Ongoing regulatory compliance obligations
Regulatory compliance is a 3 step process. The third step covers the ongoing activities needed to maintain compliance.
For organisations
For facilities
For GMO dealings
- Request changes to your licence
- Report non-compliance or unintended presence of GMOs
- Comply with OGTR’s routine monitoring
Our cooperative compliance principles
We take a cooperative compliance approach, with an emphasis on education, engagement and awareness-raising. Our open communication, backed by strong regulation, has helped to create an environment in which cooperative compliance works from day to day, year to year.
We achieve compliance by:
- actively monitoring higher risk activities
- building cooperative compliance supported by the availability of enforcement action if necessary
- educating and raising awareness in the regulated community and others
- working with other regulators
- providing feedback into OGTR evaluation processes
- actively supporting organisations seeking to develop best practice models.
Generally, organisations working with GMOs strive to minimise risks (including reputational risks). Many organisations perform to a high standard when delivering on their compliance obligations. The OGTR’s active inspection program also provides an effective deterrent.
Monitoring
We assess compliance with the gene technology legislation through monitoring activities including:
- profiling of work with GMOs to aid strategic planning of monitoring activities
- routinely inspecting crop field trials, certified laboratories, and clinical trials
- conducting unannounced inspections (spot checks)
- conducting audits and practice reviews
- performing incident reviews in response to ‘self-reported’ issues or non-compliances
- investigating allegations of non-compliance or breaches of the legislation.
Learn more about routine monitoring.
Enforcement
We have a range of enforcement powers. In extreme circumstances, significant financial penalties or prison terms may be imposed by the courts.
However, our cooperative compliance approach has been effective. Since the establishment of the legislation every issue has been resolved without the need for prosecution under the Gene Technology Act 2000.