33 
binding resolution that the conduct of artificial recombinant DNA 
research in the State be carried out under the N1H guidelines. Ac- 
cording to the attorney general of New Jersey, the council “chose not 
to adopt the positions of the public advocate and its own hearing of- 
ficer regarding any modifications of the NIH guidelines.” 
An exception is a resolution of the New York Coimcil (No. 1013, 
August 25, 1977) , calling on the Congress “to preserve local autonomy” 
in the regulation of recombinant DNA research, although the Gover- 
nor of New York, in vetoing a bill passed by the State legislature, 
stated that such regulation “should be national in application and not 
imposed in random fashion from State to State.” (Statement of Gov. 
Hugh Carey, August 12, 1977.) 
On the other hand, there are areas of public health where the States 
have traditionally had regulatory responsibilities and developed some 
competence. Marc Lappe referred to the California Health Depart- 
ments supervision of clinical laboratories. In a letter submitted to the 
subcommittee, the director of the laboratory division of the Connect- 
icut State Department of Health reported that his agency had regis- 
tered and inspected facilities engaged in recombinant DNA research 
in accord with the State’s public health statutes and regulations. 
David Newburger, professor of law at Washington University in St. 
Louis, generalized : 
Under our Federal system of government, the States have a right to protect 
the health and safety of their citizens, just as the Federal Government exercises 
some rights in that area on a nationwide basis. Unless there is some compelling 
national reason for us to distinguish this kind of research from all other re- 
search, I cannot see any reason to preempt the area. 
View a of the subcommittee 
The subcommittee believes that legislation or administrative action 
to regulate recombinant DNA research should correct the deficiencies 
of the present system but retain its successful features as well as 
maintain continuity. In view of the fact that existing statutory author- 
ities are, on the whole, adequate to regulate commercial applications 
of the technology, no new Federal agency is needed. (See below.) 
Instead, legislation should assign authority to the Secretary of Health, 
Education, and Welfare, who will draw upon the expertise of NIH 
in formulating standards but should delegate monitoring and enforce- 
ment responsibilities to the Center for Disease Control or another suit- 
able agency in the Department. The subcommittee agrees that NIH 
may appear to be compromised by its commitment to supporting re- 
combinant DNA research ; nor is it well equipped by previous regula- 
tory experience to perform the latter functions. The subcommittee is 
concerned that HEW give adequate attention to recombinant DNA 
research directed toward agricultural, energy, and other nonhealth 
applications, but believes that no other Federal agency has comparable 
expertise in the broad range of work with recombinant DNA. 
The present membership of the Recombinant DNA Molecule Pro- 
gram Advisory Committee should form the core of an expanded ad- 
visory committee to the Secretary, including members with expertise 
in regulatory procedures, safety and health regulation, and laboratory 
work. Lay opinion should also be represented. In view of the rapid 
development of recombinant DNA research, however, the legisla- 
[Appendix B — 292] 
