May 21-23 - MINUTES OF MEETING 
19 
The RAC accepted proposal III-C-7-a by a vote of 19 to 2 with 2 abstentions, 
and proposal III-C-7-b by a vote of 18 to 0, with 1 abstention. 
XIII. CRITERIA FOR CHARACTERIZED CLONES 
ORDA and the RAC have received several requests for clarification and 
amplification of footnote 3 of the Guidelines concerning what data should 
be considered by the IBCs in determining whether DNA recombinants are 
characterized and free of harmful sequences. At the February 15-16, 1979 
RAC meeting. Dr. Setlow appointed a Working Group consisting of Drs. Day, 
Lewis, and Walters to develop criteria for characterized clones. It was 
noted that these judgments have been made on a case-by-case basis to date 
and criteria had not been developed. Dr. Setlow, in addition, solicited, 
frcm various experts in the field, advice in an attempt to formulate 
principles. The report of the Working Group (639) was discussed at the 
meeting. 
Dr. Wallace Rowe independently sought advice and comments frcm several 
immunologists on the question of risk of induced autoimmunity frcm 
exposure to recombinant clones for human proteins, e.g. hormones. A 
letter from Dr. Beckwith in response to comments made in response to 
Dr. Rowe's letter was read by Dr. Krimsky at the meeting. 
It was noted in the RAC discussion that the question of autoimmunity 
induced by bacterial or viral antigens is still controversial and may 
require future risk assessment experiments. A motion to delete the first 
section of the report, entitled "Absence of Potentially Harmful Genes," 
was not carried. The vote was 6 in favor, 15 opposed. 
The RAC voted 17 to 2, with 2 abstentions, to adept a revised section, 
"Absence of potentially harmful genes," as amended by Drs. Kutter and 
Walters, as follows: 
" Absence of Potentially Harmful Genes . Part (a) of 
Footnote 3 specifies examples of harmful sequences 
which are of special concern. The potential for a 
significant public health problem due to induced 
autoimmunity from exposure to EC. coli K-12 containing 
either mammalian hormones or other biologically 
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