Residential College 
Eatt ^ladraagle 
The University of Michigan 
Ann Arbor, Michigan 48109 
(313) 763-0176 
September 2, 1981 
Dr. William Gartland 
ORDA 
National Institutes of Health 
Building 31, Room 4852 
Bethesda, Maryland 20014 
Dear Dr. Gartland: 
I am opposed to the proposal from Eli Lilly & Co. (#1027 and #7, Federal 
Register, August 4, 1981). This proposal would exempt large-scale work 
Involving E.coll K-12, Saccharamyces cerevlslae. Bacillus subtills, and any other 
host-vector systems listed In Appendix C of the guidelines. 
I have the following comments on Dr. Irving Johnson's Justification of 
the proposal: 
1. The statement that "the principle of the absence of Increased risk with 
Increased volume has been accepted by the RAC" Is quite Inaccurate, and not 
supported by the record. The claim Is based on the decision of the RAC at Its 
June 1980 meeting to delete a sentence In section I-D-6 of the guidelines which 
read as follows: 
"We differentiate between small- and large-scale experiments with 
organisms containing recombinant DNAs because the probability of escape 
from containment barriers normally Increases with Increasing scale." 
(Minutes, June 5-6, 1980, p.28-9) 
The minutes of the meeting show that discussion of the proposal to delete this 
sentence was limited to the narrow Issue of Its accuracy. There Is no Indication 
that the decision was based on the far broader principle claimed by Dr. Johnson. 
Indeed, there is a strong Indication that the committee did not accept that 
principle since It also voted to leave the full prohibition on large-scale work 
In place (p.29). 
2. The fact that "no unforeseen difficulties have been encountered" when the 
Industry has operated under controls Involving prior review cannot be used to 
Justify the claim that no problems will arise when controls are removed. Perhaps 
the genetic engineering Industry has done so well because the controls were so 
effective; or perhaps It Is because relatively little work has been undertaken; 
or perhaps It Is because, as Dr. Johnson would claim, all the processes Involved 
are safe. In fact, we do not know, because we do not have the social science 
or risk assessment data which might begin to give Indications of the level of safety of 
large-scale genetic engineering* 
[6031 
