ENA/5 
DD-NIH (43 Fed * Reg . 33048) indicates that the rationale for 
allowing exceptions from the classes of prohibited experiments is to 
provide for experiments for which there are "compelling social or 
scientific reasons reasons, for example, risk assessment experiments." 
This is an appropriately rigorous standard for approving exceptions. 
Yet I-D does not require that the benefits of the experiment must be 
compelling before an exception will be approved. I-D merely states 
that weight will be given in the decision making process "both to 
scientific and social benefits and to potential risks." Clearly, the 
standard for excepting experiments differs between PRG-NIH and DD-NIH. 
Yet only the "Guidelines" will have the indisputable force of law. 
With the PRG-NIH language, many potentially hazardous experiments 
which provide the potential for only minimal benefit may be excepted. 
The language of I-D should be changed to allow only experiments that 
will provide compelling benefits to be excepted. 
This is only one example of where DD-NIH and PRG-NIH differ on 
extremely crucial issues. Yet again, only the "Guidelines" will have 
the indesputable force of law. DHEW should carefully screen the 
Environmental Impact Assessment, DD-NIH, and PRG-NIH to eliminate any 
contradictions. All information necessary for compliance should be 
written into the "Gui delines" themeselves and not remain scattered 
throughout the Federal Register package. 
I-E-4. Recombinant DNA activities should be exempted from the 
"Guidelines" only if they do not present a significant risk to health 
or the environment. The criterion for granting exemptions should be 
safety and not whether DNA exchange already goes on in nature. 
I-E-5. Once again, the public participation and public comment 
provisions of this section are too vague. New classes of recombinant 
DNA molecules should be exempted from the "Guidelines" only by regula- 
[A-340] 
