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parts shall be accessible for cleaning. Pipes shall have smooth outer and inner surfaces coated with nickel, tin, or other approved metal, and fittings shall have smooth outer and inner surfaces coated with nickel, tin, or other approved metal, and shall be of such design that no pockets or recesses occur on the inside between the pipes and fittings: Provided, however, That open conductors having smooth outer and inner surfaces coated with nickel, tin, or other approved metal may be used in place of pipe. All pumps, pipes, fittings, and conductors shall be kept in a sanitary condition.** [Reg. 3, sec. 7]

301.10 Cleanliness of employees and clothing worn. Managers of process or renovated butter factories shall require employees to be cleanly. Aprons, smocks, and other outer clothing worn by employees who handle or in any way come in contact with the process or renovated butter or any ingredient entering into the manufacture of same shall be of material that can be made sanitary by washing, and only clean garments shall be worn. All persons who handle process or renovated butter or any material entering into the manufacture of same shall be required to keep their hands clean, and they shall be required also to pay particular attention to the cleanliness of their boots and shoes.*+ [Reg. 3, sec. 8]

301.11 Communicable diseases. No person affected with tuberculosis or other communicable disease shall be employed in any factory where process or renovated butter is manufactured, and any employees who may be suspected of being so affected shall be reported by the inspector to the manager of the factory and to the Chief of Bureau.*f [Reg. 3, sec. 9]

301.12 Closets, toilets, and dressing rooms; location and equipment. All water closets, toilet rooms, and dressing rooms shaĪl be entirely separated from the compartments in which process or renovated butter is manufactured, prepared, packed, stored, or otherwise handled; and where such rooms open into compartments in which process or renovated butter is handled they shall be provided with properly ventilated vestibules and automatically closing doors. They shall be conveniently located, sufficient in number, ample in size, and fitted with modern lavatory accommodations, including toilet paper, soap, running hot and cold water, etc., and shall be properly lighted, suitably ventilated, and kept clean and sanitary.*+ [Reg. 3, sec. 10)

301.13 Contamination of factories and storehouses. The factory in which process or renovated butter is manufactured, prepared, packed, stored, or otherwise handled shall be kept free from odors coming from poultry rooms, egg rooms, toilet rooms, catch basins, or any other objectionable source, and shall be kept free from flies and other vermin; and all rooms or compartments shall be provided with cuspidors so designed as to prevent them from being upset, and made of such material and construction as to be readily disinfected, and employees who expectorate shall be required to use them.** [Reg. 3, sec. 11]

**For statutory and source citations, see note to $ 301.1.

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SANITATION AND SANITARY INSPECTION OF PRODUCTS OF AND MATERIAL

FROM WHICH PROCESS OR RENOVATED BUTTER IS MANUFACTURED

301.14 Inspections of materials and quantities manufactured. Rigid sanitary inspections will also be made of the character and condition of the materials going into the manufacture of process or renovated butter and of the quantity and quality of process or renovated butter manufactured.** (Reg. 4, sec. 1]

301.15 Use of soiled fat prohibited. Due care must be taken to prevent process or renovated butter, in any stage of its manufacture, from falling on the floor, and in the event of its having so fallen, the soiled portion shall not be used. Butterfat collected from floors, drains, or catch basins shall not be used in the manufacture of process or renovated butter.** [Reg. 4, sec. 2]

301.16 Only pure, clean water and ice permitted. Only good, clean, and wholesome water and ice shall be used in the preparation and manufacture of process or renovated butter and, whenever there is any doubt regarding the purity of the water supply, the facts shall be reported to the Chief of Bureau.** [Reg. 4, sec. 3]

301.17 Only clean air permitted for blowing and aerating. Air used in blowing or aerating the oil during the process of manufacture shall be pure and clean, and shall be taken from the outside of the building; and in order to prevent the use of air which is contaminated with dust, smoke, objectionable odors, etc., some approved method of purification, such as washing or filtering through cotton, shall be provided.** (Reg. 4, sec. 4]

301.18 Pasteurization of cream and milk. In manufacturing process or renovated butter all cream, milk or skim milk used must be pasteurized.*+ [Reg. 4, sec. 5]

301.19 Handling, storing, etc., of milk and cream. All milk, skim milk, dried milk, dried skim milk, cream, and analogous substances used in the making of process or renovated butter shall be kept, stored, and handled in a sanitary manner in accordance with accepted dairy practices.** (Reg. 4, sec. 6]

301.20 Handling, storing, etc., of other ingredients. All other materials including salt and butter color entering into the manufacture of process or renovated butter shall also be kept, stored, and handled in a sanitary manner.*+ [Reg. 4, sec. 7]

301.21 Handling, storing, etc., of cartons. All cartons, parchment wrappers, liners, packages, tubs, cans, tins, or other containers used for packaging process or renovated butter shall be stored, kept, and handled in a sanitary manner.*+ [Reg. 4, sec. 8]

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**For statutory and source citations, see note to $ 301.1.

THE MARKING, LABELING AND BRANDING OF PROCESS

OR RENOVATED BUTTER1

301.22 Statutory packages. (a) Before removal from the factory each package of process or renovated butter shall have legibly printed or stenciled on one of its sides the legend "Process butter or “Renovated butter"; also the factory number, district, and State, and the net weight, in the following manner:

PROCESS BUTTER
Factory No. 2, 2d Dist. New York

Net Weight, 60 lbs. (b) The legend "Process Butter" or "Renovated Butter" shall be in boldface gothic letters not less than three-quarters of an inch square and the other words and figures not less than half an inch square. The color of the legend shall be in strong contrast to that of the package.** [Reg. 5, sec. 1]

301.23 Carton and wrapper. The wrappers, cartons, or other containers in which prints or rolls are placed shall be branded with the legend "Process Butter” or “Renovated Butter” in boldface gothic letters, not less than three-eighths of an inch square. Such legend shall form a strong contrast to the color of the wrapper or container. No other marks shall be made on the side of the wrapper or container on which the legend is placed.** [Reg. 5, sec. 2]

301.24 Net weight requirements; pictorial misrepresentations prohibited. Each package must show the manufacturer's name and address or the factory number, district, and State, and bear a plain and conspicuous statement of the net weight of contents. Such wrappers, cartons, or other containers shall bear no pictorial or other representation which may create the impression that the article is butter as defined by the Act of Congress of March 4, 1923 (42 Stat. 1500; 21 U.S.C. 6).** [Reg. 5, sec. 3]

301.25 Surface impression. The top surface of solid-packed goods shall be imprinted with the legend "Process Butter” or “Renovated Butter” in plain gothic letters not less than half an inch square, and impressed at least an eighth of an inch deep. Prints and rolls shall be similarly impressed

with letters not less than three-eighths of an inch square. The surface impression may be omitted from prints and rolls of less than a pound unit weight, provided there is compliance with all other requirements.** [Reg. 5, sec. 4]

301.26 Brands requiring approval. With the exception of shipping marks, any marks, brands, or labels, other than those prescribed by the regulations in this chapter, shall be approved by the Secretary of Agriculture before they are used on packages of process or renovated butter.** (Reg. 5, sec. 5]

301.27 Evidence of approval. Approved copies of all marks, brands, or labels shall be retained at the manufacturer's registered

1

88 301.22-301.35 were originally promulgated by the Commissioner of Internal Revenue and approved by the Secretary of the Treasury and the Secretary of Agriculture. See 26 CFR 310.128–310.131.

**For statutory and source citations, see note to s 301.1.

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place of business, available for inspection by an inspector.*1 [Reg. 5, sec. 6]

301.28 Penalties. Every manufacturer of process or renovated butter who fails to brand the product and the containers in which it is packed is punishable by a fine of not less than $50 nor more than $500 or by imprisonment for not less than 1 month nor more than 6 months, or both. Every person who removes any such brands from any package of process or renovated butter is punishable by a fine not exceeding $1,000 or imprisonment not exceeding 1 year, or both, as provided in section 4, Act of March 3, 1891, made applicable by section 5, Act of May 9, 1902 (32 Stat. 196; 26 U.S.C. 995–997.** [Reg. 5, sec. 7]

301.29 Misbranding under Food and Drugs Act. Misbranding any article of food intended for interstate commerce, or manufactured or offered for sale in any Territory of the United States or the District of Columbia, is prohibited. That for the purposes of the Food and Drugs Act an article shall also be deemed to be misbranded in the case of food

(a) If it be an imitation of, or offered for sale under the distinctive name of, another article;

(b) If it be labeled or branded so as to deceive or mislead the purchaser, or purports to be a foreign product when not so, or if the contents of the package, as originally put up, shall have been removed in whole or in part and other contents shall have been placed in such package;

(c) If in package form, the quantity of the contents be not plainly and conspicuously marked on the outside of the package in terms of weight, measure, or numerical count; or

(d) If the package containing it or its label shall bear any statement, design, or device regarding the ingredients or the substances contained therein, which statement, design, or device shall be false or misleading in any particular.

No provision of the regulations in this chapter shall be construed so as to relieve any person from compliance with the Federal Food and Drugs Act.** [Reg. 5, sec. 8]

CROSS REFERENCE: For general provisions of regulations issued under the Federal Food and Drugs Act, see 21 CFR 1.1–1.89.

301.30 Authority to inspect. Inspectors of the Department of Agriculture, appointed for the purpose by the Secretary of Agriculture, are authorized to enter all factories and storehouses where process or renovated butter is manufactured, packed, or prepared for market for the purpose of examination or inspection authorized by this Act.** [Reg. 5, sec. 9]

301.31 Report of condition. Periodic inspection of each factory shall be made by such inspectors who will submit a complete report to the Chief of Bureau on the sanitation of the premises, the character and condition of the materials used, and the quantity and quality of process or renovated butter produced. The sanitary provisions of the Meat Inspection Act shall apply to the sanitary inspec

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*+For statutory and source citations, see note to g 301.1.

tion of process or renovated butter factories. (See Act of Aug. 10, 1912 (37 Stat. 273).)*+ [Reg. 5, sec. 10]

301.32 Impure ingredients. Process or renovated butter containing any filthy, decomposed, or putrid animal or vegetable substance shall be deemed adulterated under the Food and Drugs Act.** [Reg. 5, sec. 11]

301.33 Deleterious products seizable. The Secretary of Agriculture will determine whether or not materials being used in the manufacture of process or renovated butter will be deleterious to health or unwholesome in the finished product. If any materials which have been so determined to be deleterious to health or unwholesome in the finished product are found to be present in any process or renovated butter, intended for, or in course of, exportation or shipment in interstate commerce, such process or renovated butter will be confiscated, as provided for in s 301.44.** [Reg. 5, sec. 12]

301.34 Exportation requirements. Original packages of process or renovated butter for export shall be stamped and branded as in the case of packages for domestic use and may be covered with cloth, jute, or burlap. The outer covering shall be conspicuously stenciled with the legend "Process Butter" or "Renovated Butter", in boldface gothic letters not less than an inch square, and the words "For Export Only” on the line beneath, in similar letters not less than three-eighths of an inch square.*1 [Reg. 5, sec. 13]

301.35 Inspection and certification of export product. Process or renovated butter for export shall be examined by inspectors of the Department of Agriculture, who will issue a certificate as to its purity, quality, and grade and the sufficiency of the stamps and brands. If inspection is not made before the outer coverings are placed upon the packages, the exporter may be required to remove them.*1 [Reg. 5, sec. 14]

301.36 Marks, labels, and brands defined. All marks, brands, or labels, within the meaning of the regulations in this chapter shall include printed, lithographed, or embossed labels, stickers, seals, wrappers, and receptacles.** (Reg. 5, sec. 15]

301.37 Marks, labels, and brands for export product in English; literal translation authorized. Marks, brands, or labels to be affixed to process or renovated butter intended for export shall in all cases be printed in the English language, but they may also be literally translated into foreign languages.*+ [Reg. 5, sec. 16]

301.38 Approval of Chief of Bureau required for marks, brands, cartons, etc.; copies shall be available for examination. No mark, brand, stencil, sticker, label, or seal to be affixed to any tin, carton, wrapper, or other container in which process or renovated butter is placed shall be used until it is approved in its final form by the Chief of Bureau. Triplicates of new trade labels in the form of sketches, proofs, or photographic copies shall be transmitted direct or through inspectors to the Chief of Bureau for approval, and finished trade labels, cartons, or wrappers shall not be prepared in advance of such approval of sketches. After such labels, cartons,

**For statutory and source citations, see note to § 301.1.

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