18 
Dr. Talbot said that modification of Section III-B-3 is not the appropriate 
way to make the changes Dr. Ross proposes, since Section III-B-3 deals only 
With prokaryotes. Dr. Talbot suggested tl^t Section III-0-2, "Experiments 
Involving Prokaryotes Nonpathogenic for Man, Animals, or Plants and/or Lower 
Eukaryotes Nonpathogenic for Man, Aninals, or Plants" could appropriately 
be modified to reflect Dr. Ross' intent. 
Dr. Fedoroff noted that Dr. Ross' proposed would change the current Section 
III-02 in two ways: it would allow cloning of ENA from nonpathogenic 
higher eukaryotes; and it would lower the level for cloning in nonpathogenic 
prokaryotes from P3 to P2. ftr. Fedoroff moved acceptance of the proposal. 
By a vote of twelve in favor, none opposed, and no abstentions the RAC adopted 
the motion. 
Section III-0-2 would be amended to read as follows; 
"III-0-2. Experiments Involving Nonpathogenic Prokaryotic and Lower 
Euicaryotic Host- Vector Systems. I^NA fron any species norpathogenic 
for man, animals, or plants may be cloned into lower eukaryotes non- 
pathogenic for man, animals, or plants at the P3 level of containment 
[2A]. ENA from any species nonpathogenic for man, animals, or plants 
nay be cloned into prokaryotes nonpathogenic for man, animals, or plants 
at the P2 level of containment (2A] . Data supporting the contention 
that the donor and recipient are nonpathogenic must be submitted to 
the local IBC. Lower levels of physical containment may be assigned 
by ORDA on a case-by-case basis for specific donor-recipient 
combinations. (See Section IV-E-l-b-(3)-(h) . )" 
IX. PROPOSED AMENEMENT OF SECTION I-D-6 
Dr. MdCinney opened discussion of the proposal (tabs 1027, 1035/5) by 
Dr. Irving Johnson of Eli Lilly and Oompany to amend Section I-D-6 of the 
Guidelines as follows (modified language underlined); 
"I-D-6. Large-scale experiments (e.g. more than 10 liters of 
culture] with organisms containing recombinant DNAs other than 
those listed in ^>pendix C, Paragraphs 2, 3, and 4 of the Guidelines , 
unless the recombinant ENAs are rigorously characterized and the 
absence of harmful sequences established (3). (See Section 
IV-E-l-b-(3)-(d).)" 
The text in Appendix C dealing with large-scale experiments in Paragraph 2 
( E. coli K-12 host-vector systems). Paragraph 3 (S^ cerevisiae host-vector 
systems), and Paragraph 4 ( B. subtilis host-vector systems) would be replaced 
with the following revised text; 
"Large-scale experiments (e.g. more than 10 liters of culture) 
require prior IBC review and approval." 
[209] 
