McVicar stated that the CDC may not have the authority to regulate 
animal safety procedures. 
Dr. McVicar proposed the removal of the Appendix B from the NIH 
Guidelines because the CDC has a similar list that forms part of 
their regulation of etiologic agents, and the CDC updates the list. 
It would be useful if all agencies could refer to that list with a 
reference to it in the NIH Guidelines. Dr. Stevenson added that 
the Department of Commerce has classifications ( ECCN 4997B and 
4998B) that contain portions of the list in the NIH Guidelines. He 
emphasized that in order to apply biotechnology regulations 
uniformly, a single list is required. Dr. McVicar agreed, though 
he argued that it may be impossible to design and create an agreed- 
upon mechanism. 
Dr. Atlas argued that the Subcommittee should focus on questions 
for the RAC. He asked if all recombinant DNA molecules should be 
defined as "etiologic agents" for shipping purposes. In addition, 
he asked whether the Subcommittee should recommend the deletion 
from Appendix H of “he statement "shipped only as an etiologic 
agent." Perhaps e Subcommittee could agree upon a new 
definition. Dr ,-.c„as suggested that if the recombinant DNA 
molecule is within a host organism classified as "etiologic," then 
it should be shipped as an "etiologic agent." Nonetheless, the 
question remained on whether for shipping purposes the label 
"etiologic agent" should apply to a recombinant molecule that 
originated in an etiologic agent and had been placed in a non- 
etiologic host organism. Dr. McVicar believed that in the latter 
case, it should be shipped as an "etiologic agent" solely if it has 
expressed etiologic characteristics. 
Dr. McKinney mentioned that the EPA had trouble when it attempted 
to categorize a non-etiologic host organism that included 
recombinant molecules from an etiologic agent as "etiologic." For 
example, although the E. coli K-12 sequence contained recombinant 
DNA molecules from a pathogen, it was not toxic. He suggested that 
the Subcommittee recommend the deletion of "only as an etiologic 
agent" from the preamble of Appendix H. In Section H-I of Appendix 
H, biosafety level (BL) 3 should be handled differently. He asked 
if the citations for BL1 through BL3 in Appendix H-I were 
appropriate. Dr. McVicar stated that the CDC predominantly 
regulated BL3 and BL4. Dr. McKinney described the characteristics 
of the physical containment levels. BL1 is designed for organisms 
that pose no hazard to human health. BL2 is designed for organisms 
that pose moderate potential health hazards to human health, which 
is a very sharp distinction from BL1 . BL3 contains infectious 
agents indigenous to the U.S. that are hazardous to human health. 
BL4 contains exotic infectious agents that are imported into the 
U.S. that are hazardous to human health. In comparison with the 
classes of organisms in Appendix B, Dr. McVicar stated that Class 3 
consisted of infectious agents that could be spread by aerosol. 
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Recombinant DNA Research, Volume 13 
