Dr. William Gartland 
4 
3. Criteria for characterized clones (//9) 
9a: Absence of potentially hazardous genes 
The statement that "in E.coli the risk of induced autoimmunity from exposure 
to clones that produce proteins that are either human hormones or other biologically 
active molecules is considered insignificant" is scientifically inaccurate and 
irresponsible. The most accurate statement that can be made at present regarding 
the risk of inducing autoimmunity is that this risk is u nknown . Discussion of 
this risk at the February meeting of the RAC demonstrated wide variation in scientific 
opinion in the absence of data and clearly showed the need for empirical studies 
to resolve the uncertainties involved. This need is also reflected in the proposed 
risk assessment plan ( Federal Register , April 2, 1979) which calls for "animal 
studies of hormone-producing strains of E.coli generated by recombinant DNA 
technology" and studies of "the possible occurrence of autoantibodies or autoreactive 
cells due to the production of cells due to the production of eukaryotic poly- 
peptides by bacteria that colonize higher organisms." 
IV. Comments on Proposed Plan for a Program to Assess the Risks of Recombinant 
DNA Research (Federal Register, April 2, 1979) 
1. Significance of the Rowe-Martin experiment on the lnfectivity of polyoma DNA 
cloned in E.coli K-12 
The statement that this experiment produced "no evidence that the inserted 
DNA produced any special hazard" is misleading. In fact, this experiment produced 
some positive results whose significance is still being investigated. The results of 
this experiment should be reviewed in depth by the RAC at its May meeting .Additional 
comments by members of the Coalition will be submitted to ORDA. 
2 . Part III. Scientific Aspects of Recombinant DNA Risk Assessment Plan: Higher 
Eukaryotes (Federal Register, p. 19303, col. 2) 
There is little evidence to support the statement that the "possibility of 
(1) creating novel nondefective viruses as a result of the insertion of a new DNA 
fragment or (2) altering the host range of the viral vector" is "unlikely." 
Specific risk assessment studies on these possibilities should be planned and 
carried out. 
Francine Robinson Simring- 
Executive Director 
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