University of Hawaii at Manoa 
Cancer Center of Hawaii 
Basic Science Unit 
1997 East-West Road • Honolulu, Hawaii 968 22 
Telephone: (808) 948-7197 
Office of the Director 
August 25, 1978 
Dr. Donald S. Frederickson , Director 
national Institutes of Health 
Bethesda, Maryland 20014 
Dear Dr. Frederickson: 
I appreciate being sent a copy of the Proposed Revised Guidelines 
for Recombinant DNA Research, and also being asked for my comments on the 
proposed revisions. In general, I am glad to see that the containment 
requirements for these experiments are being revised to conform more 
closely to present estimates of the risks involved, i»e_., little or none. 
However, I fear that the revised guidelines fail to remedy some of the 
more serious problems in the present system, and it is for this reason that 
I am writing these comments, in response to your invitation. 
It has been said that there are two types of hazards associated with 
performing recombinant-DNA experiments. The first type, which is what 
everyone talks about, is the biological hazard from the organisms themselves. 
These hazards are purely hypothetical, and in most cases, are not likely to 
exist. The second type of hazard, however, is very real — the tangle of 
bureaucratic regulations and red tape which has come to ensnarl this research, 
largely because of what are now seen as misconceptions in early estimates 
of possible biological hazards. Over the past two or three years 3 the public 
perception of the possible risk from recombinant-DNA work has relaxed con- 
siderably, as new knowledge has emerged and no evidence of hazards has been 
uncovered; in the same time period, however, the bureaucratic requirements 
for documents reporting such experiments have escalated. In addition, since 
no mention of "M's" or any of the other rules appears in the original guide- 
lines, the requirements imposed have frequently seemed arbitrary, ambiguous, 
and confusing . This has led to such situations as the recent one at 
Harvard, in which no threat to public health or safety was at issue, but which 
has made everyone involved look bad, including the rulemakers at NIH. 
[A-50] 
■ 
AN EQUAL OPPORTUNITY EMPLOYER 
