COMMENT ON THE PROPOSED REVISED 
GUIDELINES FOR RECOMBINANT DNA RESEARCH 
Periodic updating and reconsideration of the NIH Guidelines for Recombin- 
ant DNA Research is a necessary activity of which the Coalition for Re- 
sponsible Genetic Research approves. However, the manner in which the 
current proposal for revisions has taken place is not satisfactory. A 
serious omission in the process has been the failure to obtain the input of 
relevant scientific disciplines, such as pollution biologists, microbial 
ecologists, and epidemiologists, in the consideration of the revisions. Al- 
though the December 15-16, 1977 public meeting at NIH was a positive step, 
it should have been held before the . revisions were drafted, as a means of 
developing needed information. Furthermore, an opportunity for effective 
public participation has not been provided for by the NIH. Nor was an envir- 
onmental impact statement prepared on the revisions as required by law. 
The Coalition for Responsible Genetic Research is opposed to relaxation of 
the NIH Guidelines at this time for the following reasons: 
(1) There is insufficient scientific evidence to warrant relaxation; 
(2) Unpublished research has been used as a basis for the proposed 
revised Guidelines in violation of classical scientific canon; 
(3) A systematic risk assessment program has not been conducted in 
order to determine the levels of hazard; 
(4) The procedures by which the Guidelines are being revised are 
inadequate . 
Further action on relaxation of the NIH Guidelines should be suspended until 
these defects are remedied. 
Concerning Roles and Responsiblities : we feel that in order to protect 
against the influence of competitive pressures, the biohazard safety officer 
should not be involved in biological research, but should have as his sole 
responsibility the control of biologic hazards. Also, there should be sub- 
stantial representation on the biohazards safety committee of laboratory 
support personnel and members of the local community. These requirements 
should be extended to all institutions regardless of the P level of recomb- 
inant DNA work being performed there. 
We are especially concerned that the proposed revised Guidelines contain 
provisions for exemptions from the list of prohibited experiments and for 
exemption from limits on culture volume. We feel that it is premature to 
contemplate such exemption before systematic risk assessment has taken 
place. Further, since the NIH is promoting this technology, we do not feel 
that it can take an appropriately neutral stance in judging operations that 
will affect the entire society. Some other body, not involved in the promo- 
tion of recombinant DNA activities , should be responsible for review and 
assessment of all application for exemption. In addition, there should be 
a provision for formal public review of all exemptions to the Guidelines and 
compliance with the National Environmental Policy Act with respect to such 
exemptions. 
[Appendix A — 2331 
