The holder of an existing genetically modified organism (GMO) licence may apply to the Gene Technology Regulator (the Regulator) to vary, surrender or suspend the licence; or to have the licence transferred to another (consenting) party.
The Gene Technology Act 2000 (the Act) sets out requirements for licence variations, surrenders, suspensions and transfers in Sections 68–72. The following processes apply.
VariationTo apply for a variation to an existing GMO licence, a licence holder must write to the Regulator with details of the licence (its identification number and title) and the requested variation.
The Regulator has developed a guide to help licence holders determine whether a request for variation will be considered as variation or will require a new licence application. The Policy on variation of GMO licences can be found at Operational Policies.
After a licence holder applies for a variation, the Regulator has 90 days to approve or refuse the variation.
The Regulator assesses each variation application on a case-by-case basis, and considers the relevant Risk Assessment and Risk Management Plan. The Regulator may ask for more information from the licence holder. For variations to Dealings involving Intentional Release (DIR) licences, the Regulator may also consult relevant agencies and authorities.
The Regulator will only approve a variation if it is satisfied that the:
- risks can be managed
- requested variation is in accordance with other requirements in the Act (Section 71).
The requested variation must not commence unless it has been approved, and not before notification of its approval has been received. People covered by the licence must be informed of the varied conditions and must comply with the varied licence.
The Regulator may also vary a licence on the Regulator’s own initiative, in which case the Regulator would normally inform a licence holder before making the variation.