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 trial in size, locations and duration, 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.
Introduction 2
The application 2
Confidential Commercial Information 2
Risk management plan 3
Conclusions of the RARMP 3
Table of Contents 4
Abbreviations 5
Technical Summary 7
Introduction 7
The application 7
Confidential Commercial Information 7
Risk assessment 7
Risk management plan 8
Licence conditions 8
Other regulatory considerations 9
Identification of issues to be addressed for future releases 9
Conclusions of the RARMP 9
Appendix A Summary of issues raised in submissions received from prescribed experts, agencies and authorities 60
Appendix B Summary of issues raised in submissions received from the public 62
ACT
|
Australian Capital Territory
|
the Act
|
Gene Technology Act 2000
|
APVMA
|
Australian Pesticides and Veterinary Medicines Authority
|
BHK21
|
immortalised baby hamster kidney cell line number 21
|
CCI
|
Confidential Commercial Information as declared under section 185 of the Gene Technology Act 2000
|
CD
|
Cluster of Differentiation
|
CTLA-4
|
Cytotoxic T-Lymphocyte Antigen 4 (also known as CD152)
|
CTN
|
Clinical trial notification
|
CTX
|
Clinical trial exemption
|
DAFF
|
Department of Agriculture, Fisheries and Forestry
|
DIR
|
Dealings Involving intentional Release
|
DNIR
|
Dealings Not Involving intentional Release
|
DNA
|
Deoxyribonucleic Acid
|
EEV
|
external enveloped virus
|
fowlpox
|
Fowlpox virus
|
FSANZ
|
Food Standards Australia New Zealand
|
GM
|
Genetically Modified
|
GM-CSF
|
Granulocyte macrophage-colony stimulating factor
|
GMO
|
Genetically Modified Organism
|
GTTAC
|
Gene Technology Technical Advisory Committee
|
HGT
|
Horizontal Gene Transfer
|
HIV
|
Human immunodeficiency virus
|
HREC
|
Human Research Ethics Committee
|
IATA
|
International Air Transport Authority
|
ICAM-1
|
Intercellular adhesion molecule-1 (also known as CD54)
|
ICH
|
International Conference on Harmonisation
|
ICH-GCP
|
International Conference on Harmonisation Good Clinical Practice standard.
|
IL
|
Interleukin
|
IMV
|
internal mature virus
|
ITR
|
inverted terminal repetitions
|
kb
|
kilobase(s)
|
LFA-1
|
Leukocyte function associated antigen-1 (also known as CD11a/CD18)
|
LFA-3
|
Leukocyte function associated antigen-3 (also known as CD58)
|
LGA
|
Local government area
|
Mac-1
|
macrophage adhesion ligand-1 (also known as Integrin alpha M (ITGAM), complement receptor 3 (CR3) and CD11b/CD18)
|
ml
|
Millilitre
|
mRNA
|
Messenger Ribonucleic Acid
|
NHMRC
|
National Health and Medical Research Council
|
NSW
|
New South Wales
|
NICNAS
|
National Industrial Chemicals Notification and Assessment Scheme
|
NYCBH
|
New York City Board of Health
|
OGTR
|
Office of the Gene Technology Regulator
|
PC2
|
Physical containment level 2
|
PCR
|
Polymerase Chain Reaction
|
PPD
|
PPD Australia Pty Ltd
|
PROSTVAC-F
|
Recombinant Fowlpox virus that expresses human genes encoding B7.1, LFA-3, ICAM-1 and modified PSA (also referred to in this document as GM fowlpox)
|
PROSTVAC-V
|
Recombinant Vaccinia virus that expresses human genes encoding B7.1, LFA-3, ICAM-1 and modified PSA (also referred to in this document as GM vaccinia)
|
PSA
|
prostate-specific antigen
|
QLD
|
Queensland
|
Q-PCR
|
Quantitative Polymerase Chain Reaction
|
RARMP
|
Risk Assessment and Risk Management Plan
|
the Regulations
|
Gene Technology Regulations 2001
|
the Regulator
|
Gene Technology Regulator
|
REV
|
Reticuloendotheliosis virus
|
RNA
|
Ribonucleic acid
|
SA
|
South Australia
|
TGA
|
Therapeutic Goods Administration
|
TNFα
|
Tumour necrosis factor alpha
|
TRICOM
|
Triad of co-stimulatory molecules
|
USA
|
United States of America
|
UV
|
Ultra violet
|
VIC
|
Victoria
|
VIG
|
Vaccinia hyperimmune gamma-globulin
|
vaccinia
|
Vaccinia virus
|
WA
|
Western Australia
|
WHO
|
World Health Organisation
|
