Making of the Gene Technology Amendment Regulations 2011

The Gene Technology Amendment Regulations 2011 (Amendment Regulations 2011) were made by the Administrator of the Commonwealth of Australia on 2 June 2011. The Amendment Regulations 2011 are a disallowable instrument and were tabled in the House of Representatives on 14 June 2011 and the Senate on 15 June 2011.

The Amendment Regulations 2011 represents the culmination of a technical review of the Gene Technology Regulations 2001 (the Regulations) initiated by the Regulator in 2008-2009. Consultation with a wide range of stakeholders was undertaken and feedback in submissions was taken into consideration in finalising the Amendment Regulations 2011. The amendments include changes to: classification of some GMO dealings as exempt dealings or NLRDs; classification of some GMO dealings involving viral vectors; and the oversight and timeframes of NLRDs.

The Amendment Regulations are due to commence on 1 September 2011.

International collaboration and coordination

Under the Act the Regulator’s functions include:
  • monitoring international practice in relation to regulation of GMOs
  • maintaining links with international organisations that deal with the regulation of gene technology and with agencies that regulate GMOs in countries outside Australia
  • promoting the harmonisation of risk assessments relating to GMOs and GM products by regulatory agencies.
International collaboration and coordination activities undertaken during the quarter involved a presentation or participation in:
  • International Life Sciences Institute (ILSI) Conference on Environmental Risk Assessment of Genetically Modified Crops, Hanoi, Vietnam, June 2011
  • ILSI Conference on Risk Assessment of Genetically Modified Crops, New Delhi, India, May 2011
  • ILSI Biotechnology Workshop 2011, Paris, France, May 2011
  • Organisation for Economic Co-operation and Development (OECD) working group on Harmonisation of Regulatory Oversight in Biotechnology (WGHROB) 25th meeting, Paris, France, May 2011
  • World Health Organization (WHO) informal consultation on guidelines for environmental risk assessment of GM Dengue vaccines, Geneva, Switzerland, April 2011.

Advice on gene technology regulation

The Regulator and the OGTR endeavour to participate in events that inform stakeholders, the Australian community and/or users about the regulatory system.
OGTR officers also participated in the following meetings/conferences:
  • 39th GTTAC meeting, Canberra, May 2011
  • 7th Meeting of the Australasian Gene Therapy Society, Melbourne, May 2011
  • 33rd Conference of Australian Society of Sugarcane Technologists, Mackay, May 2011
  • Exploring the impact of social technologies on science communication, Brisbane, April 2011
  • 5th GTECCC meeting, Canberra, April 2011

Accredited organisations and Institutional Biosafety Committee training

The fourth National Institutional Biosafety Committee Forum was held in Canberra on 7 and 8 June 2011 at the National Gallery of Australia. Representatives from all States and Territories except the Northern Territory attended; 137 delegates represented 64 accredited organisations.

The forum was opened with an address from Professor Peter Rathjen, Vice-Chancellor, University of Tasmania and the Regulator followed with an update of the achievements of the OGTR over the past 10 years. A number of guest speakers from other Australian Government agencies and the IBCs, as well as officers from several sections of the OGTR, also gave presentations.

The forum facilitated exchange of information between IBCs and the OGTR and provided an arena in which to discuss the impending changes to Gene Technology Regulations 2001. The two day meeting also provided an opportunity for organisations to discuss specific issues with OGTR staff.

Feedback was strongly positive. Attendees found the Forum interesting and informative, and valued the opportunity to meet OGTR staff in person and to exchange ideas with IBC members from other organisations.

OGTR website usage and statistics

The OGTR website is a comprehensive source of information on activities of the office. The tables below provide information on the number of hits on the OGTR website and the number of visitor sessions by month and day of week pattern during the quarter.

Month Hits1 Visits2
April 190,842 24,028
May 214,302 24,770
June 218,873 218,873

1A hit is a request made to the server. Each file that is requested is counted as a hit
2Visits" is the number of times the OGTR website has been visited.

The most popular pages viewed on the OGTR website during the period were:
  • What's New
  • Maps of Trial Sites
  • About the OGTR
  • List of applications and licences for Dealings involving Intentional Release (DIR) of GMOs into the environment
  • Guidelines and forms for Certification of Physical Containment Facilities
  • Forms and Guidelines
  • List of Intentional Release of Licence Application under Evaluation
  • Publications
  • Record of GMOs and GM Product Dealings
  • IBC & Accredited Organisations Information
The most popular downloaded documents were:
  • Risk Analysis Framework
  • The Biology of Ananas comosus var. comosus (Pineapple)
  • The Biology of Carica papaya L. (Papaya, pawpaw, paw paw)
  • The Biology and Ecology of Rice (Oryza sativa) in Australia
  • The Biology of Gossypium hirsutum L. and Gossypium barbadeuse L. (Cotton)
  • PC2 Laboratory guidelines
  • The Biology of Saccharum spp (Sugarcane)
  • The Biology of Hybrid Tea Rose (Rosa x hybrida)
  • Operation of the Gene Technology Regulator Annual Report 2009-2010
  • The Biology of Triticum aestivum L. em Thell. (Bread Wheat).
The OGTR welcomes feedback on ways to improve the provision of information on gene technology regulation.

Internet contacts and freecall number

OGTR email address and freecall number

The OGTR’s 1800 number and email address are points of contact for members of the public and other interested parties to obtain information about the regulation of GMOs. Assistance with specific questions and additional mechanisms for public feedback are among some of the services provided by the 1800 line and email facilities. The table below describes the activity of these facilities throughout the quarter.

Month Emails OGTR 1800 Number
April 100 78
May 175 107
June 84 94

Monitoring and compliance email inbox

The OGTR maintains an email inbox to provide a central point for accredited organisations to contact the OGTR regarding monitoring and compliance matters, such as queries, notifications required under licences, and self reporting of non-compliances. The email inbox ensures that all communications are answered efficiently while monitoring staff are away from the office. The inbox received 129 emails during the quarter.

Statutory Committee email inbox

The Regulatory Practice and Secretariat Section maintain an email inbox to facilitate efficient communication between committee members and secretariat staff.

The inbox ensures that all communications are answered in a timely manner by secretariat staff. The inbox received 343 emails during the quarter.

Application and Licence Management email inbox

This electronic mail inbox provides a central, shared communication point to allow efficient coordination of responses for correspondence and queries about applications received by the Application and Licence Management Section. The inbox received 407 emails during the quarter.

Contained Dealings Evaluation Section email inbox

This email inbox provides a central common point for efficient coordination of responses to queries relating to classification of GMO dealings, certification requirements for higher level containment facilities and GMO licences accessed by the contained dealings evaluation section. The inbox received 213 emails during the quarter.