Effective February 14, 2003, a
new final rule by the U.S. Department of
Transportation ("DOT") will go into
effect, changing the way diagnostic
specimens are defined, classified,
packaged, and transported.
Diagnostic Specimens are now listed as
Hazardous Materials:
"Diagnostic Specimens", previously
exempt from regulation will now be
listed in the Hazardous Material Tables
of Title 49 CFR and will be subject to
the new rules summarized here. These
rules relate to specimens that are
potentially infectious only, and so
formalin-fixed tissues (for example) are
exempted. This document is only a
summary and the complete regulation
should be examined at:
http://www.epa.gov/fedrgstr/EPA-IMPACT/2001/January/Day-22/i92.htm
to ensure accurate interpretation.
Definition of
Diagnostic Specimens:
A Diagnostic Specimen is defined as "any
human or animal material, including
excreta, secreta, blood and its
components, tissue, and tissue fluids
being transported for diagnostic or
investigational purposes, but excluding
live infected humans or animals."
Packaging Required
For Shipment of Diagnostic Specimens: Generally,
unless Diagnostic Specimens are
transported by ‘ground based private or
contract carriers using dedicated
vehicles’, these materials must conform
to the standards listed below. (Note:
these regulations DO APPLY to FedEx and
other commercial shipping companies. The
stringent parcel size limitation in the
section "Diagnostic Specimen Shipments
by Air" below is important for any
company that routinely ships by air.)
Ask your carrier for a copy of the
document "Packing Instruction 650" which
includes additional requirements.
Diagnostic
Specimens must be packaged in triple
packaging consisting of:
A primary
receptacle: Primary receptacles
must be packed in secondary
packaging in such a way that,
under normal conditions of
transport, they cannot break, be
punctured, or leak their contents
into the secondary packaging.
Leak-proof
secondary packaging: Secondary
packaging(s) must be secured in
outer packaging(s) with suitable
cushioning material such that any
leakage of the contents will not
impair the protective properties
of the cushioning material or the
outer packaging. If several
fragile primary receptacles are
placed in a single secondary
packaging, they must be
individually wrapped or separated
so as to prevent contact between
them.
Outer
packaging: The completed package
must be capable of successfully
passing the drop test at a drop
height of at least 1.2 meters (3.9
Feet). (There is no size limit to
parcels containing animal bodies
or body parts.)
The outer
packaging must be clearly and durably
marked with the words "Diagnostic
Specimen".
Liquid
Diagnostic Specimens - must be
packaged where the:
Primary
receptacle is leak-proof with a
volumetric capacity of not more than
500 ml (16.9 ounces)
Absorbent
material of sufficient quantity to
absorb the entire contents of the
primary receptacle(s) is placed
between the primary receptacle and
secondary packaging
Multiple
fragile primary receptacles placed
in a single secondary packaging must
be individually wrapped or separated
so as to prevent contact between
them
Secondary
packaging is leak-proof
Diagnostic
Specimen Shipments by Air
additionally require that:
The primary
receptacle or the secondary
container is capable of withstanding
without leakage an internal pressure
of 95 kpa (14 psi)
The outer
packaging does not exceed 4 L (1
gallon) capacity.
Note: this volume limitation does
not apply to parcels containing
‘animal body parts, whole organs, or
whole bodies even if known to
contain or suspected of containing
an infectious substance’. However,
the outer package must be labeled to
indicate that the contents are
subject to special provision 49CFR
A82.
Training
Requirements:
Persons preparing or transporting
diagnostic specimens "must know about
and be able to apply the requirements
of Sec. 173.199 {Title 49 CFR} to
specific shipments".
