12 
discuss Che approach to revision and to assign portions of the Guidelines 
for redrafting. Then we met again several weeks later to consider our 
drafts, and the combined draft was then circulated to the full Recombinant 
DNA Committee for its May 1977 meeting. However, at that meeting the dis- 
cussion and agreement as to the proposed revisions were not quite reached, 
so another meeting was held in June of 1977, last June, and a consensus then 
reached, and the draft prepared over the summer by ORDA and given to Dr. 
Fredrickson in September, as you have heard. 
I think it is interesting to remember that the subcommittee began to 
approach revision during a very cold winter here in the East, and I think some 
of us felt a very chilly winter in Washington in regard to the likelihood of 
a fairly extensive legislation concerning this technology. As the winter 
progressed, there was, in our minds, increasing evidence and an increasing 
number of opinions that suggested to most of us that the potential hazards 
of this technology had been somewhat overestimated. I think by June all of 
us were comfortable with certain reductions in some of the suggested con- 
tainment levels in the previous Guidelines. You will be hearing about this 
in the next two days. I personally feel that subsequent data have borne out 
this conclusion. 
Now, I just have a few words to say in regard to the introduction, and 
I will speak for a moment particularly about the definition, rather than 
Dr. Helinski, as you just heard. 
At the time we began to work on the revisions, there were a number of 
new definitions circulating around the country, new proposed definitions. 
Ours, I think, started off to reflect a definition that was proposed for 
some of the legislation then in process, and it has evolved somewhat from 
that. We think it is a workable definition, although I think many of you 
may feel that it was clearly written by a committee. Indeed it was. 
The proposed new definition primarily intends to suggest the exclusion 
of certain types of work from the Guidelines and therefore from possible 
regulation. We would propose to exclude work with naked DNA, feeling that 
this is not hazardous and that it is only conceivably hazardous in a live 
organism. We would also propose in this definition to exclude from the 
Guidelines, and from possible regulation, recombinant DNA which is a combi- 
nation of two DNAs , each of which can naturally replicate in an organism. 
We believe that there has been ample opportunity in such a case for natural 
recombination between these two DNAs, and that they are not novel and not 
hazardous . 
Now, to suggest how this might be dealt with operationally, we took 
the tack of suggesting that there be formed a list of non-novel DNA com- 
binations which would then be excluded from the Guidelines. We took this 
point of view so that an investigator could not start using a potentially 
hazardous combination which nobody knew about, but rather he would have to 
use — without being subject to the Guidel ines--he would have to use combina- 
tions that had already specifically been placed upon a list. 
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