Dr. Donald S. Fredrickson 
-3- 
August 24, 1978 
C. While the new proposed guidelines acknowledge the problem of certifi- 
cation (p. 33132) and considerable more input from laboratory health 
experts, e.g., on your decision regarding mouth pipetting, they still 
do not require the special training procedures which are now standard 
for certain laboratories doing work with pathogenic organisms. 
1 ) Recommendation 
Specify that lab workers in P2 and higher facilities take and pass 
certain training courses, or demonstrate equivalent competency, 
prior to working directly with recombinant DNA organisms. A 
centralized and uniform certification process would be extremely 
desirable for P3 and P4 level workers. 
D. The policy on noncompliance is vague and weak. It invites too much 
latitude in defining penalties by encouraging discretion to be used, 
from exoneration to full penalties, without mention of due process 
to injured parties (l.e., workers). 
1 ) Recommendation 
Sec. IV-D-l-b on Page 33087, remove the word "may" and replace with 
"shall ... upon an affirmative finding after due process, that a 
willful violation has in fact occurred. Negligence may result in 
similar suspension, limitation, or termination of NIH funds." 
3. Substantive Concerns 
A. The premise on which containment levels for shotgun experiments was 
lowered is problematic. If in fact eukaryote DNA contains intra- 
genic DNA, such that maturation mechanisms are necessary to effect 
gene expression, it does not follow that all such eukaryote genes 
have such molecular spacers: certainly, this would be unlikely for 
short but biologically active polypeptides like bradykinin where 
only 7, 8 or 9 amino acids are necessary for biological activity. 
Moreover, since it is possible if not likely (as many recombinant 
DNA proponents argue) that genic exchange has been going on across 
phylogenetic barrers, why would it not be likely that eukaryotic DNA 
includes segments of potentially active DNA from procaryotes. 
1) Recommendation 
Potentially recombinant DNA shotgunned from such organisms, e.g., 
birds and mammals other than primates, should either be tested for 
such sequences (perhaps by hybridization studies with the DNA of 
their natural commensals and intestianal flora); or the necessary 
experiments left at the P3 and EK2 level. 
[A-44] 
