19 
Mr. Rif kin asked if RAC was going to consider ethical concerns. Mr. Mitchell 
said that RAC at its last meeting in September 1983 had accepted the recom- 
mendations of the RAC Working Group on Social and Ethical Issues and thereby 
agreed to review the ethical concerns of use of recombinant ENA technology 
in human subjects. 
VI. PROPOSED GUir>RT.TNES FOR SUBMISSIONS UNDER SECTION III-A-2 
Dr. Vidaver, a member of the RAC Plant Working Gtoup, said the working 
group had received proposals under Appendix L, Release into the Environment 
of Certain Plants, which had been deficient in the types and amount of 
information submitted. The Plant Working Group has, therefore, prepared 
a draft document (tab 1135) to provide guidance for individuals preparing 
submissions. Dr. Vidaver said the proposed requirements include but are 
not limited to common and scientific names, data on plant homogeneity, 
strain designations, methods by which vectors will be constructed, the 
use of host organisms, monitoring, etc. 
Dr. Sharpies said the proposed guidelines would serve a useful function. 
She asked if similar lists exist for non-plant submissions. Dr. Gottesman 
said this type of list grew out of RAC's experience in reviewing specific 
issues. For example, earlier in RAC's history a list was developed for 
submissions for certification of EK2 host-vector systems. She thought 
that as more cases involving deliberate release of genetically engineered 
plants are reviewed, additional requirements will be developed and added to 
the list. Dr. Tblin added that this list focuses on plants as the Plant 
Working Group developed the list in response to requests involving field 
testing of plants. 
Dr. Alexander suggested six additional items should be included in the 
guidelines. These are: (1) transport (dissemination) and survival infor- 
mation from the laboratory and greenhouse; (2) the sensitivity of counting 
methods; (3) full details on procedures to prevent, control, or monitor 
spread; (4) known hosts of the microorganisms including both economic and 
non-eccnomic species; (5) a citation of published information on the 
persistence and/or decline of the organism in natural environments; and 
(6) information about the soil. 
Dr. McKinney said he agreed with one of the points made by Dr. Alexander. 
He added that ecological and environmental information on the test plot 
such as temperature range, rainfall, and humidity should also be reviewed. 
He thought the prcpoeal should specify when monitoring would be stopped; 
for exanple, should monitoring continue after the experiment itself is 
terminated? 
Dr. Gottesman discussed the six items suggested by Dc. Alexander. Dr. Tolin 
said Dr. Alexander's first point concerning transport and survival informa- 
tion is implicit in the Plant Working Group Guidelines (tab 1135) under item 
10, "Provide data from greenhouse and/or growth chamber studies under simu- 
lated field conditions to support prospective field studies." 
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