6 
document offering guidance to investigators wishing to submit for NTH 
approval under Appendix L of the NIH Guidelines experiments involving 
"release to the envirorment" of plants containing recanbinant ENA. The 
RAC had unanimously accepted that document. 
Dr. McGarrity said the working group subsequently began to prepare a "points 
to consider" document offering guidance to investigators wishing to s limit 
for NIH approval proposed experiments involving "release to the envirorment" 
of microorganisms rrodified using recombinant DNA techniques. 
Dr. McGarrity said the working group in preliminary structuring of the 
document focused on three issues: (1) Is the organism unique? (2) Wmat is 
the probability of establishment in the envirorment of the recombinant 
organism or the recombinant DNA it contains? (3) Vhat is the probability 
of the organism or a product of the organism causing harm? 
Dr. McGarrity said the preliminary draft document requests: a summary of 
the proposed research including objectives, significance, and justifica- 
tion? characteristics of the modified organism and the parental organism; 
the source and nature of the introduced DNA sequences; the procedure by 
which the genes were inserted into the host organism; information on the 
stability and expression of the modified organism; a comparison of the 
modified organism to the parental organism; and an evaluation of the 
biological interactions that may result as a consequence of the release. 
Ihe document also requests a description of the trial site, and micro- 
biological and environmental monitoring . 
Dr. McGarrity said proposals will be reviewed on a case-by-case basis; 
rigid guidelines or rigid criteria to assay or monitor ary particular 
submission proposal will not be established. Ihe finished "points to 
consider" document will be a guidance document vhich will net be incorpo- 
rated into the NIH Guidelines. 
Dr. McGarrity said the working group had seme misgivings about sending the 
draft document to RAC at this time. This draft is not a final document 
but a preliminary working document which will inevitably be revised. Seme 
working group members have not yet seen the entire draft document. The 
working group recognizes, however, the importance of these issue and wishes 
to offer RAC a progress report now; it hopes to present a final version of 
the "points to consider" document at the next RAC meeting. 
Mr. Mitchell asked Dr. Sharpies whether she thought the most important envi- 
ronmental questions had been included in the draft document. Dr. Sharpies 
replied the major considerations had been incorporated in the draft document. 
Dr. Gottesman said "iniqueness" is one important issue vhich the working 
group should address; i.e., if a rrodified organism is similar to an orc^nian 
already existing in nature, then perhaps a preposed field trial of such an 
organism need not be as extensively evaluated as a field trial of a novel 
organism. 
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