§ 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 heretofore been delegated, or to whom there may hereafter be delegated the authority to act in his stead.
( 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.
( 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 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 145 °F (vat pasteurization)
30 minutes. 161 °F (high temperature short time pasteurization)
15 seconds. 191 °F (higher heat shorter time pasteurization)
1.0 second. 194 °F (higher heat shorter time pasteurization)
0.5 second. 201 °F (higher heat shorter time pasteurization)
0.1 second. 204 °F (higher heat shorter time pasteurization)
.05 second. 212 °F (higher heat shorter time pasteurization)
.01 second.
Products Having Dairy Ingredients With a Fat Content of 10 Percent or More, or Contain Added Sweeteners
150 °F
30 minutes. 166 °F
15 seconds.
Frozen Dessert Mix
155 °F
30 minutes. 175 °F
25 seconds.
Condensed Milk To Be Repasteurized
166 °F
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 Fifteenth Street, NW 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.
[40 FR 47911, Oct. 10, 1975. Redesignated at 42 FR 32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 50 FR 34672, Aug. 27, 1985; 58 FR 42413, Aug. 9, 1993; 59 FR 24321, May 10, 1994; 59 FR 50121, Sept. 30, 1994; 67 FR 48974, July 29, 2002]