PART in (Cont’d) 
Paqe Eight 
Attachment IV - Page 12 
to coordinate their respective activities. What is to be the 
principal function of this board. Will the board have any 
authority or influence in the decision-making process of the 
regulatory agencies. 
6. There needs to be a clarification as to how each 
advisory committee in the respective agencies is to work. Would 
such advisory committees be involved in product applications or 
only in the review or discussion of general policy issues. If 
this approach is taken, what would be the mechanism for the 
advisory committee to engage in a meaningful discussion prior to 
a decision by the agency itself. 
7. There needs to be a clarification as to whether the 
separate RACs, at each agency, would be required to hold their 
meetings in public following a thirty-day (30) publication of 
notice in the Federal Register. 
8. A clarification is needed to distinguish between 
research and commercial application. When does one activity 
end and the other begin. When would regulatory agencies assume 
responsibility for research which is to become a commercial 
product. It is suggested that all basic research and initial 
research directed toward a commercial product be primarily lodged 
with NIH-RAC insofar as it affects risk assessment of the essential 
factors of molecular science. 
9. Similar clarifications are needed to establish 
distinction between laboratory research and deliberate release 
of a modified organism. Is research conducted within green- 
houses to be considered laboratory research? 
10. In connection with the research, production and use of 
viral or bacterial vaccine utilizing DNA technology, which will 
soon be available for clinical trials, there needs to be a 
clarification as to whether such product constitutes a deliberate 
release of a modified organism. If so, which agency would be the 
appropriate agency for primary review. 
11. What mechanism would be established, and by what 
agency, to determine if an agency has the necessary expertise 
to make a competent and adequate scientific review of a proposal. 
Example ; An agriculture product intended to be ultimately 
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