APPENDIX J 
would appear to be covered in most cases by the Act's definition of 
"chemical substance." Section 5 of the Act, however, explicitly exempts 
registration of chemical substances used in small quantities for the 
purposes of scientific experimentation or analysis. This represents 
a most serious deficiency, as the registration of activities was thought 
to be an essential element of any regulatory effort. Also, in order 
to meet the specifications of the Act, recombinant DNA research would 
have to be found to present "an unreasonable risk of injury to health 
or the environment." 
The Hazardous Materials Transportation Act (HMTA) and Section 361 
of the Public Health Service (PHS) Act give the Department of Transporta- 
tion (dot) and the Center for Disease Control (CDC), respectively, 
authority to regulate the shipment of hazardous materials in interstate 
commerce. Both the DOT and the CDC, in implementing these acts with 
respect to biological products, have essentially aimed at imposing 
labeling, packaging, and shipping requirements, and were found to 
be wanting for regulation of all recombinant DNA research. 
The Environmental Defense Fund, in November 1976, petitioned the 
DHEW to regulate recombinant DNA research under Section 361 of the PHS Act. 
(The petition is included in Appendix IV.) The Subcommittee carefully 
reviewed this section, which is directed to organisms that are communicable 
and cause human disease. Thus, under this section, there would have to 
be a reasonable basis for concluding that the products of all recombinant 
DNA research may cause human disease and are communicable. Further, Section 
Appendix J — 9 
