194 
officer to medical records, but these presumably would be records that were — 
the histories of which were taken by a medical person, not the biological 
safety officer. 
DR. FREDRICKSON: Mr. Hutt. 
MR. HUTT: Could you briefly describe the procedure that you have used 
in certification of the EK2 system in 1976 that you mentioned? 
DR. WALTERS: Well, the procedure is spelled out in the previous Guide- 
lines, and perhaps "spelled out" is stating it too strongly. The procedure 
mentioned in the 1976 Guidelines is that certification is the responsibility 
of the Recombinant Advisory Committee. From the beginning, expert sub- 
committees — 
MR. HUTT: I wonder if I could ask the question this way. Was there 
an application filed with the Committee? Was that application made public? 
Was public notice of a meeting to consider the application given in the 
Federal Register? Was it done in an open meeting? Were interested people 
invited to attend and give their comments? Was that in fact accomplished? 
That is the kind of procedure I am interested in, in finding out what 
happened . 
DR. WALTERS: All right. There was always a technical subcommittee who 
considered any application. In fact, there were two technical subcommittees, 
one for plasmid host-vector systems, and one for bacteriophage host-vector 
systems. Those groups met, and when their meetings were in Washington they 
were certainly de facto open to the public; I don't think there was any public 
announcement of the meetings to the technical subcommittees. 
These applications were then always considered at a publicly announced 
meeting of the full Committee. The fact that an EK2 application was going to 
be considered was not explicitly mentioned in the announcement of the meeting. 
And then, of course, the next step was the Director of the NIH, and his own 
review of the proposal for certification. 
MR. HUTT: Thank you. 
MS. KING: I would like to ask a point of clarification. Does the 
assurance filed with NIH cover non-Government funded research, which it would, 
for example, in the human research area, the experimentation on human subjects 
area? 
DR. FREDRICKSON: Ms. King, I missed the first part of your question. 
MS. KING: Does the assurance filed with NIH also apply to non-Government 
funded research, as it does in the human experimentation area? 
DR. FREDRICKSON: There is no regulation as there is in the instance 
of human experimentation, as you are now aware, which would so automatically 
make that assumption. 
[ 398 ] 
