Biotechnology Overview

Biotechnology

Biotechnology is a broad term used to describe the use of biological systems (living organisms) to create new products or alter the properties of existing products. The term has been used for more than a century to describe techniques used in the cross-breeding of plants, enzyme production and alcoholic fermentation.

Gene Technology

In recent times, developments in gene technology (also known as “genetic engineering” and “genetic modification”') have revolutionised the area of biotechnology. Scientists are now able to modify an organism by directly incorporating (or deleting) one or more genes into its DNA to create a specific, desired characteristic. This is a very precise form of biotechnology and allows scientists to introduce or alter specific characteristics of an organism.

Applications

It is generally accepted that the responsible use of biotechnology offers Australia an opportunity to greatly enhance its international competitiveness and its standard of living through the development of new products made using gene technology and biotechnology. There is a broad range of applications in areas such as:

• Research;
• Agriculture;
• Medicine;
• Food Processing;
• Manufacturing; and
• Environmental Management.

Issues

Whilst biotechnology and gene technology are powerful enabling tools, their use also raises many issues which need to be addressed. For example there may be health risks, such as possible allergic reactions, associated with genetically modified food which do not occur in the same food that has not been modified. There are also broader, non-scientific issues including social, ethical and moral concerns relating to humans “playing God” by manipulating the natural genetic structure of organisms.

Regulation

To ensure Australian public health and safety and our unique environment is adequately protected from possible negative impacts in the development and use of gene technology, the Commonwealth, State and Territory Governments have developed a national Gene Technology Regulatory Framework.

Federal Framework

Background

Gene technology regulation in Australia is currently overseen by a number of different regulatory bodies, depending on the intended use of the relevant Genetically Modified Organism (GMO) or Genetically Modified (GM) product. Regulators include:

• Australian and New Zealand Food Authority (ANZFA) – regulating food standards and labelling;
• Therapeutic Goods Administration (TGA) - regulating therapeutic goods and human gene therapy;
• National Registration Authority (NRA) – regulating agricultural and veterinary chemicals;
• National Industrial Chemicals Notification and Assessment Scheme (NICNAS) – regulating industrial chemicals;
• Australian Quarantine and Inspection Service (AQIS) – regulating import and exports of GM products or GMOs; and
• National Health and Medical Research Council (NHMRC) – overseeing research involving human gene therapy.

The Genetic Manipulation Advisory Committee (GMAC) was established in 1987 to provide advice to these agencies on the environmental and safety implications of GMOs. However, as a non-statutory body with no direct legal power to enforce its decisions, and with the rapid advancement in biotechnology resulting in an emergence of GMOs that do not fall within the legislative mandate of existing regulators, it became necessary to provide additional safeguards to protect the Australian public.

The New Framework

Following two years of negotiation between the Commonwealth, State and Territory Governments, the Gene Technology Commonwealth Bill 2000 was passed by Federal Parliament in December 2000. The Commonwealth Gene Technology Act 2000 establishes a national scheme to regulate gene technology and provides a framework to achieve coordination across all levels of Government. The aim of the Act is to “protect the environment and the health and safety of Australians by identifying and managing risks posed by or as a result of gene technology”.

Key Elements

The new framework will regulate gene technology through the formalisation of:

• A risk assessment process where possible hazards are identified and the likelihood of their occurrence assessed;
• A licensing scheme for industry and institutions using biotechnology to develop products or in their research;
• The establishment of a Canberra based Office of Gene Technology Regulator (GTR) to carry out those functions;
• The creation of a Ministerial Council for Gene Technology to develop policy principles to guide the decisions of the GTR; and
• The establishment of three independent national advisory committees with expertise in the science of gene technology, ethical matters and community concerns related to the use of gene technology.

Principles

The two key principles underpinning the scheme are:

• transparency in the regulatory process; and
• community involvement in policy development.

The Process

All industry and institutions will need to apply to the GTR for a license to deal with GMOs unless:

• The dealing falls within an exempt category within the regulations;
• The dealing falls within a category in the legislation which is considered very low risk;
• The dealing has been licensed for a certain period of time and the GTR is satisfied the dealings with the GMO are sufficiently safe.

Complementary Regulation

The new national gene regulatory scheme will operate alongside existing regulatory systems for the regulation of food, therapeutic goods, agricultural and veterinary chemicals and industrial chemicals. Existing regulators will still regulate products and/or activities covered by existing legislation. However, these regulators will be required to work closely with the GTR and take into account the advice of the GTR when considering applications for products and/or activities dealing in GMOs.

Timeframe

The GTR will be fully operational on 21 June 2001. In the meantime, an Interim Office of the Gene Technology Regulator has been established within the Commonwealth Department of Health and Aged Care to manage the existing approach. The Interim Office is currently working closely with GMAC, to ensure the health and safety of the Australian community and environment, until the GTR becomes fully operational.

Figure 1 National

Victorian Framework

Inter-Governmental Agreement

As part of its commitment to the Commonwealth Government’s regulatory framework, the Victorian Government will be a signatory to an Inter-Governmental Agreement on the use of biotechnology in Australia. This agreement will include the planned enactment of complementary State legislation in the Spring 2001 session of Parliament. The State legislation will mirror the federal legislation to ensure the Commonwealth’s coverage in regulating dealings with gene technology is comprehensive.

Coordination

A Biotechnology Safety and Ethics Unit (BSEU) has been established within the Department of Human Services to coordinate the Victorian Government’s participation in the national scheme regulating gene technology. The BSEU will be responsible for informing the Victorian community about the national scheme, and responding to public concerns about issues surrounding safety and ethics in gene technology and biotechnology.

Advisory Committees

The Inter Departmental Committee (IDC) for Biotechnology Safety and Ethics is chaired by the Director of Public Health and has representatives from the Department of the Human Services (DHS), Department of Natural Resources and Environment (DNRE), Department of Justice (DOJ), Department of Premier and Cabinet (DPC), Department of State and Regional Development (DSRD), and the Environment Protection Authority (EPA). It will provide advice to the Victorian Government on the implementation of the regulatory framework, related safety and ethical issues, codes of practice, and the communication of Government policy. The IDC will not be involved in issues other than safety and ethics or policies relating to industry development.

The Victorian Government will also seek independent advice on ethical issues associated with biotechnology in Victoria as needed. A Victorian Code of Ethical Practice in Gene Technology will be developed.

Minister For Health

The State Minister for Health will be Victoria’s representative on the Commonwealth Government’s Ministerial Council for Gene Technology. The Minister for Health will receive advice from both the IDC and the proposed Victorian Biotechnology Ethics Advisory Committee.

Figure 2 Victoria

Regulatory & Advisory Bodies

Commonwealth Statutory Bodies Under The Gene Technology Act

Office of the Gene Technology Regulator (GTR)

The Office of the Gene Technology Regulator (GTR) is a Commonwealth statutory body which, under the Commonwealth Gene Technology Act 2000, will administer the new gene technology regulatory system, and monitor and enforce the legislation. Its roles include developing and publishing standards, procedural guidelines and codes of practice in relation to genetically modified organisms; and providing balanced information to the public, other regulatory agencies and the States and Territories about the regulation of genetically modified organisms. The GTR acts on the advice of the Ministerial Council and the three Commonwealth Committees established by the legislation.

Genetic Manipulation and Advisory Committee (GMAC)

The Genetic Manipulation and Advisory Committee (GMAC) is a scientific advisory body responsible for overseeing the development and use of genetic manipulation techniques in Australia and providing advice to the various regulatory bodies on the safety and environmental implications of GMOs. It will be replaced by the Gene Technology Technical Advisory Committee when the national scheme begins operation.

Ministerial Council for Gene Technology

The Ministerial Council for Gene Technology is comprised of Commonwealth, State and Territory Ministers and is responsible for overseeing the operation of the GTR. The Ministerial Council will advise the GTR on policy and codes of practice to underpin the regulatory system. It will also coordinate with other ministerial councils in relation to gene technology, advise on the appointment of the GTR, and advise on the appointment of members to the Gene Technology Technical Advisory Committee.

Gene Technology Technical Advisory Committee (GTTAC)

The Gene Technology Technical Advisory Committee (GTTAC) provides scientific and technical advice to the GTR and the Ministerial Council on matters of gene technology, GMOs and GM products. It also advises on applications made under the legislation and the need for guidelines in relation to GMOs and GM products. The GTTAC will be comprised of members appointed by the Commonwealth Health Minister. The appointees will have a broad range of skills and experience in areas such as molecular biology, ecology, genetics, virology, entomology, agricultural or aquacultural systems, biosafety engineering, public health, occupational health and safety, risk assessment, clinical medicine, biochemistry, pharmacology, pathology, botany, microbiology, animal biology, immunology and toxicology. The membership will include one member of the GTCCC, one member of the GTEC and one layperson.

Gene Technology Community Consultative Committee (GTCCC)

The Gene Technology Community Consultative Committee (GTCCC) is a consultative committee established to advise the Ministerial Council and the GTR on community concerns relating to gene technology, and on the development of policy documents and codes of practice to guide the GTR. The GTCCC will be comprised of community representatives, appointed by the Commonwealth Minister for Health, who have no technical expertise, but can speak on issues such as ethics, religious issues, conservation issues, cultural issues, indigenous issues, consumer issues and regional development issues. The appointments will include one member of the GTEC and one member of the GTTAC.

Gene Technology Ethics Committee (GTEC)

The Gene Technology Ethics Committee (GTEC) will provide advice to the GTR and the Ministerial Council on the ethics of gene technology and develop ethics guidelines and prohibitive directives in relation to GMOs and GM products where there are ethical concerns. The GTEC will be comprised of members, appointed by the Commonwealth Minister for Health, who have skills or experience in ethics and the environment, health ethics, applied ethics, law, religious practices, population health, agricultural practices, animal health and welfare, or issues relating to gene technology. The appointments will include one member of the GTCCC and one member of the GTTAC.

Industry Regulators

Therapeutic Goods Administration (TGA)

TGA is administered under the Commonwealth Department of Health and Aged Care, and is responsible ensuring therapeutic goods available in Australia (including GM goods) are of an acceptable standard, under the Therapeutic Goods Act 1989. TGA is responsible for regulating human gene therapy, including clinical research and marketing of products for human gene therapy.

Australian and New Zealand Food Authority (ANZFA)

ANZFA is a partnership between the Commonwealth, State, Territory and New Zealand Governments. It is responsible for developing, varying and reviewing standards for food (including GM food products) available in Australia and New Zealand, under the Australia New Zealand Food Authority Act 1991.

National Industrial Chemicals Notification and Assessment Scheme (NICNAS)

NICNAS is Commonwealth Government agency which regulates industrial chemicals for health and environmental effects, under the Industrial Chemicals (Notification and Assessment) Act 1989.

Australian Quarantine and Inspection Service (AQIS)

AQIS regulates the import and export of GM products and GMOs under the Quarantine Act 1908, the Imported Food Control Act 1992 and the Export Control Act 1982.

National Registration Authority for Agricultural and Veterinary Chemicals (NRA)

NRA is responsible for registering all agricultural and veterinary chemicals (including GM chemicals), under the Agricultural and Veterinary Chemicals (Code) Act 1994. It ensures all chemicals on the market are safe and effective and do not have adverse effects on the environment when used as directed.

Victorian Bodies

Biotechnology Safety and Ethics Unit (BSEU)

The Biotechnology Safety and Ethics Unit (BSEU) has been established within the Public Health Division of the Department of Human Services to coordinate the Victorian Government’s participation in the national scheme regulating gene technology. It will also be responsible for informing the Victorian community about the national scheme, and responding to public concerns about issues surrounding the safety and ethics of gene technology and biotechnology.

Interdepartmental Committee on Biotechnology Safety and Ethics (IDC)

The Inter-Departmental Committee (IDC) is chaired by the Director of Public Health, and comprises representatives from the Department of Human Services (DHS), Department of Natural Resources and Environment (DNRE), Department of Justice (DOJ), Department of Premier and Cabinet (DPC), Department of State and Regional Development (DSRD), and the Environment Protection Authority (EPA). It provides advice to Victorian Government on the implementation of the regulatory framework, related safety and ethical issues, and also provides advice to Victorian Government on the communication of policy to the Victorian community.

Victorian Biotechnology Ethics Advisory Committee

The proposed Victorian Biotechnology Ethics Advisory Committee will provide strategic and independent advice to the Victorian Government on ethical matters relating to the use of gene technology and other non-traditional biotechnologies as they relate to Victoria. This committee will also assist with the development of the State codes of practice when working with GMOs.

Frequently Asked Questions

Who currently regulates biotechnology in Australia?

Biotechnology in Australia is currently regulated by a number of different regulatory bodies depending on the intended use of the Genetically Modified Organism (GMO) or Genetically Modified (GM) product. These regulators include:

• Australian and New Zealand Food Authority (ANZFA) – regulating food standards and labelling;
• Therapeutic Goods Administration (TGA) - regulating therapeutic goods and human gene therapy;
• National Registration Authority (NRA) – regulating agricultural and veterinary chemicals;
• National Industrial Chemicals Notification and Assessment Scheme (NICNAS) – regulating industrial chemicals;
• Australian Quarantine and Inspection Service (AQIS) – regulating import and exports of GM products and GMOs; and
• National Health and Medical Research Council (NHMRC) – overseeing research involving human gene therapy.

The Genetic Manipulation Advisory Committee (GMAC) also provides advice to these agencies on the safety and environmental implications of GMOs.

Why has legislation been introduced to provide for another regulatory body?

The rapid advancement in biotechnology has resulted in the emergence of GMOs that do no fall within the legislative power of existing regulators. The Commonwealth Gene Technology Act 2000 was introduced to protect the environment and the health and safety of Australians, and to increase transparency in industry’s dealings with biotechnology. The Act provides an overall scheme to identify and manage risks posed by, or as a result of, gene technology, and to regulate any areas not currently regulated by an existing regulatory body.

What does the new legislation do?

The Commonwealth Gene Technology Act 2000 establishes a national scheme to regulate gene technology and provides a framework to achieve coordination across Government. Specifically, it will regulate gene technology through the formalisation of:

• A risk assessment process where possible hazards are identified and the likelihood of the occurrence assessed;
• A licensing scheme for industry and institutions using biotechnology to develop products or in their research;
• The establishment of a Canberra based Office of Gene Technology Regulator to carry out those functions;
• The creation of a Ministerial Council for Gene Technology to develop policy principles to support the decisions of the Gene Technology Regulator; and
• The establishment of three independent national advisory committees with expertise in the science of gene technology, ethical matters and community concerns related to the use of gene technology.

Who will administer the legislative scheme?

The legislative scheme will be administered by the Office of the Gene Technology Regulator (GTR), an independent statutory office that will monitor and enforce the legislation. The GTR will receive license applications from industry and institutions for the use of gene technology, and assess the proposed use for risk.

Who will oversee the Gene Technology Regulator?

The Ministerial Council for Gene Technology comprising of Ministers from the Commonwealth and each State and Territory, will oversee the regulatory framework and will provide advice to the GTR on policy principles to assist it in its decision making.

Who will advise the GTR and the Ministerial Council?

It is proposed that three statutory advisory committees will also be created to provide advice to both the GTR and the Ministerial Council. The proposed advisory committees include:

• A Gene Technology Technical Advisory Committee which will advise the Ministerial Council and the GTR on risk assessments for individual applications;
• A Gene Technology Ethics Committee which will advise the Ministerial Council and the GTR on ethical matters arising in the regulatory framework; and
• A Gene Technology Community Consultative Committee which will advise the Ministerial Council and the GTR on general concerns.

How will the new legislation affect the roles of the current regulatory bodies?

The new legislation will operate alongside existing regulatory systems for the regulation of food, therapeutic goods, agricultural and veterinary chemicals and industrial chemicals. Existing regulators will still regulate products and/or activities covered by existing legislation. However, existing regulators will be required to work closely with the Office of Gene Technology Regulator (GTR) to harmonise risk assessment on GMOs and GM products. This working arrangement will include the sharing of databases and the requirement for existing regulators to take into account the advice of the GTR when considering applications for GMOs and GM products.

How does Victoria fit into the national framework?

The Victorian Government has agreed to enact complementary State legislation to mirror the Commonwealth legislation as part of an Inter-Governmental Agreement (IGA).

Who represents Victoria in the national scheme?

The Victorian Minister for Health will represent Victoria on the Ministerial Council for Gene Technology.

Who will coordinate Victoria’s role in the national scheme?

A Biotechnology Safety and Ethics Unit (BSEU) has been established within the Public Health Division of the Victorian Department of Human Services to provide a central coordination role for the Victorian Government’s participation in the national scheme in relation to biotechnology safety and ethics. The BSEU will be responsible for informing the Victorian community about the national scheme, and responding to public concerns about issues surrounding gene technology and biotechnology.

Is Victoria establishing its own regulatory framework on biotechnology?

The Victorian Government is establishing a State regulatory framework for biotechnology. The State framework will include a high level Inter Departmental Committee and independent advisory committee, both of which will report directly to the Victorian Minister for Health, who is also Victoria’s representative on the Ministerial Committee for Gene Technology.

Who is represented on the Inter-Departmental Committee and what is its role in the State framework?

The Inter Departmental Committee (IDC) is chaired by the Director of Public Health, and has representatives from the Department of Human Services (DHS), Department of Natural Resources and Environment (DNRE), Department of Justice (DOJ), Department of Premier and Cabinet (DPC), the Department of State and Regional Development (DSRD), and the Environment Protection Authority (EPA). The IDC will provide advice to the Victorian Government on the implementation of the regulatory framework, related safety and ethical issues, codes of practice, and the communication of Government policy.

Will independent advice be provided?

It is proposed that a Victorian Biotechnology Ethics Advisory Committee be established to provide strategic and independent advice to Government on ethical matters related to the use of gene technology and other biotechnologies as they relate to Victoria. This committee will also assist with the development of the State codes of practice when working with GMOs.

How does the Victorian community raise concerns and issues about biotechnology?

A community consultation process will be developed to identify the process where the Victorian community can raise concerns, and receive information on biotechnology safety and ethics.

Who do I contact to receive further information?

For further information about Gene Technology and Biotechnology, contact the Commonwealth Government’s Gene Technology Information Service on 1800 631 276.

For further information about Victoria’s role in the national scheme, contact the Biotechnology Safety and Ethics Unit within the Department of Human Services on (03) 9637 4998.