Dr. Donald Fredrickson 
2 
January 19, 1978 
pathogens as researchers in this field. It must know that we have 
promulgated restrictive guidelines not to protect it from a known 
hazard, but to guard against the possibility that new organisms 
generated by this research could exert some harmful influence on 
us, and that we have taken these steps even though there is no firm 
theoretical basis for believing that such harm could result. 
Physical and Biological Containment 
These sections have been carefully and thoughtfully set forth 
in the Revised Guidelines, and I can add nothing to your considera- 
tion of them. 
Experimental Guidelines 
Based on the testimony presented at the December meeting, the 
assignments of physical and biological containment standards for 
plant and animal viruses ought to be reviewed by the Recombinant DNA 
Molecule Program Advisory Committee. These assignments appear to 
have been made on the basis of the Committee's perception of political 
acceptability, not on the basis of professional judgments as to risk. 
This is a great mistake and perverts the process of drafting guidelines. 
That process depends, in the first instance, upon obtaining expert 
advice as to risk from a professional panel unfettered by political 
constraints. This technical advice is then rendered to you so that, 
with the aid of your own advisory committee, you can assess that 
advice in light of broader considerations, such as public acceptability. 
If the technical advice you receive has already been diluted by political 
concerns, your task is made exceedingly difficult and the public is 
denied the opportunity of ascertaining who is making the technical 
assessments and who the political ones. 
This difficulty may explain in part why the Revised Guidelines 
make containment assignments for virus studies which are not in 
accord with those made in Europe. If you were to arrange an early 
meeting with European scientists, these matters could be discussed, 
and it might be made clearer than it is now why our standards differ 
so from theirs. 
A further difficulty with the Revised Guidelines, which they 
share with the original guidelines, is that the philosophy of assign- 
ment is not clearly set forth. Put another way, there should be a 
firm theoretical foundation for the assignment of physical and 
biological containment levels if, indeed, this is possible. This 
is particularly important because there is no present evidence that 
any of this research can create harmful organisms. In the absence 
of such evidence, the NIH should clearly state why it believes some 
experiments to be more hazardous than others, and why some experiments 
are banned. 
[Appendix A — 219] 
