Dr. Donald S. Fredericks on 
Page -2- 
August 25 y 1978 
My first recommendation for remedying this situation is to return to 
the original ideas of the conferees at Asilomar and elsewhere y and delegate 
the responsibility for all enforcement of the recombinant-DNA guidelines to 
the local Institutional Biosafety Cormittees (IBC's). I know y from con- 
versations with Dr. Paul Berg y that this is exactly what he and most of the 
other scientists at Asilomar had in mind , rather than regulation of indi- 
vidual investigators from Washington. The NIH Office of Recombinant DNA 
Activities (ORDA) has no way of knowing , in fact y if the experiments being 
performed y or the facilities in use , bear any resemblance to their descrip- 
tions in the MBA. The central ORDA could use its time much more profitably 
in simply insuring that the various IBC’s were doing their fobs satisfactorily. 
This would include such factors as making sure that the committee membership 
was adequate for its job y and receiving periodic reports from the cormittee 
on recombinant-DNA work which it was regulating. Although a system of this 
type would seem to be the simplest and best way of enforcing the guidelines y 
I do not expect it to be adopted. Experience would indicate that while the 
number of forms required by a government organization increases periodically y 
it almost never decreases . The burden of the MUA y adding little or nothing 
to safety but much to inconvenience , will probably be with us for a long 
time. 
As a secondary recommendation y therefore y I would urge that you at 
least consider removing the most obviously unnecessary requirement in this 
area y namely y that a completed MU A must accompany every grant application 
involving recombinant DNA before the application will be reviewed. Since 
the majority of grant applications in this area y as any other area y do not 
result in a funded project y no recombinant-DNA experiments are ever per- 
formed as a result , and the time and effort which go into all these MUA's 
are totally wasted. Secondly y real compliance with this rule is almost 
never possible for new projects y for the following reasons: in order for 
an IBC really to be able to evaluate a proposed project y they must have the 
completed grant application before them. Rowever y it is well known that 
most grant applications are not completed until just before the deadline 
date y and it is unlikely that the committee will be meeting at exactly that 
time y or even within a short time thereafter. If the MUA is submitted with 
the grant application y then y the thoroughness of evaluation by the IBC is 
somewhat questionable y at best. Finally y the review process for NIH grants 
has been stretched out to such interminable lengths (7 to 10 months y at 
best) , that even if an application eventually is funded y the MUA originally 
submitted will be so old that a new one will have to be submitted before 
beginning work on the project. Most of this unnecessary effort could be 
avoided by requiring only that an approved MUA must be on file with ORDA 
before any experiments involving recombinant DNA could begin. The choice 
of whether to submit the MUA early y and have it approved before the 
activation of the grant y or to wait until a project was funded y would then 
be left to the investigator . This procedure would involve neither any -risk 
to public health or safety y nor the delegation of any enforcement authority 
now held by ORDA. 
I am sure you realize that continued compliance with the letter and 
spirit of the recombinant-DNA guidelines depends to a large extent on the 
[A-51] 
