Director 
National Institutes of Health 
August 27, 1979 
Page 2 
It is obvious that there are important differences, relevant to 
the question of compliance with the Guidelines, between the kinds 
of institutions presently subject to the Guidelines and private 
corporations that engage in recombinant DNA activities on a profit- 
seeking basis. Nevertheless, we see no insuperable obstacles to 
compliance by Genex with the Guidelines, and we are fully prepared 
to undertake such compliance on a voluntary basis. At the same 
time, we are sufficiently realistic to recognize that some presently 
unanticipated problems may in fact arise in the light of actual 
experience under the Guidelines; if so we would be hopeful that 
NIH would be receptive to discussions concerning possible changes 
in or even, in unusual cases, possible exemptions from the Guideline 
provisions . 
There is, however, one procedural aspect of the proposed Supplement 
to the Guidelines that we do find troublesome. That is the 
requirement for an Institutional Biosafety Committee that includes 
at least two public members who are not affiliated with the company. 
While we fully support the objectives of this requirement, we are 
concerned about its feasibility in the private enterprise context. 
It would probably be necessary to disclose proprietary information 
to members of the .IBS, and the kinds of persons who would be suitable 
under IV-D-2 , and willing to serve, as public members of an IBC for 
a company like Genex would probably not be experienced with respect 
to confidentiality agreements. We doubt, moreover, that they would 
find service on the IBC sufficiently interesting to produce their 
regular attendance at meetings without payment of substantial 
honoraria, which would make the maintenance of the IBS unduly 
expensive to small companies. 
We would urge, therefore, that such companies be given greater 
flexibility with respect to composition of the IBC's. This might 
be accomplished by inclusion of language such as the following in 
Section VI-B: 
"At least two members (but not less than 20% of the membership 
of the committee) shall be individuals who (1) if they are 
from disciplines relevant to recombinant DNA technology, 
biological safety, or engineering, shall not be affiliated 
with the institution (apart from their membership on the 
Institutional Biosafety Committee, whether or not they are 
compensated for their services as members) , or (2) if they 
are not from such disciplines, shall not provide services to 
the institution on a compensated basis (excluding compensation 
for their membership on the IBC) to the extent of 20% or more 
of the aggregate time spent by them in their employment, 
occupation, or profession. Such members shall be of such 
occupation, profession, status, or accomplishment that they 
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