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his certification. Second, the Director of NIH makes the final decision on 
whether a particular system will in fact be certified. The advantages of this 
two-step procedure are that it allows the Director of NIH to solicit ad- 
ditional expert opinions and that it clearly places final responsibility for 
certification in the hands of an identifiable public official. 
The explicit statement in Part IV D, page 49603, that the Recombinant 
Advisory Committee merely recommends the certification of host-vector systems, 
should serve in the future to obviate the kind of misunderstanding which has 
sometimes occurred during the past year and a half. 
Fourth, the exemption provision. In Part IV D, again, page 49605, a 
paragraph has been added which describes a proposed administrative mechanism 
for making exceptions to the Guidelines in specified circumstances. Recom- 
mendations for such exemptions would be made by the Recombinant Advisory 
Committee. The final decision concerning such recommended exemptions would 
be made by the Director of NIH. The paragraph on exemptions begins with 
the general statement of the possibility of a justifiable exemption in ex- 
ceptional circumstances. It continues by providing an example which was 
discussed at some length yesterday, the possible need for exemptions from the 
Guidelines in order to allow risk-assessment studies to proceed. The para- 
graph concludes by envisioning the possibility of exemptions for specific 
experiments which are currently prohibited — for example, experiments in which 
the inserted DNA sequence would be derived from a Class 3 pathogen. 
The general rationale for the addition of the exemption paragraph is to 
allow for a limited degree of flexibility in the application of these encyclo- 
pedic Guidelines between annual or biennial revisions. The Recombinant 
Advisory Committee would clearly require that compelling reasons be advanced 
before giving consideration to any proposed exemptions. Final authority for 
granting such an exemption would rest with an identifiable public official, 
the Director of NIH. 
These, then, are the four major changes in Part IV on roles and responsi- 
bilities. 
DR. FREDRICKSON: Thank you, Dr. Walters. Would you remain there for 
a moment while we allow the Committee to comment or perhaps raise questions 
for you? 
Dr. DeRoos. 
DR. DE ROOS: The question was raised yesterday by one of the public 
witnesses, I believe, about whether or not there was an intent that the 
biological safety officer be a physician. I don't interpret it that way, 
but I just wondered if you would confirm that. 
DR. WALTERS: That is correct, that the intent is not that this be a 
medical person. There is reference in the duties of the biological safety 
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