Revision of the Guidelines Subcommittee - 12/07/90 
Dr. Monica Riley, Chair, called the Revision of the Guidelines Subcommittee meeting 
to order. Dr. Riley stated that the subcommittee meeting will be devoted to the 
discussion of the Revision of Appendix K of the NIH Guidelines for Research Involving 
Recombinant DNA Molecules (51 FR 16958) 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 (RAC) revise Appendix K of the NIH Guidelines 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. During the RAC meeting on October 16, 1990, the 
recommendations made by the Revision of the NIH Guidelines Subcommittee were 
considered. Following a discussion, it was decided that further modifications of Appendix 
K were necessary. Accordingly, the matter was referred back to the subcommittee. 
The Revision of the NIH Guidelines Subcommittee met on December 7, 1990, with the 
following recommendations to the RAC for its meeting on February 4, 1991. 
Proposed revision of Appendix K reads as follows: 
"Appendix 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 appendk 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." 
"All provisions of the Guidelines shall apply to large-scale research or production 
with the following modifications: 
"• Appendix K shall replace portions of Appendix G when quantities in excess 
of 10 liters of culture are involved in research or production. Appendix K- 
II applies to GLSP; Appendices G-I and G-II, as indicated in 
accompanying table, apply to Biosafety Levels (BL) BLl-LS, BL2-LS, and 
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Recombinant DNA Research, Volume 14 
