Cfl- 77-j^? 
January 12, 1978 
The Honorable Judge John Lewis Smith, Jr. 
U.S. District Court for the District of Columbia 
Washington, D.C. 20001 
RE: Civil Case No. 77-0916; 
Ferdinand J. Mack, Jr. vs. Joseph A. Califano, Jr. et al. 
FILED 
JAN 23 W8 
JAMES F. DAVEY, Clerk 
YOUR HONOR: 
I am Dr. Naum S. Bers, a bio-medical engineer from Rockville, Maryland, 
well qualified and certified for the administrative management of safety 
in bio-medical laboratories of high containment research facilities, such 
as those at Ft. Detrick, in Frederick, Maryland. Accordingly, I am well 
aware of the record of Court in the above referred to case, and its latest 
entries have prompted me to write this letter which I wish, respectfully, • 
to be regarded as an expression of my views and recommendations for your 
consideration, as follows: 
In my confirmed opinion, no adequate data base has been available to the 
authors of the NIH Guidelines for Recombinant DNA Research ... so as to 
establish with any desired probabilistic confidence what might be prudent 
controls and proper levels of containment for the "permitted experiments" 
under those Guidelines. To correct for that deficiency, NIH officials 
have been advised to generate an Intramural Risk Assessment Progranv/Plan 
of/"special experiments" for which, if necessary, the NIH Director may 
even grant some justified exemptions, -under very strict controls. 
Unfortunately, however, no such Risk Assessment Prograny^Plan has been 
generated yet ... to say nothing of an Environmental Impact Statement (EIS) 
that would be required for it under the Nat'l Envir'l Protection Act (NEPA). 
[Appendix C — 101] 
