Dir 111 Limited and controlled release of wheat and barley genetically modified for altered grain composition, nutrient utilisation efficiency, disease resistance or stress tolerance Applicant

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 licence conditions.

As none of the seven 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 imposed 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, location and duration requested by the applicant, as these were important considerations in establishing the context for assessing the risks.

The licence conditions require CSIRO to limit the release to a total area of 2.3 ha per year at one site between May 2012 and June 2017, inclusive. The control measures include containment provisions at the trial site; preventing the use of GM plant materials in human food or animal feed, except for a range of carefully controlled, small scale animal and human nutritional trials; 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 RARMP

The risk assessment concluded that this limited and controlled release of up to 292 lines of GM wheat and 41 lines of GM barley on a maximum total area of 2.3 ha per year over five years in the ACT, 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, licence conditions have been imposed to limit the release to the size, location 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.

Table of Contents

Introduction 3

The application 3

Confidential Commercial Information 4

Risk assessment 4

Risk management plan 4

Conclusions of the RARMP 5

Table of Contents 6

Abbreviations 7

Technical Summary 8

Introduction 8

The application 8

Confidential Commercial Information 9

Risk assessment 9

Risk management plan 10

Licence conditions 10

Other regulatory considerations 11

Identification of issues to be addressed for future releases 11

Suitability of the applicant 11

Conclusions of the RARMP 12

References 64

Abbreviations

ABC	Adenosine triphosphate (ATP)-binding cassette
AlaAT	Alanine aminotransferase gene
APVMA	Australian Pesticides and Veterinary Medicines Authority
bar	Phosphinothricin acetyl transferase gene
bla	Β-lactamase gene
CaMV	Cauliflower mosaic virus
CCI	Confidential Commercial Information as declared under section 185 of the Gene Technology Act 2000
cDNA	Complementary DNA created using Reverse Transcription from messenger RNA (mRNA)
CIMMYT	International Maize and Wheat Improvement Center
DIR	Dealings involving Intentional Release
DNA	Deoxyribonucleic acid
EFSA	European Food Safety Authority
FAO	Food and Agriculture Organization
FSANZ	Food Standards Australia New Zealand
GM	Genetically Modified
GMO	Genetically Modified Organism
GWD	α-glucan water dikinase
ha	Hectare
HGT	Horizontal Gene Transfer
hpt	Hygromycin phosphotransferase gene
JECFA	Joint FAO and WHO Expert Committee on Food Additives
km	Kilometre
m	Metre
NHMRC	National Health and Medical Research Council
NLRD	Notifiable Low Risk Dealing
Nos	Nopaline synthase gene
nptII	Neomycin phosphotransferase type II gene
OGTR	Office of the Gene Technology Regulator
PC2	Physical containment level 2
PCR	Polymerase Chain Reaction
PDR	Pleiotropic drug resistance
RARMP	Risk Assessment and Risk Management Plan
Regulations	Gene Technology Regulations 2001
Regulator	Gene Technology Regulator
RNAi	RNA interference
SBE	Starch branching enzyme
T-DNA	Transfer DNA
TGA	Therapeutic Goods Administration
the Act	The Gene Technology Act 2000
Ubi	Polyubiquitin gene
WHO	World Health Organization