Ch. 11— Regulation of Genetic Engineering • 217 
quent appro\ als to be unnecessary and burden- 
some. 
Information about whether the Guidelines 
ha\ e been a disad\ antage for L'.S. companies in 
international competition is scanty. E.xamples 
include the appro.ximately 1-year headstart two 
European groups were gi\ en while the cloning 
of hepatitis B \ irus was prohibited, the ad\ an- 
tage some European companies had in using 
certain species of bacteria for cloning under 
conditions that were prohibited in the L^nited 
States, and the delays some pharmaceutical 
companies faced because they had to build bet- 
ter containment facilities. 
The present (iuidelines are a comprehensive, 
dexible, and nonhurdensome way of dealing 
w ith the physical risks associated v\ ith rDN'A re- 
search while permitting the work to go for- 
ward. That is all they u ere e\ er intended to do. 
The Scope of the Guidelines.— In many 
respects, the Guidelines do not address the full 
scope of the risks of genetic engineering. They 
co\ er one technique, albeit the most important; 
they do not address the admittedly uncertain, 
long-term cultural risks: they are not legally 
binding on researchers recei\ ing funds from 
agencies other than N’lH; and they are not bind- 
ing on industry. 
Other genetic techniques present risks simi- 
lar to those posed by rD\,A, but to a lesser de- 
gree. Recombinant Di\A is the most \ersatile 
and efficient technique; it uses the greatest 
\ariety of genetic material from the widest 
number of sources with reasonable assurance 
of expression by the host cell. Cell fusion of 
micro-organisms, which also in\ ol\ es the uncer- 
tain risk of recombining the genetic material of 
different species, is significantly less versatile 
and efficient than rDNA but mixes more genetic 
material. In addition, the parental cells may con- 
tain partial viral genomes that could combine to 
form a complete genome when the cells are 
fused. Transformation, a technique known for 
decades, similarly imolves moving pieces of 
D\A betw een different cells. How'ever, it is sig- 
nificantly less versatile and efficient than cell fu- 
sion, and it is generally considered to be virtual- 
ly risk-free. Thus, cell fusion is in a gray area 
between the other two techniques; yet no risk 
assessment has been done, and no Federal over- 
sight exists. 
Another limitation in the scope of the guide- 
lines— and in the process by which they were 
formulated— is that long-range cultural risks (as 
distinguished from policy issues related to safe- 
ty) were never addressed. As noted by the Di- 
rector of NIH:'-* 
. . . NIH has been addressing the policy ques- 
tions in\'olving the safety of this research, not 
the potential future application ... to the alter- 
ing of the genetic character of higher forms of 
life, including man’ . . . 
Perhaps it was inappropriate to do more. Such 
ethical issues might be considered premature in 
view of the level of the development of the tech- 
nology'. The desire among many molecular bi- 
ologists to mo\ e ahead w'ith the research meant 
that experiments were being done; therefore 
the immediate potential for harm was to health 
and the en\ironment. Thus, it was arguably 
necessary to develop a framework to deal with 
the risks based on what was known at the time. 
On the other hand, the broader questions of 
where the research might eventually lead and 
whether it should be done at all have been 
raised in the public debate. They have not been 
formally considered by the Federal Govern- 
ment. 
Another limitation in the scope of the Guide- 
lines is their nonapplicability to research 
funded or performed by other Federal agencies. 
However, agencies supporting such research 
are complying with the Guidelines as a matter of 
policy. There appears to be little reason for 
questioning these declarations of general policy. 
In practice, problems might arise if a mission is 
perceived to be at odds with the Guidelines or 
because of simple bureaucratic defense of terri- 
tory— e.g., when the 1976 Guidelines were pro- 
mulgated, tw'o agencies— the Department of De- 
fense (DOD) and the National Science Founda- 
tion (NSF)— reserved the right to deviate for rea- 
sons of national security or differing interpreta- 
'MS F.R. 60103, Dec. 22, 1978, citing 43 F.R. 33067, July 28, 
1978. 
