Dr. Donald S. Fredrickson 
Page Two 
The Guidelines should also contain clear procedures 
for filing and processing of complaints, including rigorous 
time limits for investigation, issuance of notice of findings, 
conduct of administrative hearings where appropriate, and 
initiation of enforcement action. Provisions should be 
made for expedited review and enforcement in any case where 
research is permitted to continue pending correction of 
violations or satisfactory resolution of disputed complaints. 
We fully understand the concern that a complaint procedure 
may sometimes prevent decision makers from allocating resources 
effectively, and we agree that a great deal of thought needs to 
be given to devising other enforcement mechanisms. Nevertheless, 
the shortcomings which often accrue to complaint mechanisms 
are peculiarly absent when such a procedure is applied to the 
rather unique problems of recombinant DNA research. In this 
particular field, even given the exigencies of tight budgets 
and scarce resources, we doubt the Department would ever need 
to choose between conducting general compliance reviews and 
processing individual complaints, or between investigating 
widespread instances of systemic violations and resolving 
allegations affecting only a few people. Because the potential 
dangers the Guidelines are intended to prevent are so vast 
and irreversible and because each violation will by its very 
nature threaten large numbers of people, we expect the number 
of violations to be relatively small and the importance of 
investigating each complaint to be great. 
The Guidelines and the MUA should also specify that any 
person who may be adversely affected by research violations 
will be considered a person aggrieved, with the right to pursue 
administrative remedies through a complaint and hearing procedure. 
Moreover, the MUA should specify that it is a contract intended 
to benefit all third parties who may be affected by violations. 
This will permit private parties to initiate legal action to 
enforce the provisions of the MUA. Without such a provision, 
there will be no safety valve to prevent future administrators 
from disregarding the Guidelines or to stop experiments which 
are being conducted irresponsibly. Such a safety valve is 
especially essential where, as here, a short period of neglect 
could result in an incomparable disaster. 
With thanks for the consideration you and the other members 
of the Review Committee have given our previous comments. 
Sincerely yours. 
Sanford A. Newman 
Herbert Semmel 
SAN : vl 
cc: F. Peter Libassi 
Jim Hinchman 
[A-438] 
