DNA/ 10 
that the laboratory in question can meet the requirements of those 
containment levels. Only upon receipt of NIH concurrence with the 
IBC assessment of the containment levels and laboratory competence, 
should the research project should be allowed to begin. This 
approach moots question of a time frame.) 
However, if DHEW decides to allow certain experiments to begin 
after approval by the IBC, then a procedure for bringing protocols 
into compliance with the results of NIH review is a necessity. EDF 
suggests that NIH order the research to be halted until the 
protocols are brought into compliance. Another option would be to 
allow 15 days for protocol modification. If NIH did not recieve 
IBC notice of completed modification by this time, funds would be 
halted. 
IV-A-l-e. PRG-NIH allows each IBC to determine whether a medical 
surveillance program will be instituted for a recombinant DNA activity. 
EDF recognizes the scientific difficulties inherent in monitoring the 
health effects of recombinant DNA research. However, in other reg- 
ulatory arenas analytic methodology is often a prerequisite for use 
of a hazardous substance. FDA has proposed that analytic methodology 
for determining residues be a prerequisite for approval of carcinogenic 
animal feed additives (42 Fed . Reg . 10412) . OSHA regulations require 
medical surveillance of workers contacting carcinogenic chemicals 
(see for example 42 Federal Register 54147). OSHA's experience has 
unfortunately revealed that without government intervention the 
voluntary establishment by regulated individuals of medical surveill- 
ance programs is extremely unlikely. 
EDF recommends that NIH be required to determine the necessity 
for medical surveillance programs of recombinant DNA personnel. If 
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