- 2 - 
SCHERING CORPORATION 
o it invites widespread development of regulation, potentially 
conflicting, at the state and local level. An example of what might 
happen took place in 1981 when the RAC was considering the 
Baltimore-Campbel 1 proposal to reduce the Guidelines to a code of 
voluntary practice. Anticipating the void that would be created by 
the discontinuation of N I H oversight, the Massachusetts Public Health 
Association (MPHA) received a grant to develop a "model ordinance" to 
assist communities in developing legislation when the Guidelines were 
eliminated. The original draft was excessively restrictive in 
nature. For example, all large scale work with E. coli K-12 would 
essentially require P2 rather than PI physical containment. 
o Advances in rDNA technology and the development of products that will 
come from its use would no longer proceed in an orderly fashion and 
would likely stagnate. 
If RAC continues in its present mode, we forsee the potential for 
increased workload as it positions itself to deal with new applications of 
rDNA technology. However, we believe this will be a temporary increase and 
will mimic its approach to oversight of biomedical research: early on, when 
the perceived hazards were great, RAC responded with frequent meetings and 
stringent Guidelines for the conduct of research. When it was proven that 
these initial fears were unfounded, RAC again responded by shifting review of 
proposals to working groups, relaxing the Guidelines and ultimately 
transferring responsibi ity for review of facilty design and experimental 
protocols to the local IBCs. 
With respect to the question of closed portions of RAC meetings, consider 
the following: many federal agencies, for example, FDA and EPA have rules to 
protect confidential information which is essential to these agencies in the 
conduct of their business. We believe that without such protection, RAC may 
not receive the data it needs to make a proper risk assessment judgement. 
Further, closed meetings by RAC are not without precedent. Review of 
submissions from industry prior to transfer of this responsibility to the 
local IBCs in 1978 was held in closed session to protect proprietary 
information. 
In summary, we agree that these questions concerning boundaries for NIH 
and RAC oversight are important and that RAC should periodically evaluate its 
role. RAC has done a credible job in dealing with issues facing this 
technology. We believe this process should continue and that RAC should play 
a central oversight role for all applications of this technology. Creation of 
the 'new' boundries proposed in these questions will rekindle public 
apprehension, invite new regulation at all levels of government and delay the 
orderly development of this technology. 
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