Dr. Donald Fredrickson 
January 3, 1978 
Page Three 
the standards and criteria documents put out by other regulatory 
agencies. The OSHA standards for toxic substances mandate in 
detail required work practices, training and medical follow-up. 
5. Inclusion of all hazardous recombinant DNA research 
under the guidelines. Any recombinant DNA activity that poses 
a risk to health or the environment should be covered by the 
guidelines regardless of whether the organism created is a novel 
one. S.1217 recognized this principle by mandating that only 
safe non-novel organisms were excluded from the guidelines. 
The aim of the guidelines is to protect public health and the 
environment from the hazards, not the novelty, of biological 
research . 
6. Procedures for considering requests for exceptions to 
prohibited experiments must be delineated. The guidelines 
contain no criteria on which these decisions will be made. 
Moreover, there is no provision for publication of requests 
in the Federal Register and subsequent public comment. Pro- 
cedures for public disclosure and comment on requests for new 
host-vector systems must also be worked out. 
7. Extension of the guidelines to all recombinant DNA 
work at a facility receiving federal funds. 
I urge you not to finalize revisions of the guidelines until 
the substantial modifications outlined herein and by other wit- 
nesses at the meeting are completed. I would be happy to discuss 
these matters further with members of your staff. 
Sincerely 
Leslie Dach 
Science Associate 
LD/jkr 
[Appendix A — 174] 
