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cordance with the provisions of these regulations and that when thus prepared, tested, and marked, they were not worthless, contaminated, dangerous, or harmful.

REGULATION 2.-LICENSES AND INSPECTIONS

SECTION 1. Every establishment in the United States at which any virus, serum, toxin, or analogous product is prepared for sale, barter, or exchange in the District of Columbia or in any Territory of or place under the jurisdiction of the United States, or for shipment or delivery for shipment from any State or Territory or the District of Columbia to any other State or Territory or the District of Columbia, shall hold an unexpired, unsuspended, and unrevoked license, issued by the Secretary of Agriculture, and shall have inspection under these regulations.

SECTION 2. All viruses, serums, toxins, and analogous products produced at licensed establishments shall be prepared, handled, stored, marked, received for transportation, and transported as required by these regulations.

SECTION 3. Paragraph 1. The proprietor or operator of each establishment of the kind specified in section 1 of this regulation shall make application in writing to the Secretary of Agriculture for a license. When one proprietor conducts more than one establishment, a separate application shall be made for a license for each establishment. Blank forms of application will be furnished upon request addressed to the Bureau of Animal Industry, Washington, D. C.

Paragraph 2. Triplicate copies of plans, properly drawn to scale, and of specifications, including plumbing and drainage of establishments, together with triplicate copies of all labels and advertising matter to be used in connection with or relating to all viruses, serums, toxins, and analogous products prepared therein, shall accompany the application for a license, unless these

plans, specifications, labels, and advertising matter have already been approved in writing by the bureau.

Paragraph 3. In case of change in ownership or location while an application is pending, or after a license has been issued, a new application shall be made.

SECTION 4. Paragraph 1. A license will not be issued unless the condition of the establishment and the methods of preparation are such as reasonably to insure that the product will accomplish the object for which it is intended and that such product is not worthless, contaminated, dangerous, or harmful.

Paragraph 2. A license will not be issued unless and until the establishment is prepared to operate under the direct supervision of a competent person trained in bacteriological technique and in the preparation of viruses, serums, toxins, or analogous products named in the application.

Paragraph 3. A license will not be issued for the preparation of any virus, serum, toxin, or analogous product if advertised so as to mislead or deceive the purchaser, or if the package or container in which the same is intended to be sold, bartered, exchanged, or shipped bears or contains any statement, design, or device which is false or misleading in any particular.

SECTION 5. Paragraph 1. A license will be issued only after inspection of the establishment by a bureau employee has shown that the condition and equipment of the establishment and the methods of preparing, handling, and storing are in conformity with these regulations.

Paragraph 2. Licenses shall be numbered and shall be in the following form:

UNITED STATES VETERINARY LICENSE No.....

WASHINGTON, D. C.,

19..

This is to certify that, pursuant to the terms of the act of Congress approved March 4, 1913 (37 Stat., 832),

governing the preparation, sale, barter, exchange, shipment, and importation of viruses, serums, toxins, and analogous products intended for use in the treatment of domestic animals,

hereby licensed to maintain at.

city or town of........

..is

.Street,

State of.

an establishment for the preparation of... during the calendar year 19....

This license is subject to suspension or revocation if the licensee violates or fails to comply with any provision of said act approved March 4, 1913, or of the regulations made thereunder.

Countersigned:

Secretary of Agriculture.

Chief, Bureau of Animal Industry.

Two or more licenses may bear the same number when they are issued to firms under the same ownership or control, provided a serial letter is added when necessary, to identify each license.

Paragraph 3. Each license shall teminate at the end of the calendar year for which it is issued.

SECTION 6. Paragraph 1. No viruses, serums, toxins, or analogous products shall be prepared in whole or in part in a licensed establishment by any other licensed establishment unless authorized in advance by the chief of bureau.

Paragraph 2. Each licensed establishment shall be separate and distinct from any unlicensed establishment in which any virus, serum, toxin, or analogous product is prepared or handled.

Paragraph 3. When a license is issued the bureau shall inform the proprietor or operator of the establishment of the requirements of these regulations. If the establishment at the time the license is issued contains any viruses, serums, toxins, or analogous products, which

have not theretofore been prepared, and of which the containers have not been theretofore marked, in compliance with these regulations, the identity of the same shall be maintained and they shall not be shipped or delivered for shipment from any State or Territory or the District of Columbia to any other State or Territory or the District of Columbia, or otherwise dealt with as products prepared under these regulations. The establishment shall adopt and enforce all necessary measures, and shall comply with all such directions as the chief of bureau may prescribe for carrying out the purposes of this paragraph.

REGULATION 3.-PERMITS

SECTION 1. Each importer of viruses, serums, toxins, or analogous products shall hold an unexpired, unsuspended, and unrevoked permit issued by the Secretary of Agriculture.

SECTION 2. Paragraph 1. Each importer of viruses, serums, toxins, and analogous products shall make application in writing to the Secretary of Agriculture for a permit. The application shall specify the port or ports of entry at which the imported articles will be cleared through the customs. Blank forms of application will be furnished upon request addressed to the Bureau of Animal Industry, Washington, D. C.

Paragraph 2. Each application for a permit shall be accompanied by the affidavit of the actual manufacturer produced before an American consular officer, giving the city or town where the viruses, serums, toxins, or analogous products mentioned therein are prepared, and stating that said products are not worthless, contaminated, dangerous, or harmful, whether the products were derived from animals, and if so derived, that such animals had not been exposed to any infectious or contagious disease, except as may have been essential in the

preparation of the products and as specified in the affidavit.

Paragraph 3. Each application for a permit shall be accompanied by the written consent of the actual manufacturer that properly accredited employees of the department shall have the privilege of inspecting, without previous notification, all parts of the establishment at which such viruses, serums, toxins, or analogous products are prepared, and all processes of and all records kept relative to the preparation of such products at such times as may be demanded by the aforesaid employees.

Paragraph 4. Each application for permit shall be accompanied by triplicate copies of all labels and advertising matter.

SECTION 3. A permit will not be issued for the importation of any viruses, serums, toxins, or analogous products if advertised so as to mislead or deceive the purchaser, or if the package or container in which the same is intended to be sold, bartered, exchanged, shipped, or imported, bears or contains any statement, design, or device which is false or misleading in any particular. SECTION 4. Paragraph 1. Permits shall be numbered and shall be in the following form:

UNITED STATES VETERINARY PERMIT NO.....

19...

WASHINGTON, D. C., ..... This is to certify that, pursuant to the terms of the act of Congress approved March 4, 1913 (37 Stat., 832), governing the preparation, sale, barter, exchange, shipment, and importation of viruses, serums, toxins, and analogous products intended for use in the treatment of domestic animals, of

State of...

is hereby authorized, so far as the jurisdiction of the Department of Agriculture is concerned, to import.... manufactured by...

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into the United States through the port

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