Risk Assessment and Risk Management Plan


Section 2 Previous releases and international approvals



Download 0.66 Mb.
Page4/20
Date02.06.2016
Size0.66 Mb.
1   2   3   4   5   6   7   8   9   ...   20

Section 2 Previous releases and international approvals


Section 2.1 Previous Australian releases

  1. Under the former voluntary system overseen by the GMAC, there were two releases of GM papayas:

  • PR-108 (Queensland Department of Primary Industries) comprised GM papaya plants resistant to Papaya Ring Spot Virus (PRSV) and involved up to 100 plants released in an area up to 0.15 hectares; and

  • PR-128 (University of Queensland) comprised 20 GM papaya plants modified for delayed fruit ripening released in an area up to 1 hectare (originally, approval was given to grow 1000 GM papaya plants).

  1. As noted previously, the current application involves the continued evaluation of three types of GM papayas approved for release under PR-128, and the release of five additional types of GM papayas.

  2. There have been no applications for general (commercial) release of GM papayas in Australia to date.

Section 2.2 Australian approvals for other GM crops with a delayed fruit ripening trait

  1. As noted above, there have been no applications for general (commercial) release of other GM fruit crops with delayed ripening in Australia to date. However, a GM carnation with down-regulation of ethylene production via insertion of a truncated ACC synthase gene, which has enhanced vase life, was approved for commercial release in Australia under the former voluntary system (GR-1). The limited and controlled release of pineapples with decreased ethylene production was authorised by the previous voluntary system under deemed licence PR-95. Applications to continue both these releases are currently under consideration by the Regulator.

Section 2.3 Approvals by other Australian government agencies

  1. The OGTR is responsible for assessing the biosafety risks to human health and the environment associated with development and use of GMOs. Other government regulatory requirements must also be met in respect of the release of the GMOs, and the use of products of the GMO, including the requirements of Food Standards Australia New Zealand (FSANZ).

  2. Food Standards Australia New Zealand (FSANZ) is responsible for human food safety assessment. As the trials proposed in this application represent an early ‘proof of concept’ stage of development, the applicant has not as yet applied to FSANZ for evaluation of material from the GM papayas for use in human food. FSANZ approval would need to be obtained before it could be used in human food.

  3. Further information about food safety and food labelling are available from FSANZ:

Food Standard Australia New Zealand

PO Box 7186

Canberra Mail Centre ACT 2610

Phone: (02) 6271 2222

Fax: (02) 6271 2278

E-mail: info@foodstandards.gov.au



http://www.foodstandards.gov.au
Section 2.4 International approvals for GM papayas and other GM crops with delayed fruit ripening trait

  1. GM papaya lines resistant to papaya ring spot virus (PRSV) are grown in Hawaii and were approved for commercial use in the USA in 1996.

  2. Other fruit species genetically modified for delayed fruit ripening have been approved for commercial release in the USA and Canada:

  • Tomato (Lycopersicon esculentum) modified for delayed fruit ripening via insertion of a truncated ACC synthase gene was approved for commercial release in the USA and Canada in 1995;

  • Tomato modified for delayed fruit ripening via degradation of essential components of ethylene biosynthesis by introduced enzymes (ACC deaminase or S-adenosylmethionine (SAM) hydrolase) were approved for commercial release in the USA in 1995 and 1996, respectively;

  • Two types of tomato modified for delayed fruit ripening via suppression of the activity of fruit softening (polygalacturonase genes) were approved for commercial release in the USA (1994) and Canada (1995 and 1996);

  • Approval for melon (Cucumis melo) modified for delayed fruit ripening via expression of the SAM hydrolase gene, is currently pending in the USA.

chapter 2 SUMMARY OF THE RISK ASSESSMENT AND THE RISK MANAGEMENT PLAN


  1. The Act and the Regulations require that risks associated with dealings with GMOs are identified and assessed as to whether they can be managed to protect human health and safety and the environment (see Appendix 6).

Section 1 Issues raised in submissions on the application and the risk assessment and risk management plan


  1. Comments received in response to the consultation on the risk assessment and risk management plan undertaken with expert groups and key stakeholders, as required by Section 50, of the Act and with the public, as required by Section 52 of the Act (see Appendix 6), were very important in shaping this risk assessment and risk management plan, which formed the basis of the final decision on the application.

  2. Written submissions received from the agencies and authorities prescribed by Section 50 of the Act in relation to DIR application number 026/2002 suggested that the following issues should be addressed in the risk assessment and the risk management plan:

  • toxicity of the introduced proteins to soil microorganisms, invertebrates, birds and mammals including humans (Appendix 2 refers);

  • persistence or accumulation of the introduced proteins in the environment and potential for adverse impacts resulting from the presence of the introduced proteins in the environment (Appendices 1 and 2 refer);

  • potential for transfer of the introduced genes from the GM papaya to other papaya plants, related plants and microorganisms and potential for subsequent ecological impacts (Appendix 4 refers);

  • potential for the genetic modifications to alter the level, formation or breakdown of potentially toxic plant metabolites, for example components of the ethylene biosynthesis pathway, or to have other unintended impacts on the plant phenotype (Appendices 1 and 2 refer);

  • measures to prevent the unintended exposure of humans or other organisms to the GMOs and the unintended spread of the GMOs, pollen, seed or vegetative propagules beyond the release site (Appendix 5 refers);

  • measures to prevent the occurrence of GM papaya volunteers at the release site after completion of the release (Appendix 5 refers); and

  • data requirements for the future development of the GMOs (Chapter 2, Section 3 refers).

  1. In total the Regulator received three submissions from the public on this application and the associated risk assessment and risk management plan. None of the submissions specifically addressed matters relating to the protection of human health and safety or the environment. A summary of these written submissions is provided in Appendix 7.



Share with your friends:
1   2   3   4   5   6   7   8   9   ...   20




The database is protected by copyright ©essaydocs.org 2020
send message

    Main page