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



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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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