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CDC is in the process of
revising our Transportation Regulation (42 CFR 72: Interstate Shipment
of Etiologic Agents) to unify with other federal regulations.
For information on the transportation of etiologic agents (infectious
substances) and related materials, such as diagnostic specimens, please
refer to regulations issued in the Department of Transportation (DOT)
final rule "Hazardous
Materials - Revision to Standards for Infectious Substances"
(67 FR 53118, August 14, 2002). The rule revises definitions, packaging,
and other shipping requirements for infectious substances under the Hazardous
Materials Regulations (49 CFR Part 171-178) to make them more consistent
with requirements in international standards and incorporate former agency
exemptions.
For more information,
please contact the DOT's Hazardous Materials Information Center at 1-800-467-4922
from 9:00 a.m.-5:00 p.m. Eastern time, Monday-Friday, except federal holidays.
For information on
the new DHHS and USDA Select Agent programs, please refer to the following
websites:
For Department of Health and Human Services (DHHS) Regulations see:
http://www.cdc.gov/od/sap/and
http://www.cdc.gov/OD/sap/docs/42cfr73.pdf
For US Department of Agriculture (USDA) Regulations see:
http://www.aphis.usda.gov/vs/ncie/bta.html
and http://www.cdc.gov/OD/sap/docs/btarule.pdf
Interstate Shipment of Etiologic Agents
42 CFR Part 72
Federal Register, Vol. 45, No. 141-Monday, July 21, 1980.
Part 72-Interstate Shipment of Etiologic Agents 1
Centers for Disease Control and Prevention
Office of Health and Safety
Biosafety Branch
(Date Last Rev'd: March 9, 1995)
1 The requirements
of this part 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.
Sec.
- 72.1 Definitions
- 72.2 Transportation of diagnostic
specimens, biological products, and other materials; minimum packaging
requirements.
- 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 amended. 42 U.S.C. 216; sec.
361, 58 Stat. 703, (42 U.S.C 264)
§72.1 Definitions
As used in this part: "Biological product" means a biological
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 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 transportation which is entirely within a State
or possessions, [a] from a point of origin in any State or possession
to a point of destination in any other State or possession, or [b]
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.
§72.2 Transportation of diagnostic
specimens, biological products, and other materials; 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 which such person
reasonably believe may 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.
§72.3 Transportation of materials
containing certain etiologic agents; minimum packaging requirements.
Notwithstanding the provisions of §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 packaged, labeled, and shipped in accordance with the requirements
specified in paragraphs [a]-[f] of this section:
Bacterial Agents |
Acinetobacter calcoaceticus. |
Leptospira interrogans - all serovars. |
Actinobacillus - all species. |
Listeria - all species. |
Actinomycetaceae - all members. |
Mimae polymorhpa. |
Aeromonas hydrophilia. |
Moraxella - all species. |
Arachnia propionica. |
Mycobacterium - all species. |
Arizona hinshawii - all serotypes. |
Mycoplasma - all species. |
Bacillus anthracis. |
Neisseria gonorrhoeae, N. meningitidis. |
Bacteroides spp. |
Nocardia asteroides. |
Bartonella - all species. |
Pasteurella - all species. |
Bordetella - all species. |
Plesiomonas shigelloides. |
Borrelia recurrentis, B. vincenti. |
Proteus - all species. |
Brucella - all species. |
Pseudomonas mallei. |
Campylobacter (Vibrio) foetus, C. (Vibrio)
jejuni. |
Pseudomonas pseudomallei. |
Chlamydia psittaci, C. trachomatis. |
Salmonella - all species and all serotypes. |
Clostridium botulinum, Cl. chauvoei,Cl. haemolyticum,
Cl. histolyticum,Cl. novyi, Cl. septicum, Cl. tetani. |
Shigella - all species and all serotypes. |
Corynebacterium diphtheriae, C. equi,C. haemolyticum,
C. pseudotuberculosis,C. pyogenes, C. renale. |
Sphaerophorus necrophorus. |
Edwarsiella tarda. |
Staphylococcus aureus. |
Erysipelothrix insidiosa. |
Streptobacillus moniliformis. |
Escherichia coli, all enteropathogenic
serotypes. |
Streptococcus pneumoniae. |
Francisella [Pasteurella] Tularensis. |
Streptococcus pyogenes. |
Haemophilus ducreyi, H. influenzae. |
Treponema careteum, T. pallidum, and T. pertenue. |
Klebsiella - all species and all serotypes. |
Vibrio cholerae, V. parahaemolyticus |
Legionella - all species and all Legionella-like
organisms. |
Yersinia (Pasteurella) pestis,Y. enterocolitica. |
|
|
Fungal Agents |
Blastomyces dermatitidis. |
Histoplasma capsulatum. |
Coccidioides immitis. |
Paracoccidioides brasiliensis. |
Cryptococcus neoformans. |
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Viral and Rickettsial Agents
|
Adenoviruses - human - all types. |
Measles virus. |
Arboviruses - all types. |
Mumps virus. |
Coxiella burnetii. |
Parainfluenza viruses - all types. |
Coxsackie A and B viruses - all types. |
Polioviruses - all types. |
Creutzfeldt - Jacob agent. |
Rabies virus - all strains. |
Cytomegaloviruses. |
Reoviruses - all types. |
Dengue viruses - all types. |
Respiratory syncytial virus. |
Ebola viruses. |
Rhinoviruses - all types. |
Echoviruses - all types. |
Rickettsia - all species. |
Encephalomyocarditis virus. |
Rocha limaea quintana. |
Hemorrhagic fever agents including , but
not limited to, Crimean hemorrhagic fever (Congo), Junin, Machupo
viruses, and Korean hemorrhagic fever viruses. |
Rotaviruses - all types.
Rubella virus.
Simian virus 40. |
Hepatitis associated materials (hepatitis A,
hepatitis B, hepatitis nonA-nonB). |
Tick - borne encephalitis virus complex, including
Russian spring-summer encephalitis, Kyasanur forest disease,
Omsk hemorrhagic fever, and Central European encephalitis viruses.
|
Herpesvirus - all members. |
Vaccinia virus. |
Infectious bronchitis - like virus. |
Varicella virus. |
Influenza viruses - all types. |
Variola major and Variola minor viruses |
Kuru agent. |
Vesicular stomatis viruses - all types |
Lassa virus. |
White pox viruses. |
Lymphocytic choriomeningitis virus. |
Yellow fever virus.2
|
Marburg virus. |
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 should 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[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 place
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 place 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 place so that the secondary container does nor 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:
[2] The color of material on which the label is printed must be white,
symbol red, and the printing in red or white as illustrated.
[3] The label must be a rectangle measuring 51 millimeters (mm) [2
inches] by 10.25 mm [4 inches] long. 1
[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 the 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
[e] Damaged packages.
The carrier shall promptly, upon discovery of evidence of leakage
or any other damage to packages bearing Etiologic Agents/Biomedical
Material label, isolate the package and notify the Director, Centers
for Disease Control and Prevention, 1600 Clifton Road, N.E., Atlanta,
Georgia 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 the 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 major and Variola minor and White pox viruses.
- Yersinia (Pasteurella) pestis
§72.4 Notice of delivery;
failure to receive.
When notice of delivery of materials known to contain etiologic agents
listed in 72.3[f] is not received by the sender within 5 days following
the anticipated delivery of the package, the sender shall notify the
Director, Centers for Disease Control and Prevention, 1600 Clifton
Road, N.E., Atlanta, Georgia 30333, by telephone (404) 633-5313.
§72.5 Requirements; variations.
The Director, Centers for Disease Control and Prevention, may approve
variations from the requirements of this section if, upon review and
evaluation, it is found that such variations provide protection at
least equivalent to that provided by compliance with the requirements
specified in this section and such findings are made a matter of official
record.
US Department of Health and Human Services
Public Health Service
Centers for Disease Control and Prevention
Atlanta, Georgia 30333
Telephone: (404) 639-3235
Effective August 20,1980
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