Dr. Fredrickson 
- 2 - 
January 9, 1978 
I recalled a rather detailed survey I did of the lunar receiving laboratory sev- 
eral years ago to analyze human and mechanical failures in containment. Among 
some other observations, I was impressed with the financial implications of not 
knowing risk; it was extremely expensive to bring in scientists from long distances 
to work in this heavily-monitored, high- containment facility before there was an 
appropriate assessment of risk. After there was an appropriate assessment of risk, 
the work on "moon rocks" proceeded much more rapidly in a variety of locations 
throughout the country. In concluding, I strongly concur with the flexibility pro- 
vided in the proposed guideline for prudent granting of variances to conduct risk 
assessment research. 
3. DEFINITION AND ELIMINATION OF P-1 CONTAINMENT CATEGORY - I would agree 
with the new approach to the definition of recombinant DNA, as discussed by 
Dr. Maxine Singer; that is to define recombinant DNA molecules as novel or non- 
novel and to include synthetic molecules. The revision of this definition in 
combination with the section on containment provides an argument for deletion of 
the P-1 containment category. I suggest this because it seems to me that most of 
the research which would be done in the P-1 category of containment is that which 
would be defined as non-novel. Since this research would no longer fall under the 
guidelines, there would no longer be a need for the P-1 containment classification. 
Also, it seems to me that there are other arguments for eliminating this cat- 
egory of containment. Without P-1 the NIH guidelines would have categories of 
containment more consistent with those for viral oncology studies and research 
with other hazardous biologic agents. Also, from Dr. Barkley’s discussions, it 
appears that we would be more consistent with the European countries. In addition, 
elimination of P-1 would take into account the suggestion in the EMBO telegram 
that mouth pipetting not be permitted in recombinant DNA research. It should be 
made clear that my suggestion for eliminating the P-1 category does not imply a 
relaxation of containment requirements for P-2. 
4. STRENGTH AND UNIFOR M ITY OF BIOHAZARD COMMITTEES- It is important that 
there be a great deal of confidence in the operation and processes of our insti- 
tutional biohazards committees. There was an analagous situation several years 
ago when radiation committees had to undergo the same "growing pains" which bio- 
hazards committees are now undergoing on college and university campuses through- 
out the country. I believe that from the standpoint of efficiency, efficacy and 
public confidence in these committees, it is important that there be uniformity 
of effort from campus to campus. To assist biohazards committees, I would recom- 
mend an additional appendix in the guidelines to provide guidance for implementation 
of some of the provisions in the section on institutional roles and responsibilities. 
This appendix could include some further, more specific recommendations on such 
matters as medical surveillance and the means for institutional biohazards committees 
to certify that laboratory workers have received adequate training. 
5. GUIDANCE FOR SELECTION OF VARIOUS COMBINATIONS OF PHYSICAL AND BIOLOGICAL 
CONTAINMENT- As I refer to the matter of appendices, I was pleased to hear of your 
intention to include a revised form of Appendix D. The proposed guidelines provide 
(Table I) an opportunity to select from various combinations of physical and bio- 
logical containment for a particular experiment. From Dr. Barkley's discussion, 
it was clear to me that the investigator and the biohazard committee should apply 
some judgment regarding the most appropriate selection for combination of physical 
and biological containment. For example. Dr. Barkley used a particular illustra- 
tion to demonstrate differing combinations of the most appropriate containment 
[Appendix A — 203] 
