24 
in the background material to the Guidelines include what were at the time 
unpublished articles, informal reports from conferences, letters, and other 
documents which have not been submitted to traditional means of scientific 
review nor to public debate. 
The fact that the NIH Advisory Committee gained access to new infor- 
mation and used it in developing the new Guidelines without securing outside 
comment while decisions were being made makes a mockery of public partici- 
pation in this process. As a result, many of the changes seem arbitrary 
and baffling, even to those of us who, for some reason or another, follow 
this issue. If the NIH is committed to getting public input, it must equip 
the public with the data its own Advisory Committee used to justify its 
decisions . 
I find it ironic that while the NIH requires rigor in establishing 
proof from its grantees, it should settle for less in its own operation. 
And while intelligent evaluation of new information may have characterized 
the meetings of the Advisory Committee, NIH, by presenting the Guidelines 
as a fait accompli with no indications of the reasoning behind the revisions, 
is undermining the principles of informed democratic decision-making. 
Essentially we have no inkling as to how the Committee reached its 
decisions. I quote one example from the background document. It says, 
"There are categories of experiments for which the containment levels are 
specifically mandated in the 1976 Guidelines, but for which some discretion 
is permitted in the proposed revision." What does that mean? The logic 
and justification for such discretion should be matters for discussion by a 
wide range of individuals and not confined to an advisory committee whose 
composition and scope is not representative of the various positions and 
perspectives on this issue. 
One of the changes which to me doesn't have adequate justification 
is included in the introduction, and that concerns the definition of recom- 
binant DNA. And while I am not going to go into detail — I am going to leave 
that to some of the more scientifically oriented people who are going to 
testify — I still would like to make the point that while it may be reasonable 
to make a list of non-novel and non-hazardous organisms, we must always focus 
not on proving or protecting non-novelty, but on insuring safety of these 
organisms. That is a key. 
I will confine my remarks to the introduction. One other point that 
I think should be changed is the last paragraph in the introduction where 
it is urged that all publications dealing with recombinant DNA include a 
description of the physical and biological containment procedures employed. 
I think this should be made a little more explicit by the Advisory Com- 
mittee — not just urged, but required — because I think it is a very important 
process to get people to follow the Guidelines and to explain how they did 
it, and under what circumstances. I think the only way to do that is to 
publish it along with the results of experiments. 
That is about all I have to say on the introduction. 
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