Ch.11 — Regulation of Genetic Engineering • 223 
One conflict of interest not soh ed by expand- 
ing the dix ersity of the RAC’s membership is in- 
stitutional in nature. the agency hax ing pri- 
mary responsibility for developing and adminis- 
tering the Guidelines, \ ie\vs its mission as one of 
promoting biomedical research. Although the 
Guidelines are not regulations, they contain 
many of the elements of regulations. They set 
standards, offer a limited means to monitor for 
compliance, and proxide for enforcement, at 
least for institutions receix ing NIH grants to do 
rDN'.A xvork; thus, they may be considered 
quasi-regulatory. Regulation is not only foreign 
but antithetical to XIH's mission. The current 
Director stated publicly at the June 1980 RAC 
meeting that the role of \IH is not one of a 
regulator, a role that must he axoided. Under 
these circumstances, perhaps another agency, 
or another part of DHHS, might he more appro- 
priate for oxerseeing the Guidelines, since the 
attitudes and priorities of promoters are usually 
quite different from that of regulators. 
If R.AC has alxvays been essentially a technical 
adx isory body, xvho then has made the x alue de- 
cisions concerning the acceptability of the risks 
presented by rDXA and the means for dealing 
xvith them? The final decisionmaker has been 
the Director of XIH, xvith the notable exception 
in the case of the 1978 Guidelines, xvhich con- 
tained the significant procedural revisions 
needed to meet Secretary Califano’s approval. 
The Director did hax e access to diverse points 
of x’iexv through the Director’s Adx isory Com- 
mittee meetings and the public hearings held 
before the 1978 Guidelines. (See app. III-A.) In 
addition, major actions xvere alxvays accom- 
panied by a statement discussing the relevant 
issues and explaining the basis for the decisions; 
after the 1978 revisions, major actions had to be 
proposed for public comment before decisions 
xvere made. In theory, it may have been prefer- 
able for the public to hax e been substantially in- 
volxed in the actual formation of the original 
Guidelines rather than simply to have reacted to 
a finished product. However, this probably 
w ould have sloxved the process at a time when 
the strong desire of the molecular biologists to 
^'Califano, op. cit. 
use the rDNA techniques could have threatened 
the notion of self-regulation. Today, there ap- 
pears to be reasonable opportunity for public 
input through the process of commenting on 
proposed actions. 
Conclusion 
The Guidelines are the result of an extraor- 
dinary, conscientious effort by a combination of 
scientists, the public, and the Federal Govern- 
ment, all operating in an unfamiliar realm. They 
appear to be a reasonable solution to the prob- 
lem of hoxv to minimize the risks to health and 
the environment posed by rDNA research in an 
academic setting, xvhile permitting as much of 
that research as possible to proceed. They do 
not in any xvay deal xvith other molecular genet- 
ic techniques or xvith the long-term social or 
philosophical issues that may be associated with 
genetic engineering. 
The Guidelines have been an evolving docu- 
ment. As more has been learned about rDNA 
and molecular genetics, containment levels 
have been significantly lowered. Also, the de- 
gree of Federal ox'ersight has been substantially 
lessened. Under the November 1980 Guidelines, 
virtually all responsibility for monitoring com- 
pliance is placed on the IBCs. NIH’s role will in- 
x'olve primarily: 1) continuing interpretation of 
the Guidelines, 2) certifying new host-vector 
systems, 3) serving as a clearinghouse of infor- 
mation, 4) continuing risk assessment experi- 
ments, and 5) coordinating Federal and local ac- 
tivities. 
The most significant short-term limitation of 
the Guidelines is the way they deal with com- 
mercial applications and products of rDNA tech- 
niques. Although large-scale containment levels 
and related administrative procedures exist, 
there are several reasons for questioning the ef- 
fectiveness of the voluntary compliance con- 
cept. The most serious problem has been the 
lack of expertise in fermentation technology on 
RAC. In addition, since the Guidelines are not 
legally binding upon industry, the NIH lacks en- 
forcement authority, although there has been 
no evidence of industrial noncompliance. Final- 
ly, because of its role as a promoter of bio- 
