230 • Impacts of Applied Genetics— Micro-Organisms, Plants, and Animals 
tional issue that can be handled most effectively 
at the Federal level. 
A few jurisdictions have used their authority 
in the case of rDNA. * The most comprehensive 
regulation was created by the States of Mary- 
'Cambridge, Mass., established a citizens' study group that rec- 
ommended that researchers be subject to some additional re- 
strictions beyond those of the Guidelines. These were embodied in 
an ordinance passed by the City Council on Feb. 7, 1977. Berkeley, 
Calif., passed an ordinance requiring private research to conform 
to the Guidelines. Similar ordinances or resolutions were passed 
by Princeton, N.J., Amherst, Mass., and Emeryville, Calif. 
Conclusion 
The initial question with respect to regulating 
genetic engineering is how to define the scope 
of the problem. This will depend largely on 
what groups are involved in that process and 
how they view the nature, magnitude, and 
acceptability of the risks. Similarly, the means 
of addressing the problem will be determined 
by how it is defined and who is involved in the 
actual decisionmaking process. For these rea- 
sons, it is important that regulatory mechanisms 
combine scientific expertise with procedures to 
accommodate the values of those bearing the 
risk so that society may have confidence in 
those mechanisms. 
Currently, genetic techniques and their prod- 
ucts are regulated by a combination of the 
Issue ai 
ISSUE: How could Congress address the 
risks associated with genetic en- 
gineering? 
A number of options are available, ranging 
from deregulation through comprehensive new 
regulation. An underlying issue for most of 
these options is: What are the constitutional 
constraints placed on congressional regulation 
of molecular genetic techniques, particularly 
when they are used in research? (This is dis- 
cussed in app. III-B.) 
land and New York.'*^ Currently, there is little, 
if any, effort on the State or local level to pass 
laws or ordinances covering rDNA or similar 
genetic techniques, and there is little activity 
under the existing laws. 
^“Annotated Code o f Maryland, ;irt. 43 §§ 898-910 (supp. 19781 
“^McKinnev’s Consolidated Laws of New )'ork, Public MimIiIi Law . 
art. 32-A §§3220-3223 (supp. 1980) 
Guidelines, Federal statutes protecting health 
and the environment, some State or local laws, 
and the judicially created law of torts, which is 
available to compensate injuries after they oc- 
cur. In most cases, this system appears adequate 
to deal with the risks to health and the en\ iron- 
ment. However, there is some concern regard- 
ing commercial applications for the following 
reasons: 1) the voluntary applicability of the 
Guidelines to industry, 2) RAC's insufficient ex- 
pertise in fermentation technology, 3) the po- 
tential interpretive problems in apjilying ex- 
isting law to the workplace and to situations 
where , micro-organisms are intentionally re- 
leased into the enviornment, and 4) the absence 
of a definitive regulatory posture l)v the 
agencies. 
Options 
OPTIONS: 
A: Congress could maintain the status quo hy let- 
ting NIH and the regulatory agertcies set the 
Federal policy. 
This option requires Congress to detcMTiiine 
that legislation to remedy the limitations in cur- 
rent Federal oversight would result in unnec«*s- 
sary and burdensome regulation. No knov\ti 
harm to health or the em iionnuMit has (m • 
curred under the current system, and the agen- 
cies generally have significant legal authoiit\ 
