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BMBL Appendix C
Transportation and Transfer of Biological Agents
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Biological agents include infectious agents of humans,
plants, and animals, as well as the toxins that may be produced by microbes and by genetic
material potentially hazardous by itself or when introduced into a suitable vector.
Etiologic agents and infectious substances are closely related terms that are found in the
transfer and transportation regulations. Biological agents may exist as purified and
concentrated cultures but may also be present in a variety of materials such as body
fluids, tissues, soil samples, etc. Biological agents and the materials that are known or
suspected to contain them are recognized by federal and state governments as hazardous
materials and their transportation and transfer is subject to regulatory control. Transportation refers to the packaging and shipping of these
materials by air, land, or sea, generally by a commercial conveyance. Transfer
refers to the process of exchanging these materials between facilities. |
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Regulations on the transportation of biological agents
are aimed at ensuring that the public and the workers in the transportation chain are
protected from exposure to any agent that might be in the package. Protection is achieved
through (a) the requirements for rigorous packaging that will withstand rough handling and
contain all liquid material within the package without leakage to the outside, (b)
appropriate labeling of the package with the biohazard symbol and other labels to alert
the workers in the transportation chain to the hazardous contents of the package, c)
documentation of the hazardous contents of the package should such information be
necessary in an emergency situation, and (d) training of workers in the transportation
chain to familiarize them with the hazardous contents so as to be able to respond to
emergency situations. |
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Public Health Service 42 CFR Part 72. Interstate
Transportation of Etiologic Agents. This regulation is in revision to harmonize it
with the other U.S. and international regulations. A copy of the current regulation may be
obtained from the Internet at: http://www.cdc.gov/od/ohs Department
of Transportation. 49 CFR Parts 171-178. Hazardous Materials Regulations.
Applies to the shipment of both biological agents and clinical
specimens. Information may be obtained from the Internet at:
http://www.dot.gov.rules.html
United States Postal Service. 39 CFR Part 111. Mailability of
Etiologic Agents. Codified in the Domestic Mail Manual 124.38: Etiologic Agent
Preparations. A copy of the Domestic Mail Manual may be obtained from the Government
Printing Office by calling 1-202-512-1800 or from the Internet at:
http://www.access.gpo.gov
Occupational Health and Safety Administration (OSHA). 29 CFR
Part 1910.1030. Occupational Exposure to Bloodborne Pathogens. Provides minimal
packaging and labeling requirements for transport of blood and body fluids within the
laboratory and outside of it. Information may be obtained from your local OSHA office or
from the Internet: http://osha.gov
Dangerous Goods Regulations (DGR). International Air Transport
Association (IATA). These regulations provide packaging and labeling requirements for
infectious substances and materials, as well as clinical specimens that have a low
probability of containing an infectious substance. These are the regulations followed by
the airlines. These regulations are derived from the Committee of Experts on the Transport
of Dangerous Goods, United Nations Secretariat, and the Technical Instructions for the
Transport of Dangerous Goods by air which is provided by the International Civil Aviation
Organization (ICAO). A copy of the DGR may be obtained by calling 1-800-716-6326 or
through the Internet at: http://www.iata.org, or http://www.who.org |
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Figure 1 shows the generalized "triple"
(primary receptacle, water tight secondary packaging, durable outer packaging) packaging
required for a biological agent of human disease or materials that are known or suspected
of containing them. This packaging requires the "Infectious Substance" label
shown in Figure 2 on the outside of the package. This packaging must be certified to meet
rigorous performance tests as outlined in the DOT, USPS, PHS, and IATA regulations. Clinical specimens with a low probability of containing an infectious agent
are also required to be "triple" packaged, but performance tests require only
that the package shall not leak after a four-foot drop test. DOT, PHS, and IATA require a
"clinical specimen" label on the outside of the package. |
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Regulations on the transfer of biological agents are
aimed at ensuring that the change in possession of biological materials is within the best
interests of the public and the nation. These regulations require documentation of the
personnel, facilities, and justification of need for the biological agent in the transfer
process and subsequent approval of the transfer process by a federal authority. The
following regulations fit in this category: |
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42 CFR Part 71 Foreign Quarantine. Part 71.54
Etiologic Agents, Hosts and Vectors. This regulation requires an import permit from
the Centers for Disease Control and Prevention for importing etiologic agents of human
disease and any materials, including live animals or insects, that may contain them. An
application and information on importation permits may be obtained by calling
1-888-CDC-FAXX and enter document number 101000 or on the Internet at: http://www.cdc.gov/od/ohs/biosfty/imprtper.html |
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9 CFR Parts 92, 94, 95 96, 122 and 130. These
regulations requires an import permit from the United States Department of Agriculture
(USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services to import
or domestically transfer etiologic agents of livestock, poultry, other animals, and any
materials that might contain these etiologic agents. Information may be obtained at (301)
734-3277, or from the Internet at: http://aphisweb.aphis.usda.gov/ncie. |
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7 CFR Part 330. Federal Plant Pest Regulations;
General; Plant Pests; Soil; Stone and Quarry Products; Garbage. This regulation
requires a permit to import or domestically transfer a plant pest, plant biological agent,
or any material that might contain them. Information can be obtained by calling
301-734-3277 or through the Internet at: http://www.aphis.usda.gov./ppq/ppqpermits.html.
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42 CFR Part 72.6 Additional Requirements for
Facilities Transferring or Receiving Select Agents. Facilities transferring or
receiving select agents must be registered with the CDC and each transfer of a select
agent must be documented. Information may be obtained on the Internet at: http://www.cdc.gov/od/ohs/lrsat.htm |
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Department of Commerce. 15 CFR Parts 730 to 799. This
regulation requires that exporters of a wide variety of etiologic agents of human, plant
and animal diseases, including genetic material, and products which might be used for
culture of large amounts of agents, will require an export license. Information may
be obtained by calling the DoC Bureau of Export Administration at 202-482-4811 or through
the Internet at: http://bxa.fedworld.gov, or http://www.bxa.doc.gov Figures 1 and 2 illustrate the packaging and labeling of infectious
substances and clinical specimens in volumes of less than 50 ml. in accordance with the
provisions of subparagraph 72.3(a) of the regulation on Interstate Shipment of Etiologic
Agents (42 CFR, Part 72). A revision is pending that may result in additional package
labeling requirements, but this has not been issued in final form as of the publication of
this fourth edition of BMBL.
For further information on any provision of this regulation contact:
Centers for Disease Control and Prevention
Attn: External Activities Program
Mail Stop F-05
1600 Clifton Road N.E.
Atlanta, GA 30333
Telephone: (404) 639-7233
FAX: (404) 639-2294
Note that the shipper's name, address and telephone number must be
on the outer and inner containers. The reader is also advised to refer to additional
provisions of the Department of Transportation (49 CFR, Parts 171-180) Hazardous Materials
Regulations. |
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