Revision of the Guidelines Subcommittee - 
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. 
"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 destroys 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 or eukaryotic cell 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., fermentors, factories, filters, 
thermal oxidizers) designed to achieve containment. 
Recombinant DNA Research, Volume 14 
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