The first Guidelines promulgated by the NIH were drafted for the emergency 
situation in which research on recombinant DNA was being contemplated or con- 
ducted independently in various laboratories. They have turned out to have 
been excessively cautious. This was commendable for the sudden new situation 
which confronted science. In view of the consensus of scientists that the 
first Guidelines are too stringent, a revision is in order. The proposed 
revised Guidelines published in the September 27, 1977, Federal Register 
and the testimony presented by individuals and members of the Advisory 
Committee to Dr. Frederickson on December 15th and l 6 th have convinced me 
1. Adoption of the proposed revised Guidelines is wise and 
indicated. 
2. Since periodic future reviews and revisions are provided 
for, it would be unwise to delay adoption while con- 
sidering further more sweeping easing of the original 
recommendations . 
3. Consideration should be given to a number of suggestions 
such as some from the Embo Advisory Committee (Document 
32, Comments) like the possibility of extending trade- 
offs to P 2 and P 3 physical containment. 
4. Plants should be included. 
5. While experimental results to date have not revealed any 
cause for alarm, we are still in a state of relative ig- 
norance; it may require generations to fully assess the 
impact of recombinant DNA on health, genes, and the en- 
vironment. Methods for gathering data for subsequent 
evaluation should, therefore, be established as soon as 
possible as a sound basis for future revisions. 
6 . Industry should be formally brought under the Guidelines 
and provision should be made to respect confidentiality 
when necessary for the protection of private enterprise. 
I do not favor police duties for NIH. Compliance should be the responsi- 
bility of some other governmental agency. 
that: 
[Appendix A — 228] 
