168 
risk-assessment data or risk-assessment feelings for that kind of an experi- 
ment, or is it based more on a generalized feeling? Or is that something 
that has to be answered on a case by case basis? Then I don't really need 
an answer. 
DR. FREDRICKSON: I think the decisions will probably end up having to 
be done very much on a case by case basis, but clearly we are not talking 
about a generic rule behind which there is a vast amount of experience. I 
think the discussion brought that out. 
Professor Rosenblith. 
PROFESSOR ROSENBLITH: I think that you won't be surprised to hear from 
me for station identification. This is a further instance where a single 
step is a single step is a single step. It says, "may give approval for a 
single-step reduction in physical or biological containment," as if these 
were equivalent steps. 
DR. FREDRICKSON: Then next you are going to ask if that is an ordinal 
or — 
PROFESSOR ROSENBLITH: That's right, and it turned out that it could be 
taught in ten minutes. 
(Laughter . ) 
DR. FREDRICKSON: Objection recorded. 
Ms. Pfund, you are next, please. On the experimental guidelines, this 
section, please. 
MS. PFUND: Right. I would just like to second what Leslie has said as 
far as the experimental guidelines go. And also, I share the concerns of both 
Leslie and Dr. Sinsheimer in the matter of permitting the institutional bio- 
hazards committees to lower containment for characterized clones. I think 
that too often these committees fail to critically investigate either the data 
or the working habits of the investigator in question, and because diversity 
of representation on these committees is not required, decisions may be made 
without paying sufficient attention to the quality or scope of the data sub- 
mitted. For these reasons I don't approve of this provision. 
However, I think it could be resolved by strengthening the composition 
of the institutional biohazards committee, and also by strengthening the en- 
forcement procedure and provisions of these Guidelines. 
Similarly, with the exemption section, I have concern that there are no 
provisions in the Guidelines for adjusting containment to the increased li- 
ter capacity of these experiments. I would like to see that specified some 
more. Also, I think it should be recognized that, as Dr. Duvick and some 
other industrial representatives have mentioned in the past, the exemption 
from the ten-liter limit and also the exemption for the release of organisms 
[ 372 ] 
