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Risk management plan

Risk management is used to protect the health and safety of people and to protect the environment by controlling or mitigating risk. The risk management plan evaluates and treats identified risks, evaluates controls and limits proposed by the applicant, and considers general risk management measures. The risk management plan is given effect through proposed licence conditions.

As none of the eight risk scenarios characterised in the risk assessment give rise to an identified risk that requires further assessment, the level of risk from the proposed dealings is assessed to be negligible. The Regulator's Risk Analysis Framework defines negligible risks as insubstantial, with no present need to invoke actions for their mitigation in the risk management plan. However, conditions are proposed to restrict the spread and persistence of the GMOs and their genetic material in the environment and to limit the proposed release to the size, locations and duration requested by the applicant, as these were important considerations in establishing the context for assessing the risks.

The proposed licence conditions, detailed in Chapter 4 of the RARMP, would require the University of Adelaide to limit the release to a total area of 0.75 ha at three sites between June 2010 and December 2015. The control measures would include containment provisions at the trial site, preventing the use of GM plant materials in human food or animal feed; destroying GM plant materials not required for further studies; transporting GM plant materials in accordance with the Regulator’s transportation guidelines; and conducting post-harvest monitoring at the trial site to ensure all GMOs are destroyed.

Conclusions of the consultation RARMP

The risk assessment concludes that this proposed limited and controlled release of up to 1161 GM wheat lines and 1179 GM barley lines on a maximum total area of 0.75 ha over five years in the LGAs of Marion and Wakefield, South Australia and Corrigin, Western Australia, poses negligible risks to the health and safety of people or the environment as a result of gene technology.

The risk management plan concludes that these negligible risks do not require specific risk treatment measures. If a licence were to be issued, conditions are proposed to restrict the release to the size, locations and duration proposed by the applicant, and to require controls in line with those proposed by the applicant, as these were important considerations in establishing the context for assessing the risks.

Call for comment

The Regulator invites comments on the RARMP for application DIR 102, including the licence conditions proposed if a licence were to be issued to the University of Adelaide for this release. The closing date for written submissions is 1 June 2010.

The Regulator would particularly value comments relating to risks to the health and safety of people or the environment posed by the proposed release.

All comments relating to the protection of people or the environment that are received by the closing date will be considered by the Regulator in finalising the RARMP, which will then form the basis of his decision whether or not to issue a licence.

Please note that issues such as food safety and labelling, the use of agricultural chemicals and marketability and trade implications do NOT fall within the scope of the evaluations that the Regulator is required to conduct under the Gene Technology Act 2000 and corresponding State and Territory legislation as these are the responsibilities of other agencies and authorities.

The consultation RARMP can be accessed on the OGTR website under 'What's New' or you can request a copy of the RARMP or the application from the OGTR. Please quote application number DIR 102.

The Regulator's Risk Analysis Framework and review documents, The Biology of Triticum aestivum L. em Thell. (bread wheat) and The Biology of Hordeum vulgare L. (barley), and a plain English Questions and Answers on this application can also be accessed on the OGTR website or obtained from the OGTR.

If you have any questions about the RARMP or the evaluation process, please contact:

The Office of the Gene Technology Regulator

MDP 54 GPO Box 9848 Canberra ACT 2601

Tel: [phone]

Fax: [phone]

Email: [e-mail]

Website: http://www.ogtr.gov.au

Table of Contents

Introduction 4

The application 4

Confidential Commercial Information 4

Risk assessment 5

Risk management plan 5

Conclusions of the consultation RARMP 6

Call for comment 7

Table of Contents 8

Abbreviations 9

Technical Summary 11

Introduction 11

The application 11

Confidential Commercial Information 12

Risk assessment 12

Risk management plan 13

Proposed licence conditions 13

Other regulatory considerations 14

Identification of issues to be addressed for future releases 14

Conclusions of the consultation RARMP 14

Abbreviations

the Act	Gene Technology Act 2000
APVMA	Australian Pesticides and Veterinary Medicines Authority
AQIS	Australian Quarantine and Inspection Service
CCI	Confidential Commercial Information as declared under section 185 of the Gene Technology Act 2000
CaMV	Cauliflower mosaic virus
DIR	Dealings involving Intentional Release
DNA	Deoxyribonucleic Acid
FSANZ	Food Standards Australia New Zealand
GM	Genetically Modified
GMO	Genetically Modified Organism
GTTAC	Gene Technology Technical Advisory Committee
ha	Hectare
HGT	Horizontal gene transfer
HPT	Hygromycin phosphotransferase
km	kilometre
m	metre
mm	millimetre
mRNA	Messenger Ribonucleic Acid
NUE	Nitrogen Use Efficiency
OECD	Organisation for Economic Cooperation and Development
OGTR	Office of the Gene Technology Regulator
PCR	Polymerase Chain Reaction
RARMP	Risk Assessment and Risk Management Plan
the Regulations	Gene Technology Regulations 2001
the Regulator	Gene Technology Regulator
RNA	Ribonucleic Acid
TGA	Therapeutic Goods Administration

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