2 
Flexible Regulations 
H.R. 11192 provides the HEW Secretary with a great deal of flexi- 
bility in implementing interim regulations. As you are aware, Mr. 
Chairman, the Report on the Science Policy Implications of DNA Recombinant 
Molecule Research by the Science, Research, and Technology Subcommittee 
supports this position. We believe it essential that the scope and 
mandate for regulation are based on clear scientific evidence of the 
safety or risks of this research. New scientific information on the 
safety of E. coli K-12 (the principal organism used in these experiments) 
indicates that extensive regulation in this research area is unwarranted. 
The report of the Commerce Committee accompanying H.R. 11192 and the 
report of your Subcommittee cite this evidence. Indeed, additional 
evidence suggests that recombinant DNA research in the laboratory may be 
very similar to events which occur in nature. If such evidence continues 
to accumulate, then the concern about creating new forms of life will be 
put into a new perspective. 
At a public hearing on the proposed revisions to the Guidelines 
held by the Advisory Committee to the Director (DAC) , NIH, on December 
15-16, 1977, there was support for flexibility in the administration of 
the NIH Guidelines. There was strong support for a provision that would 
allow the Director, NIH, on the recommendation of the Recombinant DNA 
Molecule Program Advisory Committee (RAC) to exempt risk assessment 
experiments from the requirements of the Guidelines. There was general 
agreement that risk assessment experiments are essential to determine 
[Appendix B — 178] 
