17 
II-H-1. Purified DNA Other Than Plasmids , Bacteriophages , and 
Other Viruses . The Guidelines stipulate that the formation of ENA recom- 
binants from cellular ENAs that have been purified and for which the 
absence of harmful sequences has been established can be carried out 
under lower containment conditions than those required for the corre- 
sponding shotgun experiment. IBC approval is sufficient for such a 
reduction of containment level, except for (i) primate DNA, which 
also requires prior NIH approval, or (ii) any lowering of containment 
to levels below PI + EK1, which also requires prior NIH approval (see 
Section III-A-3-a of the Guidelines) . 
The IBC must notify ORDA in writing of all such actions. Many 
of these notifications will be in the form of a new or revised MUA. 
II-H-2. Characterized Clones of ENA Recombinants . The Guidelines 
permit IBCs to give approval for a single-step reduction in physical or 
biological containment on receipt of evidence of (i) characterization of 
a clone derived from a shotgun experiment and (ii) the absence of harmful 
sequences (see Section III-A-3-b of the Guidelines). IBC approval is 
sufficient for such a reduction except for (i) primate DNA which requires 
prior NIH approval, (ii) any lowering of containment to levels below PI 
+ EK1, which also requires prior NIH approval or (iii) any lowering of 
containment by more than one step in either physical or biological con- 
tainment [see Section III-A-3-b-(2) of the Guidelines)]. The IBC must 
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