Monitoring and Compliance StrategyThe aim of OGTR monitoring and compliance activities is to ensure that dealings with genetically modified organisms (GMOs) comply with legislative obligations and are consistent with the object of the Gene Technology Act 2000 (the Act):
- ‘to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with GMOs’.
- the dissemination of a GMO and its genetic material is restricted
- the persistence of a GMO in the environment is restricted
- the containment of GMOs for dealings not involving intentional release
- effective management of GMOs is maintained.
- routine inspections including spot checks; and
- audits, practice reviews, investigations and related enforcement activities.
InspectionsRoutine inspections of field trials and contained dealings (carried out in certified laboratories and other containment facilities) are conducted to ensure compliance with licence and certification conditions. These inspections include announced inspections and unannounced spot checks.
The OGTR strategy for conducting inspections draws on accumulated operational experience and risk profiling in relation to compliance. For example, OGTR field trial inspections coincide, where possible, with periods or circumstances when non-compliance with licence conditions designed to restrict the spread and persistence of the GMOs are more likely to occur (for example, during flowering and harvest of GM crops). Post-harvest monitoring continues until the site is free of volunteers.
The inspection of contained dealings involves inspection of certified physical containment (PC) facilities under Dealings Not Involving Intentional Release (DNIRs) licences and Notifiable Low Risk Dealings (NLRDs). For monitoring purposes, certified facilities are grouped into higher and lower containment types. PC4, PC3 and PC2 large-scale laboratories are categorised as higher-level containment facilities and the remaining facility types are categorised as lower-level containment facilities. At least 20% of higher-level physical containment facilities are monitored annually. As well as examining the integrity of the physical structure of the facility, inspections cover the general work practices used in handling GMOs.
Practice ReviewsThe OGTR may initiate Practice Reviews in response to observations made during monitoring activities, or to follow up incident reports that may relate to non-compliance with licence conditions by accredited organisations. The objective of Practice Reviews is to determine if licence conditions can be, and are being, effectively implemented.
An accredited organisation may request a Practice Review to assess the effectiveness of systems used by its IBC(s) to ensure that dealings are being conducted in accordance with the Act.
The primary focus of the review process is to determine whether or not practices being used pose potential human health or environmental risks that require implementation of any management actions. In certain instances, where a suspected non-compliance with the Act is identified, the issue may be referred for investigation.
AuditsAudits can be initiated by the OGTR or at the request of an accredited organisation. An audit can entail:
- documentary evidence
- assessments of procedures and practices.
- verify that an accredited organisation has relevant and effective management procedures and practices to meet requirements under the Act, including accreditation requirements, guidelines and any licence conditions applicable to a GMO dealing under the Act
- assess whether or not procedures and practices provide mechanisms to identify and resolve emerging risks
- where appropriate suggest improvements to procedures and practices.
InvestigationsAn investigation is an inquiry into a suspected non-compliance with the Act (Cth) and corresponding state laws with the aim of gathering evidence. An investigation may be initiated: as a consequence of monitoring by the OGTR; self-reporting by an accredited organisation; or by third party reporting.
Previous Monitoring Activities were reported in the Operation of the Gene Technology Regulator Quarterly Reports. See the Annual and Quarterly Reports under the Gene Technology Act 2000 page.
Quarterly activities reports
2018Quarterly activities report for July-September 2018 (PDF 156 KB)
Quarterly activities report for July-September 2018 (DOCX 35 KB)
Quarterly activities report for April-June 2018 (PDF 147 KB)
Quarterly activities report for April-June 2018 (DOCX 33 KB)
Quarterly activities report for January-March 2018 (PDF 139 KB)
Quarterly activities report for January-March 2018 (DOCX 33 KB)
2017Quarterly activities report for October-December 2017 (PDF 29 KB)
Quarterly activities report for October-December 2017 (DOCX 33 KB)
Quarterly activities report for July-September 2017 (PDF 29 KB)
Quarterly activities report for July-September 2017 (DOCX 29 KB)
Quarterly activities report for April-June 2017 (PDF 25 KB)
Quarterly activities report for April-June 2017 (DOCX 32 KB)
Quarterly activities report for January-March 2017 (PDF 24 KB)
Quarterly activities report for January-March 2017 (DOCX 31 KB)
2016Quarterly activities report for October-December 2016 (PDF 29 KB)
Quarterly activities report for October-December 2016 (DOCX 32 KB)
Quarterly activities report for July-September 2016 (PDF 23 KB)
Quarterly activities report for July-September 2016 (DOCX 31 KB)
Quarterly activities report for April-June 2016 (PDF 22 KB)
Quarterly activities report for April-June 2016 (DOCX 28 KB)
Quarterly activities report for January-March 2016 (PDF 22 KB)
Quarterly activities report for January-March 2016 (DOCX 28 KB)
2015Quarterly activities report for October-December 2015 (PDF 23 KB)
Quarterly activities report for October-December 2015 (DOCX 29 KB)