Page 10 - Revision of the Guidelines Subcommittee - 10/15/90 
"c. The vector/insert should be well characterized and free from known harmful 
sequences; should be limited in size as much as possible to the DNA required 
to perform the intended function; should not increase the stability of the 
construct in the environment unless that is a requirement of the intended 
function; should be poorly mobilizable; and should not transfer any resistance 
markers to microorganisms not known to acquire them naturally if such 
acquisition could compromise the use of a drug to control disease agents in 
human or veterinary medicine or agriculture. 
"Inactivation- Any process that reduces the ability of a specific microbiological agent 
or eukaryotic cell to self-replicate. 
"Incidental release-The discharge of a microbiological agent or eukaryotic cell from 
a containment system that is expected when the system is appropriately designed and 
properly operated and maintained. 
"Minimization-The design and operation of containment systems in order that any 
incidental release is a de minimis release. 
"Pathogen-Any microbiological agent containing sufficient genetic information, 
which upon expression of such information is capable of producing disease in 
healthy people, plants or animals. 
"Physical barrier-Equipment, facilities and devices (e.g., fermenters, factories, filters, 
thermal oxidizers) designed to achieve containment. 
"Release-The discharge of a microbiological agent or eukaryotic cell from a 
containment system. Discharges can be incidental or accidental. Incidental releases 
are de minimis in nature; accidental releases may be de minimis in nature." 
The subcommittee recommended acceptance of these revisions to Appendix K with the 
following changes: 
1. The acronym "GILSP," which stands for "Good Industrial Large-Scale Practices," 
should be changed to "GLSP" to indicate "Good Large-Scale Practices" since this 
Appendix is not limited to industry specifically, but to all large-scale facilities; 
2. Strike the word "industrial" under Appendix K-I, "Selection of Physical Containment 
Levels," lines 18 and 24 of the first paragraph on page 37847, since the appendix will 
apply to all large-scale facilities; 
3. Under Appendix K-II-A, strike the final sentence, "Processes and equipment should 
be designed and constructed to assure integrity of the production organism and 
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