66 
There are few decisions of the courts in which these public health 
provisions have been construed. But those cases that have considered 
the scope of section 361 do not provide convincing authority for the 
belief that the Secretary's powers under that section are as broad as 
they must be to accomplish pervasive regulation of recombinant DXA 
research. The most recent case to construe section 361 was decided last 
year by the federal district court in the eastern district of Louisiana. 
Louisiana v. Math-exes, 427 F.Supp. 174 ( 1977) . The Secretary of HEW 
had banned the interstate and intrastate sale of all small turtles because 
of the danger that the turtles were or might he infected with two 
known communicable diseases. In that case, the court reasoned because 
the chances of contamination or re-contamination of turtles were so 
high (54 percent or greater) , that “a total ban is permissible as neces- 
sary to prevent the spead of communicable disease.” The alternative, 
the court noted, was to adopt a “patently unreasonable*’ and “onerous 
testing scheme.’’ While an intrastate ban was deemed necessary, and 
the court sanctioned regulation to prevent the possibility of spread, 
etc. of disease, it is significant that well-known and widespread com- 
municable disease already specified in the federal regulations were in- 
volved. Thus, the Secretary’s regulatory authority will, in some cases, 
extend to intrastate regulation of potential disease, but the case does 
not support the conclusion that this is true in all circumstances, par- 
ticularly those involving unspecified and as yet non-existent “dis- 
eases.” We found no case supportive of the position that hypothetical 
dangers and diseases are within the scope of section 361. 
On the other hand, presented with a case involving grave danger 
and the possible spread of recombinant DXA generated disease, the 
courts may choose to give section 361 and even more expansive inter- 
pretation that was applied in Louisiana- v. Mathews. It should be con- 
sidered however, that the courts have not yet dealt with this and 
litigation would inevitably result from extension of section 361 to 
recombinant DXA research. We have reviewed the letter of January 6. 
1978 from Peter Barton Hutt to Gilbero S. Omenn and we recognize 
that his argument is persuasive. But we cannot, with assurance con- 
clude that the Secretary’s regulatory authority under section 361 is as 
broad as Mr. Hutt suggests. In the event that new legislation to pro- 
vide authority for DXA l’egulation is deemed inadvisable at this time, 
we do agree that the Public Health Service Act may currently be- the 
most effective means to regulate the conduct of recombinant DXA 
research. 
Additionally you have asked for legal precedent supportive of the 
use of section 361 to regulate nonbacterial or nonviral research. The 
Drinking Water Standards, set out at 42 C.F.R. § 72.20, define pollu- 
tion to mean the presence of “any foreign substance” including “or- 
ganic, inorganic, radiological, or biological” products that may “con- 
stitute a hazard or impair the usefulness of the water.” Currently 
however, these standards are the only ones promulgated under the 
Public Health Service Act which extend beyond bacterial, fungal, or 
viral, rickettsial and chlamydial etiologic agents. See. 42 O.F.R. § 72.25 
(a) (c). We are aware of no court case that has dealt with the further 
extension of these regulations to agents other than virable organisms 
and their toxins. 
[Appendix B — 325] 
