Commercial release of canola genetically modified for herbicide tolerance and a hybrid breeding system

Conclusions of the consultation RARMP

The risk assessment concludes that this proposed commercial release of GM InVigor® x Roundup Ready® canola, to be grown in all commercial canola growing areas of Australia, and the entry of products derived from the GM canola into general commerce Australia wide, 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, general conditions are proposed to ensure that there is ongoing oversight of the release.

Call for comment

The Gene Technology Regulator (the Regulator) invites comments on the Risk Assessment and Risk Management Plan (RARMP) for application DIR 108, including the licence conditions proposed if a licence were to be issued to Bayer CropScience Pty Ltd for this release. The closing date for written submissions is 18 October 2011.

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 108.

The Regulator's Risk Analysis Framework and a review document, The Biology of Brassica napus L. (canola), 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 3

The application 3

Risk assessment 4

Risk management 4

Conclusions of the consultation RARMP 4

Call for comment 6

Table of Contents 7

Abbreviations 8

Introduction 9

The application 9

Risk assessment 10

Risk management plan 11

Proposed licence conditions 11

Other regulatory considerations 11

Conclusions of the consultation RARMP 12

Abbreviations

the Act	Gene Technology Act 2000
APHIS	Animal and Plant Health Inspection Service of the US Department of Agriculture
APVMA	Australian Pesticides and Veterinary Medicines Authority
AQIS	Australian Quarantine and Inspection Service
CaMV	Cauliflower mosaic virus
CMP	Crop Management Plan
EFSA	European Food Safety Authority
EPSPS	5-enolpyruvylshikimate-3-phosphate synthase
DIR	Dealing involving Intentional Release
DNA	Deoxyribonucleic Acid
EFSA	European Food Safety Authority
ELISA	Enzyme linked immunosorbent assay
FSANZ	Food Standards Australia New Zealand
FMV	Figwort mosaic virus
GM	Genetically Modified
GMAC	Genetic Manipulation Advisory Committee
GMO	Genetically Modified Organism
GOX	glyphosate oxidoreductase
GTTAC	Gene Technology Technical Advisory Committee
HGT	Horizontal gene transfer
kD	kilodalton
LGA	Local Government Area
m	metre
mm	millimetre
mRNA	messenger ribonucleic acid
MS	Male-sterile
NICNAS	National Industrial Chemicals Notification and Assessment Scheme
nptII	neomycin phosphotransferase II gene
OECD	Organisation for Economic Co-operation and Development
OGTR	Office of the Gene Technology Regulator
OSA	Outside scope of the assessment
PAT	phosphinothricin acetyl transferase
PRR	Post release review
RARMP	Risk Assessment and Management Plan
the Regulations	Gene Technology Regulations 2001
the Regulator	Gene Technology Regulator
RF	Restorer of fertility
RNA	Ribonucleic Acid
T-DNA	Transfer DNA
Ti	Tumour inducing
TGA	Therapeutic Goods Administration
TT	Triazine tolerant
USDA	United States Department of Agriculture
US EPA	United States Environmental Protection Agency
US FDA	United States Food and Drug Administration

PAGE INTENTIONALLY LEFT BLANKTechnical Summary