6 
and inexpensive method complex biologicals needed in medicine, also 
expressed concern that there may be hazards associated with altering 
the genetic make-up of cells, particularly microorganisms which 
might be infectious. Because such modified organisms would never 
have existed in nature, and, therefore, might have unpredictable prop- 
erties, perhaps even posing a serious threat to human health or the 
environment, these scientists called for the formation of a study com- 
mittee to recommend specific actions and develop research guidelines. 
As an eventual result of this initiative, the National Institutes of 
Health (NIH) released, on June 23, 1976, Guidelines for Research 
Involving Recombinant DNA Molecules. These guidelines prescribe 
safety techniques to be followed and define different levels of physical 
and biological containment which would be imposed on each experi- 
ment, according to the degree of potential hazard presumed to be as- 
sociated with each such recombinant DNA activity. The guidelines 
also specify that approval of each project on safety grounds and of 
the containment facilities available must be given by a local biohaz- 
ards committee before a research grant to carry out such a project 
would be awarded by NIH. 
The NIH Guidelines, however, are not regulations. They can only 
be imposed as binding upon NIH employees, or those receiving grant 
or contract funds from NIH. Thus, while the NIH Guidelines may 
serve as a model for the safe conduct of recombinant DNA research 
generally, they have no official standing in the other Government agen- 
cies supporting or engaged in recombinant DNA research, in state 
or privately supported research, or in private industry. Some Federal 
agencies (NSF, ERDA) have adopted the guidelines for their own 
grantees while others (USDA) support them only in spirit. 
It is generally agreed that if recombinant DNA research and tech- 
nology do indeed pose potential hazards to health or the environment, 
then safety requirements imposed upon such activities should not de- 
pend on whether or not NIH, or the Federal Government, is directly 
involved. Thus, a number of State and local governments beginning 
with Cambridge, Mass., in 1976, have considered imposing compre- 
hensive recombinant DNA regulations of their own. However, such 
local actions present the possibility of safety regulations which could 
differ considerably from State to State, or city to city. 
Recognizing the need for uniform and comprehensive safety regu- 
lations for recombinant DNA research and technology, an interagency 
committee chaired by Dr. Donald Fredrickson, Director of the Na- 
tional Institutes of Health, deliberated for several months as to wheth- 
er or not any Federal agency had the statutory authority to promul- 
gate comprehensive regulations for recombinant DNA activities. In 
March 1977, just prior to the recombinant DNA hearings held by the 
Subcommittee on Health and the Environment, the interagency com- 
mittee announced its conclusion that while some existing laws, such 
as the Public Health Service Act and the Toxic Substances Control 
Act, allowed limited regulatory authority to promulgate safety regu- 
lations for recombinant DNA activities, none was sufficiently com- 
prehensive. This committee proposed to Congress that legislation be 
enacted to regulate all recombinant DNA activities. 
At the hearings held by the Subcommittee on Health and the En- 
vironment on March 15, i6 and 17, 1977, there was nearly unanimous 
agreement that comprehensive Federal legislation should be enacted, 
[Appendix B — 136] 
