The Honorable Patricia Roberts Harris 
December 30, 1979 
Page Five 
II . System of Voluntary Registration, Certification and Compliance 
(p . 69229) . (Arguments supporting this proposal are given in 
the NIH director's "decision document," p.69247 f.) 
The proposal entails the development by NIH of a voluntary system 
of compliance to cover recombinant DNA research, development, and 
applications in the private sector. This proposal should be rejected 
for the following reasons: 
1. There is much evidence from other areas of technological develop- 
ment which shows that systems of voluntary compliance are not 
generally effective. Deviant behavior is a fairly common phenomenon 
of our time, and certainly it is not unknown in the field of occu- 
pational health and safety.* It would be naive to suppose that such 
behavior will not occur under a system of voluntary compliance for 
the recombinant DNA field, especially in view of the intense com- 
petitive pressures acting in this field. 
2. In implementing a system of voluntary compliance, NIH would assume 
quasi-regulatory functions with respect to the private sector. Yet 
the NIH director has repeatedly stated that he has no wish for the 
Institutes to take on the responsibility of assuring compliance with 
its standards. As Dr. Fredrickson stated in December, 1977: 
I do want to ....reiterate something that I have, per- 
sonally, speaking for NIH, now said in testifying before 
at least four congressional committees on this question 
of legislative proposals to regulate recombinant DNA ex- 
periments, and that is roughly the following. It is that 
I believe it a conflict of interest for the National 
Institutes of Health to be both the sponsor, the conductor, 
and the regulator in the sense of the enforcer, of guide- 
lines for this type of research. 
We feel it an important responsibility on our part to 
engage to the maximum our own resources and those of the 
broad community which we support in the preparation and 
promulgation of standards, but we cannot conduct here on 
this campus roughly ten percent of the research which is 
now under NIH aegis and pretend also to police the entire 
country, or to be the regulator in the sense that agencies 
long or recently established for the purpose of regulation ** 
could do. We have not the expertise. We have not the desire. 
* See, e.g. the testimony of Dr . J . Finklea, Hearings of the 
Subcommittee on Health and Environment, Committee on Interstate 
and Foreign Commerce, U.S. House of Representatives, 95th 
Congress, p.287f. 
** Transcript of the proceedings of the December 15-16, 1977 
meeting of the Advisory , Committee to the Director, NIH, in 
Department of Health, Education, and Welfare, Recombinant DNA 
Research (U . S . Government Printing Office: Washington D.C., 
September , 1978), vol.III, p.459. 
[ 629 ] 
