experiments as sufficient reasoning to exempt those same organisms for 
deliberate release. The scale and concentration of organisms involved 
in an environmental release, in conjunction with the complexity of 
ecological systems, makes the situations of laboratory and of landscape 
distinctive One obvious difference is competition. In a laboratory 
setting one is not necessarily concerned about competition in the 
ecosystem, such as the displacement of INA* with INA' We therefore 
oppose the proposed change that would exempt organisms from RAC 
review based solely on this criterion. 
3 1 In reference to the proposed revisions of Appendices C-II. C-III and 
C-IV. the CRG stronglv opposes lessening the BL1 -LS physical 
containment conditions in the NIH guidelines for large-scale 
fermentation experiments. This action represents a fundamental change 
in the NIH guidelines and would be a major action for the RAC. The 
rationale for this position suggests that BL1-LS containment presents an 
obstacle to commercial development. The CRG does not accept this 
reasoning as the basis for changing a major policy. 
The proposal also neglects to take into account the implications for 
worker, as well as community, health and safety and what the basis for 
this exemption should be. At the very minimum the CRG recommends, 
1 ) that this proposal be reviewed by NIOSH and OSHA before 
implementation and 2) that conclusive evidence be presented for public 
comment that the removal of the requirement for closed system large 
scale manufacturing using recombinant organisms will not have a 
negative impact on the health and safety of the workers in the plant, or 
on the communities surrounding these plants. 
Thank you for considering these comments. 
^inrprplv 
Nachama L. Wilker 
Executive Director 
Recombinant DNA Research, Volume 1 1 
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