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Schedule Sch 2 - Gene Technology Regulations 2001 - Dealings exempt from licensing | Zoe

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Gene Technology Regulations 2001

Sch 2Dealings exempt from licensing

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Schedule 2—Dealings exempt from licensing

(regulation 6)

Note: Subregulation 6(1) sets out other requirements for exempt dealings.

Part 1 Exempt dealings

Part 1—Exempt dealings

Item	Description of dealing
2	A dealing with a genetically modified Caenorhabditis elegans, unless:(a) an advantage is conferred on the animal by the genetic modification; or(b) as a result of the genetic modification, the animal is capable of secreting or producing an infectious agent.
3	A dealing with an animal into which genetically modified somatic cells have been introduced, if:(a) the somatic cells are not capable of giving rise to infectious agents as a result of the genetic modification; and(b) the animal is not infected with a virus that is capable of recombining with the genetically modified nucleic acid in the somatic cells.
3A	A dealing with an animal whose somatic cells have been genetically modified in vivo by a replication defective viral vector, if:
	(a) the in vivo modification occurred as part of a previous dealing; and(b) the replication defective viral vector is no longer in the animal; and
	(c) no germ line cells have been genetically modified; and
	(d) the somatic cells cannot give rise to infectious agents as a result of the genetic modification; and(e) the animal is not infected with a virus that can recombine with the genetically modified nucleic acid in the somatic cells of the animal.
4	(1) Subject to subitem (2), a dealing involving a host/vector system mentioned in Part 2 of this Schedule and producing no more than 25 litres of GMO culture in each vessel containing the resultant culture.
	(2) The donor nucleic acid:(a) must meet either of the following requirements:(i) it must not be derived from organisms implicated in, or with a history of causing, disease in otherwise healthy:(A) human beings; or(B) animals; or(C) plants; or(D) fungi;(ii) it must be characterised and the information derived from its characterisation show that it is unlikely to increase the capacity of the host or vector to cause harm; and
	Example: 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.