Ch. 1— Summary: Issues and Options • 21 
using an existing o\ ersight mechanism. I'he ma- 
jor changes that uDukl have to he made in the 
area ot enforcement. I’rest'iit penalties for non- 
compliance— suspension or termination of re- 
search funtls— ai'(' ohv iously inapplic able to in- 
dustry. In addition, procedui'c's for monitoi'ing 
compliance' would ha\ e to he strengthenc'd. 
I'lie main disadvantage of this option is that 
MH is not a regulatory agency. Since \'IH 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 he given 
the authority to enforce the (lUidelines. 
£. Congress could require an environmental im- 
pact statenient and agency approval before 
any genetically engineered organism is inten- 
tionally released into the environnwnt. 
There have been numerous cases where an 
animal or plant species has been introduced into 
a new env ironment and has spread in an uncon- 
trolled and undesirable fashion. Vet in pollution 
control, mineral leaching, and enhanced oil 
recov erv, it might be desirable to release large 
numbers of engineered micro-organisms into 
the environment. 
The Guidelines currently prohibit deliberate 
release of any organism containing rDNA with- 
out approval of NIH. One disadvantage of this 
prohibition is that it lacks the force of law. 
.Another is that approval may be granted on a 
finding that the release would present "no sig- 
nificant risk to health or the environment;” a 
tougher or more specific standard may be de- 
sirable. 
A required study of the possible conse- 
quences of releasing a genetically engineered 
organism w'ould be an important step in ensur- 
ing safety. An impact statement could be filed 
before permission is granted to release the 
organism. How'ever, companies and individuals 
might be discouraged from developing useful 
organisms if this process became too burden- 
some and costly. 
F. Congress could pass legislation regulating all 
types and phases of genetic engineering from 
research through commercial production. 
This option would deal comprehensively and 
directly with the risks of novel molecular 
genetic techniciues. A s()ecific statute would 
eliminate the uncertainties over the extent to 
which present law covers particular applica- 
tions of genetic engineering and any concerns 
about the effectiveness of voluntary compliance 
with the Guidelines. Alternatively, the legisla- 
tion couki take the form of amending existing 
laws to clarify their applicability to genetic 
engineering. 
Other molecular genetic technicjues, wliile 
not as widely used and effective as rDNA, raise 
similar concerns. Of the current techni(|ues, cell 
fusion is the prime candidate for being treated 
like I'DNA in any regulatory framework. No risk 
assessment of this technique has been done, and 
no Federal oversight exists. 
The principal argument against this option is 
that the current system appears to be working 
fairly well, and the limited risks of the tech- 
niques may not warrant the significantly in- 
creased regulatory burden that would result 
from such legislation. 
G. Congress could require NIH to rescind the 
Guidelines. 
Deregulation w ould have the adv'antage of al- 
lowing money and personnel currently involved 
in implementing the Guidelines at the Federal 
and local levels to be used for other purposes. 
There are several reasons for retaining the 
Guidelines. Sufficient scientific concern exists 
for the Guidelines to prohibit certain experi- 
ments and to require containment for others. 
Most experiments can be done at the lowest, 
least burdensome containment levels. NIH is 
serving an important role as a centralized over- 
sight and information coordinating body, and 
the system has been flexible enough in the past 
to liberalize the restrictions as evidence in- 
dicated lower risk than originally thought. 
H. Congress could consider the need for regulat- 
ing work with all hazardous micro-organisms 
and viruses, whether or not they are genet- 
ically engineered. 
It was not w ithin the scope of this study to ex- 
amine this issue, but it is an emerging one that 
Congress may wish to consider. 
