disease illustrate that the Secretary has the authority under §361 
to regulate infectious agents from any source/ transmitted by any 
means 
Because microorganisms produced by recombinant DNA activities 
may spread disease among humans, it has already been recognized 
that regulations promulgated pursuant to authority under §361 
control transportation of DNA materials. Section II-C of the NIH 
Guidelines (41 Fed. Reg. 27914) states that the shipment of 
recombinant DNA materials is governed by 42 C.F.R. §72.25 which 
specifies safety requirements for the transportation of etiologic 
1 / 
agents. An "etiologic agent" is defined as " . . .a viable micro-- 
organism or its toxin which causes, or may cause, human disease." 
(42 C.F.R. 572.25(a)(1)) Recombinant research and the commercial 
use of recombinant technology pose an even greater risk that the 
public will be exposed to infectious agents than does transporta- 
tion. The same risk of communicable disease which gives the 
Secretary the authority to regulate the transpor tation of recombinant 
materials under §361 gives him the authority to regulate all re- 
combinant. DNA activities. 
V. Re lief 
By this petition EDF and NRDC seek the following relief: 
1. A legislative-type hearing to develop a policy on 
recombinant DNA research and technology. 
2. Regulations binding on all parties conducting recombinant 
DNA research or otherwise engaged in recomb inant DNA technology. 
17 §72.25 applies to microorganisms listed in subsection (C) which 
includes most microorganisms used in recombinant DNA research such 
as E. coli, Simian Viruses, Salmonella. 
59 
[ 339 ] 
