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necessary if institutions are to comply with the "Guidelines" in a 
timely fashion. Without such time frames, each case must be handled 
in an ad hoc fashion and the opportunity for delay is open ended. 
IV-C-1. EDF's comments on procedures for regulating non-NIH 
funded projects will be discussed in the section of these comments 
dealing with Appendix C. It is EDF's contention that no recombinant 
DNA project at an institution, subject to bhe "Guidelines", should 
begin without NIH certification that the containment levels assigned 
by the IBC are appropriate. 
IV-C-3-a. See section IV-A-2-f of these comments. 
Appendix C 
EDF maintains that no recombinant DNA experiment should be 
initiated or altered until NIH approves the IBC project approval. 
II-E. EDF disagrees with the rationale for limiting NIH oversight 
only to changes in experiments which as a result of the requested change 
require P-4 containment. While EDF agrees that P-4 facilities should 
receive particular NIH attention, EDF is also concerned that if the 
IBC mistakenly assigns a P-4 experiment to another containment level, 
NIH will not be aware of this action until a MUA is forwarded to NIH. 
The potential for harm continues until NIH reviews the MUA. Therefore, 
at the very least NIH should require that all requested changes that 
result in a P-3 or P-4 classification be approved by NIH before work 
is begun. EDF is concerned that all changes in biological material 
used and the physical location of experiments requires the IBC to 
reassess the applicable containment requirements, laboratory design, 
and equipment. This reassessment, raises the possibility of IBC 
error. In addition, the pressure to approve a request for a change 
[A-357] 
