Dr. Donald Fredrickson 
Page 2 
September 22, 1978 
ability of pharmaceutical firms to design new and more effective 
antibiotics using recombinant DNA technology. For example, im- 
portant new antibiotics could be developed by inserting, into 
known antibiotic producing organisms, genes coding for enzymes to 
modify the original antibiotics. In order to develop new anti- 
biotics utilizing this technology, however, many different anti- 
biotic producers will have to be screened, most of which are 
members of the genus Streptomyces . The fact that it is clearly 
not feasible to develop separate HV-1 systems for all of these 
organisms coupled with the realization that no biohazard would 
be generated by these experiments, indicates that the framers of 
the revised Guidelines have not adequately considered the potential 
benefits and risks from these types of experiments. The proposed 
amendment would allow much of this work to proceed without increas- 
ing the hypothetical risk to workers, the public, or the environment. 
2 . IV-A-2-f , Amend this section to read : 
IV-A-2-f. Keep minutes of meetings and, upon request, make them 
available to the public ( excep t confidential or proprietary data 
and information ) . 
Justification 
The Upjohn Company has voluntarily established an Institutional 
Biosafety Committee (IBC) with twelve members, four of whom are 
from the local community and are not employed by the company. 
In Section IV-A-2 of the Proposed Revised Guidelines, it is 
stated that "The principal functions of the IBC are to review 
and oversee all recombinant DNA projects and to advise the 
institution and ORDA whether the proposals and the research 
comply with the NIH Guidelines." Experience has shown that 
in order for this committee to perform these functions , it 
will be necessary for it to consider confidential or pro- 
prietary data and information belonging to the company which 
are valuable company assets. At the time of consideration, 
these assets may not be protected by patents. The company 
and the IBC believe that the minutes of the committee should 
contain at least the substance of the data and information 
it considered in performing these functions. However, if 
the minutes are made available to the public, these assets 
could be damaged, i.e., the data and information in the 
minutes would be available to competitors and premature 
disclosure might prevent the company from obtaining adequate 
protection for its inventions under the patent laws of the 
[A-257] 
