24 
mental Defense F und relied in its petition to the Secretary of HEW. 
This section authorizes the Surgeon General, with the approval of 
the Secretary, to “make and enforce such regulations as in his judg- 
ment are necessary to prevent the introduction, transmission, or spread 
of communicable diseases” from foreign countries into the United 
States or from one State to another. He may provide for “inspection, 
fumigation, disinfection, sanitation * * * and other measures” to 
carry out such regulations. 
Section 368 provides for a fine of $1,000 or imprisonment for not 
more than 1 year, or both, of persons who violate the regulations under 
section 361. The Interagency Committee suggested that this authority 
could be broadly interpreted to support regulation of most recom- 
binant DNA research activities, although it might not apply to re- 
search with materials that could pose a hazard only to nonhuman 
animals, plants, or the environment. On the other hand, unless a rea- 
sonable basis could be shown for concluding that the products of 
recombinant DNA research might actually cause human disease and be 
communicable, the Interagency Committee was concerned that the 
regulations might not withstand legal challenge. 
Although the Carter administration endorsed the Interagency Com- 
mittee report and proposed legislation that was introduced in the 
last session in both Houses, the failure of Congress to act in the fol- 
lowing months led the executive to reconsider alternative ways of 
insuring universal compliance with the NIH research guidelines. 
In his testimony to the subcommittee on November 8, 1977, Office 
of Science and Technology Policy Director Frank Press proposed 
that the Department of Commerce undertake a program of “voluntary 
compliance and meaningful surveillance” involving businesses 
engaged in recombinant DNA research. Press said that the Depart- 
ment planned to consult with pharmaceutical and other firms on 
appropriate procedures for external monitoring of their recombinant 
DNA research activities. These discussions are still in progress. 
Following its hearings, the chairman of the subcommittee wrote to 
Press and HEW Secretary Califano in part to ask their current views 
on the use of section 361 to regulate either research with or commercial 
applications of recombinant DNA. At the same time, OSTP requested 
HEW to reconsider use of this authority in the absence of new legisla- 
tion. In his reply to the subcommittee, the Secretary stated, “Our 
office of the General Counsel * * * believes it is preferable for a regu- 
latory effort of the magnitude required to oversee all recombinaiit 
DNA activities, whether or not known to affect human health, to be 
based on the explicit support of the Congress as well as that of the 
administration, particularly in light of the active interest the Con- 
gress has shown in this area. The consensus needed for this type of 
program is not best established by applying a general provision of law 
to this specific situation.” 
In a separate letter to the subcommittee, Frank Press acknowledged 
Secretary Califano’s preference for specific legislative authority, 
OSTP had, nevertheless, reviewed the administrative history of section 
361 and concluded that its application to recombinant DNA research 
would be appropriate. Press pointed out that the Public Health Serv- 
ice and the Food and Drug Administration have used the act’s 
unusually broad delegation of authority in a variety of ways to regu- 
[Appendix B — 283] 
