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Excerpt from the Gene Technology Regulations 2001 (Statutory Rules 2001 No. 106 as amended) (the Regulations), effective from 1 September 2011
Part 1 of Schedule 2 of the Regulations describes the type of dealings with are classified as exempt. Part 2 of Schedule 2 determines the host/vector system relevant to Item 4 of Part 1. These host/vector systems are also relevant to the classification of Notifiable Low Risk Dealings (NLRDs) and Dealings not involving Intentional Release (DNIR) in Schedule 3 of the Regulations.
Schedule 2 Dealings exempt from licensing(regulation 6)
Note Subregulation 6 (1) sets out other requirements for exempt dealings
Part 1 Exempt dealings
|Item||Description of dealing|
|2||A dealing with a genetically modified Caenorhabditis elegans, unless:
|3||A dealing with an animal into which genetically modified somatic cells have been introduced, if:
|3A||A dealing with an animal whose somatic cells have been genetically modified in vivo by a replication defective viral vector, if
Donor nucleic acid would not comply with subparagraph (ii) if its characterisation shows that, in relation to the capacity of the host or vector to cause harm, it:
(a) provides an advantage; or
(b) adds a potential host species or mode of transmission; or
(c) increases its virulence, pathogenicity or transmissibility; and
(A) is not available in the cell into which the nucleic acid is introduced; and
(B) will not become available during the dealing; and
||A dealing involving shot-gun cloning, or the preparation of a cDNA library, in a host/vector system mentioned in item 1 of Part 2 of this Schedule, if the donor nucleic acid is not derived from either:
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Part 2 Host/vector systems for exempt dealings
|1||Bacteria||Escherichia coli K12, E. coli B , E. coli C or E. coli Nissle 1917 — any derivative that does not contain:
|Bacillus — specified species — asporogenic strains with a reversion frequency of less than 10-7:
|Pseudomonas putida — strain KT 2440||
|Streptomyces — specified species:
Agrobacterium rhizogenes — disarmed strains
Agrobacterium tumefaciens — disarmed strains
Oenococcus oeni syn.
Rhizobium (including the genus Allorhizobium)
Sphingopyxis alaskensis syn.
Synechococcus — specified strains:
(a) PCC 7002
(b) PCC 7942
(c) WH 8102
Synechocystis species — strain PCC 6803
Vibrio cholerae CVD103-HgR
Neurospora crassa — laboratory strains
|3||Slime moulds||Dictyostelium species||
|4||Tisse culture||Any of the following if they cannot spontaneously generate a whole animal:
|Either of the following if they are not intended, and are not likely without human intervention, to vegetatively propagate, flower or regenerate into a whole plant:
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