45 
clear that Congress intended that materials not be approved for use 
until risks are identified and judgments made on the extent to which 
those risks can be tolerated. Very few, if any, of the commercial uses 
of recombinant DNA technology should escape the premanufacturing 
review provisions of these three statutes. 
A necessary adjunct to any mechanism for premanufacturing re- 
view is the authority to take regulatory action where there is cause 
for concern but no irrefutable evidence of injury. TVliile this principle 
is embraced in most statutes controlling hazardous materials, it is 
particularly important when controlling risks associated with re- 
combinant DNA applications since we know far less about their effects 
on health and the environment. 
After a recombinant DNA molecule or organism has been approved 
for use and manufacture has begun, generally a greater degree of risk 
must be evident in order to take action, in part because the economic 
effects of regulation are greater. While in theory an absence of assur- 
ance of safety of a pesticide or drug should result in withdrawal of 
its approval, action is rarely taken unless positive indicators of risk 
are developed from test data or other evidence. Nonetheless, it is clear 
that evidence of actual injury, as opposed to risk, need not be dem- 
onstrated. Recent cases in environmental law support this conclusion. 
The major exception appears to be in standards established for the 
protection of worker health under OSHA. The authority of the Secre- 
tary of Labor under that act is limited to recognized hazards to the 
working environment. In American Mining and Refining Company v. 
The Occupational Safety and. Health Review Commission (501 F. 2d 
504 (1974)) the court ruled that the regulatory authority under that 
act covers only airborne contaminants known to be dangerous. Whether 
OSHA’s authority extends to unquantifiable and speculative dangers 
is thus questionable. (See Appendix.) 
Under TOSCA, the Administrator of EPA is required to exercise 
his authority to the extent that risks may not be prevented or reduced 
to a sufficient extent by actions under Federal laws not administered 
by EPA (section 9(a)). Since actual injury need not be shown in 
order to take action under TOSCA. EPA has the authority and re- 
sponsibility to protect worker health if the authority of OSHA is 
insufficient. 
CONTROL OF MANUFACTURE 
The previous discussion has focused largely on the authority of 
existing statutes to control the products of recombinant DNA re- 
search following their manufacture. An equally important consider- 
ation is whether existing statutes are sufficient to control hazards that 
may arise in the process of production and expose those inside or 
outside the facility to risks. While certain statutes, such as the Clean 
Air Act and the Federal Water Pollution Control Act, provide con- 
trol over waterborne effluents and airborne emissions, the authority 
of these statutes does not extend to specifying the manner of produc- 
tion in order to avoid the effluent or emission. Likewise, OSHA gives 
the Secretary of Labor authority to establish environmental standards 
within the workplace but does not give the Secretary authority to 
specify the manner of production of any substance. 
[Appendix B — 304] 
