Ch.11 — Regulation of Genetic Engineering • 233 
t 
in fermentation and other industrial technolo- 
gies to RAC if production, as well as research, is 
to be adequately covered. In addition, the rec- 
ommendations for large-scale containment pro- 
cedures would have to be made part of the 
, Guidelines. 
The major changes would have to be made 
; with respect to enforcement. Present penalties 
for noncompliance— suspension or termination 
of research funds— are obviously inapplicable to 
industry. In addition, procedures for monitor- 
ing compliance could be strengthened. Some of 
the elements of option C could be used. An 
added or alternative approach would be to in- 
spect facilities. 
The main disad\ antage of this option is that 
NIH is not a regulatory agency. Since NIH has 
traditionally viewed its mission as promoting 
biomedical research, it would have a conflict of 
interest between regulation and promotion. 
One of the regulatory agencies could be given 
the authority to enforce the Guidelines and to 
adopt changes therein. NIH could then continue 
in a scientific advisory role. 
E. Congress could require an environmental im- 
pact statement and agency approval before 
any genetically engineered organism is inten- 
tionally released into the environment. 
There have been numerous cases where an 
animal or plant species has been introduced into 
a new environment and has spread in an uncon- 
trolled and undersirable fashion. One of the 
early fears about rDNA was that a new path- 
ogenic or otherwise undesirable micro-orga- 
nism could establish an environmental niche. 
Yet in pollution control, mineral leaching, and 
enhanced oil recovery, it might be desirable to 
release large numbers of engineered micro-or- 
ganisms into the environment. 
The Guidelines currently prohibit deliberate 
release of any organism containing rDNA with- 
out approval by the Director of NTH on advice of 
RAC. The obvious disadvantage of this prohibi- 
tion is that it lacks the force of law. The release 
of such an organism without NIH approval 
would be a prima facie case of negligence, if the 
organism caused harm. However, it may be 
more desirable social policy to attempt to pre- 
vent this type of harm through regulation 
rather than to compensate for injuries through 
lawsuits. Another possible disadvantage of the 
present system is that approval may be granted 
on a finding that the release would present "no 
significant risk to health or the environment;” a 
tougher or more specific standard than this may 
be desirable. 
A required study of the possible consequen- 
ces following the release of a genetically 
engineered organism, especially a micro-orga- 
nism, would be an important step in ensuring 
safety. This option could be implemented by re- 
quiring those proposing to release the organism 
to file an impact statement with an agency such 
as NIH or EPA, which would then grant or deny 
permission to release the organism. A disad- 
vantage of this option is that companies and in- 
dividuals might be discouraged from developing 
useful organisms if this process became too 
burdensome and costly. 
F. Congress could pass legislation regulating all 
types and phases of genetic engineering, from 
research through commercial production. 
The main advantage of this option would be 
to deal comprehensively and directly with the 
risks of novel molecular genetic techniques, 
rather than relying on the current patchwork 
system. A specific statute would eliminate the 
uncertainties over the extent to which present 
law covers particular applications of genetic en- 
gineering, such as pollution control, and any 
concerns about the effectiveness of voluntary 
compliance with the Guidelines. 
Other molecular genetic techniques, while 
not as widely used and effective as rDNA, raise 
similar concerns. Of the current techniques, cell 
fusion is the prime candidate for being treated 
like rDNA in any regulatory framework. It per- 
mits the recombination of chromosomes of 
species that do not recombine naturally, and it 
may permit the DNA of latent viruses in the cells 
to recombine into harmful viruses. No risk as- 
sessment of this technique has been done, and 
no Federal oversight exists. 
The principal arguments against this option 
are that the current system appears to be work- 
ing fairly well, and that the limited risks of the 
