expensive, and unnecessary requirements for large-scale containment are 
specifically replaced by less stringent requirements, instead of exempting 
organisms covered by Appendices C-II, C-III, and C-IV from all containment 
guidelines? 
Because these questions are not addressed, the changes proposed in 
Section IV appear intended to incorporate into the NIH Guidelines the passage 
from the Coordinated Framework for Biotechnology that states that, 
"...large-scale containment of many low risk DNA derived industrial 
microorganisms need be no greater than those appropriate for the unmodified 
parent organisms," as much as to relieve the fermentation industry of 
containment responsibilities. 
A subsequent passage from the same page of the Coordinated Framework 
(Federal Register 51:23304) notes that, "By the time a genetically engineered 
product is ready for commercialization, it will have undergone substantial 
review and testing during the research phase, and thus, information regarding 
its safety should be available." Given this point, it seems more appropriate 
to specify relaxed BL1-LS containment on a case-by-case basis than to 
completely exempt all organisms covered by Appendices C-II, C-III, and 
C- IV- - including untested organisms in the research phase- -from the NIH 
Guidelines. A list of engineered organisms currently employed by the 
fermentation industry to which relaxed containment guidelines apply could be 
added to Appendix C. 
Thank you for your attention. 
Yours truly, 
Rebecca J. Goldburg, Bh.D. 
Staff Scientist 
Recombinant DNA Research, Volume 1 1 
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