20 • Impacts of Applied Genetics— Micro-Organisms, Piants, and Animals 
situations, regulatory actions based on such in- 
terpretations could be challenged in court. In 
anv e\ent, those agencies that could have 
substantial regulatory authority over commer- 
cial genetic engineering have not yet officially 
acted to assert that authority. 
Issue and Options — Regulation 
ISSUE: How could Congress address the 
risks presented by genetic engi- 
neering? 
OPTIONS: 
A. Congress could maintain the status quo by let- 
ting NIH and the regulatory agencies set the 
Federal policy. 
Congress might determine that legislation to 
remedy the limitations in current Federal over- 
sight would result in unnecessary and burden- 
some regulation. No known harm to health or 
the en\'ironment has occurred under current 
regulation. Also the agencies generally have the 
legal authority and expertise to adapt to most 
new problems posed by genetic engineering. 
The disadvantages are the lack of a central- 
ized, uniform Federal response to the problem, 
and the possibility that risks associated with 
commercial applications will not be adequately 
addressed. Conflicting or redundant regulations 
of different agencies would result in unneces- 
sary burdens on those regulated. 
B. Congress could require that the Federal Inter- 
agency Advisory Committee on Recombinant 
DNA Research prepare a comprehensive re- 
port on its members' collective authority to 
regulate rDNA and on their regulatory inten- 
tions. 
The Industrial Practices Subcommittee of this 
Committee has been studying agency authority 
over commercial rDNA activities. Presently, 
there is little official guidance on regulatory re- 
quirements for companies that may soon mar- 
ket products made by rDNA methods. A con- 
gressionally mandated report would ensure full 
consideration of these issues by the agencies 
and expedite the process. On the other hand, 
the agencies are studying the situation, which 
must be done before they can act. Also, it is 
often easier and more efficient to act on each 
case as it arises, rather than on a hypothetical 
basis before the fact. 
C. Congress could require that all recombinant 
DNA activity be monitored for a limited num- 
ber of years. 
This represents a "wait and see" |K)silion by 
Congress and the middle ground between the 
status quo and full regulation. It recognizes and 
balances the following factors: 1) the absence of 
demonstrated harm to human health or the en- 
vironment from genetic engineering; 2) the con- 
tinuing concern that genetic engineering pre- 
sents risks; 3) the lack of sufficient knowledge 
and experience from which to make a final judg- 
ment; 4) the existence of an oversight mech- 
anism that seems to be working well, hut that 
has clear limitations with respect to commercial 
activities; 5) the virtual abolition of Federal 
monitoring of rDNA acti\ ities by recent amend- 
ments to the Guidelines; and 6) the expected in- 
crease in commercial genetic engineering. 
This option would pro\ ide a data ha.se that 
could be used for: 1) determining the effec- 
tiveness of voluntary compliance with the 
Guidelines by industry, and mandatory com[)li- 
ance by Federal grantees; 2) determining the 
quality and consistency of the local self-regu- 
latory actions; 3) continuing a formal risk ass('ss- 
ment program; 4) identifying \ ague oi' conflict- 
ing provisions of the Guidelines for rev ision; .3) 
identifying emerging trends or problems; and (i) 
tracing any long-term adverse im[)acts on health 
or the environment to their soui'ces. 
The obvious disadvantage of this option 
would be the required paperwork and (dfort by 
scientists, universities, corporations, and the 
Federal Government. 
D. Congress could make the NIH Cuidelines ap- 
plicable to all rDNA work done in the I 'idled 
States. 
This option would eliminate any concern 
about the effectiveness of voluntary ('ompliance 
with the Guidelines, and it has the ad\ antage ot 
