Cooperation and Development (OECD) has issued an advisory document 
on safety considerations [ RECOMBINANT DNA SAFETY CONSIDERATIONS : 
Safety Considerations for Industrial , Agricul tural and 
Environmental Applications of Organisms Derived by Recombinant DNA 
Techniques ; OECD, Paris 1986]. 
The OECD document utilizes many of the concepts set forth in 
the NIH Guidelines but goes further. For fermentations that 
involve microorganisms which have an established history of safety 
the concept of Good Industrial Large Scale Practice (GILSP) has 
been established. GILSP is based on the premise that a recombinant 
organism will be no more hazardous than the sum of its parts: the 
host and any added genetic material. If this new construct is no 
more hazardous than the unmodified host, no new containment 
practices need be utilized during fermentation. This manner of 
assessment is based on the nature of the product as opposed to any 
process by which the product was derived. 
IBA believes that it would be appropriate for the Recombinant 
DNA Advisory Committee (RAC) to approve this amendment, bringing 
the NIH Guidelines into conformity with the OECD Guidelines. We 
would further suggest that if the RAC approves this amendment that 
both the OECD paper and one by Kuenzi (Kuenzi et al: "Safe 
Biotechnology — General Considerations", in: Applied Microbiology 
and Biotechnology , Springer-Ver lag 1985, 2_1, pp. 1-6) be referenced 
by footnote in this section. These actions will establish a 
framework for information submittals to IBCs regarding containment 
of recombinanat DNA organisms during large scale fermentations. An 
investigator who meets the outlined criteria will present the IBC 
with enough information to permit a reasoned determination of 
containment conditions. 
IBA thanks the NIH for the opportunity to comment on this 
issue. We hope that these comments are useful to NIH-RAC as they 
deliberate on this matter. 
Sincerely , 
Enc losure 
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Recombinant DNA Research, Volume 13 
