2 - 
development. Nonetheless, this type of experimentation has raised 
issues of safety for biological experimentation in general, and is 
therefore an appropriate place to begin devising desirable regulatory 
policies. The issue is all the more focused because of the implica- 
tions of genetic engineering in higher animals possessed by the 
recombinant technology. 
In my view, the integrity of science requires that decisions 
which could have great effect upon the public well-being should be 
made with sound public understanding and assent. The new guidelines 
do not assure significant public participation at either federal or 
local levels. I think that the federal government should set the 
example by establishing a representative public body to advice on 
this and related policy issues concerning new biological techniques, 
and I also think that the guidelines should require significant public 
participation in Institutional Biohazard Comnittees. Only in these 
ways can useful public contributions be obtained and a level of trust 
established between the scientific comnunity and the citizens. 
3. Commercial applications . Whatever problems exist with recombinant 
technology, they are likely to be intensified during large scale 
comnercial exploitation. The present guidelines speak only of volun- 
tary industrial observation of regulations. I consider this grossly 
inadequate and would suggest that HEW either act administratively 
to assure industrial compliance or introduce legislation requiring it. 
There is no way to avoid uncertainty on virtually all issues of safety of recom- 
binant work or of soundness in application of the techniques to commercial or 
medical purposes. Each new experiment or large scale process will potentially 
create new problems. If anything is certain, it is that uncertainty will remain 
with us. Prudence therefore requires careful epidemiological study of our 
experience in both small and large scale operations, citizens' understanding 
of and concurrence with the purposes of the work and the risks which should be 
run, and uniform compliance with reasonable regulations by all agencies employing 
recombinant techniques. In each of these areas, the new guidelines are deficient, 
often seriously so. 
I would urge that the guidelines be amended to: (1) mandate effective health mon- 
itoring practices at each involved institution, (2) mandate carefully designed 
epidemiological studies for various classes of recombinant experiments to be done 
under HEW auspices, (3) establish a federal advisory committee with broad public 
representation, (4) increase and mandate public participation in Institutional 
Biohazard Comnittees and (5) require industrial compliance with the guidelines. 
Some of these proposals can be accomplished easily; others will require consider- 
able thought. Many of us will be willing to contribute to that thought should 
you wish us to do so. 
Thank you for considering these suggestions. 
Warmest regards. 
Hal lman, M.D. 
Pro Medicine 
HRIT.bso 
cc: Senator Edward M. Kennedy Senator Adlai Stevenson 
Mr. Peter Libassi 
Dr. Julius Richmond 
Sin 
LA-255] 
