“containment structure means a containment facility that is a vehicle, room, building, or other structure, set aside and equipped for the development of genetically modified organisms

“genetic element, in relation to a new organism, means—

• “(a) heritable material; and

• “(b) any genes, nucleic acids, or other molecules from the organism that can, without human intervention, replicate in a biological system and transfer a character or trait to another organism or to subsequent generations of the organism

“heritable material, in relation to a new organism, means viable biological material, including gametes and spores, arising from the organism that can, without human intervention, regenerate the organism or reproduce a new generation of the same species of the organism”.

“44A Additional matters to be considered for certain developments and field tests

• “(1) This section applies to an application—

  • “(a) to develop a new organism in containment that is a genetically modified organism, to the extent that the development does not take place in a containment structure:

  • “(b) to field test a new organism in containment if the new organism is a genetically modified organism.

  “(2) In deciding whether to approve or decline an application, the Authority must take into account—

  • “(a) any adverse effects of developing or field testing the organism on—

    • “(i) human health and safety; and

    • “(ii) the environment, in particular ecosystems and their constituent parts; and

  • “(b) any alternative method of achieving the research objective that has fewer adverse effects on the matters referred to in paragraph (a) than the development or field test; and

  • “(c) any effects resulting from the transfer of any genetic elements to other organisms in or around the site of the development or field test.

  “(3) The matters referred to in subsection (2) are in addition to the matters referred to in sections 44 and 45.

  “(4) In this section, field test does not include large-scale fermentation of micro-organisms inside a containment structure.”

“45A Controls required for certain developments and for all field tests

• “(1) This section applies to an approval under section 45—

  • “(a) to develop a new organism in containment that is a genetically modified organism, to the extent that the development does not take place in a containment structure; or

  • “(b) to field test a new organism in containment if the new organism is a genetically modified organism.

  “(2) An approval—

  • “(a) must include controls to ensure that, after the end of the development or field test, the organism and any heritable material from the organism is removed or destroyed; and

  • “(b) may include controls to ensure that, after the end of the development or field test and after heritable material is removed or destroyed, some or all of the genetic elements remaining from the organism are removed or destroyed.

  “(3) In subsection (2), destroyed includes leaving genetic elements to break down or become inactive at the site of the development or field test.”

“6A

• Controls imposed on an approval to field test a genetically modified organism—

  • “(a) must specify—

    • “(i) inspection and monitoring of containment facilities during the field test; and

    • “(ii) inspection and monitoring of the site, after the field test, to ensure that all heritable material is removed or destroyed; and

  • “(b) may specify inspection of the site before field testing commences.

“6B

• Clause 6A applies, with all necessary modifications, to controls imposed on an approval to develop a new organism that is a genetically modified organism, to the extent that the development does not take place in a containment structure.”