57 
Professor Newburger 
The National Science Foundation has supported a number of studies 
■of factors associated with the development and commercialization of 
ideas developed under Federal research funding. David J. Newburger, 
School of Law, Washington University, completed two projects for 
NSF which involved an examination of the questions of regulation 
and innovations in chemical and allied products industries. As he 
views the DNA debate, there appear to be two policy problems. These 
are: the possibility that public and worker health and safety might 
be endangered ; and the possibility that research and innovation might 
be curtailed unduly by regulation. According to Mr. Newburger, the 
science policy dilemma is to solve both of these problems simul- 
taneously. In his opinion, in order to do so, the Government should 
provide the regulatory agency with the right to develop flexible en- 
forcement devices and appropriate penalties. However, in order for 
such an approach to work, those affected, such as the developers of 
new processes, must have a clear understanding as soon as possible 
as to what these regulations will be. 
Mr. Newburger noted that one step in the enforcement of the desired 
conduct of research would be to construct licensing requirements 
which : prohibit unqualified individuals from engaging in the research; 
require licenses for people who are to engage in the research and 
assure their competence; and, control the sale of the substances needed 
in the research, such as the restriction enzymes, in order to limit the 
unauthorized conduct of research. 
The issue of Federal preemption of local authority was addressed 
again by the participants in this panel just as it had been touched 
upon by other panelists. Opinion continued to be mixed, however. If 
a trend could be detected at all, it seemed to be one of preference for 
Federal preemption in order to insure national standards. One sug- 
gestion which seemed acceptable would be to establish Federal 
standards with the local biohazards committee having the authority 
to determine the adequacy of a particular local facility to conduct the 
research. Thus, while Federal standards would prevail, local com- 
munities would have an input to certification of facilities and deter- 
mining whether appropriate levels of containment are being utilized 
in conformance with Federal requirements. Most panelists seemed to 
feel that some chaos might ensue if local communities had freedom to 
accept or reject Federal criteria established for a specified kind of 
research, as with DNA recombinant research. 
Mr. Singer 
Daniel M. Singer, Attorney at Law, Washington, D.C., suggested 
that the more elaborate the bureaucracy for regulation, the higher 
will be the price paid in discouragement of research. The minimal 
requirements necessary to secure a reasonable degree of research safety 
could be met by two requirements: Certification that an institutional 
biohazards committee is established, as specified by the NIH guide- 
lines, and delivery to a central registry of approved proposals. It 
might also be desirable to provide for a 30-day evaluation period at 
the Secretary of HEW level for proposed P3 work, and possibly a 
statement of affimative approval at the Departmental level before P4 
work could be initiated. In Mr. Singer’s opinion, the construction of 
a Federal bureaucracy to license individual investigators, to review 
[Appendix B — 106] 
