Dr. Fredrickson 
-3- 
January 9, 1978 
depending upon the pathogenicity of an organism to animals outside the laboratory, 
versus pathogenicity to a laboratory worker. I would be in favor of continuing 
with the idea of options for physical and biological containments. However, Appen- 
dix D should provide guidance for use of this table by the principal investigator 
or the institutional biohazards committee. 
6. EMPHASIS OF POSSIBLE FUTURE REGULATORY AGENCY - Since Mr. Hutt and others 
brought up the matter of future regulation, I would like to add some thoughts re- 
garding design of this process. I think it is important that the staff in the 
regulatory agency which will be charged with this responsibility have a basic 
understanding of recombinant DNA technology, so that when regulations are enforced, 
there can also be consultation on how to meet the regulations. In particular, 
there should be an understanding of matters related to communicable disease control 
and epidemiology, containment techniques, and good microbiological practice in lab- 
oratories. The suggestion was made by some witnesses that the agencies' knowledge 
to regulate should take precedence and that the technical matter can be learned, 
or additional staff can be hired with appropriate technical knowledge. In this 
instance, I would suggest that it is more important to select an agency with the 
technical understanding of such matters as I described above. If there is need 
for additional understanding of the regulatory process, possibly this could be 
obtained by consultation with other regulatory agencies. In concluding my comment, 
I would like to state that I am not speaking in strong preference for one agency 
or the other, but rather for a principle; whatever agency regulates, considerable 
effort needs to be made to provide consultation along with enforcement. 
7. POSITION AND RESPONSIBILITIES OF THE BIOSAFETY OFFICER - As stated in my 
remarks during the meeting, I am in accord with the concept of a biosafety officer. 
I also agree with the flexibility provided in the guideline for the appointment of 
this person. However, in accordance with the comments of others, possibly there 
should be a footnote in the guideline which establishes the principle that this 
person not be involved in the conduct of research related to his or her responsi- 
bilities as a biosafety officer. If possible, this concept could be established 
in a general way so that it could apply on our campuses to other biosafety concerns. 
In regard to the description of the duties of the biosafety officer, I feel 
the emphasis is too much on the regulatory aspects of this position and not enough 
upon the consultative. The only duty which leaves a role for consultation relates 
to security, whereas I would suggest that perhaps the greatest opportunity which 
this person would have to provide a more fail-safe environment in which to conduct 
research relates to the areas of consultation and training. Although I can cite 
numerous instances where this might occur, one of the most effective has been for 
our biosafety officer to consult directly with the investigator as the experimental 
protocol is designed to assure safe microbiological technique. In many instances 
this not only assures safe technique, but also introduces ideas for improvement of 
technique, which increases the reliability of experiments. Consequently, I would 
recommend that the last duty of the biosafety officer be revised to read: "Provide 
consultation on such matters as preparation of memorandums of understanding and 
agreement, development of an emergency plan, design of experiments for physical 
and biological containment, and laboratory practices related to conduct of the 
research. " 
8. EXTENT OF EMERGENCY PLAN- I believe one can interpret the preparation of 
the emergency plan to relate only to what happens if spills occur within the lab- 
oratory. I would suggest that the concept of emergency plan be broadened by addition 
[Appendix A — 204] 
