Page 9 - Revision of the Guidelines Subcommittee - 10/15/90 
"Appendix K -- Definitions to Accompany Containment Grid and Proposed 
Modification of Appendix K. 
"Accidental release-The unintentional discharge of a microbiological agent (i.e., 
microorganism or virus) or eukaryotic cell due to a failure in the containment 
system. 
"Biological barrier-An impediment (naturally occurring or introduced) to the 
infectivity and/or survival of a microbiological agent or eukaryotic cell once it has 
been released into the environment. 
"Closed system-A system, which by its design and proper operation, prevents release 
of a microbiological agent or eukaryotic cell contained therein. 
"Containment-The confinement of a microbiological agent or eukaryotic cell that 
is being cultured, stored, manipulated, transported or destroyed in order to prevent 
or limit its contact with people and/or the environment. Methods used to achieve 
this include; physical and biological barriers and inactivation using physical or 
chemical means. 
" de minimis release-A release of viable microbiological agents or eukaryotic cells 
that does not result in the establishment of disease in healthy people, plants or 
animals or in uncontrolled proliferation of any microbiological agent. 
"Disinfection~A process by which viable microbiological agents are reduced to a 
level unlikely to produce disease in healthy people, plants or animals. 
"Good Industrial Large Scale Practice (GILSP) Organism-For an organism to 
qualify for GILSP consideration, it must meet the following criteria: [Reference: 
Organization for Economic Cooperation and Development, Recombinant DNA 
Safety Considerations. 1987, p. 34-35] 
"a. The host organism should be non-pathogenic, should not contain adventitious 
agents and should have an extended history of safe industrial use or have 
built-in environmental limitations that permit optimum growth in the 
industrial setting but limited survival without adverse consequences in the 
environment. 
"b. The recombinant DNA-engineered organism should be non-pathogenic, 
should be as safe in the industrial setting as the host organism, and without 
adverse consequences in the environment. 
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