Attachment IV - Page 11 
PART III 
The following sets. forth suggestions for clarification if 
in the event the proposals set forth in the Federal Register of 
the date of December 31, 1984 are adopted. They are as follows: 
1. There is a need to clarify the respectiv e and 
responsibilities of the involv ed in agriculture researc h . 
This research may result in a product which is intended to be 
released into the environment, either in the form of a micro- 
organism or in plants or animals. This activity will involve 
basic research which should be overseen by NIH, as it requires 
the expertise of molecular biologists, geneticists, plant 
pathologists and experts in agriculture application. Under the 
proposals of December 31, 1984, NSF would take up the environ- 
mental research issue, EPA would be concerned with the approval 
of the commercial product, and USDA would also be involved. The 
mechanism for reviewing such applications needs to be clarified, 
and a determination should be made as to which agency, if any, 
would have primary authority. 
2. If in the event the respective roles and responsibilities 
of the different agencies are not clearly set forth, this may 
well result in "forum shopping". Knowledgeable applicants will 
direct themselves to the most favorable "forum", and the less 
knowledgeable may actually be confused as to which agency is the 
appropriate agency for their application. 
3. A clarification is necessary to determine VihJLch 
governmental body, if any, determines the specific agency which 
has primary jurisdiction." This will be critical in applications 
which have multi-dimensional issues, problems or applications. 
4. Of critical importance is the clarification on defini 
tions of the essential .^rientific terms. The proposals purport 
ru Set torth a few definitions applicable to the technology. 
There are many more terms which have not been addressed. There 
must be a mechanism by which all agencies involved in the tech- 
nology at least subscribe an<£ accept the identical definitions 
of this technology. Perhaps the first activity of any newly 
established oversight committee would be to establish such 
definitions . 
5. There must be a precise description of the scopg and 
authority of the proposed 5 ~iotechnoloaica 1 science boaxd« What 
aut non ty , IT any, will it have over regulatory agencies. What 
ability will it have to compel, or perhaps persuade, such agencies 
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