21 
•was previously assumed. The success of the California investigators in 
cloning the rat insulin gene and in developing a synthetic gene for 
the production of the hormone somatostatin points to the possibility 
of producing a variety of hormones and industrial enzymes in large 
cultures of recombinant DNA organisms. Presumably, the organisms 
would be contained and eventually destroyed, as they are in the re- 
search laboratory: but their large volume would increase the likeli- 
hood of worker exposure and escape of the organisms from the 
facility. 
More speculative uses actually contemplate the deliberate release of 
the modified host cell into the environment for some specific purpose 
such as the conversion of organic material in sewage treatment, the 
oxidation of petroleum spills, or improvement in the nitrogen-fixing 
capability of plants. Aside from the possible hazards of the organism 
itself, these uses may have adverse indirect effects. Plants with su- 
perior nitrogen-fixing characteristics might displace others or valu- 
able resources be destroyed. Alternatively, there has been mention of 
using a modified vector, probably a virus, to infect plants or destroy 
insect pests. In these cases, environmental exposure, for example, from 
spraying, would be difficult to control. The use of a modified vector for 
correcting a genetic defect in man raises moral as well as safety 
concerns. 
The XIH guidelines do not purport to deal with these possibilities 
and the apprehensions they raise. Indeed, if the}’ were applied to the 
private sector, the 10-liter production limit on certain cultures, the ban 
on release, and the physical containment measures might singly or in 
combination preclude all of these applications. More importantly, uses 
involving the introduction of recombinant DNA molecules into a nat- 
ural environment run directly counter to the concept of biological con- 
tainment which is a principal safeguard in the guidelines. The util- 
ity of the modified organisms or vectors would depend entirely upon 
their ability to survive and/or exchange DNA with other organisms, 
whereas the hosts and vectors now prescribed for research are spe- 
cifically designed to have no such capability. 
It is impossible to predict what will be the perception of recom- 
binant DNA hazards and the status of the guidelines when and if 
an}’ of these applications becomes feasible. For the present, the risks 
in commercial exploitation of the technology appear to many observers 
to be more varied and more serious than any that may be associated 
with research experiments. Koy Curtiss doubted that commercial uses 
of genetically modified micro-organisms would pose ‘"any threat to the 
public or the well-being of any other organisms in the environment,*’ 
but said, “I think it is essential in these applications of recombinant 
technology that we obtain appropriate experimental evidence to vali- 
date this general belief.” David Newburger of Washington Univer- 
sity, St. Louis, Law School expressed concern that the issue had not 
been addressed in previous discussions of recombinant DNA 
regulation. 
[Appendix B — 281] 
