cultures. Dr. McKinney questioned whether the RAC should address 
the problems associated with plants and animals. 
Regarding shipment. Dr. McVicar added that the Federal Regulations 
for Interstate Shipment of Etiologic Agents in 42 CFR, Section 72, 
regulated solely cultures and was limited to concerns for human 
health under the Public Health Act. While it could be expanded to 
cover plants and animals, no such expansion was planned at this 
time. In earlier drafts of CDC regulations, "etiologic agents" 
were defined as "biological agents of recombinant forms," a label 
that CDC later deleted. Dr. Langston said that the Department of 
Agriculture's quarantine laws covered plants and animals. 
Dr. Cushmac stated that the Department of Transportation now 
regulates shipments exclusively from the perspective of human 
health. The DOT definition of "etiologic agent," in the Department 
of Transportation's Hazardous Materials Regulations in 49 CFR, 
Section 173.386 AI , is: "a viable microorganism or its toxin, which 
causes or may cause human diseases and is limited to those agents 
listed in 42 CFR, section 72.3, of the Department of Health and 
Human Services regulations." The Department of Transportation has 
proposed, in 53 FR 45525, on November 10, 1988, to add to this 
definition: "any agent that poses a degree of hazard similar to 
those agents." This change had been proposed in part because the 
HIV virus is not included in the CDC list. 
According to Dr. Cushmac, the Department of Transportation defers 
to the CDC and certain other groups on technical questions. For 
example, if the American Type Culture Collection states that a 
shipment has failed to meet standards described in the NIH 
Guidelines or other regulations, the Department of Transportation 
would defer to their expertise, particularly in the case of 
exemptions. In Department of Transportation regulations, the 
shippers are responsible for knowing that their shipping materials 
are hazardous and must ship them under the appropriate safety 
guidelines. Private carriers can refuse to ship items regardless 
of what the regulatory agencies say. Dr. Stevenson stated that 
carriers have often refused to transport packages labelled 
"etiologic agents" on the assumption that they are hazardous. Dr. 
Langston mentioned that commercial carriers handle etiologic agents 
according to their own standards. 
Dr. Stevenson asked how the Subcommittee should define "viable." 
On the one hand, it could include solely living, or acting, agents. 
On the other hand, it could also incorporate freeze-dried, inactive 
agents. Dr. McVicar said that the CDC doesn't employ the category 
"viable" because it was too restrictive. If an organism is capable 
of causing disease, it should be included under the definition of 
"etiologic." The CDC prefers to use "microbiological agent." Dr. 
Stevenson stated that, under fortuitous and appropriate conditions, 
a freeze-dried virus could become re-activated. 
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