78 
to the Secretary of HEW to promulgate administrative and enforce- 
ment regulations. Despite attempts to accommodate all interested 
parties, the proposed legislation has been criticized by both environ- 
mental groups and members of the scientific community. As the debate 
continues over the most appropriate means of extending the NIH 
guidelines, one must consider all options which might be effective. 
In that regard, considerable attention has been focused recently on 
the application of Section 361 of the Public Health Service Act (42 
U.S.C. § 264) to recombinant DNA research in lieu of legislation. 
Under this Section the Secretary of HEW is authorized to “make and 
enforce such regulations as in his judgment are necessary to prevent 
the introduction, transmission, or spread of communicable diseases . . .”. 
It has been suggested that Section 361 provides adequate statutory 
authority to extend the NIH guidelines to the private sector and to 
promulgate such regulations as are deemed necessary to ensure com- 
pliance with the guidelines. However, uncertainty remains as to the 
scope of coverage of Section 361 and its applicability to situations 
■where DNA research represents a potential threat to plants, animals, 
and the environment. Until we fully understand the implications of 
relying on Section 361, it would be imprudent to recommend its ap- 
plication to recombinant DNA research. 
In order to assist the Congress in its deliberations over this most 
difficult issue, I would appreciate your response to the following : 
— What is your analysis of the provisions of the two principal bills 
(H.R. 11192 and Senator Kennedy’s Amendment No. 1713 to 
S. 1217) pending before Congress which would regulate recom- 
binant DNA research ? 
— If Senate Amendment No. 1713 as presently drafted were enacted 
into law, what specific steps would you take to implement the 
requirements of that legislation ? 
— The Federal Interagency Committee on Recombinant DNA Re- 
search concluded that “no single legal authority or combination 
of authorities currently exist that would clearly reach all research 
and other uses of recombinant DNA techniques and meet all the 
requirements.” Do you agree with that conclusion ? 
— Do you feel Section 361 contains adequate statutory authority to 
implement enforcement of the NIH guidelines to the private 
sector ? 
— What problems, if any, do you see arising from the use of Section 
361 to regulate recombinant DNA research ? 
— If directed to regulate recombinant DNA research pursuant to 
Section 361, what specific regulatory action would you take to 
ensure private sector compliance with the guidelines ? 
— What legal precedent supports the application of Section 361 to 
recombinant DNA research or other forms of nonbacterial or 
nonviral research ? 
— What legal precedent would indicate that Section 361 is not 
appropriate for regulation of recombinant DNA research? 
— What action, if any, do you plan to take if it becomes clear that 
Congress will not pass legislation this session extending the NIH 
guidelines to the private sector ? 
— Although the authority of the Secretary to regulate recombinant 
DNA activities is outlined in both the House and Senate bills, 
[Appendix B-- -337] 
