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(c) Uses for which nonhuman primates may be imported and distributed. Live nonhuman primates may be imported into the United States and sold, resold, or otherwise distributed only for bona fide scientific, educational, or exhibition purposes. The importation of nonhuman primates for use in breeding colonies is also permitted provided hat all offspring will be used only for cientific, educational, or exhibition urposes. The maintenance of onhuman primates as pets, hobby, or n avocation with occasional display to he general public is not a permissible

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(d) Registration of importers. (1) Imorters of nonhuman primates shall gister with the Director in a manner Trescribed by the Director.

(2) Documentary evidence that an aporter will use all nonhuman primas solely for the permitted purposes is quired.

(3) Registration shall inlcude certifition that the nonhuman primates Ill not be shipped, sold, or otherwise ansferred to other persons or organitions without adequate proof that e primates will be used only for the =rmitted purposes.

(4) Registration shall be for 2 years, fective the date the application for gistration is approved by the Direc

r.

(5) Registration may be renewed by ing a registration application form Ith the Director not less than 30 days or more than 60 days before expiraon of the current registration.

(e) Recordkeeping and reporting_retirement for registered importers. (1) Imorters shall maintain records on each ipment of imported nonhuman priates received. The record on each ipment shall include the number of imates received, species, country of rigin, date of importation, the number

primates in the shipment that die ithin 90 days after receipt, and fause(s) of deaths. If any primates in The shipment are sold or otherwise disributed within 90 days after receipt, Whe record shall include the number of rimates in each shipment or sale, the Pates of each shipment or sale, and the dentity of the recipients. In addition, he record shall contain copies of docunents that were presented to the im

porter to establish that the recipient would use the primates solely for the permitted purposes. The records shall be maintained in an organized manner in a central location at or in close proximity to the importer's primate holding facility. The records shall be maintained for a period of 3 years and shall be available for inspection by the Director at any time.

(2) Importers shall report to the Director by telephone within 24 hours the occurrence of any illness in nonhuman primates that is suspected of being yellow fever, monkeypox, or Marburg/ Ebola disease.

(3) Importers also shall report to the Director by telephone within 24 hours the occurrence of illness in any member of their staff suspected of having an infectious disease acquired from nonhuman primates.

(f) Disease control measures. Upon receipt of evidence of exposure of nonhuman primates to & communicable disease that may constitute a threat to public health, the Director may provide for or require examination, treatment, detention, isolation, seizure, or destruction of exposed animals. Any measures required shall be at the owner's expense.

(g) Disposal of excluded nonhuman primates. Nonhuman primate(s) excluded from the United States by provisions of this section shall, at the owner's option and expense, be exported, destroyed, or given to a scientific, educational, or exhibition facility under arrangements approved by the Director. If the owner fails to dispose of the nonhuman primate by one of the approved options or fails to select a method of disposal within 7 days, the Director will select the method of disposal. Pending disposal, the nonhuman primate(s) shall be detained at the owner's expense in custody of the U.S. Customs Service at the U.S. port.

(h) Revocation of an importer's registration. (1) An importer's registration may be revoked by the Director, upon notice to the importer holding such registration, if the Director determines that the importer has failed to comply with any applicable provisions of this section. The notice shall contain a statement of the grounds upon which the revocation is based.

(2) The importer may file an answer within 20 days after receipt of the notice. Answers shall admit or deny specifically, and in detail, each allegation in the notice. Allegations in the notice not denied by answer shall be deemed admitted. Matters alleged as affirmative defenses shall be separately stated and numbered. Failure of the importer to file an answer within 20 days after receipt of the notice may be deemed an admission of all allegations of fact recited in the notice.

(3) The importer shall be entitled to a hearing with respect to the revocation upon filing a written request, either in the answer or in a separate document, with the Director within 20 days after the effective date of revocation. Failure to request a hearing shall be deemed a waiver of hearing and as consent to the submission of the case to the Director for decision based on the written record. The failure both to file an answer and to request a hearing shall be deemed to constitute consent to the making of a decision on the basis of available information.

(4) As soon as practicable after the completion of any hearing conducted pursuant to the provisions of this section, the Director shall render a final decision. A copy of such decision shall be served on the importer.

(5) An importer's registration which has been revoked may be reinstated by the Director upon inspection, examination of records, conference with the importer, and receipt of information and assurances of compliance with the requirements of this section.

(1) Other permits. In addition to the requirements under this section, permits to import certain species of nonhuman primates may also be required under other Federal regulations (50 CFR parts 17 and 23) protecting such species.

(Approved by the Office of Management and Budget under control number 0920-0134) $71.54 Etiological agents, hosts, and

vectors.

(a) A person may not import into the United States, nor distribute after importation, any etiological agent or any arthropod or other animal host or vector of human disease, or any exotic living arthropod or other animal capable

of being a host or vector of human disease unless accompanied by a permit issued by the Director.

(b) Any import coming within the provisions of this section will not be released from custody prior to receipt by the District Director of the U.S. Customs Service of a permit issued by the Director.

$71.55 Dead bodies.

The remains of a person who died of a communicable disease listed in §71.32(b) may not be brought into a U.S. port unless the body is (a) properly embalmed and placed in a hermetically sealed casket, (b) cremated, or (c) accompanied by a permit issued by the Director.

PART 72-INTERSTATE SHIPMENT OF ETIOLOGIC AGENTS1

Sec.

72.1 Definitions.

72.2 Transportation of diagnostic specimens, biological products, and other materials; minimum packaging require ments.

72.3 Transportation of materials containing certain etiologic agents; minimum packaging requirements.

72.4 Notice of delivery; failure to receive. 72.5 Requirements; variations.

AUTHORITY: Sec. 215, 58 Stat. 690, as amend ed, 42 U.S.C. 216; sec. 361, 58 Stat. 703, (42) U.S.C. 264).

SOURCE: 45 FR 48627, July 21, 1980, unless otherwise noted.

§72.1 Definitions.

As used in this part:

Biological product means a biological product prepared and manufactured in accordance with the provisions of 9 CFR parts 102–104 and 21 CFR parts 312 and 600-680 and which, in accordance with such provisions, may be shipped in interstate traffic.

Diagnostic specimen means any human or animal material including, but not limited to, excreta, secreta, blood and

1 The requirements of this part are in addition to and not in lieu of any other packag ing or other requirements for the transportation of etiologic agents in interstate traf fic prescribed by the Department of Transportation and other agencies of the Federal Government.

its components, tissue, and tissue fluids being shipped for purposes of diagnosis.

Etiologic agent means a viable microorganism or its toxin which causes, or may cause, human disease.

Interstate traffic means the movement of any conveyance or the transportation of persons or property, including any portion of such movement or ransportation which is entirely within State or possession, (a) from a point * of origin in any State or possession to point of destination in any other State or possession, or (b) between a oint of origin and a point of destinaion in the same State or possession ut through any other State, posseson, or contiguous foreign country.

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72.2 Transportation of diagnostic specimens, biological products, and other materials; minimum packaging requirements.

No person may knowingly transport cause to be transported in interstate affic, directly or indirectly, any marial including, but not limited to, dimostic specimens and biological foducts which such person reasonably lieves may contain an etiologic rent unless such material is packaged

withstand leakage of contents, ocks, pressure changes, and other nditions incident to ordinary hanIng in transportation.

12.3 Transportation of materials containing certain etiologic agents; minimum packaging requirements. Notwithstanding the provisions of 2.2, no person may knowingly transart or cause to be transported in terstate traffic, directly or indictly, any material (other than biogical products) known to contain, or asonably believed by such person to ontain, one or more of the following tiologic agents unless such material is ackaged, labeled, and shipped in acordance with the requirements speciled in paragraphs (a) through (f) of his section:

BACTERIAL AGENTS

Icinetobacter calcoaceticus.

Actinobacillus all species.

Actinomycetaceae-all members.

Aeromonas hydrophila.

Arachnia propionica.

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Francisella (Pasteurella) Tularensis.
Haemophilus ducreyi, H. influenzae.
Klebsiella-all species and all serotypes.
Legionella-all species and all Legionella-like
organisms.

Leptospira interrogans—all serovars.
Listeria-all species.
Mimae polymorpha.
Moraxella-all species.

Mycobacterium-all species.

Mycoplasma-all species.

Neisseria gonorrhoeae, N. meningitidis.
Nocardia asteroides.

Pasteurella-all species.

Plesiomonas shigelloides.
Proteus-all species.
Pseudomonas mallei.
Pseudomonas pseudomallei.

Salmonella-all species and all serotypes.
Shigella-all species and all serotypes.
Sphaerophorus necrophorus.
Staphylococcus aureus.
Streptobacillus moniliformis.
Streptococcus pneumoniae.
Streptococcus pyogenes.

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

Vibrio cholerae, V. parahemolyticus.
Yersinia (Pasteurella) pestis, Y. enterocolitica.
FUNGAL AGENTS

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

VIRAL AND RICKETTSIAL AGENTS
Adenoviruses-human-all types.

Arboviruses-all types.

Coriella burnetii.

Coxsackie A and B viruses-all types.

Creutzfeldt-Jacob agent

Cytomegaloviruses.

Dengue viruses-all types.
Ebola virus.

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Variola major and Variola minor viruses.
Vesicular stomatis viruses-all types.
White pox viruses.
Yellow fever virus.2

(a) Volume not exceeding 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 (e.g.. paper towel) to absorb the entire contents of the primary containers) in case of breakage or leakage. Bach set of primary and secondary containers shall then be enciosed in an outer shipping container constructed of corrugated fiberboard, cardboard, wood, or other material of equivalent strength.

(b) Volume greater than 50 ml. Packaging of material in volumes of 50 ml. or more shall comply with requirements specified in paragraph (a) of this section. In addition, a shock absorbent material, in volume at least equal to that of the absorbent material between the primary and secondary containers, shall be placed at the top, bottom, and sides between the secondary container and the outer shipping container. Single primary containers shall not contain more than 1,000 ml of material. However, two or more primary containers whose combined volumes do not exceed 1,000 ml may be placed in a single, secondary container. The maximum amount of etiologic agent which may be enclosed within a single outer ship ping container shall not exceed 4,000 ml.

(c) 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 placed so that the secondary container does not become loose inside the outer shipping container as the dry ice sublimates.

(d)(1) The outer shipping container of all materials containing etiologic agents transported in interstate traffic must bear a label as illustrated and described below:

This list may be revised from time to time by Notice published in the FEDERAL REGISTER to identify additional agents which must be packaged in accordance with the requirements contained in this part.

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(e) Damaged packages. The carrier all promptly, upon discovery of evigence of leakage or any other damage D packages bearing an Etiologic gents/Biomedical Material label, isoate the package and notify the Direcor, Center for Disease Control, 1600 lifton Road, NE., Atlanta, GA 30333, y telephone: (404) 633-5313. The carrier hall also notify the sender.

(f) 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 of

receipt to the sender immediately upon delivery:

Coccidioides immitis.

Ebola virus.

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

Marburg virus.

Pseudomonas mallei.

Pseudomonas pseudomallei.

Tick-borne encephalitis virus complex including, but not limited to, Russian springsummer encephalitis, Kyasanur forest disease, Omsk Hemorrhagic fever, and Central European encephalitis viruses, Variola minor, and Variola major.

Variola major, Variola minor, and Whitepox viruses.

Yersinia (Pasteurella) pestis.3

$72.4 Notice of delivery; failure to receive.

When notice of delivery of materials known to contain or reasonably believed to contain etiologic agents listed in §72.3(f) is not received by the sender within 5 days following anticipated delivery of the package, the

3This list may be revised from time to time by Notice published in the FEDERAL REGISTER to identify additional agents which must be transported in accordance with requirements contained in §72.3(f).

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