June 6, 2002

The second Quarterly Report for the Australian Office of the Gene Technology Regulator, covering the period 1 October to 31 December 2001 is now available online at http://www.ogtr.gov.au/publications/pdf/dec2001qrpt.pdf

An extract of the report's scope and key achievements of the OGTR for the period October to December 2001 are summarised below. The report illustrates the increasing breadth and volume of work as the Office successfully completed the first six months of operation of the new regulatory system for gene technology.

Structure of the Report

This report is divided into 4 parts:

1. Details activities and outcomes achieved in relation to the implementation and management of the national regulatory system.
2. Outlines the regulatory activity undertaken during the October - December 2001 quarter. This includes information about applications for, and action taken with respect to, new and deemed GMO licences and other instruments under the GT Act. It also includes details of monitoring, auditing and compliance activities by the Regulator during the quarter.
3. Reports on the activities of the three key advisory committees established under the GT Act to assist the Regulator.
4. Summarises other activities undertaken by the Office of the Gene Technology Regulator (OGTR), including reviews and research, international collaboration and coordination, advice provided on gene
   technology regulation, freedom of information requests received, and consultant contracts managed during the quarter.

The key achievements of the October - December 2001 quarter were:

• First application for a dealing involving intentional release (DIR) of a genetically modified organism (GMO)
• Establishment of committees
  Under the new regulatory system three key advisory groups have been established to assist the Regulator and the Gene Technology Ministerial Council in their decision making roles. These three committees are:
  1. The Gene Technology Technical Advisory Committee (GTTAC) - provides scientific and technical advice to the Regulator and the Ministerial Council;
  2. The Gene Technology Ethics Committee (GTEC) – provides advice to the Regulator and Ministerial Council on ethical issues relating to gene technology; and
  3. The Gene Technology Community Consultative Committee (GTCCC) - advises the Regulator and Ministerial Council on matters of general concern to the community in relation to GMOs.
• Licences and other instruments
  In the quarter the Regulator:
  ~received 38 applications for licences for dealings with GMOs
  including 6 applications for limited and controlled releases (DIR
  licences);
  ~received 107 applications seeking certification of facilities;
  ~received 4 applications for protection of confidential commercial
  information (CCI).
  ~received 1 application for accreditation of an organisation;
  ~was notified of 49 notifiable low risk dealings (NLRDs);
  ~certified 28 facilities;
  ~varied 19 DIR deemed licences; and
  ~varied 3 deemed licences for dealings not involving the intentional
  release of a GMO into the environment(DNIR).
• Monitoring and compliance
  In the December quarter, the OGTR's target to monitor at least 5% of current and post harvest trial sites per quarter, was exceeded. A total of 40 licences were the subject of monitoring by the OGTR. Eighty-four (84) sites were monitored and 87 monitoring visits were conducted, including revisits as follow-ups to 3 of the 84 sites inspected. Of the 105 trial sites that were current in the quarter, 14% or 15 sites were monitored. Of the 518 sites subject to post-harvest
  monitoring during the quarter, 13% or 69 were monitored.
  As input into a review of the Regulator's guidelines for certified facilities, a significant number of higher-level containment facilities were visited by the Monitoring and Compliance Section during the quarter. The target of 5% per quarter of higher level containment facilities receiving a monitoring visit was exceeded. In the quarter there were fifty-four (54) Physical Containment (PC) 4, PC3 and PC2 large-scale facilities operating under deemed certifications from the
  previous voluntary system. During the quarter 20% (11) of these facilities were visited. Lower level containment facilities were also inspected with ten (10) PC2 facilities and one PC1 facility visited.
  A 'gene flow' study, commissioned to examine sites in Tasmania which the Interim Office of the Gene Technology Regulator (IOGTR) teams found in February 2001 to be non-compliant with voluntary guidelines, commenced during the quarter. The results of the study are expected
  in the first half of 2002.
• Commencement of major reviews
  A review of risk assessment data requirements from GM cotton trials and a review of guidelines for the certification of facilities both commenced during the quarter. For more detail see Part 4 of the report.
• Institutional Biosafety Committee (IBC) training sessions
  The OGTR completed a national series of training and individual information sessions for IBCs and researchers to explain how the new regulatory system will operate in practice. The issues covered in these sessions included the preparation of licence applications, NLRDs and other reports required by the Regulator. A total of 10 sessions were held across Australia between 28 September and 18 October 2001. These sessions were designed to assist IBCs to better understand and fulfil their role under the new regulatory system for GMOs.
• Commencement of the Gene Technology Regulator
  Dr Sue Meek took up her position in Canberra as the inaugural Gene Technology Regulator on 3 December 2001.