DNA/4 
NIH should establish a list of toxins, experiments with which are 
prohibited. 
I-D-5. The language in this subpart does not pay sufficient 
attention to the rate of natural transfer of DNA. The crucial issue 
to be resolved is whether the proposed experiment presents a risk of 
compromising the use of an animal or human drug, regardless of whether 
the DNA transfer also occurs naturally. The burden of proof should be 
on the experimenter to demonstrate that the experiment will not com- 
promise the use of a drug. 
I-D-6. The use of the language " after appropriate notice and 
opportunity for public comment" does not adequately specify procedures 
for public notice and comment. These procedures must be described, in 
detail, in the "Guidelines". Failing this the public will have no 
assurance that the opportunity for public comment will be provided. 
If pressure for a quick decision is strong or NIH wishes to avoid 
public scrutiny, the guidelines enable it to make decisions in secret. 
In addition, valuable resources are likely to be wasted fighting out 
the mechanism of "appropriate opportunity for public comment," each 
time the opportunity is given. 
Within 10 days of receipt of an application for an exception from 
a class of prohibited experiments, NIH should publish in the Federal 
Register notice of the receipt, details of where the material sub- 
mitted in support of the exception can be obtained and the closing 
date of the public comment period. At a minimum, the comment period 
should be 45 calendar days. Final notice of agency action should also 
be published in the Federal Register . All material submitted to NIH 
should be available to the public. 
[A-339] 
