"III-A-2. Environmental applications conducted without physical [and 
biological] containment of any organism containing recombinant ENA, 
except : 
"a. Certain plants as described in Appendix L. 
"b. Deletion derivatives not otherwise covered by these Guidelines. 
"c. Organisms covered in exemption III-D-2." 
Dr. Johnson then moved that the two sentences of Dr. Vidaver be added at 
the end of the proposed further revision of Section III-A-2. After further 
discussion, Dr. Johnson amended his motion and moved adoption of Dr. Vidaver's 
first sentence for inclusion in Section III-A-2. The working group accepted 
the motion by a vote of 11 in favor, none cpoosed , and 1 abstention. 
Dr. Gottesman then moved that Dr. Vidaver's second sentence be placed under 
"a" and that Section III-A-2 be revised to read in its entirety as follows: 
"III-A-2. Deliberate release into the environment of any organism 
containing recombinant DMA except those listed below. The term 'deli- 
berate release' is defined as a planned introduction c£ recombinant 
DNA-containing microorganisms, plants, or animals into the environment. 
"a. Introductions conducted under conditons considered to be accepted 
scientific practices in which there is adequate evidence of biological 
and/or physical control of the recombinant ENA-containing organisms. 
The nature of such evidence is described in Appendices L, M, N, and 0. 
"b. Deletion derivatives not otherwise covered by these Guidelines. 
"c. Organisms covered in exemption III-D-2." 
Dr. Johnson seconded the motion and the working group passed the motion by a 
vote of 10 in favor, 1 opposed, and 1 abstention. 
Dr. Tolin stated that the U.S. Department of Agriculture will be proposing 
material for inclusion in Appendices L, M, and N. 
II. Vaccine Development. 
Dr. Levine presented information to the working group on development of 
several different varieties of live bacterial vaccines (Attachment II). He 
said that phase 1 studies of vaccines made by recombinant ENA techniques 
can be carried out in very closed facilities, but that mechanisms are needed 
to permit phase 2 and 3 clinical trials which may involve thousands of 
individuals. He pointed out that non-recanbinant live attenuated vaccines 
are tested with no special constraints and predicted that superior and 
more precise vaccines will be made by recombinant DNA techniques. 
Recombinant DNA Research, Volume 1 1 
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