25 
notion of shifting of the burden of proof in regard to these policy issues 
is premature, and we fear that it may be a prelude to a significant 
weakening of regulatory protections. It should be eliminated. 
Overall, my concerns here are that the protections in the guidelines 
are largely "paper protection." There is no effective mechanism provided 
to assure that they are realized in the day-to-day operations of the 
regulatory process. In fact, I would argue that it is good that additional 
requirements be placed on the IBCs so that "the runaway shop situation" 
is not encountered — i.e., using the analogy of the environmental regulatory 
situation, that researchers cannot claim that regulatory restrictions are 
too onerous in location X and that they will therefore pick up and run off 
to location Y. The public is concerned enough about some of the major 
advances and activities in biological research areas to want a level of 
assurance as regards its concerns for health, safety, and environment 
protection which, in an operational manner, these guidelines do not provide. 
[ 338 ] 
