86 
Unity of communicable disease. The growing conditions for shellfish have sim- 
ilarly been the subject of control since 1924 under the National Shellfish 
Sanitation Program, and FDA has proposed to establish regulations codifying 
this program in the Federal Register of June 19, 1975 (40 F.R. 25916), which are 
now being held in abeyance pending further study required by Congress in Sec- 
tion 16(b) of P.L. 94-370 ( 90 Stat. 1013, 1033). FDA proposed to codify its 
40-year history of cooperation on food sanitation programs for food service 
establishments in the Federal Register of October 1, 1974 (39 F.R. 3543S), and 
has since concluded instead to issue a model ordinance as announced in the 
Federal Register of March 22, 1977 (42 F.R. 1542S). Under the same authority, 
FDA has announced a proposed Model Retail Food Store Sanitation Ordinance 
in the Federal Register of October 25, 1977 (42 F.R. 56367) and a Model Vending 
of Food and Beverages Ordinance in the Federal Register of October 7, 1977 
(42 F.R. 54626). 
Finally, in a variety of regulations in the past few years designed to implement 
a national blood policy, FDA has utilized Section 361 to control blood banking and 
blood labeling practices in intrastate as well as interstate commerce. The pre- 
ambles to these regulations specifically mention the need for close control of all 
blood practices, in minute detail, in order to prevent communicable disease. 
Copies of the proposed regulations to establish current good manufacturing 
practice for blood and blood components published in the Federal Register of 
May 28, 1974 (39 F.R. 18614) and to require a label statement to distinguish 
volunteer from paid blood donors published in the Federal Register of Novem- 
ber 14, 1975 (40 F.R. 53040), both of which discuss this subject, and both of 
which provide extraordinary detailed requirements, are enclosed. 
V 
Questions have been raised about the degree and nature of the potential harm 
that must be shown in order to invoke the authority of Section 361. It appears 
that the language of the statute itself, its legislative history, and the court 
opinion interpreting it, place broad discretion in HEW to determine when the 
scientific evidence warrants reliance on Section 361 to prevent the possibility 
of communicable 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 poten- 
tial 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 ques- 
tion has been raised whether there is sufficient danger of communicable disease 
to justify invocation of Section 361. If indeed there is no significant possibility 
of this occurring, it is difficult to understand why the United States Congress, 
NIH, the entire scientific community, numerous state legislatures and city coun- 
cils. 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 controls 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 
recombinant 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 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 
[Appendix B — 345] 
