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(a) The smallest area within a territory, which may be a port or an airport, having a defined boundary and possessing a health organization which is able to apply the appropriate sanitary measures permitted or prescribed by these Regulations; the situation of such an area within a larger area which also possesses such a health organization shall not preclude the smaller area from being a local area for the purposes of these Regulations; or (b) an airport in connexion with which a direct transit area has been established;

CHAPTER II-SANITARY MEASURES ON

DEPARTURE

Article 30

1. The health authority for a port or an airport or for the local area in which a frontier post is situated may, when it considers it necessary, medically examine any person before his departure on an international voyage. The time and place of this examination shall be arranged to take into account the customs examination and other formalities, so as to facilitate his departure and to avoid delay.

2. The health authority referred to in paragraph 1 of this Article shall take all practicable measures

(a) To prevent the departure of any infected person or suspect;

(b) To prevent the introduction on board a ship, an aircraft, a train, or a road vehicle of possible agents of infection or vectors of a quarantinable disease.

3. Notwithstanding the provisions of subparagraph (a) of paragraph 2 of this Article, a person on an international voyage who on arrival is placed under surveillance may be allowed to continue his voyage. If he is doing so by air, the health authority for the airport shall record the fact on the General Declaration.

PART VI-SANITARY DOCUMENTS

Article 98

1. The certificates specified in Appendices 1, 2, 3, and 4 shall be printed in English and in French. An official language of the territory of issue may be added.

2. The certificates referred to in paragraph 1 of this Article shall be completed in English or in French.

Article 99

A vaccination document issued by the Armed Forces to an active member of those Forces shall be accepted in lieu of an international certificate in the form shown in Appendix 2, 3, or 4 if—

(a) It embodies medical information substantially the same as that required by such form; and

(b) I contains a statement in English or in French recording the nature and date of the vaccination and to the effect that it is issued in accordance with this Article.

PART IV-SANITARY MEASURES AND

PROCEDURES

PART X-TRANSITIONAL PROVISIONS

Article 115

1. A certificate of vaccination issued in accordance with the Convention of 21 June 1926, as amended by the Convention of 15 December 1944, or in accordance with the Convention of 12 April 1933, as amended by the Convention of 15 December 1944, before the entry-into-force of these Regulations shall continue to be valid for the period for which it was previously valid. Moreover, the validity of a certificate of vaccination against yellow fever so issued shall be extended for two years after the date on which it would otherwise have ceased to be valid.

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Subpart A-Definitions and General Provisions

§ 72.1 General definitions.

As used in this part, terms shall have the following meaning:

(a) Bactericidal treatment. The application of a method or substance for the destruction of pathogens and other organisms. (See § 72.4).

(b) Communicable diseases. Illnesses due to infectious agents or their toxic products, which may be transmitted from a reservoir to a susceptible host either directly as from an infected person or animal or indirectly through the agency of an intermediate plant or animal host, vector, or the inanimate environment.

(c) Communicable period. The period or periods during which the etiologic agent may be transferred directly or indirectly from the body of the infected person or animal to the body of another.

(d) Contamination. The presence of a certain amount of undesirable substance or material, which may contain pathogenic micro-organisms.

(e) Conveyance. Conveyance means any land or air carrier, or any vessel as defined in paragraph (o) of this section.

(f) Existing vessel. Any vessel the construction of which was started prior to the effective date of the regulations in this part.

(g) Garbage. (1) The solid animal and vegetable waste, together with the natural moisture content, resulting from the handling, preparation, or consumption of foods in houses, restaurants, hotels, kitchens, and similar establishments, or (2) any other food waste containing pork.

(h) Incubation period. The period between the implanting of disease organisms in a susceptible person and the appearance of clinical manifestation of the disease.

(i) Interstate traffic. (1) The movement of any conveyance or the transportation of persons or property, including any portion of such movement or transportation which is entirely within a State or possession, (i) from a point of origin in any State or possession to a point of destination in any

other State or possession, or (ii) between a point of origin and a point of destination in the same State or possession but through any other State, possession, or contiguous foreign country.

(2) Interstate traffic does not inIclude the following:

(i) The movement of any conveyance which is solely for the purpose of unloading persons or property transported from a foreign country, or loading persons or property for transportation to a foreign country.

(ii) The movement of any conveyance which is solely for the purpose of effecting its repair, reconstruction, rehabilitation, or storage.

(j) Minimum heat treatment. The causing of all particles in garbage to be heated to a boiling temperature and held at that temperature for a period of not less than 30 minutes.

(k) Possession. Any of the possessions of the United States, including Puerto Rico and the Virgin Islands.

(1) Potable water. Water which meets the standards prescribed in the Public Health Service Drinking Water Standards (see Subpart J of this part).

(m) State. Any State, the District of Columbia, Puerto Rico and the Virgin Islands.

(n) Utensil. Includes any kitchenware, tableware, glassware, cutlery, containers, or equipment with which food or drink comes in contact during storage, preparation, or serving.

(0) Vessel. Any passenger-carrying, cargo, or towing vessel exclusive of:

(1) Fishing boats including those used for shell-fishing;

(2) Tugs which operate only locally in specific harbors and adjacent waters;

(3) Barges without means of self-propulsion; (4) and dredges; and

Construction-equipment

boats

(5) Sand and gravel dredging and handling boats.

(p) Wash water. (See § 72.118(a).)

(q) Watering point. The specific place or water boat from which potable water is loaded on a conveyance.

(r) Shellfish. Any fresh, frozen, or incompletely cooked oysters, clams, or mussels, either shucked or in the shell,

and any fresh, frozen, or incompletely cooked edible products thereof.

[21 FR 9881, Dec. 12, 1956, as amended at 25 FR 43, Jan. 5, 1960; 27 FR 2152, Mar. 6, 1962; 36 FR 11025, June 8, 1971]

Subpart B-[Reserved]

Subpart C-Shipment of Certain
Things

§ 72.25 Etiologic agents. 1

(a) Definitions. As used in this section:

(1) An "etiologic agent" means a viable microorganism or its toxin which causes, or may cause, human disease.

(2) A "diagnostic specimen" means any human or animal material including, but not limited to, excreta, secreta, blood and its components, tissue, and tissue fluids being shipped for purposes of diagnosis.

(3) A "biological product" means a biological product prepared and manufactured in accordance with the provisions of 9 CFR Part 10, Licensed Veterinary Biological Products, 42 CFR Part 73, Licensed Human Biological Products, 21 CFR 130.3, New drugs for investigational use in humans, 9 CFR Part 103, Biological Products for Experimental Treatment of Animals, or 21 CFR 130.3(a), New drugs for investigational use in animals, and which, in accordance with such provisions, may be shipped in interstate traffic.

(b) Transportation; etiologic agent minimum packaging requirements. No person may knowingly transport or cause to be transported in interstate traffic, directly or indirectly any material, including but not limited to, diagnostic specimens and biological products, containing, or reasonably believed by such person to contain, an etiologic agent unless such material is packaged to withstand leakage of contents, shocks, pressure changes, and other conditions incident to ordinary handling in transportation.

'The requirements of this section are in addition to and not in lieu of any other packaging or other requirements for the transportation of etiologic agents in interstate traffic prescribed by the Department of Transportation and other agencies of the Federal Government.

(c) Transportation; etiologic agents subject to additional requirements. No person may knowingly transport or cause to be transported in interstate traffic, directly or indirectly, any material, other than diagnostic specimens and biological products, containing, or reasonably believed by such person to contain, one or more of the following etiologic agents unless such material is packaged in accordance with the requirements specified in paragraph (b) of this section, and unless, in addition, such material is packaged and shipped in accordance with the requirements specified in paragraphs (c)(1)-(6) of this section:

BACTERIAL AGENTS

Actinobacillus—all species.

Arizona hinshawii—all serotypes.

Bacillus anthracis.

Bartonella-all species.

Bordetella-all species.

Borrelia recurrentis, B. vincenti.

Brucella-all species.

Clostridium botulinum, Cl. chauvoei, Cl. haemolyticum, Cl. histolyticum, Cl. novyi, Cl. septicum, Cl. Tetani.

Corynebacterium diphtheriae C, equi, C. haemolyticum, C. pseudotuberculosis, C. pyogenes, C. renale.

Diplococcus (Streptococcus) pneumoniae.
Erysipelothrix insidiosa.

Escherichia coli, all enteropathogenic serotypes.

Francisella (Pasteurella) tularensis.

Haemophilus ducreyi, H. influenzae.
Herellea vaginicola.

Klebsiella-all species and all serotypes.
Leptospira interrogans—all serotypes.
Listeria-all species.

Mima polymorpha.

Moraxella-all species.

Mycobacterium—all species.

Mycoplasma-all species.

Neisseria gonorrhoeae, N. meningitidis.
Pasteurella-all species.
Pseudomonas pseudomallei.

Salmonella-all species and all serotypes.
Shigella-all species and all serotypes.
Sphaerophorus necrophorus.

Staphylococcus aureus.

Streptobacillus moniliformis.

Streptococcus pyogenes.

Treponema careteum, T. pallidum, and T. pertenue.

Vibrio fetus, V. comma, including biotype El
Tor, and V. parahemolyticus.
Yersenia (Pasteurella) pestis.

FUNGAL AGENTS

Actinomycetes (including Nocardia species, Actinomyces species and Arachnia propionica).

Blastomyces dermatitidis.
Coccidioides immitis.
Cryptococcus neoformans.
Histoplasma capsulatum.
Paracoccidiodies brasiliensis.

VIRAL, RICKETTSIAL, AND CHLAMYDIAL AGENTS
Adenoviruses-human-all types.

Arboviruses.

Coxiella burnetii.

Coxsackie A and B viruses-all types. Cytomegaloviruses.

Dengue virus.

Echoviruses-all types.

Encephalomyocarditis virus.

Hemorrhagic fever agents, including Crimean hemorrhagic fever (Congo), Junin, and Machupo viruses, and others as yet undefined.

Hepatitis-associated antigen.
Herpesvirus-all members.

Infectious bronchitis-like virus.

Influenza viruses-all types.

Lassa virus.

Lymphocytic choriomeningitis virus.

Marburg virus.

Measles virus.

Mumps virus.

Parainfluenza viruses—all types.

Polioviruses-all types.

Poxviruses-all members.

Psittacosis-Ornithosis-Trachoma-Lympho

granuloma group of agents.

Rabies virus-all strains.
Reoviruses-all types.

Respiratory syncytial virus.
Rhinoviruses-all types.
Rickettsic-all species.
Rubella virus.

Simian viruses-all types.

Tick-borne encephalitis virus complex, including Russian spring-summer encephalitis, Kyasanur forest disease, Omsk hemorrhagic fever, and Central European encephalitis viruses.

Vaccinia virus.

Varicella virus.

Vari la major and Variola minor viruses.
Vesicular stomatis virus.
Yellow fever virus.

(1) Volume less than 50 ml. Material shall be placed in a securely closed, watertight container (primary container (test tube, vial, etc.)) which shall be enclosed in a second, durable watertight container (secondary container). Several primary containers may be enclosed in a single secondary container, if the total volume of all the primary containers so enclosed does not exceed

50 ml. The space at the top, bottom, and sides between the primary and secondary containers shall contain sufficient nonparticulate absorbent material to absorb the entire contents of the primary container(s) in case of breakage or leakage. Each set of primary and secondary containers shall then be enclosed in an outer shipping container constructed of corrugated fiberboard, cardboard, wood, or other material of equivalent strength.

(2) Volume 50 ml. or greater. Packaging of material in volumes of 50 ml. or more shall include, in addition, a shock absorbent material, in volume at least equal to that of the absorbent material between the primary and secondary containers, at the top, bottom, and sides between the secondary container and the outer shipping container. Single primary containers shall not contain more than 500 ml. of material. However, two or more primary containers whose combined volumes do not exceed 500 ml. may be placed in a single, secondary container. Not more than eight secondary shipping containers may be enclosed in a single outer shipping container. (The maximum amount of etiologic agent which may be enclosed within a single outer shipping container shall not exceed 4,000 ml.)

(3) Dry ice. If dry ice is used as a refrigerant, it must be placed outside the secondary container(s). If dry ice is used between the secondary container and the outer shipping container, the shock absorbent material shall be so placed that the secondary container does not become loose inside the outer shipping container as the dry ice sublimates.

(4) Labels. The label for Etiologic Agents/Biomedical Material, except for size and color, must be as shown:

HIOLOGIC AGENTS

BIOMEDICAL MATERIAL

IN CASE OF DAMAGE

OR LEAKAG

DIRECTOR, CO: ARAN GEOHOL

404/635531

(i) The color of material on which the label is printed must be white and the symbol and printing in red.

(ii) The label must be a rectangle measuring 51 mm. (2 inches) high by 102.5 mm. (4 inches) long.

(iii) The red symbol measuring 38 mm. (1 1/2 inches) in diameter must be centered in a white square measuring 51 mm. (2 inches) on each side.

(iv) Type size of the letters of label shall be as follows:

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(5) Damaged packages. Carriers shall promptly, upon discovery of damage to the package that indicates damage to the primary container, isolate the package and notify the Director, Center for Disease Control, 1600 Clifton Road NE., Atlanta, GA 30333 (telephone (404) 633-5313), and the sender.

(6) Registered mail or equivalent system. Transportation of the following etiologic agents shall be by registered mail or an equivalent system which requires or provides for sending notification to the shipper immediately upon delivery:

Actinobacillus mallei. Coccidioides immitis.

Francisella (Pasteurella) tularensis. Hemorrhagic fever agents, including, but not limited to, Crimean hemorrhagic fever (Congo), Junin, Machupo viruses. Herpesvirus simiae (B virus).

Histoplasma capsulatum.
Lassa virus.

Marburg virus.

Pseudomonas pseudomallei.

Tick-borne encephalitis virus complex, including, but not limited to, Russian spring-summer encephalitis, Kyasanur forest disease, Omsk hemorrhagic fever, and Central European encephalitis viruses, Variola minor and Variola major. Yersenia (Pasteurella) pestis.

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(d) Notice of delivery; failure to receive. When notice of delivery of agents containing, or suspected of containing, etiologic agents listed in paragraph (c)(6) of this section is not received by the sender within 5 days following anticipated delivery of the

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