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1.—(a) non-pathogenic;
(b)no adventitious agents;
(c)proven and extended history of safe use or built-in biological barriers, which, without interfering with optimal growth in the reactor or fermenter, confer limited survivability and replicability, without adverse consequences in the environment.
2.—(a) well characterised and free from known harmful sequences;
(b)limited in size as much as possible to the genetic sequences required to perform the intended function;
(c)should not increase the stability of the construct in the environment (unless that is a requirement of intended function);
(d)should be poorly mobilisable;
(e)should not transfer any resistance markers to micro-organisms not known to acquire them naturally (if such acquisition could compromise use of drugs to control disease agents).
3.—(a) non-pathogenic;
(b)as safe in the reactor or fermenter as recipient or parental organism, but with limited survivability and/or replicability without adverse consequences in the environment.
4.—(a) those constructed entirely from a single prokaryotic recipient (including its indigenous plasmids and viruses) or from a single eukaryotic recipient (including its chloroplasts, mitochondria, plasmids, but excluding viruses);
(b)those that consist entirely of genetic sequences from different species that exchange these sequences by known physiological processes.
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