November llj., 1977 
Dr, Donald 3, Fredrickson, Director 
National Institutes of Health 
Bethesda, Maryland 20011}. 
Dear Dr, Fredrickson: 
I have been following with special interest the development of proposed 
NIH Guidelines for Recombinant DNA Research, This letter is in response 
to your public invitation for comments on your proposed revisions to such 
Guidelines, as published in the Federal Register of September 27, 1977* 
My comments pertain to revised Section IV, Roles and Responsibilities, 
While I was very pleased to have noted in that Section the ‘'addition* 1 of 
a requirement for a BIOLOGICAL SAFETY OFFICER, I am disappointed that the 
NIH Guidelines do not propose also the additional requirement .for a ! BIO- 
HAZARDS CONTROL SAFETY MANAGER, The need for two such distinct positions 
and responsibilities has long been recognized by CDC. Moreover, at CDC 
such incumbents are also separated by unlike 'dhties as EX-OFFICIO MEMBERS 
OF THE BIOHAZARDS COMMITTEE. 
I believe that the NIH Guidelines should Include an. additional requirement 
for the position of a BIOHAZARDS CONTROL SAFETY MANAGER, as CDC does, and 
that an NIH exemplary initiative* to such effect may be most appropriate 
for demonstration in the Gudelines ,,, and through its own actions. 
As illustrated in my attached information-flow-block-diagram, proposed for 
inclusion in the NIH Guidelines of the next revision, a SAFETY MANAGER'S 
primary concern would be to maintain a systematic approach to continuing 
improvements In the development, implementation, and management of programs 
aimed to evaluate for preventive and corrective actions the safety of any 
ongoing high containment Recombinant DNA Research procedure, at revised 
MUA levels of corresponding biological and physical levels of containment. 
Sincerely yours. 
•Attachment 
Naum f>. Bero, Ph,D. 
?, 0 . Box 1692 
Rockville, Maryland 20890 
[Appendix A — 57] 
