Response to the National Gene Technology Scheme Consultation Regulation Impact Statement

The direction of the proposed changes to the regulations is consistent with, and supportive of, the continued achievement of the stated purpose of the Gene Technology Act 2000 (the Act): the identification and management of risk to human health and safety and the environment (HHS&E). [...] Option B: Risk-tiering model – Preferred option Categorising all dealings on the basis of indicative risk would substantially enhance the sophistication of the regulatory system and enable the Office of the Gene Technology Regulator (OGTR)’s resources to be focussed on consideration of the highest risk dealings. [...] For example, if the objectives are to increase use of the GMO register in place of the ongoing licensing category for commercial releases of GMOs, then the application process for the GMO register will need to be streamlined. [...] Explanatory Paper – Proposed changes to definitions In response to the proposed changes to definitions as outlined in the Explanatory Paper (Page 10-17), the Academies make the following comments: The revised definition of ‘Gene Technology’ accommodates the ongoing evolution of gene technology. [...] It may be preferable for this assessment to be accommodated within the proposed risk tier framework now 4 and be included in the guidance materials to be developed during the implementation of the proposed changes to the Scheme.