Chapter 11 
Regulation of Genetic Engineering 
Introduction 
Although no e\ idence exists that any hai'mful 
organism has been created hv molecular genetic 
techniques, most e\})erts helie\e that some 
risk* is associated with genetic engineering. 
One kind is relatively certain and ciuantitiable— 
that of working with known toxins or patho- 
gens. .Another is uncertain and hypothetical— 
that of the possible creation of a [)athogenic or 
otherwise undesirable organism by reshuffling 
genes thought to he harmless. These may he 
thought of as physical risks because they con- 
cern human health or the en\ ironment. 
(x)ncern has also arisen about the possible 
long-range impacts of the techni(|ues— that they 
may eventually he used on humans in some 
morally unacceptable manner or may change 
fundamental \ iews of w hat it means to be hu- 
man. These possibilities may he thought of as 
cultural risks, since they threaten fundamental 
beliefs and v alue systems.' 
The issue of whether or not to regulate 
molecular genetic techniques— and if so, to 
what extent— defies a simple solution. Percep- 
tions of the nature, magnitude, and acceptabili- 
ty of the risks differ drastically. Approximately 
6 years ago, vv hen the scientific community it- 
self accepted a moratorium on certain classes of 
recombinant DX.A (rD\,A) research, some sci- 
entists considered the concern unnecessary. To- 
day, even though the physical risks of rDNA re- 
search are generally considered to be less than 
originally feared— and the realization of its 
benefits much closer— some people would still 
prohibit it. 
The Federal Government's approach to this 
issue has been the promulgation of the Guide- 
lines for Research Involving Recombinant DNA 
Molecules (Guidelines), by the National Insti- 
tutes of Health (NIH). (See app. III-C for infor- 
mation about what other countries have done 
" As used in this chapter, risk means the possibility of harm. The 
probabilitv of that harm occurring may be e.xtremelv low and/or 
highly uncertain. 
'H. Tristam. Engelhardt. Jr., “Taking Risks: Some Background 
Issues in the Debate Concerning Recombinant D,\'.A Research, 
Southern California Law Review o\:6,pp. 1141-1151. 1978. 
with respect to guidelines for rDNA.) Three 
other available modes of oversight or regulation 
are current Federal statutes, toi't law, and State 
and local law. 
Frameworh for the analysis 
In deciding how to address the risks posed by 
genetic engineering, some of the important 
questions that need to be examined are; 
• How broadly the scope of the issue (or 
problem) should be defined. 
—Who identifies the risks and their mag- 
nitude? 
—Who proposes the means for addressing 
the problem? 
• The nature of the procedural, decisionmak- 
ing mechanism. 
—Who decides? 
—Who will benefit from the proposed ac- 
tion and who will bear the risk? 
—Will the risk be borne voluntarily or in- 
voluntarily? 
—Who has the burden of proof? 
— SboLild a risk/benefit analysis, or some 
other approach, be used? 
• The available solutions and their adequacy. 
—Should there be full regulation, no reg- 
ulation, or something in-between? 
—What actions and actors should be cov- 
ered? 
—What is the appropriate means for en- 
forcing a regulatory decision? 
—Which agency or other group should do 
the regulating? 
Underlying these questions is the proposition, 
widely accepted by commentators on science 
policy, that scientists are qualified to assess 
physical risk, since that inyolyes measuring and 
evaluating technical data. Howeyer, a judgment 
of safety (the acceptability of that risk) can only 
be made by society through the political proc- 
ess, since it involyes weighing and choosing 
among yalues.^ 3 4 5 6 Scientists are not nec- 
^VVilliam VV. Lowrance, Of Acceptable Risk: Science and the De- 
termination of Safety (Los Altos, C;alit.: William Kaufmann, Inc., 
1976). 
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