Attaclment II - Page 1 
Proposed Guidelines for Submission Under Appendix L. 
Appendix L of the Guidelines specifies oonditions under which certain 
plants may be approved for "release into the environment" including field 
tests. Experiments in this category cannot be initiated without submission 
of relevant information on the proposed experiments to NIH, review by the 
RAC Plant Working Group, and specific approval by NIH. 
A RAC Working Group las now prepared draft submission guidelines for indi- 
viduals preparing proposals under Appendix L of the Guidelines. This 
proposed guidance is as follows : 
" Iterre for Consideration to be Included in Proposal Submissions Under 
Appendix L . 
"These annotated items were presented for consideration by prospective 
proposal submitters to facilitate the process of approval. The Working 
Group has found that the proposals so far submitted for their considera- 
tion have emitted information that is considered minimal and essential 
for their approval . Basically, the group would like to see detailed 
objectives, materials, and methods, including methodology for monitoring 
the experiments, and expected results. At a minimum summary data 
should be sufcmitted to support the proposal. A check list of detailed 
requirements should include, but is not limited to: 
"A. Description of Plant Materials. 
"1. Give common and scientific names of plants and cultivars, if 
appropr i ate. 'Tomato plants will be inoculated' is insufficient. 
"2. If appropriate, give data or information on the relative 
homogeneity of the plant cultivar , and specific genetic 
markers the cultivar is known to possess. 
"B. Vectors and Method of Introduction. 
"1. Describe the cloned DMA segment and its expression in the 
new host. 
"2. Give the method(s) by vhich the proposed ENA vector will 
be or has been constructed. Diagrams are very helpful and 
may be necessary for adequate understanding of the construct. 
Explain the advantages (and disadvantage(s) , if appropriate) 
of your vectors, if other candidate vectors could be 
considered. 
"3. If microorganisms are used to introduce vectors or are 
vectors themselves, indicate how they compare with wild-type 
strains. If disabled pathogens are used to transmit the 
vector, indicate measures that will most likely prevent 
these microorganisms from regaining or acquiring pathogenic 
potential. If the vector is likely to survive independently 
of the hosts, refer to this possibility, and provide any avail- 
able data to assess the probability of such transfer to likely 
organisms. 
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