69 
However. Louisiana did not hold that section 361 permits FDA to 
control intrastate activity in all circumstances. The court clearly ex- 
plained that the intrastate ban was justified only because it was nec- 
essary to prevent the interstate spread of disease. As the court ex- 
plained, the FDA regulation was due to the “particular facts and 
circumstances underlying the ban on turtles” which are not present 
in all cases. 1 
With reference to DXA research, there is no evidence to support 
the position that intrastate regulation is necessary to prevent the in- 
terstate spread of communicable disease. Any hazards arising from 
recombinant DXA research are at this point in time purely specula- 
tive. Mr. J. D. Watson, an eminent authority on DXA, recently wrote : 
[I]n our original statements about recombinant DXA, we 
kept referring to “potential dangers.” Instead, we should 
have said “conjectural dangers.” since there was, and still is, 
not a trace of evidence that any of the experiments pose a 
threat to those who do them, much less to the general pub- 
lic. . . . 
The strains of viruses and cells we work with in the lab- 
oratory generally are not pathogenic for men, and all we 
know about infectious diseases makes it unlikely that the ad- 
dition of a little foreign DXA will create any danger for 
those who work with recombinant DXA-bearing bacteria. 
Even if no special guidelines existed, and we only employed 
standard microbiological practices of routine sterilization, 
we should have no reason to be concerned for our health. 2 
Therefore, while we agree with Mr. Hurt that intrastate commerce 
certainly may be regulated to prevent- the spread of communicable dis- 
ease, we cannot agree that all DXA research poses such a substantial 
threat of disease that all intrastate DXA activity can be reached under 
the Public Health Service Act. Mr. Hurt's position is based on an as- 
sumption that the “very nature of the controversy itself is sufficient 
... to establish the potential for harm that is inquired under Sec- 
tion 361. If that potential were agreed not to exist, the entire issue of 
regulator}' control over this research would never have been raised in 
the first place.” Needless to say, his position is not universally held. 
Other considerations as well suggest that section 361 might not be 
interpreted to apply, across the board, to all recombinant DXA re- 
search. We briefly commend in our previous memorandum that the 
legislative intent behind the Public Health Service Act can hardly be 
said to comprehend recombinant DXA research even though the regu- 
latory authority intended under the Act is broad. Because of the unique 
nature of recombinant DXA research, arguments can be made that 
absent express legislative intent the Public Health Service Act should 
not be utilized to regulate DXA work. It has been a.rgued that recom- 
binant DXA research, especially when conducted in an academic set- 
ting, involves First Amendment freedoms of speech. Th.is has been 
urged by several constitutional law scholars as well as concerned and 
involved scientists. The nation’s highest court has expressed in sev- 
1 See, e.g. 42 C.F.R. 72.21 ; 72.22. 
5 The Washington Post , Sunday, May 14. 197S, p. D-2. 
[Appendix B — 328] 
