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(c) Uses for which nonhuman primates porter to establish that the recipient may be imported and distributed. Live would use the primates solely for the nonhuman primates may be imported permitted purposes. The records shall into the United States and sold, resold, be maintained in an organized manner or otherwise distributed only for bona in a central location at or in close fide scientific, educational, or exhi- proximity to the importer's primate bition purposes. The importation of holding facility. The records shall be nonhuman primates for use in breeding maintained for a period of 3 years and colonies is also permitted provided shall be available for inspection by the hat all offspring will be used only for Director at any time. cientific, educational, or exhibition (2) Importers shall report to the Diurposes. The maintenance of rector by telephone within 24 hours the sonhuman primates as pets, hobby, or occurrence of any illness in nonhuman n avocation with occasional display to primates that is suspected of being yelhe general public is not a permissible low fever, monkeypox, or Marburg/ se.
Ebola disease. (d) Registration of importers. (1) Im- (3) Importers also shall report to the orters of nonhuman primates shall Director by telephone within 24 hours gister with the Director in a manner the occurrence of illness in any memrescribed by the Director.
ber of their staff suspected of having an (2) Documentary evidence that an infectious disease acquired from aporter will use all nonhuman prima- nonhuman primates. 8 solely for the permitted purposes 18 (1) Disease control measures. Upon required.
ceipt of evidence of exposure of (3) Registration shall inlcude certifi- nonhuman primates to commution that the nonhuman primates nicable disease that may constitute a Ill not be shipped, sold, or otherwise threat to public health, the Director ansferred to other persons or organi- may provide for or require examinations without adequate proof that tion, treatment, detention, isolation, e primates will be used only for the seizure, or destruction of exposed anirmitted purposes.
mals. Any measures required shall be (4) Registration shall be for 2 years, at the owner's expense. fective the date the application for (8) Disposal of excluded nonhuman prigistration is approved by the Direc- mates. Nonhuman primate(s) excluded r.
from the United States by provisions of (5) Registration may be renewed by this section shall, at the owner's op ing a registration application form tion and expense, be exported, deIth the Director not less than 30 days stroyed, or given to a scientific, eduor more than 60 days before expira- cational, or exhibition facility under on of the current registration.
arrangements approved by the Direc(e) Recordkeeping and reporting re- tor. If the owner fails to dispose of the uirement for registered importers. (1) Im- nonhuman primate by one of the aprters shall maintain records on each proved options or fails to select a uipment of imported nonhuman pri- method of disposal within 7 days, the ates received. The record on each Director will select the method of disuipment shall include the number of posal. Pending disposal, the nonhuman imates received, species, country of primate(s) shall be detained at the igin, date of importation, the number owner's expense in custody of the U.S. I primates in the shipment that die Customs Service at the U.S. port. ithin 90 days after receipt, and (h) Revocation of an importer's registraLuse(s) of deaths. If any primates in tion. (1) An importer's registration may he shipment are sold or otherwise dis- be revoked by the Director, upon noibuted within 90 days after receipt, tice to the importer holding such reghe record shall include the number of istration, if the Director determines rimates in each shipment or sale, the that the importer has failed to comply ates of each shipment or sale, and the with any applicable provisions of this dentity of the recipients. In addition, section. The notice shall contain a he record shall contain copies of docu- statement of the grounds upon which nents 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 871.35 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 a hearing with respect to the revoca
a tion 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
ETIOLOGIC AGENTS 1 to the Director for decision based on the written record. The failure both to file an answer and to request a hearing
72.1 Definitions. shall be deemed to constitute consent
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; failure to receive. be served on the importer.
72.5 Requirements; variations. (5) An importer's registration which AUTHORITY: Sec. 215, 58 Stat. 690, as amendhas been revoked may be reinstated by
ed, 42 U.S.C. 216; sec. 361, 58 Stat. 703, ( the Director upon inspection, examina
U.S.C. 264). tion of records, conference with the im- SOURCE: 45 FR 48627, July 21, 1980, unlese porter, and receipt of information and
otherwise noted. assurances of compliance with the re
$72.1 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 313 (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 371.34 Etiological agents, hosts, and
limited to, excreta, secreta, blood and vectors. (a) A person may not import into the
The requirements of this part are in addiUnited States, nor distribute after im
tion to and not in lieu of any other packarportation, any etiological agent or any
ing or other requirements for the transpor arthropod or other animal host or vec
tation of etiologic agents in interstate that
fic prescribed by the Department of Transtor of human disease, or any exotic living arthropod or other animal capable
portation and other agencies of the Federal Government.
its components, tissue, and tissue quids 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 lny 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 1 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. 72.2 Transportation of diagnostic
specimens, biological products, and other materials; minimum packag
ing requirements. No person may knowingly transport 'cause to be transported in interstate affic, directly or indirectly, any marial including, but not limited to, dimnostic specimens and biological 'oducts which such person reasonably olieves may contain an etiologic fent unless such material is packaged * withstand leakage of contents, locks, pressure changes, and other inditions incident to ordinary haning in transportation. 12.3 Transportation of materials con
taining certain etiologic agents;
minimum packaging requirements. Notwithstanding the provisions of 12.2, no person may knowingly transort or
cause to be transported in iterstate 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 (1) of his section: F
Arizona hinshawii-all serotypes.
jejuni. Chlamydia psittaci, C. trachomatis. Clostridium botulinum, a. chauvoei, Ci.
haemolyticum, Ci. histolyticum.Cl. novyi, Ci.
septicum, Ci. tetani. Corynebacterium diphtheriae, C. equi, C.
haemolyticum, C. pseudotuberculosis, C.
pyogenes, C. renale. Edwarsiella tarda. Erysipelothrix insidiosa. Escherichia coli, all enteropathogenic
serotypes. 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. Morarella-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 Adenoviruseshuman-all types. Arboviruses all types. Coriella burnetii. Coxsackie A and B viruses all types. Creutzfeldt-Jacob agent Cytomegaloviruses. Dengue viruses-all types. Ebola virus.
leats 3 pacus 164-sona.
2:a sersa Thoses yes. BLOrrides. Toes. Prises. nerders. Rabieg tirik 22:18 B.1894. yes Reagi:32017 17:07: TIN. Reacts: yes Rockett. species. Rescisionon puzzana. Rotari: 13-ypes. Ribeira na 9.6.20 840 Tick-borne encepea is 33 compiez, ta
ciodisą Rasatan spr-2-41mmer eccecos11*ia, Kyasaca forest disease. Orsk bemortado lever, and Cecral European encephalisia viruses. Vaccinia virus. Variceila virus Variola major and Variola minor viruses. Venicalar stor.atla virises all types. White Doz viruses. Yellow fever virus.
(2) 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 80 enclosed does not exceed 50 ml. The space at the top, bottom, and sides between the primary
and secondary containers shall contain suicient conparticulate absorbent matarai ie... paper towel) to absorb she annire contents of the primary containers) in case of breakage or easage. Each set of primary and secondary containers shall then be enciased in an outer shipping container constricted of corrugated fiberboard, caribcari, wood, or other material of equivaient strength.
(bu Voimme greater than 50 ml. Packaging of natertal in volumes of 50 ml. or more shall comply with requirements specized in paragraph (a) of this sec- ! t100. In addition, a shock absorbent material, in volume at least equal to that of the absorbent material between the primary and secondary containers, sball be placed at the top. bottom, and sidies 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 shipping 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). I 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.
(dX(1) The outer shipping container of all materials containing etiologic agents transported in interstate trafic must bear a label as illustrated and de scribed below:
*This 118t may be revised from time to time by Notice published in the FEDERAL RUOTER to identify additional agents which must be packaged in accordance with the requirements oontained in this part.
(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. nite as illustrated.
Ebola virus. (3) The label must be a rectangle Francisella (Pasteurella) tularensis. easuring 51 millimeters (mm) (2 Hemorrhagic fever agents including, but not ches) high by 102.5 mm (4 inches) limited to, Crimean hemorrhagic fever ng.
(Congo), Junin, Machupo viruses, and Ko(4) The red symbol measuring 38 mm
rean hemorrhagic fever viruses.
Herpesvirus simiae (B virus). 5 inches) in diameter must be cen- Histoplasma capsulatum. red in a white square measuring 51 Lassa virus. en (2 inches) on each side.
Marburg virus. (5) Type size of the letters of label
Pseudomonas mallei. all be as follows:
Tick-borne encephalitis virus complex inHologic agents 10 pt. rev.
cluding, but not limited to, Russian springomedical material-14 pt.
summer encephalitis, Kyasanur forest discase of damage or leakage-10 pt. rev.
ease, Omsk Hemorrhagic fever, and Central
European encephalitis viruses, Variola otify Director CDC, Atlanta, Georgia-8 pt.
minor, and Variola major.
Variola major, Variola minor, and Whitepox 1-633-5313—10 pt. rev.
Yersinia (Pasteurella) pestis.S (e) Damaged packages. The carrier all promptly, upon discovery of evi- 872.4 Notice of delivery; failure to reence of leakage or any other damage ceive. - packages bearing an Etiologic
When notice of delivery of materials gents/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 lifton 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. (1) Registered mail or equivalent system.
This list may be revised from time to ransportation of the following etio
time by Notice published in the FEDERAL gic agents shall be by registered mail REGISTER to identify additional agents which ran equivalent system which requires must be transported in accordance with rer provides for sending notification of quirements contained in $72.3(1).