7 
them what they are -- "regulations" -- would eliminate the ambiguity which 
leads many people to believe that they are only voluntary and would highlight 
the fact that only NIH funded research is regulated, a serious lacuna which 
must be remedied. 
2. HEW should proceed with the promulgation of Parts I and IV and Section 
II. D. of the regulations, that is, the definitional, procedural and administra- 
tive sections -- with appropriate modifications. There is a need to improve 
the regulatory mechanism and create flexibility in the recombinant program. 
But it is premature to make any revisions in Part III and the remainder of Part 
II for two reasons. First, NEPA has not yet been complied with. Second, a 
convincing case has not yet been made for relaxation of containment standards. 
The meager efforts which have been made thus far to determine the risks in- 
volved in recombinant DNA activities have done little if anything to inspire 
public confidence. Even the one problem which has received a fair amount of 
attention, the use of E. coli K-12 as a host, still is a matter of scientific 
controversy, as is evident from the testimony received at this hearing. But E. 
coli K-12 is not the only host organism being used today and many others are 
contemplated for use in the near future, with no risk assessment having been 
conducted on these organisms. 
With respect to containment levels, the Director's Decision, 43 Fed. Reg. 
33058, states that, "In general, the classification may appear somewhat arbi- 
trary...". In the Environmental Impact Assessment this statement has been 
changed to read, "In general, the classification is_ somewhat arbitrary" [43 
Fed. Reg. 33117] [emphasis added). Immediately following, it is stated that: 
[The classification] depends in large part on the scientific judgment of 
the RAC rather than on demonstrable risk, because there is in fact no ac- 
tual scientific evidence that there is a hazard in any recombinant DNA ex- 
periment. [43 Fed. Reg. 33117.] 
This is not a valid rationale. "Judgment" which is scientific is based on sci- 
[A-238] 
