234 • Impacts of Applied Genetics— Micro-Organisms, Plants, and Animals 
techniques may not warrant the significantly in- 
creased regulatory burden and costs that would 
result from such legislation. Congress will have 
to decide if that system will remain adequate as 
commercial activity grows. 
If Congress were to decide on this option, the 
legislation could incorporate some or all of op- 
tions C, D, and E. The present mechanism 
created by the Guidelines could be appropriate- 
ly modified to provide the regulatory frame- 
work. The modifications could include a regis- 
tration and licensing system to provide infor- 
mation on what work was actually being done 
and a means for continuous oversight. One 
important type of information would be health 
and safety statistics gathered by monitoring 
workers involved in the production of products 
from genetically engineered organisms. Anoth- 
er modification could be a sliding scale of 
penalties for violations, ranging from monetary 
fines through revocation of operating licenses 
to criminal penalties for extreme cases. 
It would not be necessary to create a new 
agency, which would duplicate some of the re- 
sponsibilties of existing agencies. Instead, Con- 
gress could give these agencies clear regulatory 
authority by amending the appropriate statutes. 
Designating a lead agency would assure a more 
uniform interpretation and application of the 
laws. 
G. Congress could require NIH to rescind the 
Guidelines. 
This option requires Congress to determine 
that the risks of rDNA techniques are so insig- 
nificant that no control or oversight is nec- 
essary. Deregulation would have the advantage 
of allowing funds and personnel currently in- 
volved in implementing the Guidelines at the 
Federal and local levels to be used for other pur- 
poses. In fiscal year 1980, NIH spent approxi- 
mately $500,000 in administering the Guide- 
lines; figures are not available for the analogous 
cost to academia and industry. Personnel hours 
spent have not been estimated. V'ery few people 
work full-time on administering or complying 
with the Guidelines. NIH employs only six peo- 
ple full-time for this purpose, and some institu- 
tions employ full-time biological safety person- 
nel. However, over 1,000 people nationally 
devote some effort to implementing the 
Guidelines— members of the IBCs and the scien- 
tists conducting the rDNA experiments who 
must take necessary steps to comply. 
There are several reasons for retaining the 
Guidelines. First, sufficient scientific concern 
about risks exists for the Guidelines to prohibit 
certain experiments and require containment 
for others. Second, they are not particularly 
burdensome, since an estimated 80 to 85 per- 
cent of all experiments can he done at the 
lowest containment levels and an estimated 97 
percent will not require NIH approval. I hird, 
NIH will continue to serve an important role in 
continuing risk assessments, in e\aluating new 
host-vector systems, in collecting and dispersing 
information, and in interpreting the Guidelines. 
Fourth, if the Guidelines were abolished, I'cgu- 
latory activity at the State and local levels (X)uld 
again become actixe. Finally, the oversight sys- 
tem has been flexible enough in the past to lib- 
eralize restrictions as ex idence indicated loxxer 
risk. 
H. Congress could consider the need for 
regulating work with all hazardous micro- 
organisms and viruses, whether or not they 
are genetically engineered. 
Micro-organisms carrying rDNA, according to 
an increasingly accepted xiexv, represent just a 
subset of micro-organisms and x irus(?s, xx hich, 
in general, pose risks. (d)(' has puhlish(*d guide- 
lines for xvorking xvith hazardous agents such as 
polio virus. Hoxvever, such xvoi'k is not cur- 
rently subject to legally enforceable l'('deral reg- 
ulations. It xvas not xvithin the scope of this 
study to examine this issue, hut it is an emerging 
one that Congress may xvish to consid(>r. 
