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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
Packaging and
Shipping of Biomedical Material
Centers for Disease Control and Prevention
Office of Health and Safety, Biosafety Branch
(Date Last Revised: March 9, 1995)
The regulation that describes the requirements for the
proper packaging and shipping of biomedical material is found in 42
CFR Part 72- Interstate Shipment of Etiologic
Agents. This regulation has been the responsibility of the Public
Health Service since 1971 when the authority for governing the interstate
shipment of etiologic agents was delegated to CDC. The regulation
now in effect was published in 1980. It is currently in the process
of being revised and you will be notified of any changes when they
become law. It is the intent of the regulation that biomedical material
that may contain etiologic agents will be packaged and shipped in
such a way that the contents will not leak and will arrive in good
condition. What follows is a set of instructions extracted from the
regulation.
Any questions should be directed to the Office
of Health and Safety in Atlanta at 404 639-3235,
or Fax 404 639-2294.
Definitions
Biomedical materials that are known to contain, or could
contain, etiologic agents are divided into two groups:
- "Diagnostic specimens and biological products"
on the one hand and
- "materials containing certain etiologic agents"
on the other.
The former are packaged according to Part 72.2 and the latter
according to Part 72.3.
"Etiologic agent" means a
viable microorganism or its own toxin that causes, or may cause, human
disease.
"Diagnostic specimen" means
excreta, secreta, blood and its components, tissue, tissue fluids,
etc., "which (the shipper) reasonably believes may contain an
etiologic agent" and that is "being shipped for purposes
of diagnosis."
"Biological product" means
a product prepared in accordance with regulations that govern the
manufacture of vaccines, reagents, etc.
"Materials containing certain etiologic
agents" means "material known to contain or reasonable
believed (by the shipper) to contain" an etiologic agent from
a list included in the regulation. The list contains most of the Class
2, 3, and 4 agents but any etiologic agent should be handled according
to the regulation even if it is not on the list. Patient specimens
that would be expected to contain an etiologic agent should be shipped
according to the requirements in Part 72.3.
"Interstate" shipping is
interpreted to include intrastate shipping.
Packaging of diagnostic specimens and biological
products (42 CFR Part 72.2)
Such material must be "packaged to withstand leakage
of contents, shocks, pressure changes, and other conditions incident
to ordinary handling in transportation." This should be interpreted
to mean that the contents should not leak to the outside of the shipping
container, even if there should be leakage of the primary container(s)
during transit, unless the package is severely damaged, e.g., like
being run over by a transport vehicle. These packages should, on the
other hand, withstand rough handling and passage through cancellation
machines, sorters, conveyors, etc.
Packaging of materials containing.... etiologic
agents (42 CFR Part 72.3)
- A.
- There are two sets of instructions for this material, depending
upon the volume shipped.
- 1.
- Volume not exceeding 50 ml.:
-
- (a)
- The material to be shipped shall be placed in a securely
closed, watertight tube, vial, ampule or the like that is
referred to as primary container.
- (b)
- The primary container is then placed in a durable watertight
container referred to as the secondary container.
- (c)
- Several primary containers can be placed in a single secondary
container, so long as total contents of the primary containers
does not exceed 50 ml.
- (d)
- Absorbent material must be placed in the space at top,
bottom, and sides between the primary and secondary containers.
There must be enough absorbent material to absorb the entire
contents of the primary container(s) in case of breakage
or leakage and should not be nonparticulate, i.e., not sawdust,
vermiculite, etc.
- (e)
- Each set of primary and secondary containers is then placed
in an outer shipping container constructed of corrugated
fiberboard, cardboard, wood, or other material of equivalent
strength. This means that most, if not all, bags, envelopes,
and the like are not acceptable outer shipping containers.
- 2.
- Volume greater than 50 ml.:
- Packaging of these larger volumes of material must comply
with all of the foregoing requirements, but 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 outer shipping container.
- (b)
- Single primary containers shall not contain more than
1,000 ml of material, however two or more primary containers,
whose volumes do not exceed 1,000 ml, may be placed in a
single secondary container.
- (c)
- The maximum amount of etiological agent that may be enclosed
within a single outer shipping container may not exceed
4,000 ml.
- B.
- If dry ice is used, it must be placed between the secondary container(s)
and the outer shipping container and the shock absorbent material
placed so that the secondary container(s) do not become loose within
the outer shipping container as the dry ice sublimates.
- C.
- A special label, illustrated on page 3, must be placed on the
outer shipping container. This label identifies the package as containing
etiologic agents and directs anyone observing damage to the package
of leakage of contents to call CDC.
- D.
- The regulation also contains a list of etiological agents that
require special handling in addition to that stated above. These
are, by and large, Class 3 and Class 4 agents. The requirement is
that they be shipped by "registered mail or an equivalent system
which requires or provides for sending notification of receipt to
the sender immediately upon delivery."
When this notice of receipt is not received "within
5 days following anticipated delivery" the sender must notify CDC.
Biosafety Branch
(404) 639-3235
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