COVINGTON 5, BURLING 
Donald S. Fredrickson, M.D. 
March 3, 1978 
Page Nine 
"Both DOT and CDC , in implementing 
the HMTA and section 361 with respect to 
biological products, have essentially 
aimed just at imposing labeling, packag- 
ing, and shipping requirements. This 
approach is in line with the statutory 
language which emphasizes movement. 
Section 361 could perhaps be interpreted 
more broadly to serve as legal support 
for more comprehensive regulation. 
However, in order to do so there would 
presumably have to be a reasonable basis 
for concluding that the products of all 
recombinant DNA research cause or may 
cause human disease. Such a conclusion 
would undoubtedly be tenuous at best, 
and it is unlikely that resulting re- 
quirements could be effectively imposed 
and enforced." 
This is the sole analysis of Section 361 in that entire re- 
port. 
Since the December 1977 meeting, I have had occa- 
sion to investigate the legal aspects of Section 361 further. 
Enclosed is a letter I prepared for Dr. Gilbert S. Omenn of 
the Office of Science and Technology Policy on this subject. 
Suffice it to say that, in my judgment, Section 361 is 
legally available for use in governing all research on re- 
combinant DNA molecules if, as a matter of policy, the 
Department of HEW concludes that it should be so used. The 
decision whether to use Section 361 for this purpose is, of 
course, a policy decision, not a legal decision. 
Of course, the use of Section 361 would be obviated 
by enactment of legislation currently being considered by 
Congress. If that legislation is not enacted and the Depart- 
ment of HEW declines to assert jurisdiction under Section 
361, however, a serious regulatory void will exist. It is 
likely, under these circumstances, that the Occupational 
Protection Agency will be forced to exert jurisdiction under 
other regulatory statutes. This would, in my judgment, be 
a serious error. NIH obviously has the expertise in this 
matter and should not surrender its role as the lead agency. 
If the Department of HEW does default on its responsibilities, 
however, other regulatory agencies will have no alternative 
[Appendix A — 247] 
