Lecture 20 - Gene Technology Regulation

Question 1

What is Australia’s Gene Technology Regulatory Scheme

Answer 1

• Work with GMOs is regulated in Australia
• Based on a system of approvals and prohibitions
• The Gene Technology Regulator is responsible for administering the regulatory system
• The Office of the Gene Technology Regulator (OGTR) provides administrative support to the Gene Technology Regulator
• OGTR staff are part of the Department of Health

Question 2

What are the Regulations regarding the based on a system of approvals and prohibitions

Answer 2

o Gene Technology Act 2000
o Gene Technology Regulations 2001
o Corresponding State and Territory legislation

Question 3

What is a Gene Technology Regulator

Answer 3

o An independent statutory office holder with significant independence and power to regulate ‘dealings’ with GMOs

Question 4

What functions does regulator and OGTR include

Answer 4

• Coordinators consultations
• Assesses applications and issues approvals
• Certifies biocontainment facilities for work with GMOs
• Monitor and inspects facilities and sites where work with GMOs is conducted

Question 5

What is the Object of the Act

Answer 5

• To protect the health and safety of people, and to protect the environment
• Identifying risks posed by or as a result of gene technology
• Managing those risks through regulating certain dealings with GMOs

Question 6

What are the definitions of GMO

Answer 6

• An organism that has been modified using gene technology, or
• An organism that has inherited traits from an organism (eg. Genetically modified parent) where the traits that occurred in the parent organism where because of gene technology

Organism = any biological entity that is viable; or capable of reproduction; or capable of transferring genetic material

Gene technology = any technique for the modification of genes or other genetic material (excludes sexual reproduction; homologous recombination)

Question 7

Ways dealing with GMO under the Gene Technology Act

Answer 7

• Conduct experiments with the GMO
• Make, develop, produce or manufacture the GMO
• Breed the GMO
• Propagate the GMO
• Use of the GMO in the course of manufacture of a thing that is not the GMO
• Grow, raise or culture the GMO
• Import the GMO
• Transport the GMO
• Dispose of the GMO
• Possess, supply or use the GMO

Question 8

How the Regulatory System works

Answer 8

• Dealings with GMOs in Australia require a license from the Gene Technology Regulator unless the dealings can meet specific criteria
• Organisations wishing to conduct gene technology/ work with GMOs will generally become accredited by the OGTR
o UoM is an OGTR Accredited Organisation
• Accredited Organisations must have, or have access to, an Institutional Biosafety Committee (IBC) in order to be an OGTR Accredited Organisation

Question 9

The different types of dealings

Answer 9

• Exempt Dealings
• Notifiable Low Risk Dealings (NLRDs)
• Dealings NOT involving Intentional Release into the environment (DNIR)
• Dealings involving Intentional Release (DIR)

Question 10

Process of obtaining a license

Answer 10

• Preparation of a Risk Assessment and Risk Management Plan (RARMP)
• Consideration is based on the risks to the health and safety of people and the environment
• Benefits are specifically excluded
• Social, economic and marketing risks are not included
• CONSULTATIONS

Question 11

What to review in order to obtain the license

Answer 11

• Australia has a nationally consistent regulatory scheme for gene technology
• The scheme evolved due to concerns with emerging technologies that enabled the manipulation of genes across species
• The aim is to protect the health and safety of people, and the environment, by identifying risks posed by, or as a result of, gene technology, and by managing those risks through regulating certain dealings with GMOs
• The legislation extends to research, production, transport, storage, destruction or import of live or viable organisms modified by gene technology, including progeny or descendants of GMOs sharing the genetically modified trait
• Every dealing with a GMO need to be licensed by the Gene Technology Regulator, unless the dealing meets specific criteria

Question 12

What are the other regulatory agencies may need to be involve

Answer 12

• TGA
• Food Standards Australia New Zealand
• Department of Agriculture