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(c) Uses for which nonhuman primates porter to establish that the recipient ray be imported and distributed. Live would use the primates solely for the onhuman primates may be imported permitted purposes. The records shall ato the United States and sold, resold, be maintained in an organized manner r otherwise distributed only for bona in a central location at or in close de scientific, educational, or exhi- proximity to the importer's primate tion purposes. The importation of holding facility. The records shall be nhuman primates for use in breeding maintained for a period of 3 years and ilonies 18 also permitted provided shall be available for inspection by the at all offspring will be used only for Director at any time. ientific, educational, or exhibition (2) Importers shall report to the Dirposes. The maintenance of rector by telephone within 24 hours the nhuman primates as pets, hobby, or occurrence of any illness in nonhuman avocation with occasional display to primates that is suspected of being yele general public is not a permissible low fever, monkeypox, or Marburg/ e.

Ebola disease. d) Registration of importers. (1) Im- (3) Importers also shall report to the rters of nonhuman primates shall Director by telephone within 24 hours Hister with the Director in a manner the occurrence of illness in any mem'scribed by the Director.

ber of their staff suspected of having an 2) Documentary evidence that an infectious disease acquired from porter will use all nonhuman prima- nonhuman primates. solely for the permitted purposes is (1) Disease control measures. Upon reuired.

ceipt of evidence of exposure of 3) Registration shall inlcude certifi- nonhuman primates to & commuion that the nonhuman primates nicable disease that may constitute a 1 not be shipped, sold, or otherwise threat to public health, the Director nsferred to other persons or organi- may provide for or require examinaions without adequate proof that tion, treatment, detention, isolation, primates will be used only for the seizure, or destruction of exposed animitted purposes.

mals. Any measures required shall be 1) Registration shall be for 2 years, at the owner's expense. ctive the date the application for (8) Disposal of excluded nonhuman priistration is approved by the Direc- mates. Nonhuman primate(s) excluded

from the United States by provisions of Registration may be renewed by this section shall, at the owner's opng a registration application form tion and expense, be exported, deh the Director not less than 30 days stroyed, or given to a scientific, edu· more than 60 days before expira- cational, or exhibition facility under n of the current registration.

arrangements approved by the Direc5) Recordkeeping and reporting re- tor. If the owner fails to dispose of the rement for registered importers. (1) Im- nonhuman primate by one of the ap ters shall maintain records on each proved options or fails to select a pment of imported nonhuman pri- method of disposal within 7 days, the tes received. The record on each Director will select the method of dispment shall include the number of posal. Pending disposal, the nonhuman mates received, species, country of primate(s) shall be detained at the gin, date of importation, the number owner's expense in custody of the U.S. primates in the shipment that die Customs Service at the U.S. port. hin 90 days after receipt, and (h) Revocation of an importer's registraise(s) of deaths. If any primates in tion. (1) An importer's registration may • shipment are sold or otherwise dis- be revoked by the Director, upon nobuted within 90 days after receipt, tice to the importer holding such rega record shall include the number of istration, if the Director determines mates in each shipment or sale, the that the importer has failed to comply tes of each shipment or sale, and the with any applicable provisions of this entity of the recipients. In addition, section. The notice shall contain a e record shall contain copies of docu- statement of the grounds upon which ents that were presented to the im- the revocation is based.


(2) The importer may file an answer of being a host or vector of human diswithin 20 days after receipt of the no- ease unless accompanied by a permit tice. Answers shall admit or deny spe- issued by the Director. cifically, and in detail, each allegation (b) Any import coming within the in the notice. Allegations in the notice provisions of this section will not be not denied by answer shall be deemed released from custody prior to receipt admitted. Matters alleged as affirma- by the District Director of the U.S. tive defenses shall be separately stated Customs Service of a permit issued by and numbered. Failure of the importer the Director. to file an answer within 20 days after receipt of the notice may be deemed an $71.55 Dead bodies. admission of all allegations of fact re- The remains of a person who died of cited in the notice.

communicable disease listed in (3) The importer shall be entitled to

$71.32(b) may not be brought into a hearing with respect to the revoca

U.S. port unless the body is (a) proption upon filing a written request, ei

erly embalmed and placed in a herther in the answer or in a separate doc

metically sealed casket, (b) cremated, ument, with the Director within 20

or (c) accompanied by a permit issued days after the effective date of revoca

by the Director. tion. Failure to request a hearing shall be deemed a waiver of hearing and as

PART 72-INTERSTATE SHIPMENT OF consent to the submission of the case to the Director for decision based on

ETIOLOGIC AGENTS 1 the written record. The failure both to file an answer and to request a hearing

Sec. shall be deemed to constitute consent

72.1 Definitions.

72.2 Transportation of diagnostic specito the making of a decision on the

mens, biological products, and other mabasis of available information.

terlals; minimum packaging require (4) As soon as practicable after the ments. completion of any hearing conducted 72.3 Transportation of materials containing pursuant to the provisions of this sec- certain etiologic agents; minimum packtion, the Director shall render a final aging requirements. decision. A copy of such decision shall

72.4 Notice of delivery; fallure to receive. be served on the importer.

72.5 Requirements; variations. (5) An importer's registration which AUTHORITY: Sec. 215, 58 Stat. 600, as amendhas been revoked may be reinstated by

ed, 42 U.S.C. 216; sec. 361, 58 Stat. 703, (0 the Director upon inspection, examina

U.S.C. 284). tion of records, conference with the im- SOURCE: 45 FR 48627, July 21, 1980, unless porter, and receipt of information and otherwise noted. assurances of compliance with th re

872.1 Definitions. quirements of this section. (1) Other permits. In addition to the

As used in this part: requirements under this section, per

Biological product means a biological mits to import certain species of product prepared and manufactured in nonhuman primates may also be re

accordance with the provisions of 9 quired under other Federal regulations

CFR parts 102-104 and 21 CFR parts 312 (50 CFR parts 17 and 23) protecting such

and 600-680 and which, in accordance species.

with such provisions, may be shipped

in interstate traffic. (Approved by the Office of Management and

Diagnostic specimen means any human Budget under control number 0920-0134)

or animal material including, but not 871.54 Etiological agents, hosts, and

limited to, excreta, secreta, blood and vectors. (a) A person may not import into the

1 The requirements of this part are in addiUnited States, nor distribute after im

tion to and not in lieu of any other packar portation, any etiological agent or any

ing or other requirements for the transpor

tation of etiologic agents in interstate traf arthropod or other animal host or vec

fic prescribed by the Department of Transtor of human disease, or any exotic liv

portation and other agencies of the Federal ing arthropod or other animal capable


ts components, tissue, and tissue Arizona hinshawii-all serotypes. luids being shipped for purposes of di

Bacillus anthracis. gnosis.

Bacteroides spp. Etiologic agent means a viable micro

Bartonella-all species.

Bordetella-all species. rganism or its toxin which causes, or Borrelia recurrentis, B. vincenti. nay cause, human disease.

Brucella-all species. Interstate traffic means the movement Campylobacter (Vibrio) foetus, C. (Vibrio) [ any conveyance or the transpor- jejuni. ition of persons or property, including Chlamydia psittaci, C. trachomatis. ny portion of such movement or

Clostridium botulinum, C. chauvoei, Cl. ansportation which is entirely within

haemolyticum, Cl. histolyticum,Cl. novyi, Ci.

septicum, Cl. tetani. State or possession, (a) from a point

Corynebacterium diphtheriae, C. equi, C. origin in any State or possession to

haemolyticum, C. pseudotuberculosis, C. point of destination in any other

pyogenes, C. renale. Late or possession, or (b) between a Edwarsiella tarda. pint of origin and a point of destina- Erysipelothrix insidiosa. con in the same State or possession

Escherichia coli, all enteropathogenic it through any other State, posses


Francisella (Pasteurella) Tularensis. on, or contiguous foreign country.

Haemophilus ducreyi, H. influenzae. 2.2 Transportation of diagnostic

Klebsiella-all species and all serotypes. specimens, biological products, and

Legionella-all species and all Legionella-like other materials; minimum packag.

organisms. ing requirements.

Leptospira interrogans-all serovars.

Listeria-all species. No person may knowingly transport Mimae polymorpha.

cause to be transported in interstate Morasella-all species. affic, directly or indirectly, any ma

Mycobacterium-all species. Tial including, but not limited to, di

Mycoplasma-all species. nostic specimens and biological

Neisseria gonorrhoeae, N. meningitidis.

Nocardia asteroides. oducts which such person reasonably

Pasteurella-all species. lieves may contain an etiologic

Plesiomonas shigelloides. 'ent unless such material is packaged Proteus-all species.

withstand leakage of contents, Pseudomonas mallei. ocks, pressure changes, and other Pseudomonas pseudomallei. nditions incident to ordinary han- Salmonella-all species and all serotypes. Ing in transportation.

Shigellaall species and all serotypes.

Sphaerophorus necrophorus. 2.3 Transportation of materials con

Staphylococcus aureus. taining certain etiologic agents;

Streptobacillus moniliformis. minimum packaging requirements.

Streptococcus pneumoniae.

Streptococcus pyogenes. Notwithstanding the provisions of

Treponema careteum, T. pallidum, and T. 2.2, no person may knowingly trans- pertenue.

cause to be transported in Vibrio cholerae, V. parahemolyticus. terstate traffic, directly or indi- Yersinia (Pasteurella) pestis, Y. enterocolitica. ctly, any material (other than bio

FUNGAL AGENTS gical products) known to contain, or asonably believed by such person to

Blastomyces dermatitidis. untain, one or more of the following

Coccidioides immitis. iologic agents unless such material is

Cryptococcus neoformans.

Histoplasma capsulatum. ackaged, labeled, and shipped in ac

Paracoccidioides brasiliensis. ordance with the requirements specied in paragraphs (a) through (1) of


Adenoviruses-human-all types.

Arboviruses all types.

Coriella burnetii. cinetobacter calcoaceticus.

Coxsackie A and B viruses all types. ctinobacillus-all species.

Creutzfeldt-Jacob agent ctinomycetaceae all members.

Cytomegaloviruses. eromonas hydrophila.

Dengue viruses all types. rachnia propionica.

Ebola virus.

rt or

and secondary containers shall contain Freephalomyocarditis true Femarelagie Terez santa neluting, sut jot

sufficient sonparticulate absorbent

material (eg, paper towel) to absorb Congo), Jonin. Vsekuge truses sad to sae entire contents of the primary

container's) in case of breakage or Tepatitis scelated materials iepatitis & leakage. Each set of primary and secsepatitis 3. sepatitis sona-sonal.

ondary containers shall then be enTherpesvirus sil members

ciased in an outer shipping container infectious monchitisike this. Influenza virisel ya

Constructed of corrugated fiberboard, cardboard, wood, or other material of

equivalent strength Lymphocytic chartameningitis viris.

(b) Voime greater than 50 ml. PackasMarburg 171

ing of material in volumes of 50 ml. or Measles otras

more shall comply with requirements Vumpe fria.

specified in paragraph (a) of this secParainfluensa viruses oes. Polioviruses yes.

tion. In addition, a shock absorbent Porririses all sember.

material, in volume at least equal to Rabies viris il strains.

that of the absorbent material between Reovirises 11 types

the primary and secondary containers, Respiratory syscyna Tizia.

shall be placed at the top, bottom, and Prisoniruses-ames .

sides between the secondary container Packettzio-all species.

and the outer shipping container. SinRockalimano quintana Rotaviruses 11 types.

gle primary containers shall not conRabella virus

tafn more than 1,000 ml of material. Simias virus 40

However, two or more primary containTick-borne enceptalitis viris compiez, in- ers whose combined volumes do not erclading Russian spring summer encepes ceed 1,000 ml may be placed in a single, Htis, Kyasanw forest disease. Omss ber secondary container. The maximum

orttagle fever, and Central Europese es- amount of etiologic agent which may cephalitis viruses. Vaccinia virus.

be enclosed within a single outer shipVaricella virus.

ping container shall not exceed 4,000 Variola major and Variola minor viruses. Vesiculat stomatis viruses, all types.

(c) Dry ice. If dry ice is used as a reWhite poz viruses.

frigerant, it must be placed outside the Yellow fever virus. 2

secondary container(s). If dry ice is (a) Volume not exceeding 50 ml. Mate used between the secondary container rial shall be placed in a securely and the outer shipping container, the closed, watertight container (primary shock absorbent material shall be container (test tube, vial, etc.)) which placed so that the secondary container shall be enclosed in a second, durable does not become loose inside the outer watertight container (secondary con- shipping container as the dry ice subtainer). Several primary containers limates. may be enclosed in a single secondary (d/1) The outer shipping container of container, if the total volume of all the all materials containing etiologic primary containers so enclosed does agents transported in Interstate tramic not exceed 60 ml. The space at the topmust bear a label as illustrated and debottom, and sides between the primary scribed below:

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

[graphic][graphic][subsumed][merged small][graphic][subsumed][merged small]

2) The color of material on which receipt to the sender immediately upon e label is printed must be white, the delivery: mbol red, and the printing in red or

Coccidioides immitis. tite as illustrated.

Ebola virus. 3) The label must be a rectangle Francisella (Pasteurella) tularensis. asuring 51 millimeters (mm) (2 Hemorrhagic fever agents including, but not ches) high by 102.5 mm (4 inches)

limited to, Crimean hemorrhagic fever (Congo), Junin, Machupo viruses, and Ko

rean hemorrhagic fever viruses. 4) The red symbol measuring 38 mm

Herpesvirus simiae (B virus). 5 inches) in diameter must be cen

Histoplasma capsulatum. ted in a white square measuring 51 Lassa virus. n (2 inches) on each side.

Marburg virus. 5) Type size of the letters of label

Pseudomonas mallei. all be as follows:

Pseudomonas pseudomallei.

Tick-borne encephalitis virus complex inlologic agents-10 pt. rev.

cluding, but not limited to, Russian springmedical material-14 pt.

summer encephalitis, Kyasanur forest dis

ease, Omsk Hemorrhagic fever, and Central case of damage or leakage-10 pt. rev.

European encephalitis viruses, Variola tify Director CDC, Atlanta, Georgia-8 pt.

minor, and Variola major.

Variola major, Variola minor, and Whitepox -633-5313—10 pt. rev.


Yersinia (Pasteurella) pestis.3 e) Damaged packages. The carrier all promptly, upon discovery of evi- 872.4 Notice of delivery; failure to rence of leakage or any other damage ceive. packages bearing an Etiologic

When notice of delivery of materials rents/Biomedical Material label, iso

known to contain or reasonably bete the package and notify the Direc

lieved to contain etiologic agents listr, Center for Disease Control, 1600

ed in $72.3(1) is not received by the ifton Road, NE., Atlanta, GA 30333,

sender within 5 days following anticitelephone: (404) 633-5313. The carrier

pated delivery of the package, the all also notify the sender. () Registered mail or equivalent system.

3 This list may be revised from time to ansportation of the following etio

time by Notice published in the FEDERAL gic agents shall be by registered mail

REGISTER to identify additional agents which an equivalent system which requires must be transported in accordance with re: provides for sending notification of quirements contained in $72.3(1).


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