QjOopplied biochemists inc 
5300 WEST COUNTY LINE Bd, 96 NORTH. MEQUON. Wl 53092. P O BOX 25. MEOUON. 
414-242-5870 
August 31, 1978 
Dr. Donald S. Fredrickson, M.D. 
Director, National Institute of Health 
Depa rtm e n t of Health, Education and Welfare 
Building 1, Roan 137 
Bethesda, Maryland 20014 
Dear Dr. Fredrickson: 
Upon reviewing the July 28, 1978, Part IV, Federal Register on the 
National Institute of Health's proposed revised guidelines on recombi- 
nant ENA research, I have found the vast majority of the proposed guide- 
lines to be most satisfactory. 
The areas of the proposed guidelines that I find troublesome are the 
following: 
1. My first cement is in reference to physical containment 
at level P3. It is my feeling that an autoclave should be 
within the controlled laboratory area, if not in the laboratory 
itself. As stated in the proposed guidelines on page 33073 of 
paragrph II-B-3-c- (6) "An autoclave for sterilization of wastes 
and contaminated materials shall be available in the same build- 
ing (and preferably within the controlled laboratory area) ..." 
It is not rational to have the laboratory apart from unrestrict- 
ed traffic flew by a controlled access area and transport con- 
taminated materials out of the controlled area into uncontrolled 
surroundings for sterilization. There exists a potential 
hazard and a means of contamination with the autoclave not being 
present in the laboratory, at a P3 level, during recombinant 
research. 
The cost of installing an autoclave in the laboratory should not 
be a decisive factor since so many other precautions mast be 
taken at this level. It certainly would not be a double-door 
autoclave which is warranted at a P4 level, but it should at 
least be present within the laboratory to prevent a potentially 
hazardous situation. 
In sumrary, it is my suggestion that an autoclave be required 
in the laboratory, preferably in the controlled area, at a P3 
level. The level of potentially hazardous conditions do not 
warrant P4 level practices and containment, but do warrant 
tighter restrictions than a P2 level. Thus, the paragraph should 
[A-71] 
