UNIVERSITY OF CAUFORNIA. SAN DIEGO 
•nUCZUY • DAVIS • mvTN* • LOS ANCn^ • WVEMID* • SAN DUECO • SAN FUANOSCO 
SCIENCE. TECHNOLOGY AND PUBUC AFFAIRS Q-060 
LA JOLLA. CALIFORNIA 92093 
Janiiary 28, 1982 
Ct. William J. Gartland 
Department of Heatlth & Hunan Services 
National Institutes of Health 
Bethesda, Maryland 20205 
Dear Bill: 
I should like to ooment briefly on the two proposals for revisic»i of the 
NIH Guidelines tl«t are on the RAC aaenda for Fdbruary 8-9, 1982. 
The more drastic proposail made by RAC (Fed.Reo. 12/4/Cl) essentially termin- 
ates the quasi-regulatory role of fnp by traunsferrino responsibility for 
"good practice" to locad institutions who sponsor the research. The Gottesran 
proposal (Fed.Reo. 12/7/81) , on the other hand, continues the oradual con- 
striction of the quasi-regulated curea while keying central NIH responsibility 
intact. It is obvious that the "oonstriction curve" on whic±i the Gottesman 
proposal and its antecedents lie projects toward the RAC proposal at seme 
not-too-distant time. The difference between the tRO proposals thus reduces 
to the question whether the ^u^ea rerainino if the Gottearan proposal were to 
be adopted justifies oontin\«3 quasi-regulation by NIH. 
It is to be receLLled that the NIH guidelines were conceived to cope with large 
uncertainty about possible risk entailed in certain projected RENA experiments. 
In particular, attention came to focus on inadvertent pathogenic risk to investi- 
gators, supportive personnel and the general oomonity. The shape of the 
"oonstriction curve" reflects rising confidence that the rationally estimated 
risk of such inixJvertent effects is declining. 
Hewever, other areas of uncertainty that have had lesser attention have been 
repeatedly noted in the last several yeeu:s. These include; 1) Rislcs of 
deliberate efforts to create and dissminate new pathogenic aoents, as living 
organians or their products; 2) Risks of scale-v^J, whether sirply in amount of 
materials or in combination with other existina or n®>/ technologies; 3) Risks 
of deliberate dissanination into the environment of agents expected to yield 
benefits hut conceivably yielding unanticipated dysbenefits; 4) Risks of 
effects broader than bioloaical, ranaing from sociAl change to violation 
of accepted ethical principles. Estiiretes of risks in these areas have far 
less objective foundation than those relating to inadvertent pathogenic 
effects - because experience with than remains limited and because they have 
been less carefully addressed. 
(7071 
