Page 3 - Revision of the Guidelines Subcommittee • 10/15/90 
Revision of Appendix K of the "NIH Guidelines” Regarding Establishment of Guidelines 
for Level of Containment Appropriate to Good Industrial Large Scale Practices (GILSP). 
In a letter dated June 28, 1990, the Industrial Biotechnology Association (IBA) and the 
Pharmaceutical Manufacturers Association (PMA) requested that the Recombinant DNA 
Advisory Committee revise Appendix K of the NIH Guidelines for Research Involving 
Recombinant DNA Molecules to reflect a formalization of suitable containment practices 
and facilities for the conduct of large-scale experiments involving recombinant DNA- 
derived industrial microorganisms. In attachments to this request, there are proposed 
definitions and requirements pertaining to the requested changes. The Revision of the 
NIH Guidelines Subcommittee will meet on October 15 to review this request and report 
with a recommendation to the Recombinant DNA Advisory Committee. 
Proposed revision of Appendix K reads as follows: 
"Appendk K-Physical Containment for Large-Scale Uses of Organisms Containing 
Recombinant DNA Molecules. 
"This part of the Guidelines specifies physical containment guidelines for large- 
scale (greater than 10 liters of culture) research or production involving viable 
organisms containing recombinant DNA molecules. It shall apply to large-scale 
research or production activities as specified in Section III-B-5 of the Guidelines. 
It is important to note that this appendix addresses only the biological hazard 
associated with organisms containing recombinant DNA. Other hazards 
accompanying the large scale cultivation of such organisms (e.g., toxic properties 
of products; physical, mechanical and chemical aspects of downstream processing) 
are not addressed and must be considered separately, albeit in conjunction with 
this appendix." 
[Remainder of Introduction remains unchanged.] 
"Appendix K-I - Selection of Physical Containment Levels. 
"The selection of the physical containment level required for recombinant DNA 
research or production involving more than 10 liters of culture is based on the 
containment guidelines established in Part III of the Guidelines. For purposes of 
large-scale research or production, four physical containment levels are 
established. These are referred to as GILSP, BLl-LS, BL2-LS, and BL3-LS. The 
GILSP (Good Industrial Large-Scale Practice) level of physical containment is 
recommended for large-scale research or production involving viable, non- 
pathogenic, and non-toxigenic recombinant strains derived from host organisms 
that have an extended history of safe industrial use. Likewise, the GILSP level of 
physical containment is recommended for organisms such as those included in 
[318] 
Recombinant DNA Research, Volume 14 
