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The packaging methods have demonstrated containment capability. 
The methods have been extensively evaluated and shown to prevent 
leakage to the environment under rough -handling test conditions specified 
in DOT 49 CFR 173. 387 (16, 17) and under severe impact tests (e.g., 
impact on concrete at 90 miles per hour) (17). 
The packaging methods described in the Guidelines have been 
extensively employed for the shipment of highly infectious etiologic 
agents. There are no known cases of infectious disease having been 
transmitted to personnel involved in handling packaged material during 
shipment (8) . The required use of these packaging methods should 
reduce significantly any potential for leakage of recombinant DNA 
materials during shipment and for subsequent harm to the public health 
or environment. 
It is true that the labelling requirements specified in PHS 42 CFR 
72.2 5 are to be used only for "viable recombinant DNA materials in 
which any portion of the material is derived from a listed etiologic 
agent. " This limitation is based on an interpretation that PHS 42 CFR 
72.2 5 precludes the use of the label on materials not containing any 
portion of a listed etiologic agent. 
Since the label cannot be uniformly used at this time, a problem in 
surveillance during shipment is created for some recombinant DNA 
materials. The primary benefit of the label is that in the event of 
damage to the package or leakage during shipment, the Center for 
Disease Control (CDC) is notified immediately. The CDC would then 
initiate appropriate action to deal with the particular situation. This 
action may involve simply providing guidance for decontamination, or 
may involve more elaborate precautionary procedures, depending on 
the situation. The response mechanism provided by CDC, however, 
is not now available for some recombinant DNA materials that may be 
shipped. 
Although the possibility for leakage is remote, a uniform program 
for labelling and notification of CDC in the event of any problem during 
shipment is important. The Department of Transportation and the Center 
for Disease Control are considering amending Federal regulations 
governing transportation of etiologic agents to extend the coverage of 
those regulations to a number of presently excluded substances, such 
as recombinant DNA materials. The NIH will encourage these agencies 
to require labelling of all recombinant DNA materials. 
