Dir 108 Commercial release of canola genetically modified for herbicide tolerance and a hybrid breeding system

Conclusions of the RARMP

The risk assessment concluded that this commercial release of GM InVigor® x Roundup Ready® canola to be grown throughout 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 concluded that these negligible risks do not require specific risk treatment measures. However, general licence conditions have been imposed to ensure that there is ongoing oversight of the release.

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Table of Contents

Introduction 3

The application 3

Risk assessment 4

Risk management plan 4

Conclusions of the RARMP 5

Table of Contents 7

Abbreviations 8

Introduction 9

The application 9

Risk assessment 10

Risk management plan 11

Other regulatory considerations 11

Suitability of the applicant 12

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
DIR	Dealing involving Intentional Release
DNA	Deoxyribonucleic Acid
EFSA	European Food Safety Authority
ELISA	Enzyme linked immunosorbent assay
EPA	(United States) Environmental Protection Agency
EPSPS	5-enolpyruvylshikimate-3-phosphate synthase
FDA	(United States) Food and Drug Administration
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
HGT	Horizontal gene transfer
kD	kilodalton
LGA	Local Government Area
m	metre
mm	millimetre
mRNA	messenger ribonucleic acid
MS	Male-sterile
nptII	neomycin phosphotransferase II gene
OECD	Organisation for Economic Co-operation and Development
OGTR	Office of the Gene Technology Regulator
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
TT	Triazine tolerant
USDA	United States Department of Agriculture

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