record 

of 

the period in which flow diversion valve is in forward-flow position, signature or initials of 

operator. 

 (i) Surface coolers. Surface coolers shall be equipped with hinged or removable covers 

for the protection of the product. The edges of the fins shall be so designed as to divert 

condensate on nonproduct contact surfaces away from product contact surfaces. All gaskets or 

swivel connections shall be leak proof. 

 (j) Plate type heat exchangers. Plate type heat exchanger shall comply with the 3-A 

Sanitary Standards Plate Type Heat Exchangers for Milk and Milk Products. All gaskets shall be 

tight and kept in good operating order. Plates shall be opened for inspection by the operator at 
14

sufficiently frequent intervals to determine if the equipment is clean and in satisfactory condition. 

A cleaning regimen should be posted to insure proper cleaning procedures between inspection 

periods. 

 (k) Internal return tubular heat exchangers. Internal return tubular heat exchangers shall 

comply with the 3-A Sanitary Standards for Internal Return Tubular Heat Exchangers for Use 

with Milk and Milk Products. 

 (l) Pumps. Pumps used for milk, and dairy products shall be of the sanitary type and 

constructed to comply with 3-A Sanitary Standards for Pumps for Milk and Milk Products. 

Unless pumps are specifically designed for effective cleaning-in-place they shall be disassembled 

and thoroughly cleaned after use. 

 (m) Scales. All scales shall comply with National Bureau of Standards Handbook 44. 

(Latest revision). 

(1) Small capacity scales shall be capable of the following accuracy, and shall be 

graduated in no higher than one ounce graduations. 

Minimum tolerance

Ounces Pounds

Load in pounds:

 0 to 4 inclusive............................................

 5 to 10 inclusive..........................................

 11 to 20 inclusive........................................

 21 to 30 inclusive........................................

 31 to 50 inclusive........................................

 51 to 500 inclusive......................................

1

/32

1

/16

1

/8

3

/16

3

/4

0.002

.004

.008

.012

.031

.047

 (2) Large capacity scales shall be capable of the following accuracy, and shall be 

graduated in no higher than 1/4 pound graduations for scales of capacity of up to 250 pounds; 

pound graduations for scales above 250 pounds capacity. 
15

(This table taken from the presently effective 1973 revision.) 

Minimum tolerance

Ounces Pounds

Load in pounds:

 101 to 150 inclusive....................................

 151 to 250 inclusive....................................

 251 to 500 inclusive....................................

 501 to 1000 inclusive..................................

 1001 to 2500 inclusive................................

1 1/4

 2 

4 

8 

...................................

0.078

.125

.250

.500

 1.0 

Compliance shall be determined by the appropriate regulatory authority. 

 (n) Homogenizers. Homogenizers and high pressure pumps of the plunger type shall 

comply with the 3-A Sanitary Standards for Homogenizers and Pumps of the Plunger Type and 

shall be disassembled and thoroughly cleaned after use. 

 (o) New replacement or modified equipment, processing system, or utensils. All new, 

replacement or modified equipment and all processing systems, cleaning systems, utensils, or 

replacement parts shall comply with the most current, appropriate 3-A Sanitary Standards or 3-A 

Accepted Practices. If 3-A Sanitary Standards or 3-A Accepted Practices are not available, such 

equipment and replacements shall meet the general criteria of this section and the USDA 

Guidelines for the Sanitary Design and Fabrication of Dairy Processing Equipment available 

from USDA, Agricultural Marketing Service, Dairy Programs, Dairy Grading Branch or by 

accessing the Internet at www.ams.gov/dairy/grade.htm. 

 (p) Vacuumizing equipment. The vacuum chamber, as used for flavor control, shall be 

made of stainless steel or other equally corrosion resistant metal. The unit shall be constructed to 

facilitate cleaning and all product contact surfaces shall be accessible for inspection. Vacuum 

chambers located on the pasteurized side of the unit shall be isolated by means of a vacuum 

breaker and a positive activated check valve on the product inlet side and a vacuum breaker and a 

positive activated check valve on the discharge side. If direct steam is used, it should also be 

equipped with a ratio controller to regulate the composition when applicable to the finished 

product. Only steam which meets the requirements for culinary steam shall be used. The 

incoming steam supply shall be regulated by an automatic solenoid valve which will cut off the 

steam supply in the event the flow diversion valve of the pasteurizer is not in the forward flow 

position. Condensers when used shall be equipped with a water level control and an automatic 

safety shutoff valve. 
16

PERSONNEL, CLEANLINESS AND HEALTH 

§ 58.129 Cleanliness. 

 All employees shall wash their hands before beginning work and upon returning to work 

after using toilet facilities, eating, smoking or otherwise soiling their hands. They shall keep 

their hands clean and follow good hygienic practices while on duty. Expectorating or use of 

tobacco in any form shall be prohibited in each room and compartment where any milk, dairy 

products, or supplies are prepared, stored or otherwise handled. Clean white or light-colored 

washable or disposable outer garments and caps (paper caps, hard hats, or hair nets acceptable) 

shall be worn to adequately protect the hair and beards when grown by all persons engaged in 

receiving, testing, processing milk, manufacturing, packaging or handling dairy products. 

§ 58.130 Health. 

 No person afflicted with a communicable disease shall be permitted in any room or 

compartment where milk and dairy products are prepared, manufactured or otherwise handled. 

No person who has a discharging or infected wound, sore or lesion on hands, arms or other 

exposed portion of the body shall work in any dairy processing rooms or in any capacity resulting 

in contact with milk, or dairy products. Each employee whose work brings him in contact with 

the processing or handling of dairy products, containers or equipment should have a medical and 

physical examination by a registered physician or by the local department of health at the time of 

employment. An employee returning to work following illness from a communicable disease 

shall have a certificate from the attending physician to establish proof of complete recovery. 

PROTECTION AND TRANSPORT OF RAW MILK AND CREAM

§ 58.131 Equipment and facilities.

(a)(1) Milk cans. Cans used in transporting milk from dairy farm to plant shall be of 

such construction (preferably seamless with umbrella lids) as to be easily cleaned, and shall be 

inspected, repaired, and replaced as necessary to exclude substantially the use of cans and lids 

with open seams, cracks, rust, milkstone, or any unsanitary condition. Adequate provisions 

should be made so that milk in cans will be cooled immediately after milking to 500

F. or lower 

unless delivered to the plant within two hours after milking. 

(2) Farm bulk tanks. Farm bulk tanks shall comply with 3-A Sanitary Standards for Farm 

Cooling and Holding Tanks or 3-A Sanitary Standards for Farm Milk Storage Tanks, as 

applicable. They shall be installed in a milk house in accordance with the requirements of the 

regulatory agency in jurisdiction. The bulk cooling tanks shall be designed and equipped with 

refrigeration to permit the cooling of the milk to 400F. or lower within two hours after milking, 

and maintain it at 450F. or below until picked up. (b)(1) Receiving stations. Receiving 

stations shall comply with the applicable sections of this subpart covering premises, buildings, 

facilities, equipment, utensils, personnel, cleanliness and health. 
17

(2) Transfer stations. Transfer stations shall comply with the applicable sections of this 

subpart covering premises, floors, lighting, water supply, hand-washing facilities, disposal of 

wastes, general construction, repair and installation of equipment, piping and utensils and 

personnel--cleanliness and health. As climatic and operating conditions require the transfer 

station shall comply with the applicable sections for walls, ceilings, doors and windows. 

(3) Cream stations. Cream stations shall provide adequate protection and facilities for 

the handling, transferring and cooling of farm separated cream. The area shall be large enough to 

avoid undue crowding with a normal volume of business and shall be separated from other areas 

and the outside by self closing, tight fitting doors. All openings shall be screened during fly 

season. The floor, walls and ceiling shall be of satisfactory construction, in good repair and kept 

clean. Lighting and ventilation shall meet the requirements of § 58.126(d). Cooling facilities 

shall be provided to cool the cream to 500F. or lower unless shipped within 8 hours after receipt. 

Facilities shall be provided to wash, sanitize and store cans and equipment used in the operation. 

The cream should not be more than 4 days old when picked up for delivery to the processing 

plant.

 (c)(1) Transporting milk or cream. Vehicles used for the transportation of can milk or 

cream shall be of the enclosed type, constructed and operated to protect the product from extreme 

temperature, dust, or other adverse conditions and they shall be kept clean. Decking boards or 

racks shall be provided where more than one tier of cans is carried. Cans or vehicles used for the 

transportation of milk from the farm to the plant shall not be used for transporting skim milk, 

buttermilk, or whey to producers. 

(2) Transport tanks. The exterior shell shall be clean and free from open seams or cracks 

which would permit liquid to enter the jacket. The interior shell shall be stainless steel and so 

constructed that it will not buckle, sag or prevent complete drainage. All product contact 

surfaces shall be smooth, easily cleaned and maintained in good repair. The pump and hose 

cabinet shall be fully enclosed with tight fitting doors and the inlet and outlet shall be provided 

with dust covers to give adequate protection from road dust. Tank manholes should be equipped 

with an adequate filtering system during loading and unloading. New and replacement transport 

tanks shall comply with 3-A Sanitary Standards for Stainless Steel Automotive Milk and Milk 

Products Transportation Tanks for Bulk Delivery and/or Farm Pick-up Service. 

(3) Facilities for cleaning and sanitizing. Enclosed or covered facilities (as climatic 

conditions require) shall be available for washing and sanitizing of transport tanks, piping, and 

accessories, at central locations or at all plants that receive or ship milk or milk products in 

transport tanks. 

 (d) Transfer of milk to transport tank. Milk shall be transferred under sanitary conditions 

from farm bulk tanks through stainless steel piping or approved tubing. The sanitary piping and 

tubing shall be capped when not in use. 
18

QUALITY SPECIFICATIONS FOR RAW MILK 

§ 58.132 Basis for classification. 

 The quality classification of raw milk for manufacturing purposes from each producer 

shall be based on an organoleptic examination for appearance and odor, a drug residue test, and 

quality control tests for sediment content, bacterial estimate and somatic cell count. All milk 

received from producers shall not exceed the Food and Drug Administration’s established limits 

for pesticide, herbicide and drug residues. Producers shall be promptly notified of any shipment 

or portion thereof of their milk that fails to meet any of these quality specifications. 

§ 58.133 Methods for quality and wholesomeness determination.

 (a) Appearance and odor. The appearance of acceptable raw milk shall be normal and 

free of excessive coarse sediment when examined visually or by an acceptable test procedure. 

The milk shall not show any abnormal condition (including, but not limited to, curdled, ropy, 

bloody or mastitic condition), as indicated by sight or other test procedures. The odor shall be 

fresh and sweet. The milk shall be free from objectionable feed and other off-odors that 

adversely affect the finished product. 

 (b) Somatic cell count. (1) A laboratory examination to determine the level of somatic 

cells shall be made at least four times in each 6-month period at irregular intervals on milk 

received from each patron. 

(2) A screening test may be conducted on goat herd milk. When a goat herd screening 

sample test exceeds either of the following results, a confirmatory test identified in paragraph (b) 

(3) of this section shall be conducted.

(i) California Mastitis Test--Weak Positive (CMT 1). 

(ii) Wisconsin Mastitis Test--WMT value of 18 mm. 

(3) Milk shall be tested for somatic cell content by using one of the following procedures 

or by any other method approved by Standard Methods for the Examination of Dairy Products 

(confirmatory test for somatic cells in goat milk): 

(i) Direct Microscopic Somatic Cell Count (Single Strip Procedure). Pyronin Y-methyl 

green stain or “New York” modification shall be used as the confirmatory test for goat’s milk. 

 (ii) Electronic Somatic Cell Count (particle counter). 

(iii) Electronic Somatic Cell Count (fluorescent dye). 

(4) The somatic cell test identified in (b) (3) of this section shall be considered as the 

official results. 

(5) Whenever the official test indicates the presence of more than 750,000 somatic cells 

per ml. (1,500,000 per ml. for goat milk), the following procedures shall be applied: 

(i) The producer shall be notified with a warning of the excessive somatic cell count. 

(ii) Whenever two out of the last four consecutive somatic cell counts exceed 750,000 per 

ml. (1,500,000 per ml. for goat milk), the appropriate State regulatory authority shall be notified 

and a written notice given to the producer. This notice shall be in effect as long as two of the last 
19

four consecutive samples exceed 750,000 per ml. (1,500,000 per ml. for goat milk).

(6) An additional sample shall be taken after a lapse of 3 days but within 21 days of the 

notice required in paragraph (b) (5) (ii) of this section. If this sample also exceeds 750,000 per 

ml. (1,500,000 per ml. for goat milk), subsequent milkings shall not be accepted for market until 

satisfactory compliance is obtained. Shipment may be resumed and a temporary status assigned 

to the producer by the appropriate State regulatory agency when an additional sample of herd 

milk is tested and found satisfactory. The producer may be assigned a full reinstatement status 

when three out of four consecutive somatic cell count tests do not exceed 750,000 per ml. 

(1,500,000 per ml. for goat milk). The samples shall be taken at a rate of not more than two per 

week on separate days within a 3-week period. 

 (c) Drug residue level. (1) USDA-approved plants shall not accept for processing any 

milk testing positive for drug residue. All milk received at USDA-approved plants shall be 

sampled and tested prior to processing, for beta lactam drug residue. When directed by the 

regulatory agency, additional testing for other drug residues shall be performed. Samples shall be 

analyzed for beta lactams and other drug residues by methods which have been independently 

evaluated or evaluated by the Food and Drug Administration (FDA) and have been accepted by 

the (FDA) as effective to detect drug residues at current safe or tolerance levels. Safe and 

tolerance levels for particular drugs are established by the FDA and can be obtained from the 

U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition, 200 C Street 

SW., Washington, DC 20204.

(2) Individual producer milk samples for beta lactam drug residue testing shall be 

obtained from each milk shipment as follows: 

(i) Milk in farm bulk tanks. A sample shall be taken at each farm and shall include milk 

from each farm bulk tank. 

(ii) Milk in cans. A sample shall be formed separately at the receiving plant for each can 

milk producer included in a delivery, and shall be representative of all milk received from the 

producer. 

(3) Load milk samples for beta lactam drug residue testing shall be obtained from each 

milk shipment as follows: 

(i) Milk in bulk milk pickup tankers. A sample shall be taken from the bulk milk pickup 

tanker after its arrival at the plant and prior to further commingling. 

(ii) Milk in cans. A sample representing all of the milk received on a shipment shall be 

formed at the plant, using a sampling procedure that includes milk from every can on the vehicle. 

(4) Follow-up to positive-testing samples. (i) When a load sample tests positive for drug 

residue, the appropriate State regulatory agency shall be notified immediately of the positive test 

result and of the intended disposition of the shipment of milk containing the drug residue. 

(ii) Each individual producer sample represented in the positive-testing load sample shall 

be singly tested to determine the producer of the milk sample testing positive for drug residue. 

Identification of the producer responsible for producing the milk testing positive for drug residue, 

and details of the final disposition of the shipment of milk containing the drug residue, shall be 

reported immediately to the appropriate agency. 
20

(iii) Milk shipment from the producer identified as the source of milk testing positive for 

drug residue shall cease immediately and may resume only after a sample from a subsequent 

milking does not test positive for drug residue. 

§ 58.134 Sediment content for milk in cans.

 (a) Method of testing. Methods for determining the sediment content of the milk of 

individual producers shall be those described in the latest edition of Standard Methods for the 

Examination of Dairy Products. Sediment content shall be based on comparison with applicable 

charts of the United States Sediment Standards for Milk and Milk Products, available from 

USDA, AMS, Dairy Programs, Dairy Standardization Branch. 

 (b) Sediment content classification. Milk in cans shall be classified for sediment content, 

regardless of the results of the appearance and odor examination required in § 58.133(a), as 

follows: 

USDA SEDIMENT STANDARD 

 No. 1 (acceptable)--not to exceed 0.50 mg. or equivalent. 

No. 2 (acceptable) -- not to exceed 1.50 mg. or equivalent. 

No. 3 (probational, not over 10 days) -- not to exceed 2.50 mg. or equivalent. 

No. 4 (reject) -- over 2.50 mg. or equivalent. 

 (c) Frequency of tests. At least once each month, at irregular intervals, one or more cans 

of milk selected at random from each producer shall be tested. 

 (d) Acceptance or rejection of milk. If the sediment disc is classified as No. 1, No. 2, or 

No. 3 the producer's milk may be accepted. If the sediment disc is classified No. 4 the milk shall 

be rejected: Provided that, If the shipment of milk is commingled with other milk in a transport 

tank the next shipment shall not be accepted until its quality has been determined before being 

picked up; however, if the person making the test is unable to get to the farm before the next 

shipment it may be accepted but no further shipments shall be accepted unless the milk meets the 

requirements of No. 3 or better. In the case of milk classified as No. 3 or No. 4, all cans shall be 

tested. Producers of No. 3 or No. 4 milk shall be notified immediately and shall be furnished 

applicable sediment discs and the next shipment shall be tested. 

(e) Retests. On test of the next shipment all cans shall be tested Milk classified as No. 1, No. 2, 

or No. 3 may be accepted, but No. 4 milk shall be rejected. The producers of No. 3 or No. 4 

milk shall be notified immediately, furnished applicable sediment discs and the next shipment 

tested. 

This procedure of retesting successive shipments and accepting probational (No. 3) milk and 

rejecting No. 4 milk may be continued for not more than 10 calendar days. If at the end of this 

time all of the producer’s milk does not meet the acceptable sediment content classification (No. 

1 or No. 2), it shall be rejected. 
21

§ 58.135 Bacterial estimate. 

(a) Methods of Testing. Milk shall be tested for bacterial estimate by using one of the 

following methods or by any other method approved by Standard Methods for the Examination 

of Dairy Products. 

 (1) Direct Microscopic clump count 

 (2) Standard plate count 

 (3) Plate loop count 

 (4) Pectin gel plate count 

 (5) Petrifilm aerobic count 

 (6) Spiral plate count 

 (7) Hydrophobic grid membrane filter count 

 (8) Impedance/conductance count 

 (9) Reflectance calorimetry 

(b) Frequency of Testing. A laboratory examination to determine the bacterial estimate 

shall be made on a representative sample of each producer’s milk at least once each month at 

irregular intervals. Samples shall be analyzed at a laboratory in accordance with State 

regulations. 

(c) Acceptance of milk. The following procedures shall be applied with respect to 

bacterial estimates: 

 (1) Whenever the bacterial estimate indicates the presence of more than 500,000 bacteria 

per ml., the producer shall be notified with a warning of the excessive bacterial estimate. 

(2) Whenever two of the last four consecutive bacterial estimates exceed 500,000 per ml., 

the appropriate regulatory authority shall be notified and a written warning notice given to the 

producer. The notice shall be in effect so long as two out of the last four consecutive samples 

exceed 500,000 per ml. 

 (3) An additional sample shall be taken after a lapse of 3 days but within 21 days of the 

notice required in paragraph (c) (2) of this section. If this sample also exceeds 500,000 per ml., 

subsequent milkings shall be excluded from the market until satisfactory compliance is obtained. 

Shipment may be resumed when an additional sample of herd milk is tested and found 

satisfactory. 

§ 58.136 Rejected milk. 

 A plant shall reject specific milk from a producer if the milk fails to meet the 

requirements for appearance and odor (§ 58.133(a)), if it is classified No. 4 for sediment content 

(§ 58.134), or if it tests positive for drug residue (§ 58.133(c)).

§ 58.137 Excluded milk. 
22

A plant shall not accept milk from a producer if: 

 (a) The milk has been in a probational (No. 3) sediment content classification for more 

than 10 calendar days (§ 58.134); 

 b) Three of the last five milk samples have exceeded the maximum bacterial estimate of 

500,000 per ml. (§ 58.135 (c)(3)). 

 (c) Three of the last five milk samples have exceeded the maximum somatic cell count 

level of 750,000 per ml. (1,500,000 per ml. for goat milk) (§ 58.133 (b)(6)); or 

 (d) The producer’s milk shipments to either the Grade A or the manufacturing grade milk 

market currently are not permitted due to a positive drug residue test (§ 58.133(c)(4)). 

§ 58.138 Quality testing of milk from new producers. 

 A quality examination and tests shall be made on the first shipment of milk from a 

producer shipping milk to a plant for the first time or resuming shipment to a plant after a period 

of non-shipment. The milk shall meet the requirements for acceptable milk, somatic cell count 

and drug residue level (§§ 58.133, 58.134 and 58.135). The buyer shall also confirm that the 

producer’s milk is currently not excluded from the market (§ 58.137). Thereafter, the milk shall 

be tested in accordance with the provisions in §§ 58.133, 58.134 and 58.135. 

§ 58.139 Record of tests.

 Accurate records listing the results of quality and drug residue tests for each producer 

shall be kept on file at the plant. Additionally, the plant shall obtain the quality and drug residue 

test records (§ 58.148(a), (e) and (g)) for any producer transferring milk shipment from another 

plant. These records shall be available for examination by the inspector. 

§ 58.140 Field service. 

 A representative of the plant shall arrange to promptly visit the farm of each producer 

whose milk tests positive for drug residue, exceeds the maximum somatic cell count level, or 

does not meet the requirements for acceptable milk. The purpose of the visit shall be to inspect 

the milking equipment and facilities and to offer assistance to improve the quality of the 

producer’s milk and eliminate any potential causes of drug residues. A representative of the 

plant should routinely visit each producer as often as necessary to assist and encourage the 

production of high quality milk. 
23

§ 58.141 Alternate quality control program. 

 When a plant has in operation an acceptable quality program, at the producer level, which 

is approved by the Administrator as being effective in obtaining results comparable to or higher 

than the quality program as outlined above for milk or cream, then such a program may be 

accepted in lieu of the program herein prescribed. 

OPERATIONS AND OPERATING PROCEDURES 

§ 58.142 Product quality and stability. 

 The receiving, holding and processing of milk and cream and the manufacturing, 

handling, packaging, storing and delivery of dairy products shall be in accordance with clean and 

sanitary methods, consistent with good commercial practices to promote the production of the 

highest quality of finished product and improve product stability. Milk should not be more than 

three days old when picked up from the producer and delivered to the plant, receiving station or 

transfer station. 

§ 58.143 Raw product storage. 

 (a) All milk shall be held and processed under conditions and at temperatures that will 

avoid contamination and rapid deterioration. Drip milk from can washers and any other source 

shall not be used for the manufacture of dairy products. Bulk milk in storage tanks within the 

dairy plant shall be handled in such a manner as to minimize bacterial increase and shall be 

maintained at 450F. or lower until processing begins. This does not preclude holding milk at 

higher temperatures for a period of time, where applicable to particular manufacturing or 

processing practices. 

 (b) The bacteriological quality of commingled milk in storage tanks shall not exceed 

1,000,000/ml. 

§ 58.144 Pasteurization or ultra-pasteurization. 

 When pasteurization or ultra-pasteurization is intended or required, or when a product is 

designated “pasteurized” or “ultra-pasteurized” every particle of the product shall be subjected to 

such temperatures and holding periods in approved systems as will assure proper pasteurization 

or ultra-pasteurization of the product. The heat treatment by either process shall be sufficient to 

insure public health safety and to assure adequate keeping quality, yet retaining the most 

desirable flavor and body characteristics of the finished product. 
24

§ 58.145 Composition and wholesomeness. 

 All necessary precautions shall be taken to prevent contamination or adulteration of the 

milk or dairy products during manufacturing. All substances and ingredients used in the 

processing or manufacturing of any dairy product shall be subject to inspection and shall be 

wholesome and practically free from impurities. The finished products shall comply with the 

requirements of the Federal Food, Drug, and Cosmetic Act as to their composition and 

wholesomeness. 

§ 58.146 Cleaning and sanitizing treatment. 

 (a) Equipment and utensils. The equipment, sanitary piping and utensils used in receiving 

and processing of the milk, and manufacturing and handling of the product shall be maintained in 

a sanitary condition. Sanitary seal assemblies shall be removable on all agitators, pumps, and 

vats and shall be inspected at regular intervals and kept clean. Unless other provisions are 

recommended in the following supplement sections, all equipment not designed for C.I.P. 

cleaning or mechanical cleaning shall be disassembled after each day’s use for thorough cleaning. 

Dairy cleaners, detergents, wetting agents or sanitizing agents, or other similar materials which 

will not contaminate or adversely affect the products may be used. Steel wool or metal sponges 

shall not be used in the cleaning of any dairy equipment or utensils. 

(1) Product contact surfaces shall be subjected to an effective sanitizing treatment prior to 

use, except where dry cleaning is permitted. Utensils and portable equipment used in processing 

and manufacturing operations shall be stored above the floor in clean, dry locations and in a self 

draining position on racks constructed of impervious corrosion-resistant material. 

(2) C.I.P. cleaning or mechanical cleaning systems shall be used only on equipment and 

pipeline systems which have been designed, engineered and installed for that purpose. When 

such cleaning is used, careful attention shall be given to the proper procedures to assure 

satisfactory cleaning. All C.I.P. installations and cleaning procedures shall be in accordance with 

3-A Suggested Method for the Installation and Cleaning of Cleaned-In-Place Sanitary Milk 

Pipelines for Milk and Milk Products Plants. Because of the possibilities of corrosion, the 

recommendations of the cleaning compound manufacturer should be followed with respect to 

time, temperature and concentration of specific acid or alkaline solutions and bactericides. Such 

cleaning operation should be preceded by a thorough rinse at approximately 110 - 1150F. 

continuously discarding the water. Following the circulation of the cleaning solution the 

equipment and lines shall be thoroughly rinsed with lukewarm water and checks should be made 

for effectiveness of cleaning. All caps, plugs, special fittings, valve seats, cross ends, pumps, and 

tee ends shall be opened or removed and brushed clean. All non-pasteurized product contact 

surfaces should be sanitized. Immediately prior to starting the product flow, the pasteurized 

product contact surfaces shall be given sanitizing treatment. 

 (b) Milk cans and can washers. Milk cans and lids shall be cleaned, sanitized and dried 

before returning to producers. Inspection, repair or replacement of cans and lids shall be 
25

adequate to substantially exclude from use cans and lids showing open seams, cracks, rust 

condition, milkstone or any unsanitary condition. 

Washers shall be maintained in a clean and satisfactory operating condition and kept free from 

accumulation of scale or debris which will adversely affect the efficiency of the washer. Only 

washing compounds which are compatible with the water for effective cleaning, should be used. 

The can washer should be checked regularly during the run for proper operation. At the end of 

the day, the wash and rinse tanks should be drained and cleaned, jets and strainers cleaned, air 

filters checked and changed or cleaned if needed, and checks should be made for proper 

adjustment and condition of mechanical parts. 

 (c) Milk transport tanks. A covered or enclosed wash dock and cleaning and sanitizing 

facilities shall be available to all plants that receive or ship milk in tanks. Milk transport tanks, 

sanitary piping, fittings, and pumps shall be cleaned and sanitized at least once each day after 

use: Provided that, if they are not to be used immediately after emptying a load of milk, they shall 

be washed promptly after use and given bactericidal treatment immediately before use. After 

being washed and sanitized, each tank should be identified by a tag attached to the outlet valve, 

bearing the following information: Plant and specific location where cleaned, date and time of 

day of washing and sanitizing, and name of person who washed and name of person who 

sanitized the tank. The tag shall not be removed until the tank is again washed and sanitized. 

 (d) Building. All windows, glass, partitions, and skylights should be washed as often as 

necessary to keep them clean. Cracked or broken glass shall be replaced promptly. The walls, 

ceilings and doors should be washed periodically and kept free from soil and unsightly 

conditions. The shelves and ledges should be wiped or vacuumed as often as necessary to keep 

them free from dust and debris. The material picked up by the vacuum cleaners shall be disposed 

of in sealed containers which will prevent contamination or insect infestation from the waste 

material. 

§ 58.147 Insect and rodent control program. 

 In addition to any commercial pest control service, if one is utilized, a specially 

designated employee should be made responsible for the performance of a regularly scheduled 

insect and rodent control program. Poisonous substances shall be properly labeled, and shall be 

handled, stored and used in such a manner as considered satisfactory by the Environmental 

Protection Agency. 

§ 58.148 Plant records. 

 Adequate plant records shall be maintained of all required tests and analyses performed in 

the laboratory or throughout the plant during storage, processing and manufacturing, on all raw 

milk receipts and dairy products. Such records shall be available for examination at all 

reasonable times by the inspector. The following are the records which shall be maintained for 
26

examination at the plant or receiving station where performed. 

 (a) Sediment and bacterial test results on raw milk from each producer. Retain for 12 

months. 

(1) Routine tests and monthly summary of all producers showing number and percent of 

total in each class. 

(2) Retests, if initial test places milk in probationary status. 

(3) Rejections of raw milk over No. 3 in quality. 

 (b) Pasteurization recorder charts. Retain for 3 months. 

 (c) Water supply test certificate. Retain current copy for 6 months. 

 (d) Cooling and heating recorder charts. Retain for 3 months. 

 (e) Load and individual drug residue test results. Retain for 12 months. 

 (f) Notifications to appropriate State regulatory agencies of positive drug residue tests and 

intended and final dispositions of milk testing positive for drug residue. Retain for 12 months. 

 (g) Somatic cell count test results on raw milk from each producer. Retain for 12 months. 

(Approved by the Office of Management and Budget under OMB control number 0583-0047)1

§ 58.149 Alternate quality control programs for dairy products. 

 (a) When a plant has in operation an acceptable quality control program which is 

approved by the Administrator as being effective in obtaining results comparable to or higher 

than the quality control program as outlined in this subpart, then such a program may be accepted 

in lieu of the program herein prescribed. 

 (b) Where a minimum number of samples per batch of product, or per unit of time on 

continuous production runs are not specified, the phrase “as many samples shall be taken as is 

necessary to assure compliance to specific quality requirements” is used. Acceptable 

performance of this would be any method approved by the Administrator as meeting sound 

statistical methods of selecting samples and determining the number of samples to be taken. 

 

1

EDITORIAL NOTE: See table appearing in §58.100 for correct OMB control number. 
27

PACKAGING AND GENERAL IDENTIFICATION 

§ 58.150 Containers. 

 (a) The size, style, and type of packaging used for dairy products shall be commercially 

acceptable containers and packaging materials which will satisfactorily cover and protect the 

quality of the contents during storage and regular channels of trade and under normal conditions 

of handling. 

 (b) Packaging materials for dairy products shall be selected which will provide 

sufficiently low permeability to air and vapor to prevent the formation of mold growth and 

surface oxidation. In addition, the wrapper should be resistant to puncturing, tearing, cracking or 

breaking under normal conditions of handling, shipping and storage. When special type 

packaging is used, the instructions of the manufacturer shall be followed closely as to its 

application and methods of closure. 

§ 58.151 Packaging and repackaging. 

 (a) Packaging dairy products or cutting and repackaging all styles of dairy products shall 

be conducted under rigid sanitary conditions. The atmosphere of the packaging rooms, the 

equipment and packaging materials shall be practically free from mold and bacterial 

contamination. Methods for checking the level of contamination shall be as prescribed by the 

latest edition of Standard Methods or by other satisfactory methods approved by the 

Administrator. 

 (b) When officially graded bulk dairy products are to be repackaged into consumer type 

packages with official grade labels or other official identification, a supervisor of packaging shall 

be required, see subpart A of this part. (title 7, §§ 58.2 and 58.53 of the Code of Federal 

Regulations). If the packaging or repackaging is done in a plant other than the one in which the 

dairy product is manufactured, the plant, equipment, facilities and personnel shall meet the same 

requirements as outlined in this subpart. 

§ 58.152 General identification. 

 All commercial bulk packages or consumer packaged product containing dairy products 

manufactured under the provisions of this subpart shall comply with the applicable regulation of 

the Food and Drug Administration. 
28

STORAGE OF FINISHED PRODUCT 

§ 58.153 Dry storage. 

 The product should be stored at least 18 inches from the wall in aisles, rows, or sections 

and lots, in such a manner as to be orderly and easily accessible for inspection. Rooms should be 

cleaned regularly. It is recommended that dunnage or pallets be used when practical. Care shall 

be taken in the storage of any other product foreign to dairy products in the same room, in order 

to prevent impairment or damage to the dairy product from mold, absorbed odors, or vermin or 

insect infestation. Control of humidity and temperature shall be maintained at all times, 

consistent with good commercial practices, to prevent conditions detrimental to the product and 

container. 

§ 58.154 Refrigerated storage. 

 Finished product in containers subject to such conditions that will affect its useability 

shall be placed on shelves, dunnage or pallets and properly identified. It shall be stored under 

temperatures that will best maintain the initial quality. The product shall not be exposed to 

anything from which it might absorb any foreign odors or be contaminated by drippage or 

condensation. 

INSPECTION, GRADING AND OFFICIAL IDENTIFICATION 

§ 58.155 Grading. 

 Dairy products which have been processed or manufactured in accordance with the 

provisions of this subpart may be graded by the grader in accordance with the U.S. Standards for 

Grades. Laboratory analyses, when required in determining the final grade shall be conducted in 

an approved laboratory. 

§ 58.156 Inspection. 

 Dairy products, which have been processed or manufactured in an approved plant, and for 

which there are no official U.S. Standards for Grades, shall be inspected for quality by the 

inspector in accordance with contract requirements or product specifications established by the 

U.S. Department of Agriculture or other Federal agency or buyer and seller. Laboratory analysis 

when required shall be conducted in an approved laboratory. 

§ 58.157 Inspection or grading certificates. 

 All dairy products which have been processed or manufactured, packaged and inspected 

or graded in accordance with the provision of this part may be covered by an inspection or 

grading certificate issued by the inspector or grader. 
29

§ 58.158 Official identification. 

 (a) Application for authority to apply official identification to packaging material or 

containers shall be made in accordance with the provisions of subpart A of this part. (title 7, 

§§ 58.49 through 58.57 of the Code of Federal Regulations.) 

 (b) Only dairy products received, processed, or manufactured in accordance with the 

specifications contained in this subpart and inspected and/or graded in accordance with the 

provisions of this part may be identified with official identification. 

EXPLANATION OF TERMS 

§ 58.159 Terms. 

 (a) Fresh and sweet. Free from “old milk” flavor of developed acidity or other 

off-flavors. 

 (b) Normal feed. Regional feed flavors, such as alfalfa, clover, silage, or similar feeds or 

grasses (weed flavors, such as peppergrass, French weed, onion, garlic, or other obnoxious 

weeds, excluded). 

 (c) Off-flavors. Tastes or odors, such as utensil, bitter, barny, or other associated defects 

when present to a degree readily detectable. 

 (d) Developed acidity. An apparent increase from the normal acidity of the milk to a 

degree of taste and odor which is detectable. 

 (e) Extraneous matter. Foreign substances, such as filth, hair, insects and fragments 

thereof, and rodents, and materials, such as metal, fiber, wood and glass. 

 (f) Sediment. Fine particles of material other than the foreign substances and materials 

defined in paragraph (e) of this section. 

 (g) C.I.P. The abbreviation of an approved system of cleaning pipelines called 

“Cleaned-in-Place.” 

 (h) Mechanical cleaning. Denotes cleaning solely by circulation and/or flowing chemical 

detergent solution and water rinses onto and over the surfaces to be cleaned, by mechanical 

means. 
30

SUPPLEMENTAL SPECIFICATIONS FOR PLANTS MANUFACTURING, PROCESSING, 

 AND PACKAGING NONFAT DRY MILK, INSTANT NONFAT DRY MILK, DRY 

 WHOLE MILK, AND DRY BUTTERMILK 

DEFINITIONS 

§ 58.205 Meaning of words. 

 For the purpose of the regulations in this subpart, words in the singular form shall be 

deemed to impart the plural and vice versa, as the case may demand. Unless the context 

otherwise requires, the following terms shall have the following meaning: 

 (a) Nonfat dry milk. The pasteurized product resulting from the removal of fat and water 

from milk, and contains the lactose, milk proteins, and milk minerals in the same relative 

proportions as in the fresh milk from which made. It shall not contain buttermilk, or any added 

preservative, neutralizing agent or other chemical. 

 (b) Instant nonfat dry milk. Nonfat dry milk which has been produced in such a manner 

as to substantially improve its dispersing and reliquification characteristics over that produced by 

the conventional process. 

 (c) Dry whole milk. The pasteurized product resulting from the removal of water from 

milk and contains the lactose, milk proteins, milk fat, and milk minerals in the same relative 

proportions as in the fresh milk from which made. The milk may be standardized but shall not 

contain buttermilk, or any added preservative, neutralizing agent or other chemicals. 

 (d) Dry buttermilk. The product resulting from drying liquid buttermilk that was derived 

from the churning of butter and pasteurized prior to condensing at a temperature of 1610F for 15 

seconds or its equivalent in bacterial destruction. Dry buttermilk shall have a protein content of 

not less than 30.0 percent. Dry buttermilk shall not contain nor be derived from nonfat dry milk, 

dry whey, or products other than buttermilk, and shall not contain any added preservative, 

neutralizing agent, or other chemical. 

 (e) Dry buttermilk product. The product resulting from drying liquid buttermilk that was 

derived from the churning of butter and pasteurized prior to condensing at a temperature of 

1610

F for 15 seconds or its equivalent in bacterial destruction. Dry buttermilk product has a 

protein content less than 30.0 percent. Dry buttermilk product shall not contain nor be derived 

from nonfat dry milk, dry whey, or products other than buttermilk, and shall not contain any 

added preservative, neutralizing agent, or other chemical. 
31

ROOMS AND COMPARTMENTS 

§ 58.210 Dry storage of product. 

 Storage rooms for the dry storage of product shall be adequate in size, kept clean, orderly, 

free from rodents, insects, and mold, and maintained in good repair. They shall be adequately 

lighted and ventilated. The ceilings, walls, beams and floors should be free from structural 

defects and inaccessible false areas which may harbor insects. 

§ 58.211 Packaging room for bulk products. 

 A separate room or area shall be provided for filling bulk containers, and shall be 

constructed in accordance with § 58.126. The number of control panels and switch boxes in this 

area should be kept to a minimum. Control panels shall be mounted a sufficient distance from 

the walls to facilitate cleaning or satisfactorily sealed to the wall, or shall be mounted in the wall 

and provided with tight fitting removable doors to facilitate cleaning. An adequate exhaust 

system shall be provided to minimize the accumulation of product dust within the packaging 

room and where needed, a dust collector shall be provided and properly maintained to keep roofs 

and outside areas free of dry product. Only packaging materials that are used within a day’s 

operation may be kept in the packaging area. These materials shall be kept on metal racks or 

tables at least six inches off the floor. Unnecessary fixtures, equipment, or false areas which may 

collect dust and harbor insects, should not be allowed in the packaging room. 

§ 58.212 Hopper or dump room. 

 A separate room shall be provided for the transfer of bulk dry dairy products to the 

hoppers and conveyors which lead to the fillers. This room shall meet the same requirements for 

construction and facilities as the bulk packaging operation. Areas and facilities provided for the 

transfer of dry dairy products from portable bulk bins will be accepted if gasketed surfaces or 

direct connections are used that appreciably eliminate the escape of product into the area. 

§ 58.213 Repackaging room. 

 A separate room shall be provided for the filling of small packages and shall meet the 

same requirements for construction and facilities as the bulk packaging operation. 

EQUIPMENT AND UTENSILS 

§ 58.214 General construction, repair and installation. 

 All equipment and utensils necessary to the manufacture of dry milk products, including 

pasteurizer, timing-pump or device, flow diversion valve and recorder controller, shall meet the 
32

same general requirements as outlined in § 58.128 of this subpart. In addition, for certain other 

equipment the following requirements shall be met. 

§ 58.215 Pre-heaters. 

 The pre-heaters shall be of stainless steel or other equally corrosion resistant material, 

cleanable, accessible for inspection and shall be equipped with suitable automatic temperature 

controls. 

§ 58.216 Hotwells. 

 The hotwells shall be enclosed or covered and should be equipped with indicating 

thermometers either in the hotwell or in the hot milk inlet line to the hotwell. If used for holding 

high heat products, they should also have recorders. 

§ 58.217 Evaporators and/or vacuum pans. 

 Evaporators or vacuum pans or both, with open type condensers shall be equipped with 

an automatic condenser water level control, barometric leg, or so constructed so as to prevent 

water from entering the product. New or replacement units shall comply with the 3-A Sanitary 

Standards for Milk and Milk Products Evaporators and Vacuum Pans. When enclosed type 

condensers are used, no special controls are needed to prevent water from entering the product. 

Water collected from the condensing of product (cow water) in this equipment may be utilized 

for prerinsing and cleaning solution make-up; provided it is equipped with proper controls that 

will automatically divert water with entrained solids to the waste water system. “Cow water” 

shall not be used for acidified or final equipment rinse. 

§ 58.218 Surge tanks. 

 If surge tanks are used for hot milk, and temperatures of product including foam being 

held in the surge tank during processing, is not maintained at a minimum of 1500F, then two or 

more surge tanks shall be installed with cross connections to permit flushing and cleaning during 

operation. Covers easily removable for cleaning shall be provided and used at all times. 

§ 58.219 High pressure pumps and lines. 

 High pressure lines may be cleaned-in-place and shall be of such construction that dead 

ends, valves and the high pressure pumps can be disassembled for hand cleaning. The high 

pressure pump shall comply with the 3-A Sanitary Standard for Homogenizers and Pumps of the 

Plunger Type. 
33

§ 58.220 Drying systems. 

 (a) Spray dryers. Spray dryers shall be of a continuous discharge type and all product 

contact surfaces shall be of stainless steel or other equally corrosion resistant material. All joints 

and seams in the product contact surfaces shall be welded and ground smooth. All dryers shall 

be constructed so as to facilitate ease in cleaning and inspection. Sight glasses or ports of 

sufficient size shall be located at strategic positions. Dryers shall be equipped with suitable air 

intake filters. The filter system shall comply with the applicable requirements of the 3-A 

Accepted Practices for Milk and Milk Products Spray Drying Systems. The filtering system shall 

be cleaned or component parts replaced as often as necessary to maintain a clean and adequate air 

supply. In gas fired dryers, precautions should be taken to assure complete combustion. Air 

shall be drawn into the dryer from sources free from objectionable odors and smoke, dust or dirt. 

New systems, replacement systems, or portions of systems replaced shall comply with the 

requirements of the 3-A Accepted Practices for Milk and Milk Products Spray Drying Systems. 

(b) Roller dryers. (1) The drums of a roller dryer shall be smooth, readily cleanable and 

free of pits and rust. The knives shall be maintained in such condition so as not to cause scoring 

of the drums. 

(2) The end boards shall have an impervious surface and be readily cleanable. They shall 

be provided with a means of adjustment to prevent leakage and accumulation of milk solids. The 

stack, hood, the drip pan inside of the hood and related shields shall be constructed of stainless 

steel and be readily cleanable. The lower edge of the hood shall be constructed so as to prevent 

condensate from entering the product zone. The hood shall be properly located and the stack of 

adequate capacity to remove the vapors. The stack shall be closed when the dryer is not in 

operation. The augers shall be stainless steel or properly plated, and readily cleanable. The 

auger troughs and related shields shall be of stainless steel and be readily cleanable. All air 

entering the dryer room shall be filtered to eliminate dust and dirt. The filter system shall consist 

of filtering media or device that will effectively, and in accordance with good commercial 

practices, prevent the entrance of foreign substances into the drying room. The filtering system 

shall be cleaned or component parts replaced as often as necessary to maintain a clean and 

adequate air supply. All dryer adjustments shall be made and the dryer operating normally before 

food grade product is collected from the dryer. 

 (c) Other drying systems. These systems shall be constructed following the applicable 

principles of the 3-A Accepted Practices for Milk and Milk Products Spray Drying Systems. 

§ 58.221 Collectors and conveyors. 

 Collectors shall be made of stainless steel or equally noncorrosive material and should be 

constructed to facilitate cleaning and inspection. Filter sack collectors, if used, shall be in good 

condition and the system shall be of such construction that all parts are accessible for cleaning 

and inspection. Conveyors shall be of stainless steel or equally corrosion resistant material and 
34

should be constructed to facilitate thorough cleaning and inspection. 

§ 58.222 Dry dairy product cooling equipment.

 Cooling equipment shall be provided with sufficient capacity to cool the product as 

specified in § 58.240. A suitable dry air supply with an effective filtering system meeting the 

requirements of § 58.220(a) shall be provided where air cooling and conveying is used. 

§ 58.223 Special treatment equipment. 

 Any special equipment (instantizers, hammer mills, etc.) used to treat dry milk products 

shall be of sanitary construction and all parts shall be accessible for cleaning and inspection. 

New or replacement instantizing systems shall comply with the 3-A Accepted Practices for 

Instantizing Systems for Dry Milk and Dry Milk Products. 

§ 58.224 Sifters. 

 All newly installed sifters used for dry milk and dry milk products shall comply with the 

3-A Sanitary Standards for Sifters for Dry Milk and Dry Milk Products. All other sifters shall be 

constructed of stainless steel or other equally noncorrosive material and shall be of sanitary 

construction and accessible for cleaning and inspection. The mesh size of sifter screen used for 

various dry dairy products shall be those recommended in the appendix of the 3-A Standard for 

sifters. 

§ 58.225 Clothing and shoe covers. 

 Clean clothing and shoe covers shall be provided exclusively for the purpose of cleaning 

the interior of the dryer when it is necessary to enter the dryer to perform the cleaning operation. 

§ 58.226 Portable and stationary bulk bins. 

 Bulk bins shall be constructed of stainless steel, aluminum or other equally corrosion 

resistant materials, free from cracks, seams and must have an interior surface that is relatively 

smooth and easily cleanable. All product contact surfaces shall be easily accessible for cleaning. 

The capacity of each portable and bulk bin shall be limited to permit proper operating procedures 

such as sampling and daily removal of all product to preclude commingling of different days 

production. 

§ 58.227 Sampling device. 

 If automatic sampling devices are used, they shall be constructed in such a manner as to 

prevent contamination of the product, and all parts must be readily accessible for cleaning. The 

type of sampler and the sampling procedure shall be as approved by the Administrator. 
35

§ 58.228 Dump hoppers, screens, mixers and conveyors. 

 The product contact surfaces of dump hoppers, screens, mixers and conveyors which are 

used in the process of transferring dry products from bulk containers to fillers for small packages 

or containers, shall be of stainless or equally corrosion resistant material and designed to prevent 

contamination. All parts should be accessible for cleaning. The dump hoppers shall be of such 

height above floor level as to prevent foreign material or spilled product from entering the 

hopper. 

§ 58.229 Filler and packaging equipment. 

 All filling and packaging equipment shall be of sanitary construction and all parts, 

including valves and filler heads accessible for cleaning. New or replacement equipment should 

comply with the 3-A Sanitary Standards for equipment for Packaging Dry Milk and Dry Milk 

Products. 

§ 58.230 Heavy duty vacuum cleaners.

 Each plant handling dry milk products shall be equipped with a heavy duty industrial 

vacuum cleaner. The vacuum cleaner shall be of a type that has a collector or disposable bag 

which will not recontaminate the atmosphere of the processing and packaging areas. Regular 

scheduling shall be established for its use in vacuuming applicable areas. 

QUALITY SPECIFICATIONS FOR RAW MATERIALS 

§ 58.231 General. 

 All raw materials received at the drying plant shall meet the following quality 

specifications. 

§ 58.232 Milk. 

 Raw milk shall meet the requirements as outlined in §§ 58.132 through 58.138 and, 

unless processed within two hours after being received, it shall be cooled to and held at a 

temperature of 450F. or lower until processed. 

§ 58.233 Skim milk. 

 The skim milk shall be separated from whole milk meeting the requirements as outlined 

in §§ 58.132 through 58.138, and unless processed immediately, it shall be cooled to and 

maintained at a temperature of 450F. or lower from the time of separating until the time of 

processing. 
36

§ 58.234 Buttermilk. 

 Buttermilk for drying as dry buttermilk or dry buttermilk product shall be fresh and 

derived from the churning of butter, with or without the addition of harmless lactic culture. No 

preservative, neutralizing agent or other chemical may be added. Fluid buttermilk, unless 

cultured, shall be held at 450F or lower unless processed within 2 hours. 

§ 58.235 Modified dry milk products. 

 Dry milk products to which approved neutralizing agents or chemicals have been added 

or constituents removed to alter their original characteristics for processing or usage shall come 

from products meeting the requirements of §§ 58.232, 58.233, or 58.234. These products shall 

meet the applicable labeling requirements. 

OPERATIONS AND OPERATING PROCEDURES 

§ 58.236 Pasteurization and heat treatment. 

 All milk and buttermilk used in the manufacture of dry milk products and modified dry 

milk products shall be pasteurized at the plant where dried, except that acidified buttermilk 

containing 40 percent or more solids may be transported to another plant for drying without 

repasteurization. Provided the condensed product is handled according to sanitary conditions 

approved by the Administrator. 

 (a) Pasteurization. (1) All milk or skim milk to be used in the manufacture of nonfat dry 

milk shall be pasteurized prior to condensing at a minimum temperature of 1610F. for at least 

15 seconds or its equivalent in bacterial destruction. Condensed milk products made from 

pasteurized milk may be transported to a drying plant, provided that it shall be effectively 

repasteurized at the drying plant, prior to drying, at no less than 1660F. for 15 seconds or its 

equivalent in bacterial destruction. 

(2) All buttermilk to be used in the manufacture of dry buttermilk or dry buttermilk 

product shall be pasteurized prior to condensing at a temperature of 1610

F for 15 seconds or its 

equivalent in bacterial destruction. 

 (b) Heat treatment--(1) High-heat. The finished product shall not exceed 1.5 mg. 

undenatured whey protein nitrogen per gram of nonfat dry milk as classified in the U.S. 

Standards for Grades of Nonfat Dry Milk (Spray Process). 

(2) Medium-heat. The finished product shall show undenatured whey protein nitrogen 

between the levels of “high-heat” and “low-heat” (1.51 to 5.99 mg.). 

(3) Low-heat. The finished product shall show not less than 6.0 undenatured whey 

protein nitrogen per gram of non-fat dry milk as classified in the U.S. Standards for Grades of 

Nonfat Dry Milk (Spray Process). 
37

§ 58.237 Condensed surge supply. 

 Surge tanks or balance tanks if used between the evaporators and dryer shall be used to 

hold only the minimum amount of condensed product necessary for a uniform flow to the dryers. 

Such tanks holding product at temperatures below 1500F. shall be completely emptied and 

washed after each 4 hours of operation or less. Alternate tanks shall be provided to permit 

continuous operation during washing of tanks. 

§ 58.238 Condensed storage tanks. 

 (a) Excess production of condensed product over that which the dryer will take 

continuously from the pans should be bypassed through a cooler into a storage tank at 500F. or 

lower and held at this temperature until used. 

 (b) Product cut-off points shall be made at least every 24 hours and the tank completely 

emptied, washed, and sanitized before reuse. 

§ 58.239 Drying. 

 Each dryer should be operated to produce the highest quality dry product consistent with 

the most efficient operation. The dry products shall be removed from the drying chamber 

continuously during the drying process. 

§ 58.240 Cooling dry products. 

 Prior to packaging and immediately following removal from the drying chamber the dry 

product shall be cooled to a temperature not exceeding 1100 F, however, if the product is to be 

held in a bulk bin the temperature should be reduced to approximately 900F but shall be not 

more than 1100

F. 

§ 58.241 Packaging, repackaging and storage. 

 (a) Containers. Packages or containers used for the packaging of nonfat dry milk or other 

dry milk products shall be any clean, sound commercially accepted container or packaging 

material which will satisfactorily protect the contents through the regular channels of trade, 

without significant impairment of quality with respect to flavor, wholesomeness or moisture 

content under the normal conditions of handling. In no instance will containers which have 

previously been used for nonfood items, or food items which would be deleterious to the dairy 

product be allowed to be used for the bulk handling of dairy products. 

 (b) Filling. Empty containers shall be protected at all times from possible contamination 

and containers which are to be lined shall not be prepared more than one hour in advance of 

filling. Every precaution shall be taken during the filling operation to minimize product dust and 
38

spillage. When necessary a mechanical shaker shall be provided; the tapping or pounding of 

containers should be prohibited. The containers shall be closed immediately after filling and the 

exteriors shall be vacuumed or brushed when necessary to render them practically free of residual 

product before being transferred from the filling room to the palleting or dry storage areas. 

 (c) Repackaging. The entire repackaging operation shall be conducted in a sanitary 

manner with all precautions taken to prevent contamination and to minimize dust. All exterior 

surfaces of individual containers shall be practically free of product before overwrapping or 

packing in shipping containers. The room shall be kept free of dust accumulation, waste, cartons, 

liners, or other refuse. Conveyors, packaging and carton making equipment shall be vacuumed 

frequently during the operating day to prevent the accumulation of dust. No bottles or glass 

materials of any kind shall be permitted in the repackaging or hopper room. The inlet openings 

of all hoppers and bins shall be of minimum size, screened and placed well above the floor level. 

The room and all packaging equipment shall be cleaned as often as necessary to maintain a 

sanitary operation. Close attention shall be given to cleaning equipment where residues of the 

dry product may accumulate. A thorough clean-up including windows, doors, walls, light 

fixtures and ledges, should be performed as frequently as is necessary to maintain a high standard 

of cleanliness and sanitation. All waste dry dairy products including dribble product at the 

fillers, shall be properly identified and disposed of as animal feed. 

 (d) Storage--(1) Product. The packaged dry milk product shall be stored or so arranged 

in aisles, rows, or sections and lots at least 18 inches from any wall and in such a manner as to be 

orderly, easily accessible for inspection or for cleaning of the room. All bags and small 

containers of products shall be placed on pallets elevated from the floor. Products in small 

containers may be stored by methods preventing direct contact with the floor when the condition 

of the container is satisfactorily maintained. The storage room shall be kept clean and dry and all 

openings protected against entrance of insects and rodents. 

(2) Supplies. All supplies shall be placed on dunnage or pallets and arranged in an 

orderly manner for accessibility and cleaning of the room. It is preferable that supplies be stored 

in an area separate from that used for storing the dry products. Supplies shall be kept enclosed in 

their original wrapping material until used. After removal of supplies from their original 

containers, they shall be kept in an enclosed metal cabinet, bins or on shelving and if not 

enclosed shall be protected from powder, and dust or other contamination. The room should be 

vacuumed as often as necessary and kept clean and orderly. 

§ 58.242 Product adulteration.

 All necessary precautions shall be taken throughout the entire operation to prevent the 

adulteration of one product with another. The commingling of one type of liquid or dry product 

with another shall be considered as an adulteration of that product. This does not prohibit the 

normal standardization of like products in accordance with good commercial practices or the 

production of specific products for special uses, provided applicable labeling requirements are 

met. 
39

§ 58.243 Checking quality. 

 All milk, milk products and dry milk products shall be subject to inspection and analysis 

by the dairy plant for quality and condition throughout each processing operation. Periodically 

samples of product and environmental material shall be tested for salmonella. Test results shall 

be negative when samples are tested for salmonella. Line samples should be taken periodically 

as an aid to quality control in addition to the regular routine analysis made on the finished 

products. 

§ 58.244 Number of samples. 

 As many samples shall be taken from each dryer production lot as is necessary to assure 

proper composition and quality control. A sufficient number of representative samples from the 

lot shall be taken to assure compliance with the stated net weight on the container. 

§ 58.245 Method of official sample analysis. 

 Samples shall be tested according to the applicable methods of laboratory analysis 

contained in either DA Instruction 918-RL as issued by the USDA, Agricultural Marketing 

Service, Dairy Programs, or Official Methods of Analysis of the Association of Analytical 

Chemists or Standard Methods for the Examination of Dairy Products. 

§ 58.246 Cleaning of dryers, collectors, conveyors, ducts, sifters and storage bins. 

 This equipment shall be cleaned as often as is necessary to maintain such equipment in a 

clean and sanitary condition. The kind of cleaning procedure either wet or dry and the frequency 

of cleaning shall be based upon observation of actual operating results and conditions. 

§ 58.247 Insect and rodent control program. 

 In addition to any commercial pest control service, if one is utilized, a specially 

designated employee should be made responsible for the performance of a regularly scheduled 

insect and rodent control program as outlined in University of Wisconsin Extension Bulletin 

A2518 or subsequent revisions thereof, or one equivalent thereto. 
40

REQUIREMENTS FOR FINISHED PRODUCTS BEARING USDA OFFICIAL 

IDENTIFICATION 

§ 58.248 Nonfat dry milk. 

 (a) Nonfat dry milk in commercial bulk containers bearing an official identification shall 

meet the requirements of U.S. Extra Grade or U.S. Standard Grade. 

 (b) Regular nonfat dry milk in consumer size packages which bears an official 

identification shall meet the requirements of U.S. Extra Grade. In addition, the nonfat dry milk 

shall be sampled and tested in accordance with §§ 58.244 and 58.245. 

§ 58.249 Instant nonfat dry milk. 

 (a) Only instant nonfat dry milk manufactured and packaged in accordance with the 

requirements of this part and with the applicable requirements in subpart A of this part which has 

been officially inspected in process and found to be in compliance with these requirements may 

be identified with the official USDA U.S. Extra Grade, processed and packed inspection shield. 

 (b) Instant nonfat dry milk shall meet the applicable standard for U.S. Extra Grade. 

§ 58.250 Dry whole milk. 

 Dry whole milk in commercial bulk containers which bears an official identification shall 

meet the requirements for the U.S. Standards for Grades of Dry Whole Milk. Quality 

requirements for dry whole milk in consumer packages shall be for U.S. Extra Grade and shall be 

gas packed with an oxygen content of not more than 2.0 percent. 

§ 58.251 Dry buttermilk and dry buttermilk product. 

 The quality requirements for dry buttermilk or dry buttermilk product bearing an official 

identification shall be in accordance with the U.S. Standards for Grades of Dry Buttermilk and 

Dry Buttermilk Product. 

SUPPLEMENTAL SPECIFICATIONS FOR PLANTS MANUFACTURING, PROCESSING 

AND PACKAGING BUTTER AND RELATED PRODUCTS 

DEFINITIONS 

§ 58.305 Meaning of words. 

 For the purpose of the regulations in this subpart, words in the singular form shall be 
41

deemed to impart the plural and vice versa, as the case may demand. Unless the context 

otherwise requires, the following terms shall have the following meaning. 

 (a) Butter. The food product usually known as butter, and which is made exclusively 

from milk or cream, or both, with or without common salt, with or without additional coloring 

matter, and containing not less than 80 percent by weight of milkfat, all tolerances having been 

allowed for. 

 (b) Butteroil. The food product resulting from the removal of practically all of the 

moisture and solids-not-fat from butter. It contains not less than 99.6 percent fat, and not more 

than 0.3 percent moisture; and not more than 0.1 percent other butter constituents, of which the 

salt shall be not more than 0.05 percent. Antioxidants permitted to be used are as follows: 

Antioxidant Maximum level

Propyl gallate ..................................................

Butylated hydroxytoluene (BHT) ...................

Butylated hydroxyanisole (BHA) ...................

Tocopherols .....................................................

Ascorbyl palmitate ..........................................

Dilauryl thiodipropionate ................................

Antioxidant synergists

Citric acid ........................................................

Sodium citrate .................................................

Isopropyl citrate ..............................................

Phosphoric acid ...............................................

Monoglyceride citrate .....................................

0.02% of fat.

0.02% of fat.

0.02% of fat.

Limit by GMP.

Limit by GMP.

0.02% of fat.

Limit by GMP.

Limit by GMP.

0.02% of food.

Limit by GMP.

200 ppm of fat.

An inert gas may be used to flush air-tight containers before, during, and after filling. Carbon 

dioxide may not be used for this purpose. 

 (c) Anhydrous milkfat. The food product resulting from the removal of practically all of 

the moisture and the solids-not-fat from pasteurized cream or butter. It contains not less than 

99.8 percent fat and not more than 0.1 percent moisture and, when produced from butter, not 

more than 0.1 percent other butter constituents, of which the salt shall be not more than 0.05 

percent. An inert gas may be used to flush air-tight containers before, during, and after filling. 

Carbon dioxide may not be used for this purpose. 

 (d) Frozen cream. Sweet cream which has been pasteurized and frozen. It contains 

approximately 40 percent milkfat. 
42

 (e) Plastic cream. Sweet cream which has been pasteurized and contains approximately 

80 percent milkfat. 

 (f) Whipped butter. The food product is made by the uniform incorporation of air or inert 

gas into butter. 

ROOMS AND COMPARTMENTS 

§ 58.311 Coolers and freezers. 

 The coolers and freezers shall be equipped with facilities for maintaining proper 

temperature and humidity conditions, consistent with good commercial practices for the 

applicable product, to protect the equality and condition of the products during storage or during 

tempering prior to further processing. Coolers and freezers shall be kept clean, orderly, free from 

insects, rodents, and mold, and maintained in good repair. They shall be adequately lighted and 

proper circulation of air shall be maintained at all times. The floors, walls, and ceilings shall be 

of such construction as to permit thorough cleaning. 

§ 58.312 Churn rooms. 

 Churn rooms in addition to proper construction and sanitation shall be so equipped that 

the air is kept free from objectionable odors and vapors and extreme temperatures by means of 

adequate ventilation and exhaust systems or air conditioning and heating facilities. 

§ 58.313 Print and bulk packaging rooms. 

 Rooms used for packaging print or bulk butter and related products should, in addition to 

proper construction and sanitation, provide an atmosphere relatively free from mold (not more 

than 15 colonies per plate during a 15 min. exposure), dust, or other air-borne contamination and 

maintain a reasonable room temperature in accordance with good commercial practices. 

EQUIPMENT AND UTENSILS 

§ 58.314 General construction, repair and installation. 

 All equipment and utensils necessary to the manufacture of butter and related products 

shall meet the same general requirements as outlined in 58.128. In addition for certain other 

equipment, the following requirements shall be met. 

§ 58.315 Continuous churns. 

 All product contact surfaces of the churn and related equipment shall be of noncorrosive 
43

material. All non-metallic product contact surfaces shall comply with 3-A Standards for Plastic, 

Rubber, and Rubber-Like Materials. All product contact surfaces of the churn and related 

equipment shall be readily accessible for cleaning and inspection. Construction shall follow the 

applicable principles of the 3-A Sanitary Standards. 

§ 58.316 Conventional churns. 

 Churns shall be constructed of aluminum, stainless steel or equally corrosion resistant 

metal, free from cracks, and in good repair. All gasket material shall be fat resistant, nontoxic 

and reasonably durable. Seals around the doors shall be tight. 

§ 58.317 Bulk butter trucks, boats, texturizers, and packers. 

 Bulk butter trucks, boats, texturizers, and packers shall be constructed of aluminum, 

stainless steel, or equally corrosion resistant metal free from cracks, seams and must have a 

surface that is relatively smooth and easily cleanable. All non-metallic product surfaces shall 

comply with 3-A Standards for Plastic, Rubber, and Rubber-Like Material. 

§ 58.318 Butter, frozen or plastic cream melting machines. 

 Shavers, shredders or melting machines used for rapid melting of butter, frozen or plastic 

cream shall be of stainless steel or equally corrosion resistant metal, free from cracks and of 

sanitary construction, and readily cleanable. 

§ 58.319 Printing equipment. 

 All printing equipment shall be designed so as to adequately protect the product and be 

readily demountable for cleaning of product contact surfaces. All product contact surfaces shall 

be aluminum, stainless steel or equally corrosion resistant metal, or plastic, rubber and rubber 

like material which comply with 3-A standards, except that conveyors may be constructed of 

material which can be properly cleaned and maintained in a satisfactory manner. 

§ 58.320 Brine tanks. 

 Brine tanks used for the treating of parchment liners shall be constructed of noncorrosive 

material and have an adequate and safe means of heating the salt solution for the treatment of the 

liners. The tank should also be provided with a satisfactory drainage outlet. 

§ 58.321 Cream storage tanks. 

 Cream storage tanks shall meet the requirements of § 58.128(d). Cream storage tanks for 

continuous churns should be equipped with effective temperature controls and recording devices. 
44

QUALITY SPECIFICATIONS FOR RAW MATERIAL 

§ 58.322 Cream. 

 Cream separated at an approved plant and used for the manufacture of butter shall have 

been derived from raw material meeting the requirements as listed under §§ 58.132 through 

58.138 of this subpart. 

§ 58.323 [Reserved] 

§ 58.324 Butteroil. 

 To produce butteroil eligible for official certification, the butter used shall conform to the 

flavor requirements of U.S. Grade AA, U.S. Grade A, or U.S. Grade B, and shall have been 

manufactured in an approved plant. 

§ 58.325 Anhydrous milkfat. 

 Made by a continuous separation process directly from milk or cream. To produce 

anhydrous milkfat eligible for official certification, the cream used shall be comparable to the 

flavor quality specified above for U.S. Grade AA or U.S. Grade A butter. Appearance should be 

fairly smooth and uniform in consistency. The cream shall be pasteurized in accordance with the 

procedure for cream for butter making (§ 58.334a). If butter is used in the production of 

anhydrous milkfat that is eligible for official certification, the butter used shall conform to the 

flavor requirements of U.S. Grade AA or U.S. Grade A butter and shall have been manufactured 

in an approved plant. The appearance of anhydrous milkfat should be fairly smooth and uniform 

in consistency.

§ 58.326 Plastic cream. 

 To produce plastic cream eligible for official certification, the quality of the cream used 

shall meet the requirements of cream acceptable for the manufacture of U.S. Grade AA or U.S. 

Grade A butter. 

§ 58.327 Frozen cream. 

 To produce frozen cream eligible for official certification, the quality of the cream used 

shall meet the requirements of cream acceptable for the manufacture of U.S. Grade AA or U.S. 

Grade A butter. 

§ 58.328 Salt. 

 The salt shall be free-flowing, white refined sodium chloride and shall meet the 
45

requirements of The Food Chemical Codex. 

§ 58.329 Color. 

 Coloring, when used shall be Annatto or any color which is approved by the U.S. Food 

and Drug Administration. 

§ 58.330 Butter starter cultures.

 Harmless bacterial cultures when used in the development of flavor components in butter 

and related products shall have a pleasing and desirable flavor and shall have the ability to 

transmit these qualities to the finished product. 

§ 58.331 Starter distillate. 

 The refined flavor components when used to flavor butter and related products. It shall 

be of food grade quality, free of extraneous material and prepared in accordance with good 

commercial practice. 

OPERATIONS AND OPERATING PROCEDURES 

§ 58.332 Segregation of raw material. 

 The milk and cream received at the dairy plant shall meet the quality specifications as 

indicated under § 58.322. The milk and cream should be segregated by quality and processed 

separately in such a manner that the finished product will fully meet the requirements of a 

particular U.S. Grade or other specification, whichever is applicable. 

§ 58.334 Pasteurization. 

 The milk or cream shall be pasteurized at the plant where the milk or cream is processed 

into the finished product or by procedures as set forth by the Administrator. 

 (a) Cream for butter making. The cream for butter making shall be pasteurized at a 

temperature of not less than 1650F. and held continuously in a vat at such temperature for not 

less than 30 minutes; or pasteurized by HTST method at a minimum temperature of not less than 

1850F. for not less than 15 seconds; or it shall be pasteurized by any other equivalent 

temperature and holding time which will assure adequate pasteurization. Additional heat 

treatment above the minimum pasteurization requirement is advisable to insure improved 

keeping-quality characteristics. 

Adequate pasteurization control shall be used and the diversion valve shall be set to divert at no 

less than 1850

F. with a 15 second holding time or its equivalent in time and temperature to 
46

assure pasteurization. If the vat or holding method of pasteurization is used, vat covers shall be 

closed prior to holding period to assure temperature of air space reaching 50

F. higher than the 

minimum temperature during the holding time. Covers shall also be kept closed during the 

holding and cooling period. 

 (b) Cream for plastic or frozen cream. The pasteurization of cream for plastic or frozen 

cream shall be accomplished in the same manner as in paragraph (a) of this section, except, that 

the temperature for the vat method shall be not less than 1700F. for not less than 30 minutes, or 

not less than 1900

F. for not less than 15 seconds or by any other temperature and holding time 

which will assure adequate pasteurization and comparable keeping-quality characteristics. 

§ 58.335 Quality control tests. 

 All milk, cream and related products are subject to inspection for quality and condition 

throughout each processing operation. Quality control tests shall be made on flow samples as 

often as necessary to check the effectiveness of processing and manufacturing and as an aid in 

correcting deficiencies in processing and manufacturing. Routine analysis shall be made on raw 

materials and finished products to assure adequate microbiological, composition and chemical 

control. 

§ 58.336 Frequency of sampling for quality control of cream, butter and related products. 

 (a) Microbiological. Samples shall be taken from churnings or batches and should be 

taken as often as is necessary to insure microbiological control. 

 (b) Composition. Sampling and testing for product composition shall be made on churns 

or batches as often as is necessary to insure adequate composition control. For in-plant control, 

the Kohman or modified Kohman test may be used. 

 (c) Chemical--(1) Acid degree value. This test should be made on churnings or batches 

from samples taken from the cream as often as is necessary to aid in the control of lipase activity. 

(2) Free fatty acid. This test should be made on churnings or batches from samples taken 

from the butter as often as is necessary to aid in the control of lipase activity. 

 (d) Other analysis. Other chemical analysis or physical measurements shall be performed 

as often as is necessary to insure meeting grade standards and contract specifications. 

 (e) Weight or volume control. Representative samples of the packaged product should be 

checked using procedures prescribed by the Administrator during the packaging operation to 

assure compliance with the stated net weight or volume on the container. 

 (f) Keeping quality and stability. Samples from churnings shall be subjected to a seven 

day keeping quality test at a temperature of 720F. to establish and maintain a satisfactory keeping 

quality history. Optionally 980

F. for 48 hours may be used, however, in case of a dispute, the 
47

results of the seven days at 720F. will prevail. 

§ 58.337 Official test methods. 

 (a) Chemical. Chemical analyses except where otherwise prescribed herein, shall be 

made in accordance with the methods described in the latest edition of Official Methods of 

Analysis of the Association of Official Analytical Chemists, published by the Association of 

Official Analytical Chemists, the Official and Tentative Methods of the American Oil Chemists 

Society or any other methods giving equivalent results. 

 (b) Microbiological. Microbiological determinations shall be made in accordance with 

the methods described or suggested in the latest edition of Standard Methods for the Examination 

of Dairy Products, published by the American Public Health Association. 

§ 58.338 Composition and wholesomeness. 

 All ingredients used in the manufacture of butter and related products shall be subject to 

inspection and shall be wholesome and practically free from impurities. Chlorinating facilities 

shall be provided for butter wash water if needed and all other necessary precautions shall be 

taken to prevent contamination of products. All finished products shall comply with the 

requirements of the Federal Food, Drug and Cosmetic Act, as to composition and 

wholesomeness. 

§ 58.339 Containers.

 (a) Containers used for the packaging of butter and related products shall be 

commercially acceptable containers or packaging material that will satisfactorily protect the 

quality of the contents in regular channels of trade. Caps or covers which extend over the lip of 

the container shall be used on all cups or tubs containing two pounds or less, to protect the 

product from contamination during subsequent handling. 

 (b) Liners and wrappers. Supplies of parchment liners, wrappers and other packaging 

material shall be protected against dust, mold and other possible contamination. 

(1) Prior to use, parchment liners for bulk butter packages shall be completely immersed 

in a boiling salt solution in a suitable container constructed of stainless steel or other equally 

non-corrosive material. The liners shall be maintained in the solution for not less than 

30 minutes. The liners shall be effectively treated with a solution consisting of at least 

15 pounds of salt for every 85 pounds of water and shall be strengthened or changed as 

frequently as necessary to keep the solution full strength and in good condition. 

(2) Other liners such as polyethylene shall be treated or handled in such a manner as to 

prevent contamination of the liner prior to filling. 

 (c) Filling bulk butter containers. The lined butter containers shall be protected from 

possible contamination prior to filling. Use of parchment liners may be accomplished by 
48

alternately inverting one container over the other or stacking the lined boxes on their sides in a 

rack, until ready for use. When using polyethylene liners the boxes should be lined immediately 

prior to use. When packing butter into the bulk containers, care shall be taken to fill the corners 

leaving as few holes or openings as possible. The surface of the butter as well as the covering 

liner shall be smoothed evenly over the top surface before closing and sealing the container. 

Containers should be stacked only as high as the firmness of the product will support weight, so 

as not to crush or distort the container. 

§ 58.340 Printing and packaging. 

 Printing and packaging of consumer size containers of butter shall be conducted under 

sanitary conditions. Separate rooms equipped with automatic filling and packaging equipment 

should be provided. The outside cartons should be removed from bulk butter in a room outside 

of the printing operation but the parchment removal and cutting of the butter may be done in the 

print room. 

§ 58.341 Repackaging. 

 When officially graded or inspected bulk product is to be repackaged into consumer type 

packages for official grade labeling or other official identification, a supervisor of packaging 

shall be required and the plant, equipment, facilities and personnel shall meet the same 

specifications as outlined in this part, including such markings or identification as may be 

required. 

§ 58.342 General identification. 

 Commercial bulk shipping containers shall be legibly marked with the name of the 

product, net weight, name and address of manufacturer, processor or distributor or other assigned 

plant identification (manufacturer’s lot number, churn number, etc.) and any other identification 

that may be required. Packages of plastic or frozen cream shall be marked with the percent of 

milkfat. 

§ 58.343 Storage of finished product in coolers. 

 All products shall be kept under refrigeration at temperatures of 400

F. or lower after 

packaging and until ready for distribution or shipment. The products shall not be placed directly 

on floors or exposed to foreign odors or conditions such as drippage due to condensation which 

might cause package or product damage. 

§ 58.344 Storage of finished product in freezer. 

 (a) Sharp freezers. Plastic cream or frozen cream intended for storage shall be placed in 

quick freezer rooms immediately after packaging, for rapid and complete freezing within 
49

24 hours. The packages shall be piled or spaced in such a manner that air can freely circulate 

between and around the packages. The rooms shall be maintained at 100 F. or lower and shall be 

equipped to provide sufficient high velocity, air circulation for rapid freezing. After the products 

have been completely frozen, they may be transferred to a freezer storage room for continued 

storage. 

 (b) Freezer storage. The room shall be maintained at a temperature of 00

F. or lower. 

Adequate air circulation is desirable. 

Butter intended to be held more than 30 days shall be placed in a freezer room as soon as 

possible after packaging. If not frozen before being placed in the freezer, the packages shall be 

spaced in such a manner as to permit rapid freezing and repiled, if necessary, at a later time. 

REQUIREMENTS FOR FINISHED PRODUCTS BEARING USDA OFFICIAL 

IDENTIFICATION 

§ 58.345 Butter. 

 The quality requirements for butter shall be in accordance with the U.S. Standards for 

Grades of Butter for U.S. Grade AA, U.S. Grade A, or U.S. Grade B, respectively. 

 (a) In addition, the butter is subject to the following specifications when sampled and 

tested in accordance with §§ 58.336 and 58.337. 

 (b) Proteolytic count, not more than 100 per gram; yeast and mold count, not more than 

20 per gram; coliform count, not more than 10 per gram. 

 (c) Optional except when required or requested: Copper content, not more than 0.3 ppm; 

iron content, not more than 1.0 ppm; enterococci, not more than 10 per gram. 

§ 58.346 Whipped butter. 

 (a) The quality requirements for whipped butter shall be in accordance with the U.S. 

Standards for Grades of Whipped Butter for U.S. Grade AA and U.S. Grade A, respectively. 

 (b) Whipped butter shall also be subject to the following specifications when sampled and 

tested in accordance with § 58.336 and § 58.337, respectively: 

(1) Proteolytic count, not more than 50 per gram; yeast and mold count, not more than 10 

per gram; coliform count, not more than 10 per gram; and keeping-quality test, satisfactory after 

7 days at 72° F.

(2) Optional except when required or requested: Copper content, not more than 0.3 ppm; 

iron content, not more than 1.0 ppm; enterococci, not more than 10 per gram. 
50

§ 58.347 Butteroil or anhydrous milkfat. 

 The flavor shall be bland, free from rancid, oxidized or other objectionable flavors. 

 (a) In addition, the finished products shall meet the following specifications when 

sampled and tested in accordance with §§ 58.336 and 58.337: 

Butteroil Anhydrous milkfat

Milkfat ...................................

Moisture ................................

Other butter constituents 

including salt ......................

Salt .........................................

Antioxidants ..........................

Free fatty acids ......................

Peroxide value .......................

Iron content ............................

Copper content ......................

Not less than 99.6 percent ....

Not more than 0.3 percent ....

Not more than 0.1 percent ....

Not more than 0.05 percent ..

Those permitted by standards 

 of the Codex 

 Alimentarious 

Commission and 

authorized for use by the 

Food and Drug 

Administration.

Not more than 0.5 percent 

 (calculated as oleic acid).

Not more than 0.1 

 milliequivalent per 

 kilogram of fat.

Not more than 0.2 ppm .........

Not more than 0.05 ppm .......

Not less than 99.8 percent.

Not more than 0.1 percent.

Not more than 0.1 percent.

Not more than 0.05 percent.

Those permitted by standards 

 of the Codex 

 Alimentarious 

Commission and 

authorized for use by the 

Food and Drug 

Administration.

Not more than 0.3 percent 

 (calculated as oleic acid).

Not more than 0.1 

 milliequivalent per 

 kilogram of fat.

Not more than 0.2 ppm..........

Not more than 0.05 ppm .......

§ 58.348 Plastic cream. 

 The flavor shall be sweet, pleasing and desirable but may possess the following flavors to 

a slight degree; aged, bitter, flat, smothered and storage; and cooked and feed flavors to a definite 

degree. It shall be free from rancid, oxidized or other objectionable flavors. 

 (a) In addition, the finished product shall meet the following specifications when sampled 

and tested in accordance with §§ 58.336 and 58.337. 

 (b) Standard plate count, not more than 30,000 per gram; coliform count, not more than 

10 per gram; yeast and mold, not more than 20 per gram; 
51

 (c) Optional except when required or requested: Copper content not more than 0.3 ppm; 

iron content not more than 1.0 ppm. 

§ 58.349 Frozen cream. 

 The flavor shall be sweet, pleasing and desirable, but may possess the following flavors 

to a slight degree: Aged, bitter, flat, smothered, storage; and cooked and feed flavors to a definite 

degree. It shall be free from rancid, oxidized or other objectionable flavors. 

 (a) In addition, the product shall meet the following specifications when sampled and 

tested in accordance with §§ 58.336 and 58.337. Samples for analysis should be taken prior to 

freezing of the product. 

 (b) Standard plate count, not more than 30,000 per ml.; coliform count, not more than 

10 per ml.; yeast and mold, not more than 20 per ml. 

 (c) Optional except when required or requested: Copper content, not more than 0.3 ppm; 

iron content not more than 1.0 ppm. 

SUPPLEMENTAL SPECIFICATIONS FOR PLANTS MANUFACTURING AND 

PACKAGING CHEESE 

DEFINITIONS 

§ 58.405 Meaning of words. 

 For the purpose of the regulations in this subpart, words in the singular form shall be 

deemed to impart the plural and vice versa as the case may demand. Unless the context 

otherwise requires, the following terms shall have the following meaning: 

 (a) Cheese. The fresh or matured product obtained by draining after coagulation of milk, 

cream, skimmed, or partly skimmed milk or a combination of some or all of these products and 

including any cheese that conforms to the requirements of the Food and Drug Administration for 

cheeses and related cheese products (21 CFR 133). 

 (b) Milkfat from whey. The fat obtained from the separation of cheese whey. 

ROOMS AND COMPARTMENTS 

§ 58.406 Starter facility. 

 A separate starter room or properly designed starter tanks and satisfactory air movement 

techniques shall be provided for the propagation and handling of starter cultures. All necessary 

precaution shall be taken to prevent contamination of the facility, equipment and the air therein. 
52

A filtered air supply with a minimum average efficiency of 90 percent when tested in accordance 

with the ASHRAE Synthetic Dust Arrestance Test should be provided so as to obtain outward 

movement of air from the room to minimize contamination. 

§ 58.407 Make room. 

 The rooms in which the cheese is manufactured shall be of adequate size, and the 

equipment adequately spaced to permit movement around the equipment for proper cleaning and 

satisfactory working conditions. Adequate filtered air ventilation should be provided. When 

applicable, the mold count should be not more than 15 colonies per plate during a 15 minute 

exposure. 

§ 58.408 Brine room. 

 A brine room, when applicable, should be a separate room constructed so it can be readily 

cleanable. The brine room equipment shall be maintained in good repair and corrosion kept at a 

minimum. 

§ 58.409 drying room. 

 When applicable, a drying room of adequate size shall be provided to accommodate the 

maximum production of cheese during the flush period. Adequate shelving and air circulation 

shall be provided for proper drying. Temperature and humidity control facilities should be 

provided which will promote the development of a sound, dry surface of the cheese. 

§ 58.410 Paraffining room. 

 When applicable for rind cheese, a separate room or compartment should be provided for 

paraffining and boxing the cheese. The room shall be of adequate size and the temperature 

maintained near the temperature of the drying room to avoid sweating of the cheese prior to 

paraffining. 

§ 58.411 Rindless cheese wrapping area. 

 For rindless cheese a suitable space shall be provided for proper wrapping and boxing of 

the cheese. The area shall be free from dust, condensation, mold or other conditions which may 

contaminate the surface of the cheese or contribute to unsatisfactory packaging of the cheese. 

§ 58.412 Coolers or curing rooms. 

 Coolers or curing rooms where cheese is held for curing or storage shall be clean and 

maintained at the proper uniform temperature and humidity to adequately protect the cheese, and 
53

minimize the undesirable growth of mold. Proper circulation of air shall be maintained at all 

times. The shelves shall be kept clean and dry. This does not preclude the maintenance of 

suitable conditions for the curing of mold and surface ripened varieties. 

§ 58.413 Cutting and packaging rooms. 

 When small packages of cheese are cut and wrapped, separate rooms shall be provided 

for the cleaning and preparation of the bulk cheese and for the cutting and wrapping operation. 

The rooms shall be well lighted, ventilated and provided with filtered air. Air movement shall be 

outward to minimize the entrance of unfiltered air into the cutting and packaging room. The 

waste materials and waste cheese shall be disposed of in an environmentally and/or sanitary 

approved manner. 

EQUIPMENT AND UTENSILS 

§ 58.414 General construction, repair and installation. 

 All equipment and utensils necessary to the manufacture of cheese and related products 

shall meet the same general requirements as outlined in § 58.128. In addition, for certain other 

equipment the following requirements shall be met. 

§ 58.415 Starter vats. 

 Bulk starter vats shall be of stainless steel or equally corrosion resistant metal and should 

be constructed according to the applicable 3-A Sanitary Standards. New or replacement vats 

shall be constructed according to the applicable 3-A Sanitary Standards. The vats shall be in 

good repair, equipped with tight fitting lids and have adequate temperature controls such as 

valves, indicating and/or recording thermometers. 

§ 58.416 Cheese vats, tanks and drain tables. 

 (a) The vats, tanks and drain tables used for making cheese should be of metal 

construction with adequate jacket capacity for uniform heating. The inner liner shall be 

minimum 16 gauge stainless steel or other equally corrosion resistant metal, properly pitched 

from side to center and from rear to front for adequate drainage. The liner shall be smooth, free 

from excessive dents or creases and shall extend over the edge of the outer jacket. The outer 

jacket shall be constructed of stainless steel or other metal which can be kept clean and sanitary. 

The junction of the liner and outer jackets shall be constructed so as to prevent milk or cheese 

from entering the inner jacket. 

 (b) The vat, tank and/or drain table shall be equipped with a suitable sanitary outlet valve. 

Effective valves shall be provided and properly maintained to control the application of heat to 
54

this equipment. If this equipment is provided with removable cloth covers, they shall be clean. 

§ 58.417 Mechanical agitators. 

 The mechanical agitators shall be of sanitary construction. The carriages shall be of the 

enclosed type and all product contact surfaces, shields, shafts, and hubs shall be constructed of 

stainless steel or other equally corrosion resistant metal. Metal blades, forks, or stirrers shall be 

constructed of stainless steel and of material approved in the 3-A Sanitary Standards for Plastic, 

and Rubber and Rubber-Like Materials and shall be free from rough or sharp edges which might 

scratch the equipment or remove metal particles. 

§ 58.418 Automatic cheese making equipment. 

 (a) Automatic Curd Maker. The automatic curd making system shall be constructed of 

stainless steel or of material approved in the 3-A Sanitary Standards for Plastic, and Rubber and 

Rubber-Like Material. All areas shall be free from cracks and rough surfaces and constructed so 

that they can be easily cleaned. 

 (b) Curd conveying systems. The curd conveying system, conveying lines and cyclone 

separator shall be constructed of stainless steel or other equally corrosion resistant metal and in 

such manner that it can be satisfactorily cleaned. The system shall be of sufficient size to handle 

the volume of curd and be provided with filtered air of the quality satisfactory for the intended 

use. Air compressors or vacuum pumps shall not be located in the processing or packaging 

areas. 

 (c) Automatic salter. The automatic salter shall be constructed of stainless steel or other 

equally corrosion resistant metal. This equipment shall be constructed to equally distribute the 

salt throughout the curd. It shall be designed to accurately weigh the amount of salt added. The 

automatic salter shall be constructed so that it can be satisfactorily cleaned. The salting system 

shall provide for adequate absorption of the salt in the curd. Water and steam used to moisten 

the curd prior to salting shall be potable water or culinary steam. 

 (d) Automatic curd filler. The automatic curd filler shall be constructed of stainless steel 

or other equally corrosion resistant metal. This equipment shall be of sufficient size to handle 

the volume of curd and constructed and controlled so as to accurately weigh the amount of curd 

as it fills. The curd filler shall be constructed so that it can be satisfactorily cleaned. 

 (e) Hoop and barrel washer. The washer shall be constructed so that it can be 

satisfactorily cleaned. It shall also be equipped with temperature and pressure controls to ensure 

satisfactory cleaning of the hoops or barrels. It should be adequately vented to the outside. 
55

§ 58.419 Curd mill and miscellaneous equipment. 

 Knives, hand rakes, shovels, scoops, paddles, strainers, and miscellaneous equipment 

shall be stainless steel or of material approved in the 3-A Sanitary Standards for Plastic and 

Rubber-like Material. The product contact surfaces of the curd mill should be of stainless steel. 

All pieces of equipment shall be so constructed that they can be kept clean and free from rough 

or sharp edges which might scratch the equipment or remove metal particles. The wires in the 

curd knives shall be stainless steel, kept tight and replaced when necessary. 

§ 58.420 Hoops, forms and followers. 

 The hoops, forms, and followers shall be constructed of stainless steel, heavy tinned steel 

or other approved materials. If tinned, they shall be kept tinned and free from rust. All hoops, 

forms, and followers shall be kept in good repair. Drums or other special forms used to press and 

store cheese shall be clean and sanitary. 

§ 58.421 Press. 

 The cheese press should be constructed of stainless steel and all joints welded and all 

surfaces, seams and openings readily cleanable. The pressure device shall be the continuous 

type. Press cloths shall be maintained in good repair and in a sanitary condition. Single service 

press cloths shall be used only once. 

§ 58.422 Brine tank. 

 The brine tank shall be constructed of suitable non-toxic material and should be resistant 

to corrosion, pitting or flaking. The brine tank shall be operated so as to assure the brine is clean, 

well circulated, and of the proper strength and temperature for the variety of cheese being made. 

§ 58.423 Cheese vacuumizing chamber. 

 The vacuum chamber shall be satisfactorily constructed and maintained so that the 

product is not contaminated with rust or flaking paint. An inner liner of stainless steel or other 

corrosion resistant material should be provided. 

§ 58.424 Monorail. 

 The monorail shall be constructed so as to prevent foreign material from falling on the 

cheese or cheese containers. 

§ 58.425 Conveyor for moving and draining block or barrel cheese. 

 The conveyor shall be constructed so that it will not contaminate the cheese and be easily 
56

cleaned. It shall be installed so that the press drippings will not cause an environmental problem. 

§ 58.426 Rindless cheese wrapping equipment. 

 The equipment used to heat seal the wrapper applied to rindless cheese shall have square 

interior corners, reasonably smooth interior surface and have controls that shall provide uniform 

pressure and heat equally to all surfaces. The equipment used to apply shrinkable wrapping 

material to rindless cheese shall operate to maintain the natural intended shape of the cheese in 

an acceptable manner, reasonably smooth surfaces on the cheese and tightly adhere the wrapper 

to the surface of the cheese. 

§ 58.427 Paraffin tanks. 

 The metal tank should be adequate in size, have wood rather than metal racks to support 

the cheese, have heat controls and an indicating thermometer. The cheese wax shall be kept 

clean. 

§ 58.428 Speciality equipment. 

 All product contact areas of speciality equipment shall be constructed of stainless steel or 

of material approved in the 3-A Sanitary Standards for Plastic and Rubber and Rubber-Like 

Material, and constructed following 3-A Sanitary Standards principles. 

§ 58.429 Washing machine. 

 When used, the washing machine for cheese cloths and bandages shall be of commercial 

quality and size; or of sufficient size to handle the applicable load. It should be equipped with 

temperature and water level controls. 

QUALITY SPECIFICATIONS FOR RAW MATERIAL 

§ 58.430 Milk.

 The milk shall be fresh, sweet, pleasing and desirable in flavor and shall meet the 

requirements as outlined under §§ 58.132 through 58.138. The milk may be adjusted by 

separating part of the fat from the milk or by adding one or more of the following dairy products: 

Cream, skim milk, concentrated skim milk, nonfat dry milk, and water in a quantity sufficient to 

reconstitute any concentrated or dry milk used. Such dairy products shall have originated from 

raw milk meeting the same requirements as outlined under §§ 58.132 through 58.138. 

§ 58.431 Hydrogen peroxide. 

 The solution shall comply with the specification of the U.S. Pharmacopeia, except that it 
57

may exceed the concentration specified therein and it does not contain added preservative. 

Application and usage shall be as specified in the “Definitions and Standards of Identity for 

Cheese and Cheese Products,” Food and Drug Administration. 

§ 58.432 Catalase. 

 The catalase preparation shall be a stable, buffered solution, neutral in pH, having a 

potency of not less than 100 Keil units per milliliter. The source of the catalase, its application 

and usage shall be as specified in the “Definitions and Standards of Identity for Cheese and 

Cheese Products,” Food and Drug Administration. 

§ 58.433 Cheese cultures. 

 Harmless microbial cultures used in the development of acid and flavor components in 

cheese shall have a pleasing and desirable taste and odor and shall have the ability to actively 

produce the desired results in the cheese during the manufacturing process. 

§ 58.434 Calcium chloride. 

 Calcium chloride, when used, shall meet the requirements of the Food Chemical Codex. 

§ 58.435 Color. 

 Coloring when used, shall be Annatto or any cheese or butter color which meet the 

requirements of the Food and Drug Administration. 

§ 58.436 Rennet, pepsin, other milk clotting enzymes and flavor enzymes. 

 Enzyme preparations used in the manufacture of cheese shall be safe and suitable. 

§ 58.437 Salt. 

 The salt shall be free-flowing, white refined sodium chloride and shall meet the 

requirements of the Food Chemical Codex. 

OPERATIONS AND OPERATING PROCEDURES 

§ 58.438 Cheese from pasteurized milk. 

 If the cheese is labeled as pasteurized, the milk shall be pasteurized by subjecting every 

particle of milk to a minimum temperature of 1610F. for not less than 15 seconds or by any other 

acceptable combination of temperature and time treatment approved by the Administrator. 
58

HTST pasteurization units shall be equipped with the proper controls and equipment to assure 

pasteurization. If the milk is held more than 2 hours between the time of pasteurization and 

setting, it shall be cooled to 450

F. or lower until time of setting. 

§ 58.439 Cheese from unpasteurized milk. 

 If the cheese is labeled as “heat treated,” “unpasteurized,” “raw milk,” or “for 

manufacturing” the milk may be raw or heated at temperatures below pasteurization. Cheese 

made from unpasteurized milk shall be cured for a period of 60 days at a temperature not less 

than 350F. If the milk is held more than 2 hours between time of receipt or heat treatment and 

setting, it shall be cooled to 450

F. or lower until time of setting. 

§ 58.440 Make schedule. 

 A uniform schedule should be established and followed as closely as possible for the 

various steps of setting, cutting, cooking, draining the whey and milling the curd, to promote a 

uniform quality of cheese. 

§ 58.441 Records. 

 Starter and make records should be kept at least three months. 

(Approved by the Office of Management and Budget under OMB control number 0583 - 0047)1

§ 58.442 Laboratory and quality control tests. 

 (a) Chemical analyses--(1) Milkfat and moisture. One sample shall be tested from each 

vat of the finished cheese to assure compliance with composition requirements. 

(2) Test method. Chemical analysis shall be made in accordance with the methods 

described in Official Methods of Analysis of the Association of Official Analytical Chemists as 

specified in the appropriate standards of identity, the latest edition of Standard Methods or by 

other methods giving equivalent results. 

 (b) Weight or volume control. Representative samples of the finished product shall be 

checked during the packaging operation to assure compliance with the stated net weight on the 

container of consumer size packages. 

§ 58.443 Whey handling. 

 (a) Adequate sanitary facilities shall be provided for the handling of whey. If outside, 

necessary precautions shall be taken to minimize flies, insects and development of objectionable 

 

1

EDITORIAL NOTE: See table appearing in 58.100 for correct OMB control number. 
59

odors. 

 (b) Whey or whey products intended for human food shall at all times be handled in a 

sanitary manner in accordance with the procedures of this subpart as specified for handling milk 

and dairy products. 

 (c) Milkfat from whey should not be more than four days old when shipped. 

§ 58.444 Packaging and repackaging. 

 (a) Packaging rindless cheese or cutting and repackaging all styles of bulk cheese shall be 

conducted under rigid sanitary conditions. The atmosphere of the packaging rooms, the 

equipment and the packaging material shall be practically free from mold and bacterial 

contamination. 

 (b) When officially graded bulk cheese is to be repackaged into consumer type packages 

with official grade labels or other official identification, a supervisor of packaging shall be 

required. If the repackaging is performed in a plant other than the one in which the cheese is 

manufactured and the product is officially identified, the plant, equipment, facilities and 

personnel shall meet the same requirements as outlined in this part. 

§ 58.445 General identification. 

 Bulk cheese for cutting and the container for cheese for manufacturing shall be legibly 

marked with the name of the product, code or date of manufacture, vat number, officially 

designated code number or name and address of manufacturer. Each consumer sized container 

shall meet the applicable regulations of the Food and Drug Administration. 

REQUIREMENTS FOR FINISHED PRODUCTS BEARING USDA OFFICIAL 

IDENTIFICATION 

§ 58.446 Quality requirements. 

 (a) Cheddar cheese. The quality requirements for Cheddar cheese shall be in accordance 

with the U.S. Standards for Grades of Cheddar Cheese. 

 (b) Colby cheese. The quality requirements for Colby cheese shall be in accordance with 

the U.S. Standards for Grades of Colby Cheese. 

 (c) Monterey (Monterey Jack) cheese. The quality requirements for Monterey (Monterey 

Jack) cheese shall be in accordance with the U.S. Standards for Grades of Monterey (Monterey 

Jack) Cheese. 

 (d) Swiss cheese, Emmentaler cheese. The quality requirements for Swiss cheese, 
60

Emmentaler cheese shall be in accordance with the U.S. Standards for Grades for Swiss Cheese, 

Emmentaler Cheese. 

 (e) Bulk American cheese for manufacturing. The quality requirements for bulk 

American cheese for manufacturing shall be in accordance with the U.S. Standards for Grades of 

Bulk American Cheese for Manufacturing. 

SUPPLEMENTAL SPECIFICATIONS FOR PLANTS MANUFACTURING AND 

PACKAGING COTTAGE CHEESE 

DEFINITIONS 

§ 58.505 Meaning of words. 

 For the purpose of the regulations in this subpart, words in the singular form shall be 

deemed to impart the plural and vice versa, as the case may demand. Unless the context 

otherwise requires, the following terms shall have the following meaning: 

 (a) Condensed skim. Skim milk which has been condensed to approximately one-third 

the original volume in accordance with standard commercial practice. 

 (b) Cottage cheese. (1) Cottage cheese dry curd. The soft uncured cheese meeting the 

requirements of the Food and Drug Administration for dry curd cottage cheese (21 CFR 

133.129). 

 (2) Cottage cheese. The soft uncured cheese meeting the requirements of the Food and 

Drug Administration for cottage cheese (21 CFR 133.128). 

(3) Reduced Fat, Light, and Fat Free Cottage Cheese. The products conforming to all 

applicable Federal Regulations including, “Cottage cheese,” Food and Drug Administration (21 

CFR 133.128), “Dry curd cottage cheese,” Food and Drug Administration (21 CFR 133.129), 

“Nutrient content claims for fat, fatty acid, and cholesterol content of foods,” Food and Drug 

Administration (21 CFR 101.62), and “Requirements for foods named by use of a nutrient 

content claim and a standardized term,” Food and Drug Administration (21 CFR 130.10). 

 (c) Direct acidification. The production of cottage cheese, without the use of bacterial 

starter cultures, through the use of approved food grade acids. This product shall be labeled 

according to the requirements of the Food and Drug Administration, 21 CFR 133.128 or 133.129, 

as appropriate. 

 (d) Cottage cheese with fruits, nuts, chives, or other vegetables. Shall consist of cottage 

cheese to which has been added fruits, nuts, chives and other vegetables. The finished cheese 

shall comply with the requirements of the Food and Drug Administration for cottage cheese (21 
61

CFR 133.128). 

 (e) Cream. The milkfat portion of milk which rises to the surface of milk on standing or 

is separated from it by centrifugal force and contains not less than 18.0 percent of milkfat. 

 

(f) Creaming mixture. The creaming mixture in its final form may or may not be 

homogenized and shall conform to the requirements of the Food and Drug Administration (21 

CFR 133.128(b)).

ROOMS AND COMPARTMENTS 

§ 58.510 Rooms and compartments. 

 (a) Processing operations with open cheese vats should be separated from other rooms or 

areas. Excessive personnel traffic or other possible contaminating conditions should be avoided. 

Rooms, compartments, coolers, and dry storage space in which any raw material, packaging or 

ingredients supplies or finished products are handled, processed, packaged or stored shall be 

designed and constructed to assure clean and orderly operations. 

 (b) Ventilation. Processing and packaging rooms or compartments shall be ventilated to 

maintain sanitary conditions, preclude the growth of mold and air borne bacterial contaminants, 

prevent undue condensation of water vapor and minimize or eliminate objectionable odors. To 

minimize air borne contamination in processing and packaging rooms a filtered air supply 

meeting the requirements of § 58.510(c) shall be provided. The incoming air shall exert an 

outward pressure so that the movement of air will be outward and prevent the movement of 

unfiltered air inward. 

 (c) Starter facility. A separate starter room or properly designed starter tanks and 

satisfactory air movement techniques shall be provided for the propagation and handling of 

starter cultures. All necessary precautions shall be taken to prevent contamination of the room, 

equipment and the air therein. A filtered air supply with a minimum average efficiency of 90% 

when tested in accordance with the ASHRAE Synthetic Dust Arrestance Test should be provided 

so as to obtain an outward movement of air from the room to minimize contamination. 

 (d) Coolers. Coolers shall be equipped with facilities for maintaining proper temperature 

and humidity conditions, consistent with good commercial practices for the applicable product, 

to protect the quality and condition of the products. Coolers shall be kept clean, orderly and free 

from mold, and maintained in good repair. They shall be adequately lighted and proper 

circulation of air shall be maintained at all times. The floors, walls, and ceilings shall be of such 

construction as to permit thorough cleaning. 

EQUIPMENT AND UTENSILS 
62

§ 58.511 General construction, repair and installation. 

 The equipment and utensils used for the manufacture and handling of cottage cheese shall 

be as specified in § 58.128. In addition for certain other equipment the following requirements 

shall be met. 

§ 58.512 Cheese vats or tanks. 

 (a) Cheese vats or tanks shall meet the requirements of § 58.416. When direct steam 

injection is used for heating the milk, the vat or tank may be of single shell construction. The 

steam shall be culinary steam. 

 (b) Vats shall be equipped with valves to control the heating and cooling medium and a 

suitable sanitary outlet valve. Vats used for creaming curd should be equipped with a 

refrigerated cooling medium. A circulating pump for the heating and cooling medium is 

recommended. 

§ 58.513 Agitators. 

 Mechanical agitators shall meet the requirements of § 58.417. 

§ 58.514 Container fillers. 

 Shall comply with the 3-A Sanitary Standards for Equipment for Packaging Frozen 

Desserts and Cottage Cheese. 

§ 58.515 Mixers. 

 Only mixers shall be used which will mix the cheese carefully and keep shattering of the 

curd particles to a minimum. They shall be constructed in such a manner as to be readily 

cleanable. If shafts extend through the wall of the tank below the level of the product, they shall 

be equipped with proper seals which are readily removable for cleaning and sanitizing. The 

mixer shall be enclosed or equipped with tight fitting covers. 

§ 58.516 Starter vats. 

 Bulk starter vats shall meet the requirements of § 58.415. 
63

QUALITY SPECIFICATIONS FOR RAW MATERIAL 

§ 58.517 General. 

 Raw materials used for manufacturing cottage cheese shall meet the following quality 

specifications. 

§ 58.518 Milk. 

 The selection of raw milk for cottage cheese shall be in accordance with §§ 58.132 

through 58.138. 

§ 58.519 Dairy products. 

 (a) Raw skim milk. All raw skim milk obtained from a secondary source shall be 

separated from milk meeting the same quality requirements for milk as outlined in § 58.518 

above. Skim milk after being pasteurized and separated shall be cooled to 450 F. or lower unless 

the skim milk is to be set for cheese within two hours after pasteurizing. The skim milk should 

not be more than 48 hours old from the time the milk was received at the plant and the skim milk 

is set for cheese. 

 (b) Nonfat dry milk. Nonfat dry milk, when used, shall be obtained from milk meeting 

the same quality requirements as outlined in § 58.518 above. It shall be processed according to 

the requirements of this Subpart, and should meet the requirements of § 58.236(b)(3). 

 (c) Condensed skim milk. Condensed skim milk, if used, shall be prepared from raw milk 

or skim milk that meets the same quality requirements outlined above for raw milk or skim milk. 

It shall be cooled promptly after drawing from the vacuum pan or evaporator and shall have been 

pasteurized before concentrating or during the manufacture. The standard plate count of the 

concentrated milk shall not exceed 30,000 per ml. at time of use. 

 (d) Cream. Any cream used for preparing the dressing for creamed cottage cheese shall 

be separated from milk meeting at least the same quality requirements as the skim milk used for 

making the curd. The flavor of the cream shall be fresh and sweet. Cream obtained from a 

secondary source shall meet the same requirements. The creaming mixture prepared from this 

cream, after pasteurization, shall have a standard plate count of no more than 30,000 per ml. 

§ 58.520 Nondairy ingredients.

 (a) Calcium chloride. Calcium chloride, when used, shall be of food grade quality and 

free from extraneous material. 
64

 (b) Salt. Salt shall be free flowing, white refined sodium chloride and shall meet the 

requirements of The Food Chemical Codex. 

 (c) Other ingredients. Other ingredients such as fruits, nuts, chives or other vegetables 

used or blended with cottage cheese shall be reasonably free of bacteria so as not to appreciably 

increase the bacterial count of the finished product. The various ingredients in kind shall be 

consistent in size and color so as to produce the desired appearance and appeal of the finished 

product. The flavor of the ingredients used shall be natural and represent the intended flavor and 

intensity desired in the finished product. Such ingredients shall be clean, wholesome, of 

uniformly good quality, free from mold, rancid or decomposed particles. Vegetables used in 

cottage cheese may first be soaked for 15 to 20 minutes in a cold 25 to 50 ppm chlorine solution 

to appreciably reduce the bacterial population. After soaking, the vegetables shall be drained and 

used soon thereafter. 

OPERATIONS AND OPERATING PROCEDURES 

§ 58.521 Pasteurization and product flow. 

 (a) The skim milk used for the manufacture of cottage cheese shall be pasteurized not 

more than 24 hours prior to the time of setting by heating every particle of skim milk to a 

temperature of 1610 F. for not less than 15 seconds or by any other combination of temperature 

and time giving equivalent results. All skim milk must be cooled promptly to setting 

temperature. If held more than two hours between pasteurization and time of setting, the skim 

milk shall be cooled and held at 450F. or lower until set. 

 (b) Cream or cheese dressing shall be pasteurized at not less than 1500F. for not less than 

30 minutes or at not less than 1660F. for not less than 15 seconds or by any other combination of 

temperature and time treatment giving equivalent results. Cream and cheese dressing shall be 

cooled promptly to 400

F. or lower after pasteurization to aid in further cooling of cottage cheese 

curd for improved keeping quality. 

 (c) Reconstituted nonfat dry milk for cottage cheese manufacture need not be 

re-pasteurized provided it is reconstituted within two hours prior to the time of setting using 

water which is free from viable pathogenic or otherwise harmful microorganisms as well as 

microorganisms which may cause spoilage of cottage cheese. Skim milk separated from 

pasteurized whole milk need not be re-pasteurized provided it is separated in equipment from 

which all traces of raw milk from previous operations have been removed by proper cleaning and 

sanitizing. 

§ 58.522 Reconstituting nonfat dry milk. 

 Nonfat dry milk shall be reconstituted in a sanitary manner. 
65

§ 58.523 Laboratory and quality control tests. 

 (a) Quality control tests shall be made on samples as often as necessary to determine the 

shelf-life and stability of the finished product. Routine analyses shall be made on raw materials 

and finished product to assure satisfactory composition, shelf-life and stability. 

 (b) Frequency of sampling--(1) Microbiological. Samples of raw milk for testing shall be 

taken as prescribed in § 58.135. Representative samples shall be taken of finished cottage cheese 

and from each lot or batch of product used as an ingredient. For keeping quality tests 

representative samples shall be taken of finished cottage cheese; 

(2) Chemical--(i) Milkfat and Moisture. Representative samples shall be taken of cottage 

cheese; dry cottage cheese shall be tested for moisture only. 

(ii) pH. Representative samples shall be taken of finished cottage cheese. 

 (c) Test methods--(1) Microbiological. Microbiological determinations shall be made for 

coliform, psychrotrophic and yeasts and molds. These tests shall be made in accordance with the 

methods described in the latest edition of Standard Methods for the Examination of Dairy 

Products, published by the American Public Health Association. 

(2) Chemical. Chemical analysis shall be made in accordance with the methods described 

in the latest edition of Official Methods of Analysis of the Association of Official Analytical 

Chemists, published by the Association of Official Analytical Chemists, the latest edition of 

Standard Methods for the Examination of Dairy Products, or by other methods giving equivalent 

results. 

§ 58.524 Packaging and general identification. 

 (a) Containers. Containers used for packaging cottage cheese shall be any commercially 

acceptable multiple use or single service container or packaging material which will satisfactorily 

protect the contents through the regular channels of trade without significant impairment of 

quality with respect to flavor, or contamination under normal conditions of handling. Caps or 

covers which extend over the lip of the container shall be used on all cups or tubs containing two 

pounds or less, to protect the product from contamination during subsequent handling. 

 (b) Packaging. The cheese shall be packaged in a sanitary manner and automatic filling 

and capping equipment shall be used on all small sizes. The containers shall be checked weighed 

during the filling operation to assure they are filled uniformly to not less than the stated net 

weight on the container. Also care shall be taken that the cottage cheese be of uniform 

consistency at the time of packaging to assure legal composition in all packages. 

 (c) General identification. Bulk packages containing cottage cheese shall be adequately 

and legibly marked with the name of the product, net weight, name and address of the 

manufacturer, lot number, code or date of packaging and any other identification as may be 

required. Consumer size packaged products shall meet the applicable regulations of the Food 
66

and Drug Administration. 

§ 58.525 Storage of finished product. 

 Cottage cheese after packaging shall be promptly stored at a temperature of 450F. or 

lower to maintain quality and condition until loaded for distribution. During distribution and 

storage prior to sale the product should be maintained at a temperature of 450F. or lower. The 

product shall not be exposed to foreign odors or conditions such as drippage or condensation that 

might cause package or product damage. Packaged cottage cheese shall not be placed directly on 

floors. 

REQUIREMENTS FOR COTTAGE CHEESE BEARING USDA OFFICIAL 

IDENTIFICATION 

§ 58.526 Official identification. 

 (a) Only cottage cheese manufactured and packaged in accordance with the requirements 

of this part and with the applicable requirements in subpart A of this part which has been 

officially inspected in process and found to be in compliance with these requirements may be 

identified with the official USDA Quality Approved Inspection Shield. 

 (b) Nonfat dry milk. Nonfat dry milk, when used in cottage cheese bearing official 

identification, shall meet the requirements for U.S. Extra Grade (Spray Process), at time of use, 

and should be of U.S. Low Heat Classification (not less than 6.0 mg. undenatured whey protein 

nitrogen per gram of nonfat dry milk). In addition, the nonfat dry milk shall have a direct 

microscopic count not exceeding 75 million per gram. The age of the nonfat dry milk shall be 

covered by a USDA grading certificate, evidencing compliance with quality requirements, dated 

not more than 6 months prior to use of the dry milk. In the interim between manufacture and use, 

the nonfat dry milk shall be stored in a clean, dry, vermin-free space. In any case, if the nonfat 

dry milk is more than 120 days old, at time of use, it shall be examined for flavor to make certain 

that it meets the requirements for U.S. Extra Grade. 

§ 58.527 Physical requirements. 

 (a) Flavor. The cottage cheese shall possess a mild pleasing flavor, similar to fresh whole 

milk or light cream and may possess the delicate flavor and aroma of a good lactic starter. The 

product may possess to a slight degree a feed, acid, or salty flavor but shall be free from chalky, 

bitter, utensil, fruity, yeasty, or other objectionable flavors. 

 (b) Body and texture. The curd particles shall have a meaty texture, but sufficiently 

tender to permit proper absorption of cream or cheese dressing. The texture shall be smooth and 

velvety and shall not be mealy, crumbly, pasty, sticky, mushy, watery, rubbery or slimy or 

possess any other objectionable characteristics of body and texture. Small curd style (cut with 
67

1

/4 inch knives) should have curd particles approximately 1/4 inch or less in size. Large curd style 

(cut with knives over 1/4 inch) should have curd particles approximately 3

/8 inch or more in size. 

 (c) Color and appearance. The finished cottage cheese, creamed or plain curd, shall have 

an attractive natural color and appearance with curd particles of reasonably uniform size. The 

creamed cottage cheese shall be uniformly mixed with the cream or dressing properly absorbed 

or adhering to the curd so as to prevent excessive drainage. 

§ 58.528 Microbiological requirements.

 Compliance shall be based on 3 out of 5 consecutive samples taken at the time of 

packaging. 

 (a) Coliform. Not more than 10 per gram. 

 (b) Psychrotrophic. No more than 100 per gram. 

 (c) Yeasts and molds. Not more than 10 per gram. 

§ 58.529 Chemical requirements. 

 (a) Moisture. See § 58.505(b). 

 (b) Milkfat. See § 58.505(b). 

 (c) pH. Not higher than 5.2. 

 (d) Phosphatase. Not more than 4 micrograms of phenol equivalent per gram of cheese. 

§ 58.530 Keeping quality requirements. 

 Keeping quality samples taken from the packaging line shall be held at 450

F. for 10 days. 

At the end of the 10 day period the samples shall possess a satisfactory flavor and appearance, 

and shall be free from bitter, sour, fruity, or other objectionable tastes and odors. The surface 

shall not be discolored, translucent, slimy or show any other objectionable condition. 
68

SUPPLEMENTAL SPECIFICATIONS FOR PLANTS MANUFACTURING, PROCESSING 

AND PACKAGING FROZEN DESSERTS 

DEFINITIONS 

§ 58.605 Meaning of words. 

 For the purpose of the regulations in this subpart, words in the singular form shall be 

deemed to impart the plural and vice versa, as the case may demand. Unless the context 

otherwise requires, the following terms shall have the following meaning as applied to frozen 

desserts meeting FDA requirements and briefly defined as follows: 

(a) Ice cream. The product conforming to the requirements of the Food and Drug 

Administration for ice cream (21 CFR 135.110). 

(b) Frozen custard. The product conforming to the requirements of the Food and Drug 

Administration for frozen custard (21 CFR 135.110). 

 (c) Reduced Fat, Light, or Fat free Ice Cream. The products conforming to all 

applicable Federal Regulations including “Ice cream and frozen custard,” Food and Drug 

Administration (21 CFR 135.110), “Nutrient content claims for fat, fatty acid, and cholesterol 

content of foods,” Food and Drug Administration (21 CFR 101.62), and “Requirements for foods 

named by use of a nutrient content claim and a standardized term,” Food and Drug 

Administration (21 CFR 130.10). 

 (d) Sherbet. The product conforming to the requirements of the Food and Drug 

Administration for sherbet (21 CFR 135.140). 

 

 (e) Mellorine. The product conforming to the requirements of the Food and Drug 

Administration for mellorine (21 CFR 135.130). 

 

(f) Overrun. The trade expression used to reference the increase in volume of the frozen 

product over the volume of the mix. This increase in volume is due to air being whipped into the 

product during the freezing process. It is expressed as percent of the volume of the mix. 

 (g) Mix. The trade name for the combined and processed ingredients which after freezing 

become a frozen dessert. 
69

ROOMS AND COMPARTMENTS 

§ 58.619 Mix processing room. 

 The rooms used for combining mix ingredients and processing the mix shall meet the 

applicable requirements for rooms specified in 58.126. The room shall be ventilated to remove 

moisture and prevent condensation from forming on walls and ceiling. The room shall be well 

lighted. 

§ 58.620 Freezing and packaging rooms. 

 The rooms used for freezing and packaging frozen desserts shall be adequate in size to 

permit satisfactory air circulation and maintained in a clean and sanitary condition. The rooms 

shall be constructed in the same manner as prescribed above for mix rooms. 

§ 58.621 Freezing tunnels. 

 Freezing tunnels for quick freezing at extremely low temperatures shall be designed and 

constructed as to insure ease in cleaning and satisfactory conditions of operation. 

§ 58.622 Hardening and storage rooms. 

 Hardening and storage rooms for frozen desserts shall be constructed of satisfactory 

material for this purpose. The rooms shall be maintained in a clean and orderly manner. 

Adequate shelves, bins, or pallets shall be provided to keep the packages of finished products off 

the floor and to prevent damage to the containers. Sufficient refrigeration should be provided to 

insure adequate storage temperature (-100or lower). Air shall be circulated to maintain uniform 

temperature throughout the rooms. A vestibule or double entry way should be provided to 

minimize heat shock of the frozen products. 

EQUIPMENT AND UTENSILS 

§ 58.623 Homogenizer. 

 Homogenizer shall comply with 3-A Sanitary Standards. 

§ 58.624 Freezers. 

 Product contact surfaces of freezers used to lower the temperature of the liquid mix to a 

semi-frozen mass by a stirring action shall be constructed of a stainless steel or equally corrosion 

resistant metal and all parts easily accessible for cleaning and sanitizing. Batch and continuous 

freezers should comply with the applicable 3-A Standards. 
70

§ 58.625 Fruit or syrup feeders. 

 Fruit or syrup feeders inject flavoring material into the semi-frozen product. Product 

contact surfaces shall be constructed of stainless steel or equally corrosion resistant metal and all 

pumps shall be in accordance to 3-A Sanitary Standards for dairy equipment. The feeder shall be 

constructed to enable complete disassembly for cleaning and sanitizing. 

§ 58.626 Packaging equipment. 

 Packaging equipment designed to mechanically fill and close single service containers 

with frozen desserts shall be constructed so that all product contact surfaces shall be of stainless 

steel or equally corrosion-resistant metal. All product contact surfaces shall be easily accessible 

for cleaning. The design and operation of the machine shall in no way contaminate the container 

of the finished product placed therein. New or replacement equipment shall comply with the 3A 

Sanitary Standards for Equipment for Packaging Frozen Desserts and Cottage Cheese. 

QUALITY SPECIFICATIONS FOR RAW MATERIAL 

§ 58.627 Milk and dairy products. 

 To produce ice cream and related products the raw milk and cream shall meet the quality 

requirements as prescribed in §§ 58.132 through 58.138, except that only commingled milk and 

cream meeting the bacteriological requirements of No. 1 shall be used. 

§ 58.628 Sweetening agents. 

 Sweetening agents shall be clean and wholesome and consist of one or more of the 

approved sweeteners listed in § 58.605. 

§ 58.629 Flavoring agents. 

 Flavoring agents either natural or artificial shall be wholesome and free from undesirable 

flavors. They must impart the desired characteristic to the finished product. Flavoring agents 

shall be one or more of those approved in § 58.605. 

§ 58.630 Stabilizers. 

 Stabilizers shall be clean and wholesome and consist of one or more of those approved in 

§ 58.605. 

§ 58.631 Emulsifiers. 

 Emulsifiers shall be clean and wholesome and consist of one or more of those approved 
71

in § 58.605. 

§ 58.632 Acid. 

 Acids used in sherbet shall be wholesome and of food grade quality and consist of one or 

more of those approved in § 58.605. 

§ 58.633 Color. 

 Coloring used for ice cream and related products shall be those certified by the U.S. Food 

and Drug Administration as safe for human consumption. 

OPERATIONS AND OPERATING PROCEDURES 

§ 58.634 Assembling and combining mix ingredients. 

 The assembling and combining of mix ingredients for processing shall be in accordance 

with clean and sanitary methods and shall be consistent with good commercial practices. All raw 

materials shall be subjected to inspection for quality and condition prior to being combined and 

processed into the finished mix. All necessary precautions shall be taken to prevent the 

contamination of any raw material or the finished mix with any foreign substance. 

§ 58.635 Pasteurization of the mix. 

 Every particle of the mix, except added flavoring ingredients, shall be pasteurized at not 

less than 1550 F. and held at that temperature for 30 minutes or for 1750

F. for 25 seconds; or it 

may be pasteurized by any other equivalent temperature and holding time which will assure 

adequate pasteurization. 

§ 58.636 Homogenization. 

 Homogenization of the pasteurized mix shall be accomplished to effectively reduce the 

size of the milkfat globules and evenly disperse them throughout the mix. 

§ 58.637 Cooling the mix. 

 The mix shall be immediately cooled to a temperature of 450

F. or lower, and stored at 

this temperature until further processing begins. 

§ 58.638 Freezing the mix. 

 After the mix enters the freezer, it shall be frozen as rapidly as possible to assure the 

formation of minute crystals. Proper adjustment of rate of flow, refrigerant and air pressure 
72

controls shall be achieved to assure correct overrun and consistency of the product for packaging 

and further freezing. 

§ 58.639 Addition of flavor. 

 The addition of flavoring ingredients to semi-frozen mix just prior to packaging shall be 

performed in a clean and sanitary manner. Care shall be taken to insure the flavor injection 

equipment has been properly cleaned and sanitized prior to use and that the flavor ingredients are 

of good quality and wholesome. 

§ 58.640 Packaging. 

 The packaging of the semifrozen product shall be done by means which will in no way 

contaminate the container or the product. When single service containers and lids are used, they 

shall be of good construction and protect the finished product. Containers used for frozen 

products shall be stored and handled in a sanitary manner so as to protect them from dust and 

bacterial contamination. 

§ 58.641 Hardening and storage. 

 Immediately after the semifrozen product is placed in its intended container it shall be 

placed in a hardening tunnel or hardening room to continue the freezing process. Rapid freezing 

to 00to -150F is desirable to produce a good textured product. 

§ 58.642 Quality control tests. 

 All mix ingredients shall be subject to inspection for quality and condition throughout 

each processing operation. Quality control tests shall be made on flow line samples as often as 

necessary to check the effectiveness of processing and sanitation and as an aid in correcting 

deficiencies. Routine analysis shall be made on raw materials and finished products to assure 

adequate composition, weight or volume control. 

§ 58.643 Frequency of sampling. 

 (a) Microbiological. Representative samples shall be taken from each type of mix, and 

for the finished frozen product one sample from each flavor made. 

 (b) Composition. Representative samples shall be tested for fat and solids-not-fat on each 

type of mix manufactured. Spot checks shall be made on the finished products as often as is 

necessary to assure compliance with composition standards. 

 (c) Weight or volume control. Representative samples of the packaged products shall be 

checked during the packaging operation to assure compliance with the stated volume on the 
73

container as well as weight and overrun requirements. 

§ 58.644 Test methods. 

 (a) Microbiological. Microbiological determinations shall be made in accordance with 

the methods described in the latest edition of Standard Methods for the Examination of Dairy 

Products. 

 (b) Chemical. Chemical analysis shall be made in accordance with the methods described 

in the latest edition of Official Methods of Analysis of the Association of Official Analytical 

Chemists, the latest edition of Standard Methods, or by other methods giving equivalent results. 

§ 58.645 General identification. 

 The various types of frozen desserts shall be packaged and labeled in accordance with the 

applicable regulations of the Food and Drug Administration. 

REQUIREMENTS FOR FINISHED PRODUCTS BEARING USDA OFFICIAL 

IDENTIFICATION 

§ 58.646 Official identification. 

 (a) Only ice cream and related products manufactured and packaged in accordance with 

the requirements of this part and with the applicable requirements in subpart A of this part which 

have been officially inspected in process and found to be in compliance with these requirements 

may be identified with the official USDA Quality Approved Inspection Shield. 

 (b) Dairy products used in the manufacture of frozen desserts for which there are U.S. 

grades established (nonfat dry milk, whole milk, buttermilk and whey) shall be U.S. Extra Grade 

or better, and in the case of unsalted butter, shall be no lower than U.S. Grade A. Dairy products 

for which there are not USDA grade shall meet the applicable requirements of this part which 

permit such product to bear the USDA Quality Approved Inspection Shield. 

§ 58.647 Composition requirements for ice cream. 

 See § 58.605(a). 

§ 58.648 Microbiological requirements for ice cream. 

 The finished product shall contain not more than 50,000 bacteria per gram as determined 

by the standard plate count, and shall contain not more than 10 coliform organisms per gram for 

plain and not more than 20 coliform per gram in chocolate, fruit, nut or other flavors in three out 

of five samples. 
74

§ 58.649 Physical requirements for ice cream. 

 (a) Flavor. The flavor of the finished ice cream shall be pleasing and desirable, and 

characteristic of the fresh milk and cream and the particular flavoring used. 

 (b) Body and texture. The body shall be firm, have substance and readily melt to a 

creamy consistency when exposed to room temperatures; the texture shall be fine, smooth, and 

have the appearance of creaminess throughout. 

 (c) Color. The color shall be attractive, pleasing, uniform and characteristic of the flavor 

represented. 

§ 58.650 Requirements for frozen custard. 

 The same requirements apply as for ice cream except plain frozen custard shall have a 

minimum egg yolk solids content of 1.4 percent, and 1.12 percent when fruits, nuts and other 

such ingredients are used for flavoring. 

§ 58.651 Reserved 

 

§ 58.652 Composition requirements for sherbet. 

 See § 58.605(d). 

§ 58.653 Microbiological requirements for sherbet. 

 The finished product shall contain not more than 50,000 bacteria per gram as determined 

by the standard plate count and shall contain not more than 10 coliform organisms per gram in 

three out of five samples. 

§ 58.654 Physical requirements for sherbet. 

 (a) Flavor. The flavor of the finished sherbet shall be pleasing and desirable and 

characteristic of the particular flavoring used and shall impart a sweet yet tart sensation. 

 (b) Body and texture. The body shall be firm, compact, somewhat chewy and readily 

melt to an even syrupy consistency at room temperatures; the texture shall be smooth but not as 

fine as in ice cream and shall be even throughout. 

 (c) Color. The color shall be attractive, pleasing, uniform and characteristic of the flavor 

represented. 
75

SUPPLEMENTAL SPECIFICATIONS FOR PLANTS MANUFACTURING, PROCESSING 

AND PACKAGING PASTEURIZED PROCESS CHEESE AND RELATED PRODUCTS 

DEFINITIONS 

§ 58.705 Meaning of words. 

 (a) Pasteurized process cheese and related products. Pasteurized process cheese and 

related products are the foods which conform to the applicable requirements of the Food and 

Drug Administration for cheeses and related cheese products (21 CFR 133). 

 (b) Blend set up. The trade term for a particular group of vat lots of cheese selected to 

form a blend based upon their combined ability to impart the desired characteristics to a 

pasteurized process cheese product. 

 (c) Cooker batch. The amount of cheese and added optional ingredients placed into a 

cooker at one time, heated to pasteurization temperature, and held for the required length of time. 

EQUIPMENT AND UTENSILS 

§ 58.706 General construction, repair and installation.

 The equipment and utensils used for the handling and processing of cheese products shall 

be as specified in 58.128 of this subpart. In addition, for certain other equipment the following 

requirements shall be met. 

§ 58.707 Conveyors. 

 Conveyors shall be constructed of material which can be properly cleaned, will not rust, 

or otherwise contaminate the cheese, and shall be maintained in good repair. 

§ 58.708 Grinders or shredders. 

 The grinders or shredders used in the preparation of the trimmed and cleaned cheese shall 

be of corrosion-resistant material, and of such construction as to prevent contamination of the 

cheese and to allow thorough cleaning of all parts and product contact surfaces. 

§ 58.709 Cookers. 

 The cookers shall be the steam jacketed or direct steam type. They shall be constructed of 

stainless steel or other equally corrosion-resistant material. All product contact surfaces shall be 

readily accessible for cleaning. Each cooker shall be equipped with an indicating thermometer, 

and shall be equipped with a temperature recording device. The recording thermometer stem 
76

may be placed in the cooker if satisfactory time charts are obtained, if not, the stem shall be 

placed in the hotwell or filler hopper. Steam check valves on direct steam type cookers shall be 

mounted flush with cooker wall, be constructed of stainless steel and designed to prevent the 

backup of product into the steam line, or the steam line shall be constructed of stainless steel 

pipes and fittings which can be readily cleaned. If direct steam is applied to the product only 

culinary steam shall be used (see 58.127(d)). 

§ 58.710 Fillers.

 A strainer should be installed between the cooker and the filler. The hoppers of all filters 

shall be covered but the cover may have sight ports. If necessary, the hopper may have an 

agitator to prevent buildup on side wall. The filler valves and head shall be kept in good repair 

and capable of accurate measurements. Product contact surfaces shall be of stainless steel or 

other corrosion resistant material. 

QUALITY SPECIFICATIONS FOR RAW MATERIAL 

§ 58.711 Cheddar, colby, washed or soaked curd, granular or stirred curd cheese. 

 Cheese, used in the manufacture of pasteurized process cheese products should possess a 

pleasing and desirable taste and odor consistent with the age of the cheese; should have body and 

texture characteristics which will impart the desired body and texture characteristics in the 

finished product; and should possess finish and appearance characteristics which will permit 

removal of all packaging material and surface defects. The cheese should at least meet the 

requirements equivalent to U.S. Standard Grade for Bulk American Cheese for Manufacturing 

provided the quantity of the cheese with any one defect as listed for U.S. Standard Grade is 

limited to assure a satisfactory finished product. 

§ 58.712 Swiss. 

 Swiss cheese used in the manufacture of pasteurized process cheese and related products 

should be equivalent to U.S. Grade B or better, except that the cheese may be blind or possess 

finish characteristics which do not impair the interior quality. 

§ 58.713 Gruyere. 

 Gruyere cheese used in the manufacture of process cheese and related products should be 

of good wholesome quality and except for smaller eyes and sharper flavor shall meet the same 

requirements as for Swiss cheese. 

§ 58.714 Cream cheese, Neufchatel cheese. 

 These cheeses when mixed with other foods, or used for spreads and dips should possess 
77

a fresh, pleasing and desirable flavor. 

§ 58.715 Cream, plastic cream and anhydrous milkfat. 

 These food products shall be pasteurized, sweet, have a pleasing and desirable flavor and 

be free from objectionable flavors, and shall be obtained from milk which complies with the 

quality requirements as specified in 58.132 through 58.138 of this subpart. 

§ 58.716 Nonfat dry milk. 

 Nonfat dry milk used in cheese products should meet the requirements equivalent to U.S. 

Extra Grade except that the moisture content may be in excess of that specified for the particular 

grade. 

§ 58.717 Whey. 

 Whey used in cheese products should meet the requirements equivalent to USDA Extra 

Grade except that the moisture requirement for dry whey may be waived. 

§ 58.718 Flavor ingredients. 

 Flavor ingredients used in process cheese and related products shall be those permitted by 

the Food and Drug Standards of Identity, and in no way deleterious to the quality or flavor of the 

finished product. In the case of bulky flavoring ingredients such as pimento, the particles should 

be, to at least a reasonable degree, uniform in size, shape and consistency. The individual types 

of flavoring materials should be uniform in color and should impart the characteristic flavor 

desired in the finished product. 

§ 58.719 Coloring. 

 Coloring shall be Annatto or any other cheese or butter color which is approved by the 

Food and Drug Administration. 

§ 58.720 Acidifying agents. 

 Acidifying agents if used shall be those permitted by the Food and Drug Administration 

for the specific pasteurized process cheese product. 

§ 58.721 Salt. 

 Salt shall be free flowing, white refined sodium chloride and shall meet the requirements 

of The Food Chemical Codex. 
78

§ 58.722 Emulsifying agents. 

 Emulsifying agents shall be those permitted by the Food and Drug Administration for the 

specific pasteurized process cheese product, and shall be free from extraneous material. 

OPERATIONS AND OPERATING PROCEDURES 

§ 58.723 Basis for selecting cheese for processing. 

 A representative sample shall have been examined to determine fat and moisture content. 

One sample unit from each vat of cheese shall have been examined to determine the suitability of 

the vat for use in process cheese products in accordance with the flavor, body and texture 

characteristics permitted in §§ 58.711 through 58.714 as applicable, and to determine the 

characteristics it will contribute to the finished product when blended with other cheese. The 

cheese included in each blend shall be selected on the basis of the desirable qualities which will 

result in the desired finished product. Recook from equivalent blends may be used in an amount 

that will not adversely affect the finished product. Hot cheese from the filler may be added to the 

cooker in amounts which will not adversely affect the finished product. 

§ 58.724 Blending. 

 To as great an extent as is practical, each vat of cheese should be divided and distributed 

throughout numerous cooker batches. The purpose being to minimize the preponderance and 

consequent influence of any one vat on the characteristics of the finished product, and to promote 

as much uniformity as is practical. In blending also consider the final composition requirements 

for fat and moisture. Quantities of salt, color, emulsifier and other allowable ingredients to be 

added shall be calculated and predetermined for each cooker batch. 

§58.725 Trimming and cleaning. 

 The natural cheese shall be cleaned free of all non-edible portions. Paraffin and bandages 

as well as rind surface, mold or unclean areas or any other part which is unwholesome or 

unappetizing shall be removed. 

§ 58.726 Cutting and grinding. 

 The trimmed and cleaned cheese should be cut into sections of convenient size to be 

handled by the grinder or shredder. The grinding and mixing of the blended lots of cheese should 

be done in such a manner as to insure a homogeneous mixture throughout the batch. 
79

§ 58.727 Adding optional ingredients. 

 As each batch is added to the cooker, the predetermined amounts of salt, emulsifiers, 

color, or other allowable optional ingredients shall be added. However, a special blending vat 

may be used to mix the ground cheese and other ingredients before they enter the cooker to 

provide composition control. 

§ 58.728 Cooking the batch. 

 Each batch of cheese within the cooker, including the optional ingredients, shall be 

thoroughly commingled and the contents pasteurized at a temperature of at least 1580 F. and held 

at that temperature for not less than 30 seconds or any other equally effective combination of 

time and temperature approved by the Administrator. Care shall be taken to prevent the entrance 

of cheese particles or ingredients after the cooker batch of cheese has reached the final heating 

temperature. After holding for the required period of time, the hot cheese shall be emptied from 

the cooker as quickly as possible. 

§ 58.729 Forming containers. 

 Containers either lined or unlined shall be assembled and stored in a sanitary manner to 

prevent contamination. The handling of containers by filler crews should be done with extreme 

care and observance of personal cleanliness. Preforming and assembling of pouch liners and 

containers shall be kept to a minimum and the supply rotated to limit the length of time exposed 

to possible contamination prior to filling. 

§ 58.730 Filling containers. 

 Hot fluid cheese from the cookers may be held in hotwells or hoppers to assure a constant 

and even supply of processed cheese to the filler or slice former. Filler valves shall effectively 

measure the desired amount of product into the pouch or container in a sanitary manner and shall 

cut off sharply without drip or drag of cheese across the opening. An effective system shall be 

used to maintain accurate and precise weight control. Damaged or unsatisfactory packages shall 

be removed from production, and the cheese may be salvaged into sanitary containers, and added 

back to cookers. 

§ 58.731 Closing and sealing containers. 

 Pouches, liners, or containers having product contact surfaces, after filling shall be folded 

or closed and sealed in a sanitary manner, preferably by mechanical means, so as to assure 

against contamination. Each container in addition to other required labeling shall be coded in 

such a manner as to be easily identified as to date of manufacture by lot or sublot number. 
80

§ 58.732 Cooling the packaged cheese. 

 After the containers are filled they shall be stacked, or cased and stacked in such a 

manner as to prevent breaking of seals due to excessive bulging and to allow immediate 

progressive cooling of the individual containers of cheese. As a minimum the cheese should be 

cooled to a temperature of 1000 F. or lower within 24 hours after filling. The temperature of the 

cheese should be reduced further, before being shipped or if storage is intended. 

§ 58.733 Quality control tests. 

 (a) Chemical analyses. The following chemical analyses shall be performed in 

accordance with the appropriate edition of the Official Methods of Analysis of the AOAC as 

specified in the appropriate Standards of Identity or in accordance with methods that give 

equivalent results. 

(1) Cheese. A representative sample of cheese used in the manufacture of pasteurized 

process cheese products shall have been tested prior to usage to determine its moisture and fat 

content. 

(2) Pasteurized process cheese products. As many samples shall be taken of the finished 

product direct from the cooker, hopper, filler, or other location as is necessary to assure 

compliance with composition requirements. Spot checks should be made on samples from the 

cooker as frequently as is necessary to indicate pasteurization by means of the phosphatase test, 

as well as any other tests necessary to assure good quality control. 

 (b) Examination of physical characteristics. As many samples shall be taken as is 

necessary to assure meeting the required physical characteristics of the products. Representative 

samples shall be taken from production for examination of physical characteristics. The samples 

shall be examined at approximately 700F. the first day of operation after the date of processing 

for the following characteristics: (1) Finish and appearance, (2) flavor, (3) color, (4) body and 

texture, and (5) slicing or spreading properties. 

 (c) Keeping quality. During processing or preferably from the cooled stock select 

sufficient samples at random from the production run. The samples should be stored at 

approximately 500F. for 3 months for evaluation of physical characteristics as in paragraph (b) of 

this section. Additional samples may be selected and held at different temperatures or time. 

 (d) Weight control. During the filling operation as many samples shall be randomly 

selected and weighed from each production run as is necessary to assure accuracy of the net 

weight established for the finished products. 
81

REQUIREMENTS FOR PROCESSED CHEESE PRODUCTS BEARING USDA OFFICIAL 

IDENTIFICATION 

§ 58.734 Official identification. 

 Only process cheese products manufactured and packaged in accordance with the 

requirements of this part and with the applicable requirements in subpart A of this part which 

have been officially inspected in process and found to be in compliance with these requirements 

may be identified with official USDA Quality Approved Inspection Shield. 

§ 58.735 Quality specifications for raw materials. 

 (a) Cheddar colby, washed or soaked curd, granular or stirred curd cheese. Cheese, 

used in the manufacture of pasteurized process cheese products which are identified with the 

USDA official identification shall possess a pleasing and desirable taste and odor consistent with 

the age of the cheese; shall have body and texture characteristics which will impart the desired 

body and texture characteristics in the finished product; and shall possess finish and appearance 

characteristics which will permit removal of all packaging material and surface defects. The 

cheese shall at least meet the requirements of U.S. Standard Grade for Bulk American Cheese for 

Manufacturing provided the quantity of the cheese with any one defect as listed for U.S. Standard 

Grade is limited, to assure compliance with the specifications of the finished product. 

 (b) Swiss. Swiss cheese used in the manufacture of pasteurized process cheese and 

related products bearing official identification shall be U.S. Grade B or better, except that the 

cheese may be blind or possess finish characteristics which do not impair the interior quality. 

 (c) Gruyere. Gruyere cheese used in the manufacture of process cheese and related 

products shall be of good wholesome quality and except for smaller eyes and sharper flavor shall 

meet the same requirements as for Swiss cheese. 

 (d) Cream cheese, Neufchatel cheese. Mixed with other foods, or used for spreads and 

dips shall possess a fresh, pleasing and desirable flavor. 

 (e) Cream, plastic cream and anhydrous milkfat. These food products shall be 

pasteurized, sweet, have a pleasing and desirable flavor and be free from objectionable flavors, 

and shall be obtained from milk which complies with the quality requirements as specified in 

58.132 of this subpart. 

 (f) Nonfat dry milk. Nonfat dry milk used in officially identified cheese products shall 

meet the requirements of U.S. Extra Grade except that the moisture content may be in excess of 

that specified for the particular grade. 
82

 (g) Whey. Condensed or dry whey used in officially identified cheese products shall meet 

the requirements for USDA Extra Grade except that the moisture requirement for dry whey may 

be waived. 

 (h) Flavor ingredients. Flavor ingredients used in process cheese and related products 

shall be those permitted by the Food and Drug Standards of Identity, and in no way deleterious to 

the quality or flavor of the finished product. In the case of bulky flavoring ingredients such as 

pimento, the particles shall be, to at least a reasonable degree, uniform in size, shape and 

consistency. The individual types of flavoring materials shall be uniform in color and shall 

impart the characteristic flavor desired in the finished product. 

 (i) Other ingredients. For coloring, acidifying agents, salt, and emulsifying agents see 

§§ 58.719, 58.720, 58.721 and 58.722. 

QUALITY SPECIFICATIONS FOR FINISHED PRODUCTS 

§ 58.736 Pasteurized process cheese. 

Shall conform to the provisions of the Definitions and Standards of Identity for 

Pasteurized Process Cheese and Related Products, Food and Drug Administration. The average 

age of the cheese in the blend shall be such that the desired flavor, body and texture will be 

achieved in the finished product. The quality of pasteurized process cheese shall be determined 

on the basis of flavor, body and texture, color, and finish and appearance. 

(a) Flavor. Has a pleasing and desirable mild cheese taste and odor characteristic of the 

variety or varieties of cheese ingredients used. If additional optional ingredients are used they 

shall be incorporated in accordance with good commercial practices and the flavor imparted shall 

be pleasing and desirable. May have a slight cooked or very slight acid or emulsifier flavor; is 

free from any undesirable tastes and odors. 

(b) Body and texture. Shall have a medium-firm, smooth and velvety body free from 

uncooked cheese particles. Is resilient and not tough, brittle, short, weak, or sticky. It shall be 

free from pin holes or openings except those caused by trapped steam. The cheese shall slice 

freely, and shall not stick to the knife or break when cut into approximately 1/8 inch slices. If in 

sliced form, the slices shall separate readily. 

(c) Color. May be colored or uncolored but shall be uniform throughout. If colored it 

shall be bright and not be dull or faded. To promote uniformity and a common reference to 

describe color use the color designations as depicted by the National Cheese Institute standard 

color guide for cheese. 

(d) Finish and appearance. The wrapper may be slightly wrinkled but shall envelop the 
83

cheese, adhere closely to the surface, and be completely sealed and not broken or soiled. 

§ 58.737 Pasteurized process cheese food.

Shall conform to the provisions of the Definitions and Standards of Identity for 

Pasteurized Process Cheese Food and Related Products, Food and Drug Administration. The 

average age of the cheese in the blend shall be such that the desired flavor, body and texture will 

be achieved in the finished product. The quality of pasteurized process cheese food shall be 

determined on the basis of flavor, body and texture, color, and finish and appearance. 

(a) Flavor. Has a pleasing and desirable mild cheese taste and odor characteristic of the 

variety or varieties of cheese ingredients used. If additional optional ingredients are used they 

shall be incorporated in accordance with good commercial practices and the flavor imparted shall 

be pleasing and desirable. May have a slight cooked or very slight acid or emulsifier flavors; is 

free from any undesirable tastes and odors. 

(b) Body and texture. Shall have a medium-firm, smooth and velvety body free from 

uncooked cheese particles. Is resilient and not tough, brittle, short, weak, or sticky. It shall be 

free from pin holes or openings except those caused by trapped steam. The product shall slice 

freely with only a slight amount of sticking and shall not break when cut into approximately 1/8

inch slices. If in sliced form, the slices shall separate readily. 

(c) Color. May be colored or uncolored but shall be uniform throughout. If colored it 

shall be bright and not be dull or faded. To promote uniformity and a common reference to 

describe color use the color designations as depicted by the National Cheese Institute standard 

color guide for cheese. 

(d) Finish and appearance. The wrapper may be slightly wrinkled but shall envelop the 

cheese, adhere closely to the surface, and be completely sealed and not broken or soiled. 

§ 58.738 Pasteurized process cheese spread and related products.

Shall conform to the applicable provisions of the Definitions and Standards of Identity for 

Pasteurized Process Cheese Spreads, Food and Drug Administration. The pH of pasteurized 

process cheese spreads shall not be below 4.0. 

The quality of pasteurized process cheese spreads shall be determined on the basis of flavor, 

body and texture, color, and finish and appearance. 

(a) Flavor. Has a pleasing and desirable cheese taste and odor characteristic of the 

variety or varieties of cheese ingredients used. If additional optional ingredients are used they 

shall be incorporated in accordance with good commercial practices and the flavor imparted shall 

be pleasing and desirable. May have a slight cooked, acid, or emulsifier flavor; is free from any 
84

undesirable tastes and odors. 

(b) Body and texture. Shall have a smooth body free from uncooked cheese particles and 

when packaged shall form into a homogeneous plastic mass, and be free from pin holes or 

openings except those caused by trapped steam. Product made for slicing shall slice freely when 

cut into approximately 1/8 inch slices with only a slight amount of sticking. Product made for 

spreading shall be spreadable at approximately 700

F.

(c) Color. May be colored or uncolored but shall be uniform throughout. If colored it 

shall be bright and not be dull or faded. To promote uniformity and a common reference to 

describe color the color designations as depicted by the National Cheese Institute standard color 

guide for cheese may be used. 

(d) Finish and appearance. Wrappers, if used, may be slightly wrinkled but shall envelop 

the cheese, adhere closely to the surface, and be completely filled, sealed and not broken or 

soiled. 

 SUPPLEMENTAL SPECIFICATIONS FOR PLANTS MANUFACTURING, PROCESSING, 

AND PACKAGING WHEY, WHEY PRODUCTS AND LACTOSE 

DEFINITIONS 

§ 58.805 Meaning of words.

For the purpose of the regulations in this subpart, words in the singular form shall be 

deemed to impart the plural and vice versa, as the case may demand. Unless the context 

otherwise requires, the following terms shall have the following meaning: 

(a) Whey. “Whey” is the fluid obtained by separating the coagulum from milk, cream, 

and/or skim milk in cheesemaking. The acidity of the whey may be adjusted by the addition of 

safe and suitable pH adjusting ingredients. Moisture removed from cheese curd as a result of 

salting may be collected for further processing as whey if the collection of the moisture and the 

removal of the salt from the moisture are conducted in accordance with procedures approved by 

the Administrator. 

(b) Dry Whey. “Dry Whey” is the product resulting from drying fresh whey which has 

been pasteurized and to which nothing has been added as a preservative. It contains all 

constituents, except moisture, in the same relative proportions as in the whey. 
85

(c) Dry Sweet Whey. Dry whey not over 0.16 percent titratable acidity on a reconstituted 

basis. 

(d) Dry Whey---% Titratable Acidity. Dry whey over 0.16 percent, but below 0.35 

percent titratable acidity on a reconstituted basis. The blank being filled with the actual acidity. 

(e) Dry Acid Whey. Dry whey with 0.35 percent or higher titratable acidity on a 

reconstituted basis. 

(f) Modified Whey Products: 

(1) Partially demineralized whey, 

(2) Partially delactosed whey, 

(3) Demineralized whey, and 

(4) Whey protein concentrate-products defined by regulations of the Food and Drug 

Administration. 

(g) Lactose (milk sugar). That food product defined by regulations of the Food and Drug 

Administration. 

ROOMS AND COMPARTMENTS 

§ 58.806 General.

Dry storage of product, packaging room for bulk product, and hopper or dump room shall 

meet the requirements of §§ 58.210 through 58.212 as applicable. 

EQUIPMENT AND UTENSILS 

§ 58.807 General construction, repair and installation.

All equipment and utensils necessary for the manufacture of whey, whey products and 

lactose shall meet the same general requirements for materials and constructions as outlined in 

§§ 58.128 and 58.215 through 58.230 as applicable, except for the following: 

(a) Modified Whey Products. Equipment for whey fractionation, such as ultrafiltration, 

reverse osmosis, gel filtration, and electrodialysis shall be constructed in accordance with 3-A 

sanitary design principles, except where engineering requirements preclude strict adherence to 

such standards. Materials used for product contact surfaces shall meet applicable 3-A Sanitary 

Standards or Food and Drug Administration requirements. All equipment shall be of sanitary 

construction and readily cleanable. 

(b) Lactose. Equipment used in the further processing of lactose following its separation 

from whey shall have smooth surfaces, be cleanable, free from cracks or crevices, readily 
86

accessible for inspection and shall be constructed of non-toxic material meeting applicable Food 

and Drug Administration requirements and under conditions of use shall be resistant to corrosion, 

pitting or flaking. [The use of stainless steel is optional]. 

QUALITY SPECIFICATIONS FOR RAW MATERIALS 

§ 58.808 Whey.

Whey for processing shall be fresh and originate from the processing of products made 

from milk meeting the requirements as outlined in §§ 58.132 through 58.138. Only those 

ingredients approved by the Food and Drug Administration may be added to the whey for 

processing, except when restricted by this subpart. Whey products to which approved 

ingredients have been added or constituents removed to alter original characteristics for 

processing or usage shall be labeled to meet the applicable requirements. 

OPERATIONS AND OPERATING PROCEDURES 

§ 58.809 Pasteurization. 

(a) All fluid whey used in the manufacture of dry whey, dry whey products, modified 

whey products, and lactose shall be pasteurized prior to condensing. When the condensing and 

drying operations for dry whey take place at the same plant, the pasteurization may be located at 

a different point in the operation provided it will protect the quality of the finished product and 

not adversely affect the processing procedure. 

(b) Pasteurized products transported to another plant for final processing shall be 

repasteurized, except that condensed whey containing 40 percent or more solids may be 

transported to another plant for further processing into dry whey, dry whey products or lactose 

without repasteurization. 

(c) If whey is transferred to another plant for further processing, or if during the 

processing procedure unpasteurized ingredients are added (except those necessary for lactose 

crystallization), or processing procedures permit contamination or bacterial growth, the whey 

shall be repasteurized as close to the final drying operations as possible. 

§ 58.810 Temperature requirements. 

(a) Unless processed within 2 hours, all whey or condensed whey, except acid type whey 

with a titratable acidity of 0.40 percent or above, or a pH of 4.6 or below, shall be cooled to 450 F 

or less, or heated to 1450 F or higher. Other temperatures may be used when essential for the 

technology of the process, such as lactose crystallizations and membrane whey separation 

processes, when the quality and wholesomeness of the product is not impaired. 
87

(b) Recording thermometers shall be required and so located to assure that the cooling or 

heating requirements in paragraph (a) of this section are met. 

§ 58.811 General.

The operating procedures as contained in §§ 58.237 through 58.244, 58.246, 58.247, and 

58.443(a) and (b) shall be followed as applicable. 

§ 58.812 Methods of sample analysis.

Samples shall be tested according to the applicable methods of laboratory analysis 

contained in either DA Instruction 918-RL, as issued by the USDA, Agricultural Marketing 

Service, Dairy Programs, or the Official Methods of Analysis of the Association of Official 

Analytical Chemists, or Standard Methods for the Examination of Dairy Products. 

REQUIREMENTS FOR FINISHED PRODUCTS BEARING USDA OFFICIAL 

IDENTIFICATION 

§ 58.813 Dry Whey.

The quality requirements for dry whey shall be in accordance with the U.S. Standards for 

Dry Whey. 

SUPPLEMENTAL SPECIFICATIONS FOR PLANTS MANUFACTURING, PROCESSING, 

AND PACKAGING EVAPORATED AND CONDENSED MILK OR ULTRA PASTEURIZED 

PRODUCTS 

DEFINITIONS 

§ 58.905 Meaning of words.

For the purpose of the regulations in this subpart, words in the singular form shall be 

deemed to impart the plural and vice versa as the case may demand. Unless the context 

otherwise requires, the following terms shall have the following meaning: 

(a) Evaporated milk. The liquid food made by evaporating sweet milk to such point that 

it contains not less than 6.5 percent of milkfat and not less than 16.5 percent of the total milk 

solids. The finished product shall conform to the requirements of the Food and Drug 

Administration for evaporated milk (21 CFR 131.130). 

(b) Concentrated milk, plain condensed milk. The product which conforms to the 

standard of identity for evaporated milk except that it is not processed by heat to prevent 

spoilage. The container may be unsealed, and stabilizing ingredients are not used. The finished 
88

product shall conform to the requirements of the Food and Drug Administration for concentrated 

milk (21 CFR 131.115). 

(c) Sweetened condensed milk. The liquid or semi-liquid food made by evaporating a 

mixture of sweet milk and refined sugar (sucrose) or any combination of refined sugar (sucrose) 

and refined corn sugar (dextrose) to such point that the finished sweetened condensed milk 

contains not less than 28.0 percent of total milk solids and not less than 8.0 percent of milkfat. 

The quantity of sugar used is sufficient to prevent spoilage. The finished product shall conform 

to the requirements of the Food and Drug Administration for sweetened condensed milk (21 CFR 

131.120). 

(d) Ultra-pasteurized. The product shall have been thermally processed at or above 

2800 F for at least 2 seconds, either before or after packaging, so as to produce a product which 

has an extended shelf life under refrigerated conditions. 

EQUIPMENT AND UTENSILS 

§ 58.912 General construction, repair and installation.

The equipment and utensils used for processing and packaging evaporated, condensed or 

ultra pasteurized dairy products shall be as specified in 58.128. In addition for certain other 

equipment, the following requirements shall be met. 

§ 58.913 Evaporators and vacuum pans. 

All equipment used in the removal of moisture from milk or milk products for the 

purpose of concentrating the solids should comply with the requirements of the 3-A Sanitary 

Standards for Milk and Milk Products Evaporators and Vacuum Pans. 

§ 58.914 Fillers.

Both gravity and vacuum type fillers shall be of sanitary design and all product contact 

surfaces, if metal, shall be made of stainless steel or equally corrosion-resistant material; except 

that, certain evaporated milk fillers having brass parts may be approved if free from corroded 

surfaces and kept in good repair. Nonmetallic product contact surfaces shall comply with the 

requirements for 3-A Sanitary Standards for Plastic, and Rubber and Rubber-Like Materials. 

Fillers shall be designed so that they in no way will contaminate or detract from the quality of the 

product being packaged. 

§ 58.915 Batch or continuous in-container thermal processing equipment.

Batch or continuous in-container thermal processing equipment shall meet the 

requirements of the Food and Drug Administration for thermally processed low-acid foods 

packaged in hermetically sealed containers (21 CFR part 113). The equipment shall be 

maintained in such a manner as to assure control of the length of processing and to minimize the 
89

number of damaged containers. 

§ 58.916 Homogenizer.

Homogenizers where applicable shall be used to reduce the size of the fat particles and to 

evenly disperse them in the product. Homogenizers shall comply with the applicable 3-A 

Sanitary Standards. 

OPERATIONS AND OPERATING PROCEDURES 

§ 58.917 General.

There are many operations and procedures used in the preparation of evaporated, 

condensed and ultra pasteurized dairy products that are similar, therefore, the following general 

requirements will apply when such operations or procedures are used. 

§ 58.918 Standardization.

The standardization of the product to obtain a finished product of a given composition 

shall be accomplished by the addition or removal of milkfat, milk solids-not-fat and/or water. 

The ingredients added to accomplish the desired composition shall be of the same hygenic 

quality as the product being standardized. 

§ 58.919 Pre-heat, pasteurization.

When pasteurization is intended or required by either the vat method, HTST method, or 

by the HHST method it shall be accomplished by systems and equipment meeting the 

requirements outlined in 58.128. Pre-heat temperatures prior to ultra pasteurization will be 

those that have the most favorable effect on the finished product. 

§ 58.920 Homogenization.

Where applicable concentrated products shall be homogenized for the purpose of 

dispersing the fat throughout the product. The temperature of the product at time of 

homogenization and the pressure at which homogenization is accomplished will be that which 

accomplishes the most desired results in the finished products. 

§ 58.921 Concentration.

Concentrating by evaporation shall be accomplished with a minimum of chemical change 

in the product. The equipment and systems used shall in no way contaminate or adversely affect 

the desirability of the finished product. 
90

§ 58.922 Thermal processing.

The destruction of living organisms shall be performed in one of the following methods. 

(a) The complete in-container method, by heating the container and contents to a range of 2120 F 

to 2800 F for a sufficient time; (b) by a continuous flow process at or above 2800F for at least 

2 seconds, then packaged aseptically; (c) the product is first processed according to methods as in 

paragraph (b) of this section, then packaged and given further heat treatment to complete the 

process. 

§ 58.923 Filling containers.

(a) The filling of small containers with product shall be done in a sanitary manner. The 

containers shall not contaminate or detract from the quality of the product in any way. After 

filling, the container shall be hermetically sealed. 

(b) Bulk containers for the product shall be suitable and adequate to protect the product 

in storage or transit. The bulk container (including bulk tankers) shall be cleaned and sanitized 

before filling, and filled and closed in a sanitary manner. 

§ 58.924 Aseptic filling.

A previously ultra pasteurized product shall be filled under conditions which prevent 

contamination of the product by living organisms or spores. The containers prior to being filled 

shall be sterilized and maintained, in a sterile condition. The containers shall be sealed in a 

manner that prevents contamination of the product. 

§ 58.925 Sweetened condensed.

After condensing, the sweetened condensed product should be cooled rapidly to about 

850 F to induce crystallization of the oversaturated lactose. When the desired crystallization is 

reached further cooling is resumed to 680-700 F.

§ 58.926 Heat stability. 

Prior to thermal processing of concentrated products and where stabilizers are allowed, 

tests should be made on the heat stability of the product to determine necessity for, and the 

amount of stabilizer needed. Based on the stability tests, safe and suitable stabilizers and 

emulsifiers may be added. 

§ 58.927 Storage.

Finished products which are to be held more than 30 days should be stored at 

temperatures below 720 F. Precautions shall be taken to prevent freezing of the product. 
91

§ 58.928 Quality control tests.

All dairy products and other ingredients shall be subject to inspection for quality and 

condition throughout each processing operation. Quality control tests shall be made on flow 

samples as often as is necessary to check the effectiveness of processing and manufacturing and 

as an aid in correcting deficiencies. Routine analyses shall be made on raw materials and 

finished products to assure adequate composition control. For each batch or production run a 

keeping quality test shall be made to determine product stability. 

§ 58.929 Frequency of sampling for quality control.

(a) Composition. Sampling and testing for composition shall be made on batches of 

product as often as is necessary to control composition. On continuous production runs, enough 

samples shall be taken throughout the run to adequately assure composition requirements. 

(b) Other chemical analysis or physical analysis. Such tests shall be performed as often 

as is necessary to assure compliance with standards, specifications or contract requirements. 

(c) Weight or volume control. Representative samples of the packaged products shall be 

checked during the filling operation to assure compliance with the stated net weight or volume on 

the container. 

(d) Keeping quality and stability. A minimum of one sample from each batch of product 

or one representative sample per hour from a continuous production run shall be taken. For 

continuous runs, samples shall be taken at the start, each hour, and at the end of the run. Samples 

should also be taken after resumption of processing following an interruption in continuous 

operation. Each sample shall be incubated at 900 F to 1000 F for seven days. 

§ 58.930 Official test methods.

(a) Chemical. Chemical analysis, except where otherwise prescribed herein, shall be 

made in accordance with the methods described in the latest edition of Official Methods of 

Analysis of the AOAC or by the latest edition of Standard Methods for the Examination of Dairy 

Products. 

(b) Microbiological. Microbiological determinations shall be made in accordance with 

the methods described in the latest edition of Standard Methods for the Examination of Dairy 

Products. 

§ 58.931 General identification.

Bulk shipping containers shall be legibly marked with the name of the product, net 

weight, name and address of manufacturer, processor or distributor, a lot number and coded date 
92

of manufacture. Consumer sized containers shall meet the applicable regulations of the Food and 

Drug Administration. 

QUALITY SPECIFICATIONS FOR RAW MATERIALS 

§ 58.932 Milk.

The raw milk shall meet the requirements as outlined in 58.132 through 58.138. Unless 

processed within two hours after being received, it shall be cooled to, and held at a temperature 

of 450 F or lower until processed. 

§ 58.933 Stabilizers.

Shall be those permitted by the Food and Drug Administration’s Standards of Identity

as optional ingredients for specific products. Stabilizers shall be free from extraneous material, 

be of food grade quality and not be in violation of the Federal Food, Drug and Cosmetic Act. 

§ 58.934 Sugars.

Any sugar used in the manufacture of sweetened condensed or sterilized milk products 

shall be refined, and of food grade quality. 

§ 58.935 Chocolate and cocoa.

Such products used as flavor ingredients shall meet the requirements of the Food and 

Drug Administration, Definitions and Standards of Identity for Cocoa Products.

REQUIREMENTS FOR FINISHED PRODUCTS BEARING USDA OFFICIAL 

IDENTIFICATION 

§ 58.936 Milk.

To process and package evaporated and condensed milk of ultra-pasteurized dairy 

products eligible for official identification with the USDA Quality Approved Inspection Shield 

the raw incoming milk shall meet the requirements as outlined in §§ 58.132 through 58.136. 

Unless processed within two hours after being received, it shall be cooled to, and held at a 

temperature of 450 F or lower until processed. 

§ 58.937 Physical requirements for evaporated milk.

(a) Flavor. The product shall possess a sweet, pleasing and desirable flavor with not 

more than a definite cooked flavor. It shall be free from scorched, oxidized or other 

objectionable tastes and odors. 
93

(b) Body and texture. The product shall be of uniform consistency and appearance. It 

shall be smooth and free from fat separation, lumps, clots, gel formation, coarse milk solids 

precipitate or sedimentation and extraneous material. 

(c) Color. The color shall be of a natural white or light cream. 

(d) Degree of burn-on. The interior walls of the container shall not show excessive burnon of product (product fused to more than 75 percent of the inner surface of the can). 

(e) Keeping quality. Samples incubated at 90-1000 F shall show no sensory, chemical or 

microbiological deterioration after seven days. 

§ 58.938 Physical requirements and microbiological limits for sweetened condensed milk. 

(a) Flavor. Shall be sweet, clean, and free from rancid, oxidized, scorched, fermented, 

stale or other objectionable tastes and odors. 

(b) Color. Shall be white to light cream. 

(c) Texture. Shall be smooth and uniform, free from lumps or coarse graininess. There 

shall not be sufficient settling of the lactose to cause a deposit on the bottom of the container. 

(d) Body. Shall be sufficiently viscous so that the product upon being poured at room 

temperature piles up above the surface of that previously poured, but does not retain a definite 

form. 

(e) Microbiological limits.

(1) Coliforms, less than 10 per gram; (2) yeasts, less than 5 per gram; (3) molds, less than 

5 per gram; (4) total plate count, less than 1,000 per gram. 

(f) Keeping quality. Samples incubated at 90-1000 F shall show no physical evidence of 

deterioration after seven days. 

(g) Composition. Shall meet the minimum requirements of the Food and Drug 

Administration for sweetened condensed milk (21 CFR 131.120). In addition, the quantity of 

refined sugar used shall be sufficient to give a sugar-in-water ratio of not less than 61.5 percent. 

(h) Sediment. The amount of sediment retained on a lintine disc after a sample composed 

of 225 grams of product dissolved in 500 ml. of 1400 F water has passed through it, shall not 

exceed 0.10 mg. as indicated by the USDA Sediment Standard for Milk and Milk Products, 

(7 CFR 58.2726).