The Honorable Joseph A. Califano 
October 13, 1978 
Page 3 
submitting information to DHEW." The willingness of companies to register 
even completed research projects may depend on further judicial or legisla- 
tive clarification of the patentability of RDNA products. In general, I 
do not believe that the proposal invalidates the conclusion of the Sub- 
committee's report that "a program of voluntary compliance by and monitoring 
of industrial research activities is insufficient." 
Primarily, for this reason, I am pleased that the Department continues to 
support "moderate" legislation. It is unfortunate that many in Congress 
drew the opposite inference from your delay in responding to our request for 
a prompt reply to our inquiry concerning Section 361 of the Public Health 
Service Act. Although some differences remain, it seems to me that there is 
general agreement on most of the elements of legislation enumerated in your 
letter. The Subcommittee's report endorses provisions clarifying the author- 
ity of the Secretary, facilitating the issuance of administrative regulations, 
and permitting exemptions for activities that pose no significant risk; and 
it advances a reasonable compromise on the issue of Federal preemption. I 
hope that we will have your support in passing such legislation early in the 
next session. 
Let me explain why I believe that legislation is still advisable. It is true 
and, indeed, encouraging that the original concerns about possible health 
and environmental hazards associated with recombinant DNA techniques have 
diminished. This is primarily the result of recent scientific investigation 
and discussions among a wider range of biological and health scientists rather 
than failure to observe any case of illness or other harm. The latter merely 
tends to support the consensus that permitted activities conducted on the 
whole under prescribed physical and biological containment standards do not 
pose a significant risk. Be that as it may, the cautious approach that has 
been taken to the use of this technology is reasonable and it will continue 
whether or not legislation is passed. As Dr. Fredrickson observed in his 
introduction to the revised guidelines: 
... It is not the time to conclude that (the guidelines) are being 
altered in preparation for their early abandonment. Understanding 
of gene regulation and expression is increasing inexorably and at 
an awesome pace. We may predict that ways will be found to achieve 
and control the translation of foreign genes by a variety of hosts 
In some proportion to the harvest of positive results, a capability 
must be maintained for observing any capacity of these experiments to 
yield harmful products 
With adequate training of investigators and laboratory personnel, physical 
containment procedures may become routine practice, and other requirements 
of the guidelines may be dispensed with on the basis of new evidence; but 
[A-416] 
