2 
Initial concerns 
Scientists involved in genetic and biomolecular research first sug- 
gested that there might be risks associated with recombinant DXA 
experimentation. In a series of conferences and public statements 
beginning in 1973, they stressed the need to obtain more factual 
evidence concerning these hypothetical risks and the need, in the 
meantime, to devise a strategy to protect laboratory workers, the 
public, and the environment. Most scientists willingly agreed that 
they should exercise great caution during this period of risk investiga- 
tion and assessment. 
Reflecting these concerns, the National Institutes of Health in July 
1976 published guidelines governing all recombinant DXA research 
supported with XIH funds. The NTH guidelines prohibited certain ex- 
periments that were presumed to be, dangerous and prescribed pro- 
cedures for others that might create unintended hazards. Other Federal 
agencies subsequently adopted these rules, and the handful of private 
firms engaged in recombinant DXA experimentation voluntarily 
agreed to observe them. Officially, however, the guidelines did not 
cover privately funded activities; only Government-supported re- 
search projects were subject to review for compliance and penalties 
for violations. 
As the scientific community developed what the majority of re^ 
searchers considered responsible self-controls, public debate ensued 
over the relative benefits and risks of recombinant DXA. research. In 
addition to fearing that pathogenic organisms might be created in the 
laboratory and released into the environment, many persons were 
deeply concerned about tampering with the natural genetic order. 
Much of this debate took place outside of Washington, D.C., in uni- 
versities and before State legislative bodies and city councils. Several 
communities extended the NTH guidelines to privately supported 
Tesearch activities: but more restrictive regulations were considered 
and, in a few instances, were adopted. At this juncture many of the 
same scientists who raised the question of potential dangers expressed 
apprehension that excessive regulation and differing State and local 
standards would have a chilling and disruptive effect on scientific 
investigation. 
During this period ( 197T-77) additional evidence relating to the con- 
cerns about recombinant DXA research began to accumulate. The re- 
sults pointed to a high level of safety associated with the use of certain 
laboratory-developed experimental organisms, such as the K-12 strain 
of the bacterium Escherichia coli. although other presumed risks were 
still acknowledged. Some experiments indicated that many of the DNA 
recombinations initially believed by scientists to be ‘'novel” were, in 
effect, only laboratory -controlled duplications of events that occur in 
nature. There were also reports of advances in the use of recombinant 
DXA technology to produce mammalian hormones. 
For many scientists, although not all, this new evidence made it 
less necessarv and desirable for the Federal Government to regulate 
conduct of the research. Revisions of the XIH guidelines to reflect 
recent scientific findings were proposed. By mid-1977 these develop- 
ments, taken together, raised doubts about the wisdom of the type of 
legislation previously contemplated. 
[Appendix B — 262] 
