40 
and consultation procedure similar to that followed by NIH in decid- 
ing whether to release research protocols submitted by grant 
recipients. 
Recommendations for Regulation of Commercial Applications 
As discussed previously, the possible commerical applications of re- 
combinant DNA research are numerous, including the production of 
pharmaceuticals, pesticides, enzymes, plant growth stimulators, en- 
vironmental decontaminants, and other materials of value to industry, 
medicine, agriculture, and the consumer. While some applications of 
the research may be decades away, others could be available within 
a few years. 
Both the production of large cultures of recombinant DNA orga- 
nisms to manufacture useful substances and the release of modified 
hosts or vectors into the environment are contemplated. Congress has 
the responsibility to insure that any hazards associated with these 
uses of recombinant DNA techniques for commercial purposes are 
fully understood and appropriate safeguards are established to pre- 
vent any undue risk to human health or the environment. The follow- 
ing section examines a number of policy issues relevant to the appli- 
cations of recombinant DNA technology. Documents relating to the 
applicability of current statutes to the regulation of these applica- 
tions are included in the appendix. 
LOCUS OF REGULATORY RESPONSIBILITY 
Twelve existing statutes have been identified by the American Law 
Division of the Congressional Research Service as possible authori- 
ties under which to regulate commercial uses of recombinant DNA. 
(See appendix.) Since a large number of statutes are involved, it has 
been argued that the most direct way to deal with the problem is to con- 
solidate all of the regulatory authority within a single agency and a 
single authority. In fact, some legislation (for example, S. 1217) would 
effectively preempt all Federal statutes except the Occupational Safety 
and Health Act (29 U.S.C. 631, et. seq. (OSHA) ) , and lodge responsi- 
bility for the regulation of all recombinant DNA activities with the 
Secretary of Health, Education, and Welfare or an independent com- 
mission. Thus, whether or not a recombinant DNA application is pesti- 
cidal (now subject to the jurisdiction of the Environmental Protection 
Agency) , for industrial purposes (also largely in EPA ! s jurisdiction) , 
pharmaceutical (Food and Drug Administration’s jurisdiction), or 
involves the transportation of hazardous materials (Department of 
Transportation’s jurisdiction) , sole regulatory responsibility would be 
vested in a single agency. 
While a consolidation of authority appears to be in the interest of 
administrative efficiency, it would duplicate expertise and responsi- 
bilities now existing within other agencies of Government. For ex- 
ample, if an agency or commission were given jurisdiction over a 
proposed use of recombinant DNA to control insects on agricultural 
crops, this grant of authority would duplicate the function and 
expertise of EPA under the Federal Insecticide, Fungicide, and 
Rodenticide Act — 7 U.S.C. 135, et seq. (FIFRA). Similar duplica- 
[ Appendix B — 299] 
