Ch. 11— Regulation of Genetic Engineering • 231 
and expertise that should permit them to adapt 
to most new problems posed by genetic engi- 
neering. rhe agencies ha\e been consulting 
with each other through the Interagency Com- 
mittee, and the three agencies that will play the 
most important role in regulating large-scale 
commercial acti\ ities— FDA, OSHA, and ERA— 
ha\ e been studying the situation. 
The disad\ antages of this option are the lack 
of a centralized, uniform Federal response to 
the problem, and the possibility that risks 
associated with commercial applications will not 
be adequately addressed. Certain applications, 
such as the use of micro-organisms for oil re- 
covery are not unequix ocably regulated by cur- 
rent statutes; broad interpretations of statutory 
language in order to reach these situations may 
be overturned in court. Conflicting or redun- 
dant regulations of different agencies would 
result in unnecessary burdens on those regu- 
lated. In addition, some commercial acti\ity is 
now at the pilot plant stage, but the responsible 
agencies have yet to establish official policy and 
to devise a coordinated plan of action. 
B: Congress could require that the Federal Inter- 
agency Advisory Committee on Recombinant 
Di\A Research prepare a comprehensive re- 
port on its members' collective authority to 
regulate rDi\A and their regulatory intentions. 
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 rDMA methods.— e.g., 
companies are building fermentation plants 
without knowing what design or other require- 
ments OSHA may mandate for worker safety. 
As was stated by former OSHA head, Dr. Eula 
Bingham, it will take at least 2 years for OSHA to 
set standards, if the current NIOSH study shows 
a need for them.^® 
A congressionally mandated report would 
assure full consideration of these issues by the 
agencies and expedite the process. It could in- 
■•^Letter from Dr. Eula Bingham. .Assistant Secretary for Occupa- 
tional Safety and Health, to Dr. Donald Fredrickson. Director, NIH, 
Sept. 24, 1980. 
elude the following: 1) a section prepared by 
each agency that assesses its statutory authority 
and articulates what activities and products will 
be considered to come within its jurisdiction, 2) 
a summary section that evaluates the adequacy 
of existing Federal statutes and regulations as a 
whole with respect to commercial genetic en- 
gineering, and 3) a section proposing any specif- 
ic legislation considered to be necessary. 
Tbe principal disadvantages of this option are 
that it may be unnecessary and impractical. 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 tbe fact. 
C: Congress could require Federal monitoring of 
all rDNA activity for a limited number of 
years. 
This option represents a “wait and see” posi- 
tion by Congress and the middle ground be- 
tween the status quo and full regulation. It rec- 
ognizes and balances the following factors: 1) 
the absence of demonstrated harm to human 
health or the environment from genetic en- 
gineering; 2) the continuing concern that genet- 
ic engineering presents risks; 3) the lack of suf- 
ficient knowledge from which to make a final 
judgment; 4) the existence of an oversight mech- 
anism that seems to be working well, but that 
has clear limitations with respect to commercial 
activities; 5) the virtual abolition of Federal 
monitoring of rDNA activities by the recent 
amendments to the Guidelines; and 6) the ex- 
pected increase in commercial genetic engineer- 
ing activities. 
Monitoring involves the collection and eval- 
uation of information about an activity in order 
to know what is occurring, to determine the 
need for other action, and to be able to act if 
necessary. More specifically, this option would 
provide a data base that could be used for: 1) de- 
termining the effectiveness of voluntary compli- 
ance with the Guidelines by industry and man- 
datory compliance by Federal grantees, 2) de- 
termining the quality and consistency of IBC de- 
cisions and other actions, 3) continuing a formal 
risk assessment program, 4) identifying vague 
