77 
Kennedy’s letter to Califano will probably ask, among other things, 
if Section 361 is an appropriate vehicle for regulating recombinant 
DXA. “Our response will be that simple legislation is required, and 
that 361 is not an appropriate statute,” says an XI FI official. In the 
XIH view, the section does not explicitly offer preemption (although 
some legal opinion holds that it would do so in practice), use of the 
statute might imply that recombinant DXA could give rise to com- 
munciable disease, and in any case Congress should carefully frame a 
special new law if it wishes to take the step of regulating biological 
research. 
The problem of how to govern recombinant DXA research is as far 
from certain solution as ever, but the present range of likely outcomes 
is generally much less restrictive than those prevailing last 
rear. — X.TF. 
ATTACHMEXT F 
U.S. Senate, 
Committee on Commerce, Science, and Transportation, 
IF ashing ton, D.C., May 4. 1978. 
Dear Mr. Secretary : As you are undoubtedly aware, Congress is 
currently considering legislation which would regulate recombinant 
DXA research and its applications. The use of recombinant tech- 
niques to modify the fundamental genetic material offers great 
promise for all of mankind through improved understanding of 
biological processes, and varied applications in such fields as medicine, 
production of enzymes for industry, and agriculture. 
Nevertheless, as with any new field of scientific research, it is im- 
E ossible at this stage to say with absolute certainty that there is no 
azard attendant to such research. To date, there have been no illnesses 
or other harm associated with recombinant DXA research. There have 
been recombinant processes occurring in nature since life began, and 
nattire has built-in defenses against aberrant DXA strains. However, 
we cannot ignore the theoretical risks and the necessity to protect the 
health and safety of the public and the environment until further 
evidence is accumulated. 
The implications for all of science and technology from the regula- 
tion of scientific research dictate that we move cautiously and fully 
explore all of the alternatives and ramifications before embarking on 
a course of regulation. The Senate Science. Technology, and Space 
Subcommittee, of which I am the ranking member, held three days 
of hearings during November, 1077, to consider the major policy issues 
associated with recombinant DXA research. The general thrust of 
the testimony from the more than 20 witnesses was that if there is 
determined to be a need for legislation it should be directed toward 
extending the National Institutes of Health (NIH) guidelines to 
non-Fedoval funded research on recombinant DXA. I generally 
agree with that conclusion, although I am concerned that we mi<rht 
initiate unnecessary and unreasonable restrictions on the conduct of 
basic scientific research. 
Both the House and the Senate have bills pending which would ex- 
tend the NIH guidelines to the private sector and assign responsibility 
[Appendix B — 336] 
