GENE1VCOR 
Dr. William J. Gartland, Jr. 
January 19, 1987 
Option 1 would define recombinant DNA at the beginning of the 
Guidelines and ensure that there is no ambiguity as to when an 
organism is defined as recombinant. Option 2, on the other hand, may 
lead to ambiguity as it endeavors to incorporate the definition of 
rDNA with the definition of deliberate release. 
The exemption of organisms created through single base changes, 
deletions, and rearrangements within a single genome is based on 
sound scientific principles and will lead to consistent treatment of 
such organisms created through rDNA technology and naturally 
occurring organisms or those derived through traditional genetic 
manipulations such as mutation and selection. 
IV. Proposed Revisions of Appendices C-II, C-III, and C-IV 
Genencor supports the changes proposed under this section. As Dr. 
Young stated, the host organisms in these three Appendices, E. coli 
K-12, B. subtilis and Saccharaomvces cerevisiae . have been used 
safely at both the laboratory and production scale for many years. 
Their exemption from the Guidelines as host-vector systems is further 
acknowledgment that they are considered safe for recombinant DNA work 
as well. The "Coordinated Framework for Regulation of Biotechnology" 
stated that "The appropriate large-scale containment requirements for 
many low-risk [ r ] DNA derived industrial microorganisms will be no 
greater than those appropriate for the unmodified parental 
organisms." Dr. Young's proposal incorporates the long history of 
safe use of these organisms as well as the statement in the 
Coordinated Framework. 
Incorporation of the changes proposed by Dr. Young will eliminate any 
prior ambiguity in the Guidelines and make it clear to IBC's that it 
is accepted practice to handle these organisms at less than BL1-LS 
containment. As Dr. Young indicated, without this clarity, IBC's 
have been reluctant to reduce containment requirements, resulting in 
levels of containment that are needlessly expensive, unwieldy and 
unnecessary. 
Genencor wishes to thank the NIH-RAC for the opportunity to comment 
on these proposals and hopes that our comments are useful to you in 
the decision making process. 
Sincerely, 
QjLcJL J/ f 
Alice J. Caddow 
Director of Regulatory 
and Environmental Affairs 
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