Dr. Fredrickson 
- 2 - 
April 14, 1976 
Much discussion occurred with respect to the enforcement 
arrangements for the guidelines. I would suggest that this is 
not the first order of business. It seems to me the development 
of a world-wide consensus stemming from the efforts and prestige 
of NIH dealing with the policy statement and dealing with the 
technical implementing guidelines should be the current objective; 
that a subsequent step would be the issuance of NIH regulations 
and regulations of other agencies that required the application 
of the policy and the implementing guidelines as a requirement 
for Federal funding. I am inclined to believe that if the 
scientific community gets behind the NIH approach, there 
will be a strong tendency for the enforcement to be voluntary 
and self-regulated . I say this because the scientists them- 
selves engaged in this kind of research have identified the 
problem. Scientific recognition only occurs through publica- 
tion in scientific journals. I seriously doubt that a scientist 
would seek publication of the results of his effort which were 
currently carried out in a manner not consistent with the 
guidelines. I seriously doubt that any scientist would 
engage in research in a manner that was knowingly not avail- 
able for publication. Therefore, I do not think that the 
guidelines are essentially an enforcement document but rather 
are the thoughtful views of scientists as to how to protect 
themselves, their laboratory workers, and the public. 
There is identified in the papers you distributed that 
high priority should be given to research in methodologies 
of containment and safety. I would not wish to belittle the 
importance of this research but I would not be inclined to 
place it in the highest priority. It strikes me that the 
highest priority should be accorded to research that endeavors 
to disclose the extent to which Recombinant DNA research is in 
fact dangerous and what that degree of danger is. I say this 
because I believe the essential difference between the problem 
of dealing with dangerous bacteria and dangerous infectious 
viruses is that those dangers are relatively well-known while 
work in connection with Recombinant DNA is conceived to have 
a potential serious danger to the health of humans, animals, 
and agriculture but the extent of that danger, if any, is 
unknown. From this reasoning I conclude that the basic policy 
statement would recognize that the scientific community under- 
takes careful safeguards in the conduct of research involving 
dangerous substances and that the degree of those safeguards 
are related to the known danger involved in exposure to the 
particular dangerous elements. Recombinant DNA is distinguished 
from the normal conduct of research in that it involves the 
creation of new substances which may be very dangerous to man- 
kind and for ecology but the extent of that danger is speculative 
and unknown. Thus, the policy should be that where the danger 
is known, the normal process of safeguards related to the 
degree of danger should be applied. Where the danger is not 
known, but there is significant scientific speculation as to 
possible dangers, extraordinary safeguards should be employed 
until the degree of danger can be properly assessed. 
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