GEJSJEiVCOR 
Gere^cor Inc 
'80 K.mca" <Vav 415 ~42-~5C0 
South San "'anc sco. Z* 3^C8C Teex S'" 1263 GEMEN CS 
May 23, 1988 
Dr. William J. Gartland, Jr. 
Executive Secretary 
Recombinant DNA Advisory Committee 
National Institutes of Health 
12441 Parklawn Drive 
Suite 58 
Rockville, MD 20852 
Dear Dr. Gartland: 
Genencor, an enzyme manufacturing company, is writing in support of 
the proposed amendment to section III-B-5 of the NIH Guidelines for 
Research Involving Recombinant DNA Molecules suggested by Dr. Joseph 
R. Fordham of Novo Laboratories, Inc. in his letter of March 24, 
1988 . 
Section III-B-5 currently states that "The appropriate containment 
will be decided by the IBC" and where appropriate, Appendix K should 
be used. The proposed amendment would alter the Guidelines by giving 
further guidance to IBC's on appropriate containment for 
nonpathogenic, nontoxicogenic, low risk organisms which have a 
history of safe industrial use. This advice, that containment for 
these organisms need be no greater than that for the non-recombinant 
host, is in keeping with the OECD Guidelines and the OSTP policy 
statement, as referenced by Novo. It is also consistent with EPA's 
regulatory decision document on PMN 87-693 which states, "We expect 
that manufacturers of this microorganism for this product will 
follow, as a standard practice, at least Good Industrial Large-Scale 
Practice" and "The PMN strain is of sufficiently low risk that 
large-scale production is appropriate at the lowest levels of 
physical containment — Biosafety Level 1-Large Scale (BL1-LS) and 
Good Industrial Large Scale Practice (GILSP)." 
While we believe that IBC's do currently have the authority to reduce 
containment conditions, where appropriate, to a level less than 
BL1-LS (See Section III-B-5) , it is important to note that many 
industrial IBC's have not taken this latitude. The hesitancy of 
IBC's to reduce containment has been indicated by the requests 
currently before the RAC 
Recombinant DNA Research. Volume 13 
[373] 
