[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR72.3]



[Page 434-437]

 

                         TITLE 42--PUBLIC HEALTH

 

    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 72_INTERSTATE SHIPMENT OF ETIOLOGIC AGENTS \1\--Table of Contents

 

Sec.  72.3  Transportation of materials containing certain etiologic agents; 

 minimum packaging requirements.



    Notwithstanding the provisions of Sec.  72.2, no person may 

knowingly transport or cause to be transported in interstate traffic, 

directly or indirectly, any material (other than biological products) 

known to contain, or reasonably believed by such person to contain, one 

or more of the following etiologic agents unless such material is



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packaged, labeled, and shipped in accordance with the requirements 

specified in paragraphs (a) through (f) of this section:



                            Bacterial Agents



Acinetobacter calcoaceticus.

Actinobacillus-- all species.

Actinomycetaceae-- all members.

Aeromonas hydrophila.

Arachnia propionica.

Arizona hinshawii-- all serotypes.

Bacillus anthracis.

Bacteroides spp.

Bartonella-- all species.

Bordetella-- all species.

Borrelia recurrentis, B. vincenti.

Brucella-- all species.

Campylobacter (Vibrio) foetus, C. (Vibrio) jejuni.

Chlamydia psittaci, C. trachomatis.

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.

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.

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.

Coxiella burnetii.

Coxsackie A and B viruses--all types.

Creutzfeldt--Jacob agent

Cytomegaloviruses.

Dengue viruses--all types.

Ebola virus.

Echoviruses--all types.

Encephalomyocarditis virus.

Hemorrhagic fever agents including, but not limited to, Crimean 

hemorrhagic fever (Congo), Junin, Machupo viruses, and Korean 

hemorrhagic fever viruses.

Hepatitis associated materials (hepatitis A, hepatitis B, hepatitis 

nonA-nonB).

Herpesvirus--all members.

Infectious bronchitis-like virus.

Influenza viruses--all types.

Kuru agent.

Lassa virus.

Lymphocytic choriomeningitis virus.

Marburg virus.

Measles virus.

Mumps virus.

Parainfluenza viruses--all types.

Polioviruses--all types.

Poxviruses--all members.

Rabies virus--all strains.

Reoviruses--all types.

Respiratory syncytial virus.

Rhinoviruses--all types.

Rickettsia-- all species.

Rochalimaea quintana.

Rotaviruses--all types.

Rubella virus.

Simian virus 40.

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.

Variola major and Variola minor viruses.

Vesicular stomatis viruses--all types.

White pox viruses.

Yellow fever virus. \2\

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    \2\ 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.



    (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



[[Page 436]]



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 

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.

    (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 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). 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: 

[GRAPHIC] [TIFF OMITTED] TC01FE91.049



    (2) The color of material on which the label is printed must be 

white, the symbol red, and the printing in red or white as illustrated.

    (3) The label must be a rectangle measuring 51 millimeters (mm) (2 

inches) high by 102.5 mm (4 inches) long.

    (4) 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.

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



Etiologic agents--10 pt. rev.

Biomedical material--14 pt.

In case of damage or leakage--10 pt. rev.

Notify Director CDC, Atlanta, Georgia--8 pt. rev.

404-633-5313--10 pt. rev.





[[Page 437]]





    (e) Damaged packages. The carrier shall promptly, upon discovery of 

evidence of leakage or any other damage to packages bearing an Etiologic 

Agents/Biomedical Material label, isolate the package and notify the 

Director, Center for Disease Control, 1600 Clifton Road, NE., Atlanta, 

GA 30333, by telephone: (404) 633-5313. The carrier shall 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 spring-summer 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\

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    \3\ This 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 Sec.  72.3(f).

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