COVINGTON & BURLING 
Gilbert S. Omenn, Ph.D., M.D. 
January 6, 1978 
Page Eight 
existence of this controversy, which has been sufficient 
to engage the attention of the entire country, seems quite 
enough to provide a legally sufficient basis for invoking 
Section 361. Moreover, once jurisdiction is established 
the courts have held that the National Environmental Policy 
Act provides substantive authority over all environmental 
aspects of the matter. Environmental Defense Fund, Inc. 
v. Matthews , 410 F. Supp. 336 (D.D.C. 1976) . 
It is important, once again, to understand that 
Section 361 was intended by Congress broadly to authorize 
prophylatic public health measures to prevent disease be- 
fore it occurs. All that is needed to support regulations 
under this provision is either apprehension or uncertainty 
about the possibility of potential harm, the lack of adequate 
information showing that the harm cannot occur, and the 
possibility that the harm would be serious (e.g., irreversible) 
if it did occur. The more serious the nature of the poten- 
tial harm, the less is required in the way of apprehension 
or uncertainty about that harm in order to justify invoking 
regulatory controls under Section 361. 
VI 
Questions have also arisen about enforcement of any 
regulations issued under Section 361. Section 361 itself 
provides that any articles not in compliance with such 
regulations may be destroyed, and authorizes any other en- 
forcement measures that may be concluded to be necessary. 
In initially promulgating its turtle regulations, FDA in- 
cluded a requirement for bacteriological testing and certi- 
fication. In its proposed shellfish regulations, other 
enforcement mechanisms were included. Each of the PHS and 
FDA regulations issued under Section 361 has its own tailor- 
made enforcement provisions. 
Its seems clear that the statute authorizes regula- 
tions that require destruction of any materials resulting 
from activity not in compliance with regulations issued 
under Section 361. There is judicial authority for proposi- 
tion that a Federal court, using its broad equitable powers, 
may enjoin violation of any validly-promulgated government 
regulation. Section 368 specifically provides for a fine 
and/or criminal incarceration. Section 361 specifically 
[Appendix A — 264] 
