14 
requirement for use of controls. Drs. Tolin, Amtzen, and Pirone agreed. 
Dr. Arntzen said a statement concerning use of controls would logically be 
inserted in item C. Dr. Pirone suggested item C-l might include a statement 
to the effect that "data should include information on engineered and control 
plants." Dr. Scandalios felt the title of Section C should be modified to 
read: 
"Characteristics and Monitoring of Genetically Engineered and Control Plants." 
The working group accepted Dr. Scandalios' suggestion. 
Dr. Arntzen questioned whether the working group should specifically request 
that monitoring techniques be described. Dr. Fedoroff felt inclusion of a 
specific statement was unnecessary; she thought item C-2 was specifically 
saying "tell us hew you monitor. " She felt the question of whether the preposed 
monitoring was adequate should be addressed on a case-by-case basis. 
Dr. Scandalios felt the proposed modification and the genetic stability of the 
inserted DMA should be evaluated. Dr. Tolin said Appendix L-II-C specifies 
the types of modifications which may be introduced into the test plants under 
Appendix L. Dr. Lacy felt "changes" could involve deletion as well as insertion 
of genetic materials. He suggested the term "altered DNA" was more encompassing 
and should be introduced into item C-2-f. The working group agreed. 
Following this discussion the Working Group on Release into Environment agreed 
the guidance document would read as follows : 
" Proposed Guidelines for Submission Under Appendix L. 
"Appendix L of the Guidelines specifies conditions 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 preposed experiments to NIH, review by the 
RAC Plant Working Group , and specific approval by NIH. 
"The proposal should include a statement of objectives and a description of 
materials and methods, including methodology for monitoring the experiments, 
and expected results. A summary of relevant preliminary results should 
accompany the proposal. A check list of detailed requirements should include 
but not be limited to: 
"A. Description of Plant Materials. 
Give common and scientific names of plants. Identify the specific 
cultivars or genetic lines to be used. Include information on the 
relative homogeneity of the plant cultivars or lines and specific 
genetic markers they are knewn to possess. 
[438] 
