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The NIH-RAC must coordinate with other federal agencies, as listed in the 
Office of Science Technology Policy Federal Register Notice 4j), FR 50855 
regulatory matrix for biotechnology, to insure that no applicant is faced 
with a "double jeopardy" situation of seeking approval from more than one 
regulatory or oversight group for a proposed environmental test of a 
microorganism containing recombinant DNA. Multiple overlapping or 
sequential federal agency reviews must be obviated. 
Specific concerns and questions which Monsanto has regarding the March 
28th Federal Register notice are as follows: 
1. Part II, Section A, subpart 2 
Clarification and better definition of "capacity for genetic transfer" 
is requested. As stated, it is unclear whether information regarding 
genetic stability and/or genetic exchange is being requested. 
2. Part II, Section B, subpart la 
The inferred requirement for the sequence of the DNA used as the 
source of introduced DNA is not felt to be necessary. The source and 
function of the introduced DNA are considered to be reasonable 
requirements . 
3. Part II, Section B, subparts 2a-c 
Requests for information on the modes of construction and introduction 
of vectors are not felt to be routinely justifiable, based on the 
potentially highly proprietary nature of such information. In 
those limited instances where such information was considered to be 
critical based on a case-by-case review, provisions should exist to 
protect the highly proprietary nature of that information. 
4. Part II, Section B, subpart 3 
The term "genetic stability" should be defined more precisely. 
5. Part III, Section A, B, and C 
Much of the requested information would not readily be available, 
even on a long-term research basis. The proposed requirements are too 
broad, too general and too all encompassing to be realistically met. 
Reasonable limits need to be defined and definitions for terms such 
as "shifts in important ecological characteristics" and "exchange of 
genetic information between the modified organism and other organisms 
in nature need to be clarified. 
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