APRIL 27-28-MINUTES OF MEETING 
11 
pharmacologically active agent), the containment conditions 
should be the same as would be used for propagating the natural 
DNA counterpart. 
"If the synthetic DNA sequence codes for a harmless product, 
it may be propagated at the same contairment level as its purified 
natural DNA counterpart. FOr example, a synthetic DNA segment, 
to be propagated in E. coli K-12, which corresponds to a non- 
harmful gene of birds, would require P2 physical containment 
plus an EKl host-vector, or Pi + EK2. 
"If the synthetic DNA segment is not expressed in vivo as a 
polynucleotide or polypeptide product, the organisms containing 
the recombinant DNA molecules are exempt from the Guidelines." 
O. The RAC accepted the expansion of the section on "Fiingal or Similar 
Lower Eukaryotic Host-Vector Systems." The proposed language in 
Attachment II was accepted with one modification. This section, 
including minor suggestions for clarity added by Dr. Gottesman 
after the RAC meeting, would then read: 
"Fungal or Similar Lower Eukaryotic Host-Vector Systems 
"The containment criteria for DNA recombinant experiments using 
these host-vectors most closely resemble those for prokaryotes, 
rather than those for the preceding eukaryotes, since the host 
cells usually exhibit a capacity for dissemination outside the 
laboratory that is similar to that for bacteria. Therefore, the 
procedures established for certification of HV systems other 
than E. coli K-12 (Section II-D-2) will also apply to these 
fungal or similar lower eukaryotic host-vector systems. 
"Cnee approved by NIH, HVl systems may be used under P2 contain- 
ment for shotgun experiments with phages, plasmids, and DNA 
from prokaryotes other than CDC Class 2 agents (footnote), and 
lower eukaryotes that do not produce polypeptide toxins. Other 
classes of reccmoinant DNA experiments with these HVl systems 
will require prior approval and classification by NIH. Should 
HV2 or HV3 systems of this type be developed and approved by NIH, 
guidelines for their use in other types of recombinant DNA 
experiments will also be established." 
P. These concepts were accepted by the RAC, i.e., IBC review and 
& compliance with the standards of the Guidelines would be required 
Q. for all recombinant DNA research at institutions that received 
any NIH funds for reccmbinant DNA research (except, of course, 
for research covered by one of the exemptions from the Guidelines). 
[ 527 ] 
