- 2 - 
statement on page 49597, "Nevertheless, the revised guidelines continue to be 
deliberately restrictive, with the intent of erring on the side of caution". 
In the absense of any supporting evidence that would indicate that recombinant 
DNA research is hazardous (or even potentially hazardous) , the approach of 
erring on the side of caution may be counterproductive, be perpetuating public 
hysteria. 
6) Based upon the available information, Eh_ coli , K-12 , is not an epidemic pathogen, 
and therefore is a suitable host for recombinant DNA research. 
7) I am opposed to the idea that we need to develop many alternative hosts. Because 
our knowledge concerning both the genetics and biology of the proposed alternate 
hosts is primitive by comparison to E. coli, I would be forced to reevaluate my 
position on the potential risks associated with recombinant DNA research. 
8) I do not see the justification or the requirement for 3 EK-2 lambda host vector 
systems, nor do I see the logic in having a growing list of plasmids approved for 
use with x 1776. If it turns out that one is required by law to monitor personnel 
and/or the environment for the release of recombinant DNA materials, the larger 
the number of systems certified for use will compound the problem. I must point 
out that in the City of Cambridge the Cambridge Ordinance requires monitoring. 
(Monitoring the release of recombinant DNA materials and its survival in the 
laboratory worker.) 
9) I would suggest that caution be used, I am refering to page 19604, when describing 
the duties of the Biological Saefty Officer, I would change the statement, 
Subsection i, as follows, "verification that all recombinant DNA research 
personnel, etc.", be substituted for, "verification that all research personnel, 
etc.". The reason for this comment is that I do not believe that the N.I.H. 
intended to include all research with microbiological materials as the respon- 
sibility of the Biological Saefty Officer at this point in time. While I am 
not opposed to Biohazard Safety Officer involvement in other areas, I would 
suggest that since the document relates to recombinant DNA research that it 
should be stated accordingly. 
10) The Recombinant DNA Advisory Group should determine an appropriate certification 
mechanism for the determination of investigator competency. In the absence of 
a standardized test, political considerations, both internal and external, will 
determine which Institutions require demonstrative proficiency on the part of 
investigators. It is conceivable that Institutions with rigid requirements 
will suffer from investigator migration. 
11) Since the N.I.H. requires Institutions with P-3 or P-4 facilities to have a 
Biological Safety Officer and that all Institutions involved in recombinant DNA 
research provide medical monitoring and surveillance as well as an administrative 
structure for processing applications, the N.I.H. should provide a mechanism for 
defraying the cost associated with these activities. There are at least two 
mechanisms for defraying these costs; (1) the direct cost section on grant 
application could include a section on safety, or (2) , Institutions could be 
[Appendix A — 142] 
