any room, compartment, or place where any such products are being handled, shall be of clean, white material whenever practicable.

SECTION 9. The outer premises of every licensed establishment, embracing docks, driveways, approaches, yards, pens, chutes, and alleys, shall be properly drained and kept in a clean and orderly condition. The accumulation on the premises of an establishment of any material in which flies may breed is forbidden. No nuisance shall be allowed in any licensed establishment or on its premises.

SECTION 10. Every practicable precaution shall be taken to keep establishments free of flies, rats, mice, and other vermin.

SECTION 11. All parts of the carcasses of animals producing viruses, all dead animals, all refuse, and all worthless, contaminated, dangerous, or harmful viruses, serums, toxins, or analogous products, shall be incinerated or otherwise destroyed by establishments in accordance with methods approved by the chief bureau.

SECTION 12. All rooms, compartments, and other places used for preparing, handling, or storing viruses, serums, toxins, or analogous products shall be kept clean and sanitary, and all equipment, containers, instruments, and other apparatus used in preparing, handling, or storing any such products shall be thoroughly cleaned and sterilized before use.

SECTION 13. Smoking or expectorating in any room, compartment, or place in which viruses, toxins, or analogous products are prepared, handled, or stored is prohibited.

REGULATION 9.-STERILIZATION

SECTION 1. Paragraph 1. All equipment, containers, instruments, and other apparatus, before being used in preparing, handling, or storing viruses, serums, toxins, or other analogous products, except as prescribed in the

following paragraph, shall be thoroughly sterilized by live steam at a temperature of at least 120° C. for not less than one-half hour, or, by dry heat at a temperature of at least 160° C. for not less than one hour. If for any reason such methods of sterilization are impracticable, then a process known to be equally efficacious in destroying microorganisms and their spores may be substituted after approval by the chief of bureau.

Paragraph 2. Instruments used in connection with the bleeding of virus pigs and hyperimmune hogs, and other like equipment, of establishments manufacturing hog-cholera virus and anti-hog-cholera serum, which are found to be damaged by exposure to the degree of heat prescribed in the preceding paragraph, after having been thoroughly cleaned, may be sterilized by boiling for not less than 15 minutes, provided apparatus, satisfactory to the inspector in charge, is furnished for this purpose.

REGULATION 10.-STORAGE

SECTION 1. Viruses, serums, toxins, and analogous products which may be injuriously affected by exposure to light or to high temperature shall be stored in a dark, cold chamber or refrigerator at a temperature of not to exceed 55° F. All dealers in the District of Columbia or any Territory or in any place under the jurisdiction of the United States shall keep such products protected from light and under refrigeration until sold or otherwise disposed of.

REGULATION 11.-RECORDS

SECTION 1. Paragraph 1. Permanent detailed records of the sources, of the preparation, of tests for purity and potency, and of methods of preservation, of each batch of virus, serum, toxin, and analogous products shall be kept by each licensed establishment and by each

manufacturer producing such products for importation into the United States.

Paragraph 2. Permanent detailed records, in a form satisfactory to the chief of bureau, shall be maintained by each licensed establishment and by each importer, showing the sale, shipment, or other disposition of the viruses, serums, toxins, and analogous products handled.

REGULATION 12.-LABELS

SECTION 1. Paragraph 1. Each immediate or true container of viruses, serums, toxins, or analogous products, prepared for sale, barter, exchange, or shipment, by any licensed establishment, or imported into the United States, shall bear a trade label as hereinafter described.

Paragraph 2. No container of virus, serum, toxin, or analogous product shall bear a trade label unless and until the product contained therein shall have been prepared in compliance with these regulations and found not to be worthless, contaminated, dangerous, or harmful.

Paragraph 3. No person shall apply or affix, or cause to be applied or affixed, any trade label, stamp, or mark, to any container of hog-cholera virus, or anti-hogcholera serum, prepared or received in a licensed establishment except in compliance with these regulations. Suitable tags or labels of a distinct design should be used for identifying all biologics while in course of preparation.

SECTION 2. Paragraph 1. Trade labels shall bear the true name of the product contained in the package, the name and address of the manufacturer except as otherwise provided in paragraph 7 of this section, and the license or permit number assigned by the department. The license number and permit number shall be shown in either of the following forms, respectively: “U. S.

Veterinary License No.

or "U. S. Vet. License " and "U. S. Veterinary Permit No.

or "U. S. Vet. Permit No. ." Such labels shall bear all other information required by the chief of bureau and may also bear any other statement not false or misleading and which has been approved by the bureau.

Paragraph 2. Each trade label shall bear a serial number, affixed by the manufacturer, by which the product can be identified with the records of preparation.

Paragraph 3. Each trade label shall bear a return date affixed before the product is removed from the establishment. The date shown shall be a date after which the manufacturer does not guarantee the product to be of full strength or potency.

Paragraph 4. All trade labels affixed to or used in connection with each immediate or true container shall bear a dosage table and full instructions governing the use of the product.

Paragraph 5. Trade labels affixed to the immediate or true containers of viruses and products prepared from attenuated organisms shall bear, in addition to the statements required by the preceding paragraphs of this section, the following, prominently placed and lettered: "CAUTION-BURN THIS CONTAINER AND ALL UNUSED CONTENTS.'

Paragraph 6. When any virus, serum, toxin, or analogous product is prepared by a licensed establishment or imported for a person other than the one to whom a license or permit has been issued and the name and address of the distributor as well as that of the manufacturer is to appear on the label of the container thereof, a statement shall be made on the label to the effect that the virus, serum, toxin, or analogous product is distributed by such person. The term, "Distributer, "Distributers," "Distributed by," or other equivalent terms may be used, if prominently placed and lettered

in connection with the name and address of the distributing person, provided the same are not used so as to be either false or misleading.

Paragraph 7. The name and address of the manufacturer may be omitted from trade labels when any virus, serum, toxin, or analogous product is to be distributed by a person other than the manufacturer, provided the name and address of the distributor appears on such trade labels in immediate connection with a statement showing the license under which the product was manufactured. This statement, together with the name and address of the distributor, shall appear in letters of uniform size and character, and be in the following form: "Produced under U. S. Veterinary License No.

Distributed by

(name and address of distributor).' Paragraph 8. Copies of all trade labels before use shall be submitted to the bureau for examination and approval. These labels shall be submitted in triplicate, quadruplicate, or quintuplicate, as may be indicated. Triplicate copies of new trade labels in the form of sketches, proofs, or photographic copies should be submitted, through the inspector in charge, to the bureau for approval.

REGULATION 13.-COLLECTING SAMPLES

SECTION 1. Paragraph 1. Samples of viruses, serums, toxins, and analogous products shall be collected by authorized officers, agents, or employees of the department.

Paragraph 2. Samples may be purchased in the open market and the marks, brands, or tags upon the package or wrapper thereof shall be noted. The collector shall note the names of the vendor and agent of the vendor who made the sale, together with the date of purchase. The collector shall purchase representative samples.

Paragraph 3. All samples or parts of samples shall be sealed by the collector and marked with identifying marks.