COVINGTON 5. BURLING 
Gilbert S. Omenn, Ph.D., M.D. 
January 6, 1978 
Page Seven 
opinion interpreting it, place broad discretion in HEW 
to determine when the scientific evidence warrants re- 
liance on Section 361 to prevent the possibility of com- 
municable disease. Absent evidence that the HEW decision 
is wholly irrational, it is highly likely that the courts 
would uphold this exercise of discretion. 
Nor is there any limitation in Section 361 on the 
source from which the potential harm must come in order 
to justify regulation. The terms of Section 361 permit 
regulation of research or of commercial activity. Indeed, 
the present regulations governing transportation of etiologic 
agents directly affects basic research, and a number of 
regulations affect commercial activity. The law permits 
control of human beings, animals, plant material, and any 
other form of article, in order to prevent communicable 
disease . 
With specific reference to research on recombinant 
DNA molecules, the question has been raised whether there 
is sufficient danger of communicable disease to justify 
invocation of Section 361. If indeed there is no signifi- 
cant possibility of this occurring, it is difficult to 
understand why the United States Congress, NIH, the entire 
scientific community, numerous state legislatures and city 
councils, and many citizens groups, have been spending such 
an inordinate amount of time debating it. The very nature 
of the controversy itself is sufficient, in my judgment, 
to establish the potential for harm that is required under 
Section 361. If that potential were agreed not to exist, 
the entire issue of regulatory control over this research 
would never have been raised in the first place. 
More specifically, some have questioned whether con- 
trols over certain types of research on recombinant DNA 
molecules, such as research on plant materials, can be 
justified under Section 361, since arguably the need for 
control arises from potential communication of disease from 
one plant to another rather than to man. Others have argued, 
however, that so little is known about research on recom- 
binant DNA molecules that there is indeed a danger, which 
will remain until further experimentation proves otherwise, 
that research on plant materials could unleash pathogenic 
organisms to infect man, or could otherwise result in human 
infection in ways we cannot anticipate. Again, the mere 
[Appendix A — 263] 
