GENEI\ COR 
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S.H,!h 3-jn Frarc sco CA 3-1C3G 
'e.ei.'nor's Ai •j-533 - jA,’5 
January 19, 1987 
Dr. William J. Gartland, Jr. 
Office of Recombinant 
DNA Activities 
National Institutes of Health 
Bethesda , MD 20892 
RE: Proposed Actions Under Guidelines (51 FR 45650) 
Dear Dr. Gartland: 
Genencor, Inc., an enzyme manufacturing company which utilizes rDNA 
technology and voluntarily complies with the NIH Guidelines for 
Research Involving Recombinant DNA Molecules, is writting in support 
of all four proposed revisions to the Guidelines as described in the 
Federal Register of December 19, 1986 (51 FR 45650). 
I. Proposed Amendments of Sections I-A and III-A of the NIH 
Guidelines 
The revisions proposed in this section acknowledge that various 
regulatory agencies have specific statutory authority to review 
products created through recombinant DNA technology and can review 
experiments which might otherwise be reviewed by NIH. Implementation 
of this change will eliminate the potential of dual review by NIH and 
the responsible regulatory agency and will implement the statement in 
the Preamble of the "Coordinated Framework for Regulation of 
Biotechnology" regarding research approvals. Incorporating the 
proposed change into the Guidelines will remove any questions 
concerning review authority. 
II. Proposed Revisions of Section III-A-2 of the NIH Guidelines 
Genencor supports the proposed revisions to Section III-A-2 and the 
development of the associated appendices M, N, and 0. The proposed 
definition, when implemented, will provide needed clarity for the 
definition and exclude certain organisms when used under adequate, 
defined biogical and/or physical controls. This will eliminate 
unnecessary oversight for organisms meeting the criteria outlined in 
Appendices L, M, N and 0. We urge the NIH-RAC to approve this 
proposed revision and to form working groups with the appropriate 
scientific expertise to develop appendices M, N and 0 so that the 
proposals can be implemented. 
III. Proposed Revisions of Section I-B or Section III-A-2 of the 
NIH Guidelines 
While Genencor supports the intent of the proposed changes set forth 
in options 1. and 2., we encourage the NIH-RAC to adopt option 1. 
Recombinant DNA Research, Volume 1 1 
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