Bills Digest No. 11  2000-01 Gene Technology Bill 2000


Numerical Index | Alphabetical Index

WARNING:
This Digest was prepared for debate. It reflects the legislation as introduced and does not canvass subsequent amendments. This Digest does not have any official legal status. Other sources should be consulted to determine the subsequent official status of the Bill.

CONTENTS

Glossary of Terms
Passage History
Purpose
Background
Main Provisions
Concluding Comments
Appendix: Regulation of Gene Technology in Other Countries
Endnotes
Contact Officer & Copyright Details

Glossary of Terms

ANZFA

Australia New Zealand Food Authority

Biosafety Protocol

Cartagena Protocol on Biosafety

DNA

deoxyribonucleic acid

GM product

genetically modified product

GMAC

Genetic Manipulation Advisory Committee

GMO

genetically modified organism

GTA

Gene Technology Agreement

GTCCG

Gene Technology Community Consultative Group

GTEC

Gene Technology Ethics Committee

GTTAC

Gene Technology Technical Advisory Committee

IBC

Institutional Biosafety Committee

IOGTR

Interim Office of the Gene Technology Regulator

NICNAS

National Industrial Chemicals Notification and Assessment Scheme

NRA

National Registration Authority

Regulator

Gene Technology Regulator

SPSA

WTO Agreement on Sanitary and Phytosanitary Measures

State

the States, the ACT and Northern Territory

TGA

Therapeutic Goods Administration

WTO

World Trade Organisation

Passage History

Gene Technology Bill 2000

Date Introduced: 22 June 2000

House: House of Representatives

Portfolio: Health and Aged Care

Commencement: On a day fixed by Proclamation, or at the latest 6 months after Royal Assent

Purpose

The purpose of the Bill is to establish the federal component of what is hoped to be a nationally consistent scheme for regulating certain dealings with genetically modified organisms.

Background

What is Gene Technology?(1)

Gene technology(2) refers to a number of ingenious methods whereby genetic material (DNA) in the cells of target organisms is altered in very specific ways. Gene technology works essentially because there is remarkable similarity between the central biochemical systems of plants, animals, bacteria and fungi. In particular, the decoding of molecular sequences in DNA to create thousands of proteins in a cell is virtually the same mechanism in all living organisms. A meaningful sequence in DNA (that is, a gene) leads to production of a specific protein. A gene is therefore able to determine the structure of a protein and features start, stop and control switches for that protein, all in genetic code. Proteins may have an architectural function in an organism but most types are catalysts enabling the chemical processing of all the sugars, fats, hormones, vitamins, etc., which the organism needs.

Gene technology is extremely precise in that a single foreign gene can be introduced to target host cells which then decode the new gene along with all the natural genes in their DNA. Genetic material can be introduced to host cells by infecting them with genetically engineered viruses and bacteria, or simply by shooting in tiny gold pellets coated with the desired gene or genes. This level of precision means that scientists are no longer restricted to genetic shuffling which results from cross-breeding between varieties of the same or closely related species. Such traditional methods are used to introduce new traits but the choice of genes is obviously small. Inheritance of undesirable genes is also a problem in traditional methods. By comparison, through gene technology, scientists can now choose from the entire gene pool - including taking specific genes from unrelated species - in order to add, subtract or alter genetic material in the target organism. Note that, at present, it is difficult to introduce more than a very few complete genes in the one operation.

By altering the gene content of an organism, the production of specific proteins can also be added, subtracted, strengthened or weakened through the genetic coding mechanism. New proteins may be designed to serve an important purpose such as pharmaceutical production, herbicide resistance, flavour improvement or growth stimulation. Alternatively, there may be natural proteins in the target organism which are desired to be weakened or removed - unwanted flavours, fertility in pests or rotting promoters, for example. Switches can also be added so that production of a specific protein is made to depend on a chemical signal (for example, sprayed on a crop).

A distinction is often made between whole organisms or cells which are altered genetically and the purified products from those organisms. The difference is that the whole organism or its cells contain all the genetic alterations and all the new protein differences. However, a purified product cannot reproduce in the environment and is often not altered itself. An example is cottonseed oil from 'Bt cotton'.

Putting aside economic issues, there are perhaps three main issues of popular concern surrounding gene technology. These are:

  • broad ethical and religious concerns regarding the manipulation of DNA;(3)
  • concerns over the safety of genetically manipulated foods; and (4)
  • fears that damaging 'rogue' genes could escape from commercial crops or animal herds into the natural environment.(5)

By contrast, the production of pharmaceuticals such as human growth hormone using genetically engineered bacteria has been much more readily accepted.

How is Gene Technology currently regulated in Australia?

Legal responsibility for gene technology regulation in Australia is vested in different regulatory bodies depending on the intended end use of the relevant genetically modified organism (GMO) or genetically modified (GM) product.(6)

  • Foods (including GM foods) are regulated under State and Territory Food Acts, with the role of developing Food Standards resting with the Australia New Zealand Food Authority (ANZFA) under the Australia New Zealand Food Authority Act 1991 (Cth).
  • Therapeutic goods (including GM therapeutic goods) are regulated under the Therapeutic Goods Act 1989 (Cth), administered by the Therapeutic Goods Administration (TGA) within the Commonwealth Department of Health and Aged Care.
  • Human gene therapy (both clinical research and marketing of products for human gene therapy) is also regulated by the TGA. The National Health and Medical Research Council (NHMRC) also supervises research involving human gene therapy through its Gene and Related Therapies Research Advisory Panel.
  • Agricultural and veterinary (agvet) chemicals (including GM agvet chemicals) are regulated through a national scheme administered by the National Registration Authority (NRA). Regulation centres around the Agricultural and Veterinary Chemicals (Code) Act 1994 (Cth) and related legislation in all jurisdictions which controls the post-sale use of agvet chemicals.
  • Industrial chemicals are regulated through the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) under the Industrial Chemicals (Notification and Assessment) Act 1989 (Cth) and accompanying State/Territory legislation.
  • Imports and exports of GM products or GMOs are regulated under the Quarantine Act 1908 (Cth), the Imported Food Control Act 1992 (Cth) and the Export Control Act 1982 (Cth) administered by the Australian Quarantine and Inspection Service (AQIS).(7) The Australian Customs Service (ACS), under the Customs Act 1901 (Cth), has a general border control role which it undertakes with the assistance of AQIS. Other regulatory agencies also rely on the ACS to provide primary control of imports and exports.

The Genetic Manipulation Advisory Committee (GMAC)(8) provides advice to these agencies on the biosafety and environmental implications of GMOs. GMAC is a non-statutory body and has no direct legal power to enforce its decisions. Its role extends to any experiment that involves the construction or propagation of a novel substance produced by genetic manipulation, which is either:

  • unlikely to occur in nature; or
  • likely to pose a hazard to public health or to the environment.

GMAC thus oversees laboratory based research and the release of GMOs into the open environment, such as field trials and the commercial growing of GMO crops.

As of February 2000, GMAC had assessed:(9)

  • 5164 proposals for small scale contained work (mainly laboratory based work by universities and other research bodies)
  • 40 proposals for large scale contained work. The great majority of these proposals were submitted by commercial organisations.
  • 236 proposals for field trials of GMOs, mainly for genetically modified plants such as cotton or canola. Most field trials were run either by commercial organisations or the CSIRO, with a smaller number by universities or State government agencies.
  • 8 applications for general (commercial) release of GMOs. Three of these have been approved to date: Bt cotton (which was subsequently regulated by the NRA); a violet carnation; and a carnation with improved vase life. In addition, the NRA has approved, with the advice of GMAC, the release of a genetically modified plant pesticide (in 1989) and a salmonella vaccine (in 1992).

Nearly 30 per cent of the Australian cotton crop is genetically modified,(10) and it is predicted that this percentage may rise to 80 per cent by 2005.(11) Major biotechnology company Aventis also estimates there may be a million hectares of its GM canola under cultivation by 2005, which would constitute almost the entire Australian canola crop.(12)

Other than the issue of food labelling, criticism of the current regulatory system has mainly focussed on the perceived lack of transparency in GMAC's decision-making process and its apparent incapacity to ensure that conditions placed on field trials were strictly complied with. In recent times, it appears there have been four incidents requiring investigation, including the dumping of GM canola plants at an open commercial tip in Mt Gambier in March 2000,(13) and the inadvertent mixing of 69 tonnes of GM cotton seed with conventional seed in Queensland in July 2000.(14)

The current regulatory regimes for therapeutic goods, agricultural, veterinary and industrial chemicals and food containing GMOs or GM products will continue if the Bill is passed. The purpose of the Bill is to regulate dealings with GMOs, not GM products unless they are not regulated under the existing regimes. However, the informal role of GMAC in providing advice will be formalised, by conferring it on the Gene Technology Regulator (the Regulator) through legislation. The details of the Regulator's advisory role in relation to GM products is set out in the Bills Digest for the Gene Technology (Consequential Amendments) Bill 2000.

Regulation of international trade in GMOs

There are no international instruments which set down comprehensive standards for the regulation of GMOs or GM products. However, the international movement and commercial trade of GMOs are regulated by broad policy principles established by the World Trade Organisation (WTO). In addition, the Cartagena Protocol on Biosafety (the Biosafety Protocol)(15), once it comes into force,(16) will introduce more detailed rules for the assessment of the environmental and human health impacts of importing GMOs. The Bill regulates the importation of GMOs, among other things. It is therefore important that any requirements the Bill imposes upon prospective importers into Australia are consistent with the regime established by the WTO in particular.

The Agreement on Sanitary and Phytosanitary Measures (SPSA).

The only WTO instrument directly relevant to GMOs is the Agreement on Sanitary and Phytosanitary Measures (SPSA).(17) It aims in part to ensure that quarantine and related food safety and animal and plant health import rules ('sanitary or phytosanitary measures') are not unnecessarily restrictive or discriminatory in relation to international trade. Any restrictions on importation must be 'based on scientific principles' and 'applied only to the extent necessary to protect human, animal or plant life or health'.(18) In general, the SPSA provides that countries should base their protection levels on international standards, such as the Codex Alimentarius which sets standards for food safety. However, in certain situations, members may also maintain measures which result in a higher level of protection if these can be justified on grounds such as the potential economic damage that a disease or pest may cause, the costs of control, or the relative cost-effectiveness of alternative approaches to limiting risks.(19)

The SPSA also allows for a quasi-precautionary principle approach. Where scientific evidence is insufficient to fully assess the risks, countries may adopt provisional measures on the basis of available pertinent information. However, countries are then obliged to seek to obtain the additional information necessary for a more objective assessment of risk, and then review the sanitary or phytosanitary measure within a reasonable period of time.(20)

In summary, the SPSA requires a country's decision whether or not to allow the importation of a good to be based on a transparent risk assessment process. Where the outcome of the assessment provides grounds for restricting importation, any measures taken must be designed so that they do not go beyond what is necessary to reduce or eliminate the risk in question.(21) As will be seen in the Main Provisions section of this Digest, the risk assessment and decision-making process would appear to be more transparent than the current regulatory system. Given that the Regulator is not required to consider Australia's obligations under the SPSA to adopt the least trade-restrictive method of risk management in deciding what conditions to place on the importation of a GMO, it will be interesting to see if there are any complaints about the Regulator imposing conditions which are excessively restrictive of trade.(22)

Biosafety Protocol

The Biosafety Protocol is intended to protect the environment against the potential adverse environmental impacts of international trading in GMOs.(23) The focus of the Biosafety Protocol is on the impacts on biodiversity, although it also refers to risks to human health. Some GM products, such as processed foods and pharmaceuticals for human use, are generally excluded from the operation of the Biosafety Protocol.

The central aspect of the Biosafety Protocol is a 'prior notification and consent' regime for trade in GMOs. Subject to certain exceptions, intending exporters will be required to notify the importing country of the proposed GMO shipment if the GMO in question has not previously been intentionally introduced into the importing country's environment (the so-called advance informed agreement procedure). This requirement is designed to allow the importing country time to assess the environmental and human health risks of allowing the GMO into the country and thus allows them to make a fully informed decision on whether to permit the import.

Some GMOs are subject to a lesser regulatory scheme. A relatively limited notification procedure applies if the GMO is imported for direct use as 'food, feed or for processing'. This apparently represents the majority of current GMO trade. Rather than the exporter having to notify the importing country of a specific shipment, the exporting country must have notified the International Biosafety Clearing-House that it has approved the GMO for domestic release within its own environment if the GMO in question is one that might be exported.

The Biosafety Protocol also allows for a quasi-precautionary principle approach. For example it states that:(24)

A lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a [GMO]...shall not prevent that Party from taking a decision, as appropriate...in order to avoid or minimize such potential adverse effects.

The comments made above relating to the consistency of the Bill with WTO rules also apply to the Biosafety Protocol. In any case, the issue is moot until the Commonwealth makes a decision whether to sign and ratify the Protocol.

Development of the Bill

Formal Commonwealth oversight of gene technology dates back to 1981 when the Recombinant DNA Monitoring Committee was created. This Committee was replaced by GMAC later in the 1980s. In 1992, a report by the House of Representatives Standing Committee on Industry, Science and Technology(25) recommended that the Commonwealth should pass legislation to regulate GMOs, in particular to regulate the release of GMOs outside contained facilities. The Government accepted the thrust of the report and commented that it would:(26)

propose to the States and Territories that legislation be introduced under which the Commonwealth would establish an independent Genetic Manipulation Authority (GMA) to regulate the release of GMOs, including restricted releases such as field trials. The GMAC will be replaced by a new Genetic Manipulation Research Committee, GMRC. The GMRC will have legislatively defined powers to approve contained research and development of GMOs, taking into account wider issues, such as ethical issues proposed by the GMA. The GMRC will also provide specialist scientific advice to the authority in respect of release proposals.

During 1992-95, there were ongoing Commonwealth-State discussions regarding legislative options to implement this. However, there was apparently disagreement over the legislation model, leading to a cessation of negotiations by 1995.

The proposal for a legislatively-based regulatory system for gene technology was revived in October 1997 by the Commonwealth in a joint statement by Ministers Moore, Anderson and Hill.(27) The system envisaged involved:

  • the amendment of current legislation and introduction of new legislation to ensure that gene technology is covered by uniform laws and that compliance is compulsory
  • the establishment of a Gene Technology Office to administer a national regulation system which will ensure that comprehensive analysis and risk assessment are undertaken before GMOs are released. The Gene Technology Office would coordinate the release of GMOs by existing bodies, make decisions on release of GMOs not covered by existing bodies, and regulate gene technology research
  • the commencement of consultations with the public and the State and Territory Governments, and
  • the establishment of an interim Gene Technology Liaison Committee to provide advice on urgent issues which are not able to be addressed under current regulatory systems.

A Commonwealth-State Consultative Group on Gene Technology was formed shortly thereafter. This Group prepared a paper, Regulation of Gene Technology, which was circulated for 'limited public consultation'.(28) The paper included a set of policy principles that were intended to guide the development of the Bill and the administrative mechanisms. In October 1999, a follow-up paper, Proposed National Regulatory System for GMOs: How should it work?, was prepared by the newly created (Commonwealth) Interim Office of the Gene Technology Regulator (IOGTR) in collaboration with State and Territory officials for wider public consultation.(29) Some 200 written submissions were received in response to the paper.(30)

In December 1999, an exposure draft of the Bill was published and distributed. Public fora were held in all capital cities and some regional centres during March 2000. Further details on the main issues debated at these fora are contained in the Explanatory Memorandum to the Bill.(31)

It is understood that the Bill, and its accompanying regulations, was originally due to be introduced into Parliament in April 2000. The Bill was eventually introduced into the House of Representatives on 22 June 2000, and on 28 June was referred to the Senate Community Affairs Reference Committee for report by 5 September 2000.(32) An attempt by the Democrats and Senator Brown to have to time for reporting extended to 5 October was defeated.

Main Provisions

The object of the Bill is stated to be (proposed section 3):

to protect the health and safety of people, and to protect 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.

This object is to be achieved through a regulatory framework which 'provides an efficient and effective system for the application of gene technologies' (proposed section 4).

Because health and environmental concerns are the focus, the Bill does not deal with issues such as trade, or intellectual property rights in biotechnology. However, the Bill does not deal with all health and environmental concerns. Specifically, food labelling remains the responsibility of the Australia New Zealand Food Standards Council on advice from ANZFA, and genetic manipulation of humans (for example, human gene therapy or human cloning) is not covered by the Bill.

Scope and definitions

'GMO' is broadly defined to include any organism(33) that has been genetically modified, and the offspring of a GMO (proposed subsection 10(1)). A person who has had somatic cell gene therapy is not a GMO. Regulations may declare certain organisms to be GMOs, and others not to be GMOs.

The Bill will regulate certain dealings with GMOs, mainly through a licensing system. The definition of 'dealings' in proposed subsection 10(1) is extremely broad, and covers the entire life cycle of GMOs, from laboratory experiments, growth, development, production or manufacture of GMOs, use of GMOs to manufacture GM products, possession, transport and disposal of trash. The Bill also applies to importing of GMOs.

Although the scope of the Bill appears comprehensive, the Bill only applies to those dealings if they are engaged in by persons or bodies who fall within the Commonwealth's legislative power, namely trading, foreign or financial corporations(34) and the Commonwealth and Commonwealth authorities. The Bill also applies to all dealings by any person or body (proposed section 13):

  • in the course of interstate or international trade or commerce (for example, growing a crop of GM canola for sale interstate or in other countries),
  • that may cause the spread of diseases or pests (this would cover most field trials and commercial releases of GMOs, and may cover some foods and medicines), or
  • involving the supply of services to the Commonwealth or a Commonwealth authority.

The existing Commonwealth schemes regulating GM products (food, agricultural and veterinary chemicals, industrial chemicals and therapeutic goods) referred to in the Background of this Digest, will continue to operate in conjunction with the Bill (proposed sections 4(b) and 15). The Gene Technology (Consequential Amendments) Bill 2000 sets out the relationship between these existing schemes and the proposed gene technology scheme.(35) For more information, the reader is referred to the Bills Digest no 10, 2000-01 on the Gene Technology (Consequential Amendments) Bill 2000.

The Bill applies throughout the Commonwealth and in every external territory other than Norfolk Island (proposed section 7).(36) Although the Bill binds the Commonwealth, States and Territories, these entities cannot be prosecuted for an offence against the Bill (proposed section 6).

Operation as a national scheme

In the following discussion of the Bill, 'State' includes the Australian Capital Territory and the Northern Territory (see the definition of 'State' in proposed subsection 10(1)).

It is intended that the Commonwealth and the States will sign a Gene Technology Agreement (the GTA), and that all States will enact complementary legislation once the Bill has been passed by the Commonwealth Parliament.(37) Thus, any dealings which the Commonwealth is unable to regulate are intended to be covered by identical State legislation.

Additionally, State laws which are declared by the Commonwealth Minister for Health to be "corresponding State laws" may have an extended operation in areas which would otherwise be covered by the Bill. If a State with a corresponding law gives a "wind-back notice" to the Commonwealth Minister, activities by State agencies and universities, as well as all acts or omissions that may cause the spread of disease or pests, would be regulated by State legislation rather than by the Bill (proposed section 14). The Regulator and all three advisory committees may exercise functions, powers or duties conferred on them under corresponding State laws (proposed section 17).

The Commonwealth also has power to preclude a State law from regulating dealings with GMOs if the State law is inconsistent with the national scheme worked out in the GTA (proposed subsection 16(2)). The operation of the national scheme, the interrelationship between Commonwealth and State laws, and the constitutionality of the Regulator and the committees exercising functions conferred on them under State laws are issues discussed further in the Concluding Comments section of this Digest.

Governance structure for gene technology regulation

The Bill establishes the Regulator, who is responsible for making the majority of decisions relating to gene technology and GMOs. The scheme establishes a separation of policy-level decision-making from the process of making decisions on particular licence and other applications. The Regulator is responsible for the decisions on particular applications, is subject to guidance at a general level from the Ministerial Council, and is ultimately responsible to Parliament. The Regulator is assisted in his or her duties by three advisory committees also established by the Bill.

Gene Technology Regulator

The Regulator is an independent statutory office holder (proposed section 26) and is not subject to direction from anyone in relation to the performance of his or her functions, in particular whether or not to grant a GMO licence with or without conditions (proposed section 30).

The Regulator is appointed by the Governor-General with the approval of the majority of jurisdictions (proposed section 118). It seems that even if a State or Territory does not sign the GTA and does not participate in the national scheme, it will still be able to participate in the decision to appoint the Regulator. He or she will hold office for a fixed term of three to five years (proposed subsection 118(2)). It is not explicitly stated that the Regulator's appointment may be extended for a further fixed term, but in the absence of any indication to the contrary, it may be presumed that the Regulator's appointment may be extended.

The Regulator must disclose to the Minister all interests, pecuniary or otherwise, that could conflict with the performance of his or her functions (proposed section 120).

The functions of the Regulator are broad. They include (proposed section 27):

  • determining applications for GMO licences,
  • developing draft policy principles and policy guidelines to be issued by the Ministerial Council,
  • developing codes of practice, technical and procedural guidelines in relation to GMOs,
  • providing information and advice to other regulatory agencies and to the public,
  • undertaking or commissioning research in relation to risk assessment and biosafety of GMOs, and
  • promoting the harmonisation of risk assessment relating to GMOs and GM products by regulatory agencies.

The Regulator may delegate any of his or her powers or functions to an employee of the Department of Health or Aged Care, or an employee of another Commonwealth Department, authority or State agency whose functions relate to GMOs and GM products (proposed section 29). This enables the Regulator to delegate to a relevant agency such as the NRA or ANZFA.

The Regulator has discretion in the performance of his or her functions, and has the ability to obtain scientific, ethical and other advice from the three advisory committees established by the Bill. The Regulator's function is to focus on risks to the environment and to human health and safety. It is no part of his or her function to consider economic or trade issues. However, the Regulator is not entirely free, but is bound by policy principles issued by the Ministerial Council not to issue a licence if to do so would be inconsistent with a policy principle (proposed section 57). "Policy principles" are dealt with below.

The Regulator must report to the Minister annually, and give a copy of the report to each State (proposed section 136). However, the House of Representatives Standing Committee on Primary Industries and Regional Services recommended that the Regulator report at least quarterly for the first three years.(38) The Regulator also has a discretion to cause a report about matters relating to his or her functions to be tabled in either House of Parliament at any time (proposed section 137). This power is similar to that given to other fiercely independent statutory office-holders, such as the Auditor-General and the Ombudsman.(39)

Ministerial Council

The Ministerial Council will be established under the GTA (see proposed subsection 10(1)), and will consist of one or more Ministers from the Commonwealth and each participating State and Territory. The composition of the Ministerial Council (and details such as whether it includes environment Ministers or health Ministers or both) will not be known until the GTA is signed.

The role of the Ministerial Council is to oversee the operation of the Regulator, to consulting on and issue policy principles and policy guidelines to guide the Regulator, and to advise the Regulator on codes of practice and standards for persons conducting dealings with GMOs.(40)

"Policy principles" are disallowable instruments which deal with ethical issues relating to GMOs or other matters prescribed by regulations (proposed section 21), and are issued by the Ministerial Council after consultation with a number of Commonwealth, State, industry and community organisations, including the three Commonwealth advisory committees (proposed section 22). The Regulator must not to issue a GMO licence if to do so would be inconsistent with a policy principle (proposed section 57).

"Policy guidelines" are issued by the Ministerial Council, and may deal with matters relevant to the Regulator's functions. The Regulator must have regard to policy guidelines in deciding whether or not to issue a GMO licence (proposed section 56), but is not bound to follow them. Unlike policy principles, policy guidelines are not required to be made in consultation with anyone, although the Ministerial Council may choose to consult, and are not disallowable instruments (proposed section 23).

"Codes of practice", with which GMO licence-holders may be required to comply (proposed paragraph 62(2)(l)), are developed by the Regulator after extensive consultation and issued by the Ministerial Council. They will be disallowable instruments (proposed section 24) and will be of key importance in setting the standards to be complied with and outlining measures to be taken to minimise risks.

Advisory committees

Proposed Part 8 of the Bill establishes three committees:

  • the Gene Technology Technical Advisory Committee (GTTAC),
  • the Gene Technology Community Consultative Group (GTCCG), and
  • the Gene Technology Ethics Committee (GTEC).

The GTTAC will be composed of up to 20 scientific and technical experts and one layperson (proposed section 100), and will replace the current GMAC. Its function is to provide scientific and technical advice on gene technology, GMOs and GM products, including the biosafety aspects of gene technology (proposed section 101).

The GTCCG will be composed of up to 12 persons, mainly representatives of a range of sectors of the community (including the environment, public health, primary industry, local government and consumers), and one member of GTTAC and GTEC (proposed section 108). Its function is to provide advice on matters of general concern regarding GMOs (proposed section 107).

The GTEC's function is to provide advice on ethical issues relating to gene technology. It will be composed of up to 12 persons with ethical, religious or legal expertise, including one member of GTTAC and one member of the Australian Health Ethics Committee with expertise in medical research (proposed section 111). The IOGTR has commented that the GTEC:

will be modelled on the Australian Health Ethics Committee which is established under the National Health and Medical Research Council legislation in relation to human health.(41)

Only the GTTAC will be directly involved in providing advice on GMO licences and other applications (proposed section 101). The GTCCG and the GTEC will be consulted only in relation to general principles or guidelines, not in relation to specific decisions. All three committees may be consulted in relation to the need for and content of policy principles guiding the ethical decisions of the Regulator, and codes of practice applicable generally to dealings with GMOs. Only GTTAC and the GTCCG may be consulted on the need for and content of policy guidelines and technical or other specific guidelines relating to GMOs and GM products. The GTEC does not have a function to advise on policy guidelines or specific guidelines.(42)

Both GTTAC and GTEC have the ability to call on expert advisers to assist them (proposed sections 102 and 113). The advice of all three committees can only be provided if requested by the Regulator or the Ministerial Council.

All members of these three committees are appointed by the Minister after consultation with the States, the Regulator, scientific, health, environmental and industry groups, and other Ministers if the Minister considers it appropriate. All members hold part-time paid appointments. No procedures for disclosure of conflicting interests and other matters are contained in the Bill, but they may be covered by regulations (proposed paragraphs 104(1)(c), 110(1)(c) and 115(1)(c)) or determined by the committees themselves. The IOGTR expressed the view that the disclosure of conflict of interest provisions will be 'stringent',(43) but until the draft regulations are available, it is not possible to verify this.

Licensing system

Dealings with GMOs which were approved by GMAC prior to the commencement of the Bill may proceed for up to two years after the Bill commences. GMAC-approved dealings do not require a GMO licence and will not have to undergo the consultation and approval process described below, as they are deemed to have been approved and granted a GMO licence (proposed section 190).(44) There is a possibility, although the likelihood is unclear, that there may be a rush for approvals from GMAC prior to the commencement of the Bill.

Aside from GMAC-approved dealings, all dealings with GMOs are prohibited (proposed sections 32 and 33), unless they are:

  • authorised by a GMO licence,
  • notifiable low risk dealings,
  • exempt dealings, or
  • dealings included on the GMO Register.

A person wishing to conduct dealings with one or more specified GMOs must apply to the Regulator for a GMO licence, paying an application fee and providing information as required by the regulations and by the Regulator (proposed section 40). The Regulator has power to require an applicant for a GMO licence to provide further information (proposed section 42). The Regulator has a discretion to consult the applicant or another regulatory agency on any aspect of the licence application, before considering the application (proposed section 44).

A different consultation process applies to the intentional release of a GMO into the environment from that which applies to contained dealings. The different procedures are described below.

Consultation process

Intentional release to the environment

An extensive consultation process, requiring input from the States, the Environment Minister, scientific experts, local government and the community, must be undertaken prior to the Regulator issuing a licence authorising the intentional release of a GMO into the environment. "Intentional release" includes all commercial releases of a GMO, including viruses and bacteria, as well as field trials of GM crops and animals, even if such trials include measures for limiting the spread of the GMO (proposed section 11).(45)

First, the Regulator must determine whether the dealing is one which may pose a significant risk to the environment or human health and safety (proposed section 49). A number of criteria are specified which the Regulator must consider in forming an opinion about whether there may be a significant risk, including the potential for spread of the GMO, and the extent or scale of the proposed dealings (proposed subsection 49(2)). If in the Regulator's opinion there may be a significant risk, as a first step in the consultation process the Regulator must invite written submissions from the public on whether the licence should be issued. The submissions should cover the risks and means of managing those risks.

Whether or not there is a significant risk, the Regulator must prepare a risk assessment and a risk management plan to manage any risks so as to protect the health and safety of people and the environment (proposed section 50). In preparing a risk assessment and risk management plan, the Regulator is obliged to consult:

  • the States
  • the GTTAC
  • the Environment Minister, and
  • any Commonwealth authorities or agencies prescribed in the regulations.

The Regulator must also consult any local councils that he or she considers appropriate (proposed subsection 50(3)). However, it is up to the Regulator to consider which local councils it is "appropriate" to include.

The Regulator must take into account any advice given by any of these bodies, as well as any advice given by the public in written submissions under proposed section 49 (if written submissions were called for) (proposed section 51).

After preparing the risk assessment and risk management plan, the Regulator must invite written submissions from the public on those documents. The Regulator must also seek advice on the risk assessment and risk management plan from the States, the GTTAC, the Environment Minister, any Commonwealth authorities or agencies prescribed in the regulations (proposed section 52).

The Regulator also has a discretion to take other action, such as hold public hearings (proposed section 53). It is important to note that, although the Regulator is required to take into account the advice given by these persons and bodies, he or she is not required to follow the advice given by any of them. The ultimate decision remains the Regulator's, not the Environment Minister's, the States' or local government's.

Contained dealings

When the dealings to be authorised by licence do not involve intentional release of a GMO into the environment, the Regulator simply prepares a risk assessment and risk management plan. The Regulator may, but does not have to, consult the States, the GTTAC, relevant Commonwealth authorities or agencies, local councils or any other person (proposed section 47).

Licence decision

After conducting the consultation process as required, the Regulator must decide whether or not to issue a licence, with or without conditions (proposed section 55). A number of safeguards exist in the Bill. The Regulator must not issue a licence if:

  • he or she is not satisfied that the risks can be managed so as to protect the environment or the health and safety of people, having regard, among other things, to any policy guidelines issued by the Ministerial Council (proposed section 56),
  • issuing the licence would be inconsistent with a policy principle made by the Ministerial Council (proposed subsection 57(1)), or
  • he or she is not satisfied that the person applying for a licence is a suitable person (for example, having regard to any previous licence suspensions or revocations, or convictions relating to health, safety or the environment) (proposed subsection 57(2) and section 58).

Thus, the Regulator is bound by policy principles issued by the Ministerial Council under proposed section 21. He or she is not bound to follow, but must have regard to, policy guidelines issued by the Ministerial Council under proposed section 23, as well as public submissions.

The Bill does not specify the standard of evidence which will be required by the Regulator in making decisions. Environment Australia and other bodies have recommended:

  • basing assessments on replicable findings only, and
  • requiring the same type of peer review of the research evidence submitted by commercial companies to the regulatory bodies as is applied to published research.(46)

If a GMO licence is issued, the Regulator will be able to levy annual licence fees, under the Gene Technology (Licence Charges) Bill 2000. The amount of the licence fee will be prescribed by the regulations. However, the fees will be significant. The fact that they have been imposed in a separate statute indicates that they will not simply be a fee for service (as the application fees for licences are), but are in the nature of taxation.(47) The Explanatory Memorandum states that it is the Government's intention that the Regulator recover 100% of his or her costs from users of the regulatory regime, for example, through licence charges.(48)

Licence conditions

A GMO licence may cover the licence-holder and additional persons (such as employees) and will be subject to such conditions as are included in the licence, in the Regulator's discretion. These conditions may include specific provisions about waste disposal, specified containment levels, specific measures to manage risks, contingency planning, documentation, record-keeping, research, auditing and reporting (proposed section 62).

Particular GMO licence conditions may include requirements that a facility be certified to a particular containment level, or that dealings must be supervised by an Institutional Biosafety Committee established by an accredited organisation. The procedures for certification and accreditation are discussed below, and will depend on the content of guidelines to be issued by the Regulator.

Compliance with "technical guidelines" issued by the Regulator (proposed section 27) after consultation with GTTAC and the GTCCG, may also be a condition of a GMO licence (proposed paragraph 62(2)(l)). These documents, which are not currently available, will be instrumental in setting the standards to be complied with and outlining measures to be taken to minimise risks.

The Bill does not set specific buffer zones around GM crops to protect organic and GM free crops growing nearby. However, the IOGTR considers that:

acting on a broad definition of the environment, the [Regulator] will be able to set conditions to limit contamination of non GM by GM crops and punish breaches. The bill defines the environment as including 'ecosystems and their constituent parts, and natural and physical resources, and the qualities and characteristics of locations, places and areas'.(49)

Certainly the Regulator will have power to impose conditions to limit contamination. It will be up to the Regulator whether it does so, what conditions to impose, and the level of stringency required, although Regulator must be satisfied that any risks to the environment or to human health and safety can be adequately managed (proposed subsection 56(1)).

The Regulator has power to vary a licence, including imposing additional conditions or removing or varying existing conditions. The Regulator cannot vary a licence for contained dealings to authorise the intentional release of a GMO, and must be satisfied that any variations to the licence enable risks to be managed adequately (proposed section 71).

The licence-holder has a statutory obligation to inform any person covered by the licence of particular conditions which apply to the person, any variations of those conditions, or if the licence is cancelled, suspended or surrendered (proposed section 63).

Dealings with GMOs which are not subject to the licensing system

Exempt dealings, dealings listed on the GMO Register and notifiable low risk dealings will be able to be conducted without going through the consultation and licensing process.

Exempt dealings

Dealings which are stated in the regulations to be exempt will not require a GMO licence (proposed subsection 32(3)). No grounds are specified in the Bill on which certain dealings or classes of dealings with a GMO may be exempted. The IOGTR has proposed that dealings currently exempt under GMAC's guidelines for very low risk work conducted in contained facilities(50) will continue to be exempt under the Bill.

Dealings listed on the GMO Register

Certain dealings with GMOs which are of minimal risk may be included on a GMO Register maintained by the Regulator. An example of a minimal risk dealing provided by the IOGTR is a flower which has been genetically modified to enhance vase life, which has been grown subject pursuant to a GMO licence for a period of years, demonstrating that it is safe.(51) The GMO Register is open to inspection by the public (proposed section 81). The dealing must have previously been authorised by a GMO licence. Any person may undertake a dealing listed on the GMO Register without a GMO licence, subject to any conditions specified in the GMO Register (proposed sections 32 and 79).

The Regulator makes a determination that a certain dealing with a GMO be listed on the GMO Register either on his or her own initiative, or after receiving an application from a GMO licence-holder in respect of a dealing which is currently covered by a GMO licence (proposed section 78). Determinations are disallowable instruments, thus subject to the scrutiny of Parliament.(52)

Notifiable low risk dealings

Certain low risk dealings with GMOs may be regulated by regulations, and do not need to go through the licensing system. The types of dealings which will be covered by regulations are experiments with GMOs in contained facilities that are of low risk, but are not so low risk as to be exempt or included in the GMO Register. The regulations may restrict the class of persons who may undertake notifiable low risk dealings, or contain provisions requiring persons undertaking notifiable low risk dealings to notify the Regulator. Notifiable low risk dealings may be supervised by Institutional Biosafety Committees (IBCs) (proposed section 75).

There is no procedure for a person to apply to have particular activities declared to be 'notifiable low risk dealings'. They are simply declared to be such by the Governor-General (proposed section 74) after the Regulator considers whether:

  • the GMO is biologically contained, and would not be able to survive or reproduce without human intervention,
  • the dealing with the GMO would involve minimal risk to the environment or the health and safety of people, and
  • minimal or no conditions would be necessary to manage any risks.

Although the Regulator must consider these matters, he or she does not have to be satisfied that the proposed dealing with a GMO will satisfy one or all three criteria before a dealing is declared to be a 'notifiable low risk dealing'. The only thing the Regulator must positively be satisfied of before regulations are made is that the dealing would not involve an intentional release of a GMO into the environment (proposed subsection 74(2)).

As the draft regulations are currently unavailable, it is not possible to ascertain whether there are sufficient safeguards in the system for regulating low risk GMOs.

Certification and accreditation

The Bill provides procedures for certifying a facility to a particular containment level, and for the accreditation of organisations which have an IBC. Both of these procedures may permit certain dealings with GMOs to be conducted under internal supervision, with minimal supervision by the Regulator, once the Regulator is satisfied that adequate standards and supervisory mechanisms are in place. Certification or accreditation may be conditions imposed on the grant of a GMO licence (proposed section 62), or may be conditions imposed in the regulations for the conduct of notifiable low risk dealings (proposed subsection 75(2)).

The Regulator may certify a facility to a specified containment level after an application is received, together with an application fee (proposed section 83), if the facility meets the containment guidelines issued by the Regulator (proposed sections 84 and 90). Certification may be unconditional or subject to conditions (proposed section 86).

No application fee is payable on an application to become an accredited organisation (proposed section 91). Before deciding to accredit an organisation, the Regulator must consider whether the organisation has or will establish an IBC, is able to maintain the IBC, and will indemnify the members of the IBC in respect of their decisions (proposed section 92). The Regulator must also consider any other matters which are contained in guidelines issued by the Regulator under proposed section 98. As with notifiable low risk dealings, because of the way the Bill is drafted it seems the Regulator is only required to consider these matters, and is not required to be positively satisfied that an organisation has and will maintain an IBC, before making a decision to accredit the organisation.

Neither the guidelines issued by the Regulator for certification to a specified containment level, nor the guidelines for the accreditation of organisations with IBCs, are disallowable instruments.

Compliance and enforcement

Cancellation of licences

Under proposed section 68, the Regulator has power to suspend or cancel a licence for a number of reasons. Importantly, these include, if the Regulator:

  • believes on reasonable grounds that the licence-holder or a person covered by the licence has breached a condition of the licence (including by not providing additional information to the Regulator),
  • believes on reasonable grounds that the licence-holder or a person covered by the licence has committed an offence against the Bill or the regulations, or
  • becomes aware of risks which the licence-holder is not in a position to deal with adequately.

Criminal offences

Categories of offence

Proposed Part 4 of the Bill creates both mens rea and strict liability offences. In this context, a mens rea offence means an offence where it is proven that a person intentionally, knowingly or recklessly did a prohibited action. A strict liability offence is one where the offence is committed simply by doing the prohibited action. The penalties are significantly greater for mens rea offences than for strict liability offences.

The Bill further divides offences into ordinary and aggravated offences. An "aggravated offence" is one which causes, or is likely to cause, significant damage to human health and safety or to the environment (proposed section 38), and heavier penalties may be imposed. However, for an aggravated offence, the prosecution must prove that the person either intended to cause significant damage or was reckless as to whether his or her conduct would cause significant damage to human health and safety or to the environment (proposed subsection 38(2)). This applies even where a person is being prosecuted for a strict liability offence which has caused significant damage. This could be a significant hurdle. In many, perhaps most, cases, a person may have intended to conduct certain dealings (for example, to plant a crop of GMOs), but may not have intended to cause the significant damage which in fact resulted.

Offences

It is an offence to deal with a GMO if the dealing is not authorised by a GMO licence (unless the dealing is a notifiable low risk dealing, an exempt dealing, or is included on the GMO Register) (proposed sections 32 and 33).

Whereas compliance with conditions imposed by GMAC was voluntary,(53) under the Bill it is a criminal offence to breach a condition imposed on a GMO licence (proposed sections 34 and 35). This includes failure to tell the Regulator of information that subsequently comes to light about risks or contraventions of the GMO licence in relation to the dealing which is covered by a GMO licence (proposed section 65).

The maximum penalty for each of these offences for an individual is a fine of up to:

  • 2000 penalty units (currently $220,000)(54) for an aggravated offence where mens rea is proven,
  • 200 penalty units (currently $22,000) for an aggravated offence of strict liability,
  • 500 penalty units (currently $55,000) for an ordinary offence where mens rea is proven, or
  • 50 penalty units (currently $5,500) for an ordinary offence of strict liability.

A penalty of up to 5 times the maximum amount that could be imposed on an individual may be imposed on a corporation which is found guilty of these offences.(55) A corporation can be convicted of a mens rea offence if a director, employee or agent had the relevant state of mind (proposed section 188). However, if the corporation took 'reasonable precautions and exercised due diligence' to avoid the conduct, it cannot be prosecuted for an offence against the Act or regulations arising out of conduct of an employee, director or agent of the corporation (proposed subsection 188(2)).

The Bill also creates two less serious strict liability offences, namely:

  • contravening a condition on the GMO Register when dealing with a GMO which is on the GMO register (proposed section 36), and
  • undertaking a notifiable low risk dealing otherwise than in accordance with the regulations (proposed section 37).

The maximum penalty for committing either of these offences is a fine of 50 penalty units (currently $5,500).

Other offences contained in the Bill include:

  • Inspectors giving false information in relation to a warrant, or presenting a false warrant (proposed section 175). Maximum penalty: imprisonment for two years or a fine of 120 penalty units.
  • Unauthorised disclosure by officials of confidential commercial information they have access to as part of their jobs (proposed section 187). Maximum penalty: imprisonment for two years or a fine of 120 penalty units.
  • Providing false or misleading information or documents in relation to an application or in reporting required under the Act (proposed section 192). Maximum penalty: imprisonment for one year or a fine of 60 penalty units.

If a person is convicted of an offence against the Act or regulations, the court may order forfeiture to the Commonwealth of any 'thing' involved in the commission of the offence (proposed section 148). 'Thing' is broadly defined to include a substance. The Commonwealth thus has power to seize GMOs and other things, which become property of the Commonwealth. The Commonwealth must keep them until the Regulator gives a direction to sell or otherwise dispose of or destroy them.

If a person has already been punished for an offence or has paid a pecuniary penalty under a corresponding State law, that person is not liable for an offence or pecuniary penalty under the Bill in respect of the same conduct (proposed section 18).

Compliance and 'clean up' directions

The Regulator has power to give directions to a GMO licence-holder or a person covered by a GMO licence, if there are reasonable grounds to believe that the person is not complying with the Act or regulations and a direction is necessary to protect the environment or human health and safety (proposed section 146). A direction requires the person to take steps within a specified time period to comply with the Act and regulations. Such a direction could be a 'clean-up' or remediation order.

It is a strict liability offence not to take the steps required within the specified time. The maximum fine is 500 penalty units (currently $55,000), or 2000 penalty units (currently $220,000) if the failure to remediate causes significant damage (proposed subsection 146(3)).

If the person does not take the required steps within the time specified, the Regulator has power to arrange for those steps to be taken, and can recover the costs of any such action from the person (proposed subsections 146(4) and (5)). No monetary limit is imposed on the Regulator's ability to take action and recover the costs.

The Regulator or any other aggrieved person may also apply to the Federal Court of Australia for an injunction (proposed section 147) either:

  • restraining a person from committing an offence against the Act or regulations, or
  • requiring a person to do something, if not doing that thing would be an offence against the Act or regulations.

External monitoring

The Bill provides a number of mechanisms for post-approval monitoring of compliance with the conditions imposed on persons dealing with GMOs.

The Regulator has power to appoint Commonwealth or State public servants as inspectors (proposed section 150) to independently monitor compliance with the Act and regulations (proposed section 152). Given that it is an offence to breach a condition of a GMO licence (proposed sections 34 and 35), this power also enables inspectors to monitor compliance with licence conditions. Inspectors have broad powers to enter and search premises, to examine and take measurements, take samples or conduct tests, to inspect records and documents and to secure evidence before obtaining a warrant (proposed section 153). Inspectors do not necessarily need to have a warrant or consent of the occupier to enter premises. If the occupier is a GMO licence-holder or a person covered by a GMO licence, and the entry is at a reasonable time, the inspector has statutory authority to enter (proposed paragraph 152(2)(c)). This enables inspectors to conduct inspections without notice.

Inspectors may also enter premises to investigate the suspected commission of an offence, including suspected breaches of licence conditions, but only with the permission of the occupier or pursuant to a search warrant(56) (proposed section 154). In investigating an offence, inspectors may search premises, examine and take measurements, take samples or conduct tests, inspect records and documents. They may only seize material as evidence if entry to the premises was pursuant to a warrant (proposed sections 154, 155).

Inspectors also have emergency powers to deal with suspected breaches where necessary to avoid an imminent risk of death, serious illness or serious injury, or to protect the environment. These powers include power to enter and search premises, secure a thing before obtaining a warrant to seize it, or require a person to take steps to remedy breach of the Act or regulations. Inspectors also have power to take steps themselves, or arrange for someone else to remediate damage, and recover the cost from the person responsible (proposed section 158).

Further powers of inspectors are to search goods or baggage entering Australia from overseas (proposed section 164) and to seize goods if they are reasonably suspected of being evidence of the commission of an offence (proposed section 165). It is an offence for a person who owns or is associated with goods not to answer questions asked by an inspector in relation to the goods (proposed subsection 164(4)). The maximum fine is 30 penalty units (currently $3,300).

There is no provision in the Bill for a comprehensive independent auditing process to check the quality assurance systems being used by the licence-holder, and ensure the licence conditions and risk management plans are being followed.(57)

Self-monitoring

The licence-holder has a statutory obligation to inform the Regulator of any additional information as to risks, any contraventions of the licence or any unintended effects of the dealings, that he or she becomes aware of (proposed section 65). A person, such as an employee, who is covered by the licence who is not the licence-holder also has power to inform the Regulator of these things, although, unlike the licence-holder, other persons are not legislatively obliged to provide information (proposed section 66).

If a GMO licence contains a particular condition relating to monitoring or auditing, persons authorised by the licence have an obligation to allow the Regulator into premises to undertake such auditing or monitoring (proposed section 64).

GMO licences may also contain conditions requiring licence holders to conduct regular monitoring, conduct periodic reviews of risk management plans, or undertake sampling and testing to check for unintended environmental effects.(58)

Review of decisions

Broadly, decisions of the Regulator relating to the following matters are reviewable (proposed section 179):

  • licences and licence conditions,
  • certification of a facility and conditions of certification,
  • accreditation of an organisation and conditions of accreditation,
  • decisions relating to confidential commercial information, and
  • decisions of the Regulator performing functions under State laws (for example, making licensing decisions under a State law) (proposed section 19).

Decisions are only reviewable by the applicant for, or holder of, the relevant approval, not by other persons aggrieved by the Regulator's decision. Thus, a neighbouring farmer cannot apply for review of conditions imposed on a GMO licence issued for a field trial in the vicinity of his or her farm.

Decisions are first reviewed internally by the Regulator (proposed section 181), and if the applicant is not satisfied with the result, he or she may apply to the Administrative Appeals Tribunal for review (proposed section 183). Decisions of the Administrative Appeals Tribunal may be appealed to the Federal Court on a question of law.(59) Alternatively, a person may apply to the Federal Court for judicial review of a decision of the Regulator, under the Administrative Decisions (Judicial Review) Act 1977.

Confidential commercial information

A difficult aspect of the Bill is the exemption from disclosure of 'confidential commercial information'. A member of the public will be able to obtain copies of a GMO licence application, risk assessment and risk management plan, except those parts of the documents that contain confidential commercial information (proposed section 54).

Under proposed Division 3 of Part 12, a person may apply to the Regulator for a declaration that certain information is confidential commercial information (proposed section 184). Subject to the discretion mentioned below, the Regulator is obliged to declare information to be confidential commercial information if it is (proposed section 185):

  • a trade secret,
  • information with commercial or other value which would be destroyed or diminished by disclosure, or
  • information about the commercial or financial affairs of an organisation or person if disclosure would unreasonably affect that person or organisation.

It seems likely that a broad range of information in applications for research and development in new genetic technology would encompass trade secrets and commercial information. However, the Regulator has a discretion to refuse to declare the information confidential commercial information if, in the Regulator's opinion, the public interest in disclosure would outweigh the prejudice (proposed subsection 185(2)).

There are significant limitations on the use of confidential commercial information. It:

  • cannot be used by the Regulator in considering other GMO licence applications, unless the information owner gives written consent (proposed section 45),
  • cannot be disclosed in the information provided to the public during the community consultation on GMO licence applications (proposed section 54), and
  • is not recorded on the Record of GMO and GM Product Dealings (proposed subsections 138(3), (4) and (5)).

The IOGTR states that it has "attempted to strike a balance between the legitimate protection of confidential information and the need for a high level of transparency, openness and accountability of decision-making".(60)

Concluding Comments

Clearly, regulation of all aspects of gene technology in Australia is long overdue, having been recommended as long ago as 1992.(61) Whether the best form of regulation of this experimental technology is prohibition on the release of GMOs into the environment, at least in the short term until sufficient scientific evidence has been gathered to make an informed decision, is an open question. Critics often point to dangers such as herbicide resistant weeds, harmful effects on beneficial insects, or the risk of losing natural genetic diversity in crops to a single genetically modified variety, which could lead to devastating crop failures if that variety succumbs to disease.(62) On the premise that there has been little adequate or long-term testing in relation to these or other, as yet unforeseen, environmental risks or risks to human health, some commentators are questioning the desirability of gene technology, or at least the speed of its introduction. The Organic Federation of Australia has called for a moratorium on dealings with GMOs while these issues are investigated,(63) and one member of Parliament has advocated a five year moratorium on development of GMOs, to enable adequate independent research to be carried out.(64)

Separate from these environmental and health concerns are the trade issues. Some farmers have expressed concern that Australia will lose its "clean green" reputation, and that trade with countries such as the United Kingdom and Japan may be detrimentally affected as a result.(65) Tasmania, in announcing a temporary moratorium on GMO field trials, indicated that commercial marketing considerations were behind its policy.(66)

Assuming that prohibition is too extreme a reaction, the Bill needs to be examined to ascertain whether it adequately achieves its objectives of protecting the environment and human health and safety through its identification and management of the risks associated with gene technology.

The precise operation of the Bill is in some instances difficult to determine in the absence of a concluded GTA and draft regulations, guidelines and policy documents. It is anticipated that the GTA and draft regulations will not be available before the middle of August. Accepting these limitations, this section provides some discussion of broader issues arising from the Bill and whether the Bill meets its stated objectives. Other comments on specific aspects of the Bill, which have been made in the Main Provisions section above, are summarised for the reader's convenience in the following footnote.(67)

Operation as a national scheme

The Bill is intended to operate as a national scheme, requiring complementary legislation at Commonwealth, State and Territory levels. The advantage of a national cooperative scheme is its ability to regulate comprehensively all dealings with GMOs. Although the Commonwealth's constitutional powers relevant to gene technology are extensive,(68) nevertheless, the federal Government does not have constitutional power to regulate every dealing with a GMO.(69)

The Bill explicitly states it is not intended to exclude the concurrent operation of any State law (proposed subsection 16(1)). State legislation on general environmental, fisheries and land management issues, which may indirectly or incidentally regulate GMOs, will be able to coexist with the Bill. State laws which directly regulate dealings with GMOs in conformity with the national scheme agreed to under the GTA will operate concurrently with the Bill. They may even have an extended operation if they correspond sufficiently to the Bill and a "wind-back notice" is served on the Commonwealth under proposed section 14.

If a State law gets out of step with the national scheme, either because amendments agreed to nationally under the GTA are not passed, or because other amendments which have not been agreed to under the GTA are made, the Minister may revoke a declaration that the State law is a corresponding law (proposed subsection 12(2)). In that situation, the Bill would apply to the full extent of Commonwealth power.

Additionally, State laws that specifically regulate dealings with GMOs or contain specific provisions relating to dealings with GMOs, but do not correspond with the national scheme, may be listed in regulations and precluded from operating alongside the Bill (proposed subsection 16(2)).(70)

Despite these powers to revoke a declaration in relation to a "corresponding State law" and to make regulations excluding the operation of non-conforming State laws, the Commonwealth has no ability to ensure that the national scheme is uniformly amended. The continued operation of the national scheme relies on further inter-governmental agreements to approve amendments, and the passage of legislation incorporating those amendments in every jurisdiction. If one or more of the States and Territories choose not to enact complementary legislation, or not to amend the legislation in line with other jurisdictions, the scheme quickly ceases to be uniform and national in its scope. The potential for disunity is exacerbated by the existence of a "wind-back" option, allowing State legislation to regulate matters which could legitimately come under Commonwealth control.

The anticipated inter-governmental agreement on which the scheme is to be based has not yet been signed. Indeed, Tasmania has recently announced an interim moratorium on the field trials and general release of GMOs, which may affect the ability to negotiate such an agreement.(71) The future of a consistent national scheme rests on uncertain foundations if agreement cannot even be concluded prior to the commencement of the scheme.

In spite of the difficulties experienced to date in achieving inter-governmental agreement, the Bill does not even operate to the full extent of Commonwealth constitutional power. In particular, the Commonwealth has chosen not to rely on its plenary constitutional power to legislate for the territories (section 122 of the Constitution) to apply the Bill throughout the ACT and Northern Territory, but is instead relying on complementary legislation being passed by both territories. This reflects the Commonwealth's preference for a cooperative nationally consistent regulatory scheme, rather than Commonwealth legislation relying on every possible head of constitutional power.(72)

A further constitutional problem arises after the decision in R v Hughes. Under the Bill, the Regulator and all three advisory committees may exercise functions, powers or duties conferred on them under corresponding State laws (proposed section 17). It is clear that State laws may confer functions on Commonwealth officers or Commonwealth authorities, so long as a Commonwealth law consents to the conferral of power.(73) However, in R v Hughes(74) the High Court held that where State laws confer a duty on a Commonwealth officer or authority to exercise functions under State law, the Commonwealth must have a specific head of constitutional power in relation to those State functions before it may consent to exercise those functions.

The legal ramifications of the R v Hughes decision have yet to be explored.(75) It may be that the decision only applies where the duty which the Commonwealth has accepted "adversely ... affect[s] the rights of individuals".(76) Certainly, the functions conferred on the Regulator under the Bill are not coercive in the same sense as the power to conduct a criminal prosecution is. However, decisions whether or not to grant a GMO licence, to approve certification to a specified containment level, or to accredit a facility all have the potential to adversely affect individual rights.

It may also be argued that the Bill does not impose a duty on the Regulator, but merely confers power. Proposed section 17 in terms provides that a State law "may" confer functions on the Regulator or another Commonwealth body, and that body "may" exercise those functions. Nevertheless, it is possible that a duty may arise. Although the Bill does not preclude the States from conferring functions on a State agency, if there is no officer or body at State level with the ability to perform those functions relating to gene technology, the Regulator may effectively come under a duty to perform those functions.(77)

If the Regulator has a duty to exercise functions conferred under State law, there must be a specific constitutional head of power that would cover those functions. However, the very reason for the cooperative national scheme is that the Commonwealth does not have constitutional power to cover all areas in which dealings with GMOs may arise. Although the Regulator will be able to exercise State functions in many cases, as Commonwealth constitutional power covers a significant proportion of the regulation envisaged by the Bill, in some cases he or she may not constitutionally be able to do so. The only solutions to this problem are either changes to the current position, giving the Commonwealth full constitutional power to legislate with respect to gene technology,(78) or accepting the impossibility of ensuring consistent regulation, and acknowledging that differences between jurisdictions are inevitable in a federation such as ours.

Cost recovery

In May 1999 the Commonwealth Government committed $7.6 million over 2 years for the development of gene technology legislation and the establishment of the Regulator. After these two years, that is, from May 2001, the Government anticipates that the Regulator will recover 100% of his or her costs from users of the regulatory regime, for example, through licence charges.(79)

Although the Regulator will be able to charge application fees for GMO licences (proposed section 40) and for certification of a facility to a specified containment level (proposed section 83), the Regulator will not be able to fund his or her administrative costs solely or even mainly through application fees. This is because the application fees are contained in the Bill itself, and thus must be set at appropriately modest levels so as to be described as a "fee for service" and avoid being characterised as a tax and thus held invalid. By contrast, the annual GMO licence fees are separately contained in the Gene Technology (Licence Charges) Bill 2000, so can be set as high as the Regulator desires.

In practical terms, therefore, the Regulator will be required to approve a sufficient number of GMO licences to obtain the annual licence fees to continue to operate the day-to-day activities of the office and fund the Regulator's staff and administration needs. Further, and paradoxically, the Regulator will only be able to obtain the funds required to conduct independent scientific research into the risks posed by GMOs by approving enough dealings with GMOs to raise the money required.

The proposal that the Regulator operate on a full cost recovery basis has been criticised, on a number of grounds. Consumer groups have expressed concern that this will effectively make the Regulator a "captive" of industry, constrained to approve dealings with GMOs from wealthy corporations in order to continue its existence.(80) Although full cost recovery is successful for agencies such as the Therapeutic Goods Administration without compromising the standards or independence of the regulatory body, because gene technology is still in its infancy there is not the same base of accepted dealings from which licence fees may be gained.

There are also concerns that annual fees may act as a disincentive for research and development in genetic technology, as research and development by their very nature are experimental and are usually subsidised by government and encouraged by tax benefits, rather than being taxed.(81) Finally, concerns have been expressed that full cost recovery may work to the advantage of large corporations and as a deterrent to small biotechnology companies, which may not have the same capacity to pay significant licence fees.(82) Even at the commercial release stage, it is possible that the licence fees will outweigh any financial benefits of participating in trials or commercial release of GM products. For example, it was recently reported that a farmer growing GM cotton currently pays a licence fee of $150 per hectare, and saves $110 per hectare (including by using 6 litres less of pesticide). As the cotton yields are identical,(83) then unless the purchase price for GM cotton is higher than for standard cotton, growing GM cotton and paying annual licence fees is not commercially profitable.(84)

A study has been commissioned by the IOGTR, and is being conducted by KPMG, to investigate the cost of the proposed system for the regulation of gene technology.(85) Once this has been completed, it will be possible to ascertain whether it is feasible to fund the Regulator's activities through application and licence fees. The first part of the study, which was to provide various cost-recovery options, was originally due to be completed by about June 2000.(86) However, it has not yet been completed, in part due to delay in producing draft regulations for public comment. The completion of the second and final stage of the study was anticipated to be September 2000, although this date may also have been moved back.

Independence and impartiality of the Regulator

The Regulator is a statutory office holder, independent of the direction of the Government, and with strong powers including the ability to report directly to Parliament. However, the decision to require the Regulator to be 100% self-funding after mid-2001 imposes a very significant restriction on his or her independence.

Another potential derogation from the Regulator's independence is the power of delegation. The Regulator has the ability to delegate any of his or her powers or functions to an employee of the Department of Health or Aged Care, or an employee of another Commonwealth Department, authority or State agency whose functions relate to GMOs and GM products (proposed section 29). This includes functions conferred on the Regulator under other laws, such as the advising functions in relation to GM products under the existing legislation regulating food, therapeutic goods, agricultural, veterinary and industrial chemicals.(87) It could compromise the independence of the advice on the risks related to GM products if the Regulator delegated his or her functions under these schemes to the NRA, ANZFA, the TGA or the Director of NICNAS. The Explanatory Memorandum itself recognises the need for advice on GM products to be given by a body independent of the regulatory agency involved.(88) As the Bill currently stands, however, there are no limits on the Regulator's power to delegate.

Some critics complain that GMAC and the institutional biosafety committees that oversee gene technology research in individual companies and institutions, will be "dominated by proponents of gene technology."(89) As GTTAC (the successor to GMAC) will be staffed by part-time members who will also be practising scientists, and may themselves be involved in gene technology research and development, this is certainly an issue to consider. However, State and Commonwealth government bodies have expressed the view that the skills and expertise of members of GMAC, as well as the standards it enforces, are among the best in the world.(90) The House of Representatives Standing Committee on Primary Industries and Regional Services considers that the three advisory committees "will possess the expertise to assess the broader impact of GMOs."(91)

It is also possible that GTTAC may provide scientific advice which the Regulator may ultimately choose not to follow. In this important respect, the powers of GTTAC are much more restricted than those of GMAC. Under the current system, GMAC, composed of scientists, is responsible for making licensing and other decisions relating to dealings with GMOs. Under the proposed system, the final decision is made by the Regulator, a public servant who does not necessarily have scientific expertise.

Compliance and enforcement

A number of comments can be made about the adequacy of the penalties and enforcement mechanisms provided for in the Bill. The penalties for the major offences of dealing with a GMO without a licence, or breaching a condition of a GMO licence, are in monetary terms substantial. However, environmental statutes commonly impose a further penalty for each day a breach continues, thus creating a strong incentive to remedy breaches as quickly as possible.(92) This approach has not been adopted in the Bill.

Further, environmental statutes often provide for terms of imprisonment in addition to substantial fines.(93) Whereas other, less serious, offences contained in the Bill(94) may result in a term of imprisonment, no terms of imprisonment are available as an alternative penalty for the major offences (proposed sections 32 to 38), even though they may result in substantial environmental damage or health hazards.

The Bill provides for monitoring through random inspections and an obligation on licence-holders to report any breaches of the licence or unintended effects (proposed Part 11 and proposed section 65). However, comprehensive independent auditing to ensure compliance with licence conditions is not required unless it is made a condition of the GMO licence.

The Regulator has power to make remediation or "clean up" orders, or to clean up contamination himself or herself and recover the cost from the person in breach (proposed section 146). However, if a dealing with a GMO was approved by the Regulator and the person or organisation complied with all the conditions imposed, but nevertheless damage resulted, the Regulator has no power to order remediation, as there has been no breach of the legislation or the GMO licence conditions. The Regulator does have power to vary GMO licence conditions to impose additional conditions, and to suspend or cancel a GMO licence. However, the Regulator must give written notice of his or her intention to do so, and if the Regulator gives the licence holder an opportunity to make written submissions, he or she must wait at least 30 days before varying, suspending or cancelling the licence (proposed section 72). This may not assist the immediate remediation of contamination. The Regulator's emergency powers only apply if a breach of the Act or regulations is suspected (proposed section 158). The effectiveness of the Regulator's remediation powers has come into question after the IOGTR took more than two months merely to investigate allegations that GM canola plants were dumped at an open commercial tip in Mt Gambier.(95)

Opt out

As part of the initial consultations between the Commonwealth, States and Territories about developing a new scheme for regulation of Gene Technology, a series of 'without prejudice' principles were agreed and subsequently included in the 1998 Regulation of Gene Technology discussion paper. One of these principles stated:

7(d) If a participating jurisdiction considers that the release of a GMO or a GMO product will pose an unacceptable risk within its territory, then it may decline to allow release within its own territory or impose additional conditions on release within its own territory.

In subsequent debate over the form of the Bill, Tasmania and some other groups(96) have called for this principle to be incorporated into the Bill in the form of an 'opt out' clause. This would presumably enable a State or Territory to declare that either the Bill in its entirety, or a particular decision of the Regulator, did not apply to that jurisdiction.

However, the IOGTR has suggested there are potential constitutional and international trade law impediments to including such an opt out clause.(97)

In relation to the constitutional issue, it is understood that the IOGTR is concerned that a clause in the Bill permitting States to opt out could infringe either the freedom of trade and commerce between the States (section 92)(98) or the prohibition on the Commonwealth giving preference to one State over another (section 99). It is difficult to see how an opt out provision of itself could infringe section 92, although a State law attempting to give effect to the provision might infringe this freedom, depending on the nature of the law.(99) In relation to section 99, on current authority,(100) an opt out provision should also be constitutionally valid as it is not clear from a formal reading of the law on its face that it confers a 'tangible commercial advantage'.(101)

In relation to Australia's obligations under WTO rules, it is unlikely that an opt out clause would be contrary to the SPSA. This is because the clause itself is not a sanitary or phytosanitary measure. Rather, it only enables a State Government to enact a measure different to that applying elsewhere in Australia.

In any case, there may be alternative methods of giving effect to the "unacceptable risk" principle, rather than resorting to an opt out. For example, a State Government could use its influence within the proposed Ministerial Council to persuade the Council to develop policy principles under the Bill that would operate to support the establishment of one or more GM free zones to protect the diversity of Australian farming practices, including organic and non GM farming.(102) The fact that the Regulator must seek the advice of State governments and relevant local governments in preparing risk assessments for intentional releases into the environment should also give States substantial opportunity to ensure their jurisdiction is not placed at risk by decisions of the Regulator.

Adequacy of approach to risk assessment and management

A large number of important decisions are left to the discretion of the Regulator. Some decisions are given little statutory guidance, for example which dealings with GMOs are declared to be exempt or are declared to be "notifiable low-risk dealings". While the consultation process for deliberate release of GMOs is extensive, the Regulator is not bound to follow any advice he or she receives, including the technical or scientific advice provided by GTTAC. There is no requirement for any consultation prior to issuing a GMO licence for contained dealings with GMOs. Containment standards and risk management measures will depend largely on the licence conditions imposed at the discretion of the Regulator. Similarly, the agencies regulating GM foods, GM industrial, agricultural and veterinary chemicals, and GM therapeutic goods are required to obtain and consider the Regulator's advice, but are not bound to follow it. In responsible hands, discretion can be valuable in tailoring approvals to specific circumstances. Whether this system is effective in assessing and managing risks depends on the confidence reposed in the Regulator and other agencies to make the right decisions in the exercise of their discretion.

The Bill does not contain the "precautionary principle" enshrined in the Environment Protection and Biodiversity Conservation Act 1999(103) and other legislation. However, arguably the entire Bill represents a precautionary approach to the regulation of gene technology. The Regulator must not issue a GMO licence unless the Regulator has prepared a risk assessment and risk management plan (including an extensive consultation process in the case of an intentional release), and is satisfied that any risks to the environment or human health and safety can be adequately managed (proposed section 56). It is a matter for Parliament to consider whether the detailed provisions of the Bill covering exempt dealings, dealings listed on the GMO Register, notifiable low risk dealings governed by the regulations, contained dealings and the intentional release of GMOs into the environment adopt a sufficiently precautionary approach.

Legal liability for damage caused by GMOs

A bond may be imposed as a condition of a licence. In the event of a breach of the Act or of a licence condition, it may be possible to use bond money to defray some of the costs of remediation or to partly compensate persons affected.

The Regulator also has the power to order a licence holder to remediate a breach. In the case of a licence holder breaching a condition of their licence with the consequence of a nearby GMO-free crop was contaminated, it is not clear how far this remediation power would go as far as restoring the cultivator of the GMO-free crop to a 'pre-breach situation'. It may not always be possible to restore land or crops to their pre-contaminated state. It is far from clear that the Regulator's power to order remediation would extend to require the payment of damages for loss of a crop or loss of use of the land.

Even if damages were payable under the Regulator's remediation power, it is unlikely that damages would be payable for future damage, such as diminution in the value of land, or inability to grow and sell GMO-free crops for a specified future period because of market suspicion. In the recent Scottish case of GM-free rapeseed growers who were 'accidentally' supplied with a GMO seed variety, there was considerable controversy over whether the compensation offered by the company responsible accurately reflected some growers' long-term losses, including the value of the land.(104)

In another, Canadian case, a Canadian canola grower is being sued by agrochemical company Monsanto, which alleges he has been illegally growing Monsanto's patented GM canola seed on his land. The farmer is arguing that the wind carried the GM seeds onto his farm from adjoining fields.(105)

There is no provision in the Bill for a statutory right of action or a compensation fund to compensate those affected by a breach of the legislation, nor is there provision for liability or immunity of GM-free farmers who inadvertently use GM products. Persons affected by GMO contamination will continue to have recourse to the common law of trespass, public or private nuisance, and negligence.(106) This position was supported in the majority report of the House of Representatives inquiry.(107)

There have been several instances in which liability clauses have been suggested for GMO regulation legislation. As part of the review of the EU laws on GMO, the EU Environment Committee proposed that companies be strictly liable for any damage caused by their GM products.(108) This was subsequently rejected by the EU Parliament, reportedly out of concerns that it would impose too high a financial burden on companies and act as a disincentive to the GMO industry in Europe.(109) A private member's Bill was introduced in the UK Parliament in 1999 along similar lines.

Given that the open release of GMOs, particularly GM crops and animals, into the environment is a relatively recent trend, it seems questionable that the issue of potential liability for damage is left solely to the vagaries of the common law. Legal liability for negligently inflicted economic loss is still in a state of uncertainty.(110) In this climate of uncertainty, it is at least arguable that the potential cost of damage from instances of GMO contamination should be incorporated into the regulatory system, perhaps by establishing a statutory compensation scheme(111) or by creating a statutory cause of action specifying in what circumstances and against whom a suit could be brought.(112)

Other avenues of redress

A number of decisions of the Regulator are reviewable on their merits by the Administrative Appeals Tribunal (proposed sections 179 and 183). However, decisions are only reviewable by the applicant for or holder of the GMO licence or other certification or approval, not by other persons aggrieved by the Regulator's decision, such as neighbouring landholders. Landholders can apply to the Federal Court under the Administrative Decisions (Judicial Review) Act 1977 only if they can demonstrate a ground for judicial review of the Regulator's decision. Possible grounds may include allegations that the Regulator failed to consider a relevant matter, or made a decision that was so unreasonable that no reasonable person in the Regulator's position would have made it.

Appendix: Regulation of Gene Technology in Other Countries

The following provides a brief snapshot of how gene technology is regulated in a range of other countries and the European Union. It focuses on the issue of the release of gene technology into the environment through field trials and general commercial release rather than the regulation of laboratory-based gene technology research. The regulation of GM food is included in a soon to be published Current Issues Brief by Rosemary Polya, Science, Technology, Environment and Resources Group, which will provide an update on issues related to genetic engineering.

None of the countries examined has a single system which comprehensively regulates all GMOs and GM products. Like Australia, most countries regulate GM products under the existing schemes which cover similar, GM-free products. Some countries, notably the USA and Canada, even regulate GMOs themselves under a number of disparate regulatory regimes.

The European Union(113)

Directive 90/220/EEC(114), passed in 1990, regulates deliberate releases both for research and development and for placing GMOs on the market.(115) There are other Directives applying to, for example, the assessment of GMO derived foods, but these follow a reasonably similar process to that outlined below.

Before deliberately releasing a GMO into the environment or placing it on the market, a manufacturer or importer must submit a notification to the relevant agency of the European Union (EU) member State where the product is intended to be first released into the environment or placed on the market. The notification is required to contain a technical dossier of information, including a risk assessment of the product. The notification then undergoes whatever statutory or other approval process is required by the member State.

If the application is approved by the member State, it is forwarded to the European Commission and the individual member States. If no State objects to the application, the original member State's approval then effectively allows the GMO to be released or marketed anywhere in the EU.

If there are objections, the application is reviewed by a series of Scientific and Regulatory EU Committees. The application may be approved by a majority even if not all member States agree. In some cases where a GMO has been approved by the EU, individual member States have apparently invoked a 'safety clause' contained within 90/220/EEC to temporarily ban the release of certain GM products in their territories.(116) These cases have been referred to a Scientific Committee.(117)

Directive 90/220/EEC is currently under review with the final form to be decided by the European Parliament later this year. Proposed changes include improving the transparency of decision-making through the increased involvement of the public in the authorisation process, and improving monitoring of approved organisms. Pending finalisation of these changes, the EU - or at least some member States - has apparently adopted a de facto moratorium on the approval of new GMOs.(118)

United Kingdom(119)

Directive 90/220/EEC is implemented by Part VI of the Environmental Protection Act 1990 (the EPA Act) and the associated GMO (Deliberate Release) Regulations 1992.(120) Issues such as food safety, chemicals or medicines that may involve GM products are covered by separate legislation.

The EPA Act and associated regulations require, with a few exceptions, that anyone intending to release or market GMOs must first obtain the consent of the appropriate Minister. In most cases this is the Environment Minister. Applications to the Minister are to be accompanied by a risk assessment. Applicants are required to advertise their applications in the locality of the intended release. Field trial sites are disclosed in the United Kingdom.

The Environment Minister is advised by the Advisory Committee on Releases to the Environment (ACRE), which is a statutory body. The Minister may place legally enforceable conditions on any approval for release.

In 1999, the United Kingdom announced the outcome of a review of the regulatory framework for biotechnology.(121) The changes recommended mainly dealt with the perceived lack of a forward-looking strategic framework for the development of biotechnology rather than changes to the assessment process for the release of GMOs. Subsequently, the Government established the Agriculture and Environment Biotechnology Commission.

The United States of America

Responsibility for regulation of GMOs is shared between three agencies.

Under the Plant Pests Act and Plant Quarantine Act, the Department of Agriculture has responsibility for both approving the importation of GMOs and overseeing the planting and field testing of most genetically modified crops.(122)

The Toxic Substances Control Act and the Federal Insecticide, Fungicide and Rodenticide Act confer responsibility on the Federal Environmental Protection Agency (EPA) for pesticides, including crops that have been genetically modified to introduce substances toxic to pests.

The Food and Drug Agency (FDA) is responsible for safety and labelling of all foods and animal feeds derived from GM sources.(123) The relevant legislation is the Food, Drug and Cosmetic Act. The FDA is currently reviewing its requirements for testing of, and labelling of foods that have GM ingredients. Under the proposals, manufacturers would have to prove the food is 'safe'. However, there is disagreement among various groups on whether GMO foods should require more or different testing than other related GMO-free foods.

Canada

The general approach to the regulation of GMOs in Canada appears to be similar to the United States. The 1993 Federal Regulatory Framework for Biotechnology(124) essentially sets out the respective responsibilities for the various federal regulatory agencies. Like the United States, there is no central gene technology legislation or regulator. Under the 1993 framework, agencies regulating products developed using traditional techniques and processes were given responsibility for regulating similar products developed using gene technology.

The four main agencies responsible for the assessment of GMOs are Environment Canada, Health Canada, the Canadian Food Inspection Agency and the Department of Fisheries and Oceans. Gene technology applications are assessed for health and environmental impacts under the Canadian Environmental Protection Act, administered by Environment Canada, where they are not subject to assessment by the other agencies. For example, GMO crops and the issue of any negative impacts of biodiversity would appear to be regulated under the Seeds Act (administered by the Canadian Foods Inspection Authority) rather than the Canadian Environmental Protection Act.

New Zealand

The Hazardous Substances and New Organisms Act 1996 (HSNO Act) regulates the importation, experimentation with, and release of GMOs other than GM food.(125) The HSNO Act requires that the release or importation of, or other dealing with, any type of organism that was not present in New Zealand before 29 July 1998 must first be approved by the Environmental Risk Management Authority (ERMA).

Applicants are required to demonstrate to the ERMA that the benefits of the introduction of the GMO outweigh the risks. Public hearings are held to allow both the applicants and objectors to put their respective cases. Applications for trials of sugar beet, potatoes and the development of transgenetic sheep and cattle herds have been approved to date.(126)

In April 2000 the New Zealand Government announced a 12 month Royal Commission into genetic modification.(127) Pending the result of the Commission, New Zealand has also instituted a voluntary moratorium in relation to field tests and open release of GMOs.(128)

Japan

The regulation of gene technology is primarily the responsibility of the Ministry of Agriculture, Forestry and Fisheries (MAFF). Food and pharmaceuticals are regulated by the Ministry of Health and Welfare.

MAFF has issued a range of guidelines which deal variously with contained experimental research, use in industrial applications (for example, processed stock feed), field trials and general release.(129) It appears the process to gain the necessary approval varies with the applicable guidelines. Japan has also recently introduced more stringent requirements for the importation of foods. Importers will have to label a prescribed range of GM food items (particularly certain soybean and corn products) from April 2001. In addition, safety tests relating to GM foods, which to date have been voluntary, will be mandatory.

Endnotes

  1. This section, What is gene technology, has been authored by Dr Rod Panter, Director, Science, Technology, Environment and Resources Group.
  2. Further information on the basic technical concepts underlying gene technology can found in Healey, J (ed) 'Genetically Modified Food' (2000) 122 Issues in Society; or on the CSIRO Gene Technology Webpage at http://www.csiro.au/pubgenesite/index.htm
  3. See for example, Reiss, M and Straughan, R, Improving Nature: The Science and Ethics of Genetic Engineering, Cambridge Press (1996).
  4. See Moynihan, R, 'How safe are GM foods', Australian Financial Review, 29-30 July 2000, p. 28.
  5. Brookes, M, 'Running Wild', New Scientist, 31 October 1998, p. 38.
  6. Broadly speaking, a GM product is a thing derived from a GMO that is not capable of reproduction or of transferring genetic material.
  7. AQIS's current policy is to refuse an application for importation of a GMO unless it is accompanied by documentation showing approval by the Commonwealth Genetic Manipulation Advisory Committee.
  8. GMAC was formed in the late 1980s. Its mandate covered all novel genetic technologies, not just recombinant DNA procedures as its predecessor committee had. The intention was that GMAC would develop guidelines for GMO research and provide advice on human health and environmental safety to those existing regulatory agencies that had legal responsibility for approving the release of the genetically modified subject. For futher background on GMAC see http://www.health.gov.au/tga/gene/gmac/gmac.htm.
  9. Explanatory Memorandum to the Gene Technology Bill 2000, pp. 8-9.
  10. Stevenson, Andrew, "Fearful or not, there is nowhere to hide", Sydney Morning Herald, 25 July 2000.
  11. Fraser, Andrew, "Most cotton will be GM by 2005: marketer", The Australian, 27 July 2000.
  12. Woodford, James, "Crop target 2005: a million hectares", Sydney Morning Herald, 24 July 2000.
  13. The IOGTR's response to this incident has been criticised as tardy and lacking in transparency: Report of the House of Representatives Standing Committee on Primary Industries and Regional Services, Work in Progress: Proceed with Caution. Primary Producer Access to Gene Technology (published 19 June 2000), pp. 129, 167-168. The report can be found at http://www.aph.gov.au/house/committee/primind/gtinq/report/contents.htm.
  14. Metherell, Mark "Alarm over GM seed mistake", Sydney Morning Herald, 25 July 2000.
  15. The Biosafety Protocol was adopted in January 2000 and opened for signature in May 2000. More information can be found at http://www.biodiv.org/biosafe/Protocol/Index.html.
  16. This is probably unlikely to occur before 2002. Australia has not indicated whether it intends to sign to Protocol in the immediate future.
  17. See http://www.wto.org/english/docs_e/legal_e/15-sps.pdf.
  18. Article 2.2 of the SPSA.
  19. Article 5.3 of the SPSA.
  20. Article 5.7 of the SPSA.
  21. In lay terms, WTO rules provides that if two alternative measures are equally effective in reducing risk and are equally cost-effective, the importing country must choose the one that in practice is least restrictive on importers. This aims to prevent countries erecting protectionist measures in the guise of valid quarantine and other regulations.
  22. This might be an issue on which the Ministerial Council may choose to provide advice to the Regulator through policy principles or guidelines, although policy principles could not be framed in a manner which derogates from the health and safety of people or the environment (proposed subsection 21(3)). Policy principles and guidelines are discussed later in this Digest.
  23. The Protocol actually uses the term 'living modified organisms' (LMOs), but for our purposes there is little substantive difference.
  24. Article 10.6 of the Biosafety Protocol.
  25. Report of the House of Representatives Standing Committee on Industry, Science and Technology, Genetic Manipulation: The Threat or the Glory? (February 1992).
  26. The Hon Ross Free, Minister for Science and Technology, House of Representatives Debates, p. 2270, 15 October 1992
  27. 'New Regulation of Gene Technology', Joint Statement, 30 October 1997. See http://www.isr.gov.au/media/archive/october97/327-97.html.
  28. A copy of this paper can be found at: http://www.health.gov.au/tga/gene/genetech/consultation.htm
  29. A copy of this paper can be found at http://www.health.gov.au/tga/gene/genetech/discuss.pdf.
  30. Explanatory Memorandum to the Gene Technology Bill 2000, p. 36.
  31. Ibid., pp. 37-41.
  32. Terms of reference for the inquiry can be found at: http://www.aph.gov.au/senate/committee/ADVERT/Genetech.pdf.
  33. An 'organism' only includes a biological entity which is viable (capable of living or growing), or capable of reproduction or of transferring genetic material (proposed subsection 10(1)).
  34. Universities are commonly constituted as corporations. It is an unresolved issue in constitutional law whether a university could be characterised as a "trading corporation" by virtue of aspects such as selling educational services, or selling the results of research. If they do fall within this definition, all the activities of universities would fall under Commonwealth control.
  35. In summary, the relevant agency (the NRA, ANZFA, the Director of NICNAS or the TGA) must seek advice from the Regulator in relation to products which consist of or contain GM products. There is no minimum threshold for GM content, so presumably a product containing even traces of a GMO or GM product must be referred to the Regulator for his or her advice. The agency must ensure that the advice of the Regulator is taken into account in making a decision, such as to grant an approval, registration or a licence. However, although the agency must inform the Gene Technology Regulator of the decision it ultimately makes, it is not obliged to follow the advice given by the Regulator.
  36. Consultations are needed to determine whether the Bill will also apply in Norfolk Island: Explanatory Memorandum to the Gene Technology Bill 2000, pp. 46-47.
  37. See Work in Progress: Proceed with Caution, op. cit., note 13, p. 138; and Minister for Health and Aged Care, Dr Wooldridge, Second Reading Speech on the Gene Technology Bill 2000, House of Representatives Hansard, p. 16737, 22 June 2000.
  38. Work in Progress: Proceed with Caution, op. cit. note 13, p. 139.
  39. See section 17 of the Ombudsman Act 1976.
  40. Interim Office of the Gene Technology Regulator, Discussion Paper: Proposed national regulatory system for genetically modified organisms. How should it work? (October 1999) p. 19.
  41. Work in Progress: Proceed with Caution, op. cit. note 13, p. 139.
  42. See proposed sections 101, 107, 112.
  43. Work in Progress: Proceed with Caution, op. cit. note 13, p. 137.
  44. Notifiable low risk dealings, exempt dealings and dealings on the GMO Register will not be deemed to have been granted a GMO licence, as they would not require one.
  45. See also Explanatory Memorandum to the Gene Technology Bill 2000, p. 49.
  46. Work in Progress: Proceed with Caution, op. cit. note 13, p. 130.
  47. Section 55 of the Constitution requires all taxes to be levied by separate legislation. This does not apply to a 'fee for service', which may be contained in the same statute as general regulatory provisions.
  48. Explanatory Memorandum to the Gene Technology (Licence Charges) Bill 2000, p. 1.
  49. Work in Progress: Proceed with Caution, op. cit. note 13, pp. 138.
  50. IOGTR, Explanatory Guide to the Gene Technology Bill 2000, (July 2000) p. 33. GMAC's guidelines are available at http://www.health.gov.au/tga/gene/gmac/gmacguid.htm (25 July 2000). Dealings which are currently exempt include: the fusion of mammalian cells which does not generate a viable organism; protoplast fusion between non-pathogenic microorganisms; protoplast fusion, embryo-rescue, in vitro fertilisation or zygote implantation involving plant cells; the production or use of gene 'knockout' mice; the introduction of naked nucleic acids into plants or animals, unless the nucleic acid sequences are both recombinant and capable of giving rise to infectious agents; and the introduction of genetically manipulated somatic cells into animals, unless they are capable of giving rise to infectious agents.
  51. IOGTR, Explanatory Guide to the Gene Technology Bill 2000, (July 2000) p. 46.
  52. See section 46A of the Acts Interpretation Act 1901.
  53. Work in Progress: Proceed with Caution, op. cit. note 13, pp. 127-128.
  54. See section 4AA of the Crimes Act 1914.
  55. Subsection 4B(3) of the Crimes Act 1914.
  56. The provisions relating to monitoring warrants and offence-related warrants are contained in proposed Part 11 Division 10.
  57. The Discussion Paper which preceded the Bill stated that all licence-holders would be subject to independent audits: Proposed national regulatory system for genetically modified organisms: How should it work? (October 1999), pp. 32-33.
  58. These types of conditions were mentioned in the Discussion Paper which preceded the Bill: Proposed national regulatory system for genetically modified organisms: How should it work? (October 1999), p. 32. These conditions are not legislatively required under the Bill, but may be imposed on a licence at the discretion of the Regulator.
  59. Section 44 of the Administrative Appeals Tribunal Act 1975.
  60. IOGTR, Explanatory Guide to the Gene Technology Bill 2000, (July 2000) p. 67.
  61. See discussion in 'Development of the Bill' in Background section of this Digest.
  62. See Anderson, Clifton E, "Genetic Engineering" (2000) 34(2) The Futurist, 20; Froggat, Antony and Rankine, Kerry, "Brave New World Revisited" (1999) 29(8) The Ecologist 464.
  63. Miller, Claire, "GM food: minister may lack say", The Age, 28 February 2000. These concerns have been echoed by Jeremy Rifkin, author of Biotech Century: Harnessing the Gene and Remaking the World (1998), in Rifkin, Jeremy, "Flying blind into the genetic age", The Age, 25 July 2000.
  64. This has been recommended by Independent member for Calare, Peter Andren, in his dissenting report in Work in Progress: Proceed with Caution, op. cit. note 13, p. 169.
  65. Stevenson, Andrew and Millett, Michael, "Farmers push ahead with GM crops", Sydney Morning Herald, 19 July 2000.
  66. The relevant press release by Minister Llewellyn of 30 June 2000 stated: 'Our concern is with the risk of genetically modified material reaching non-modified crops...we need to take great care with the way Tasmanian food products are perceived in the market places that accept our commodities'. See also Darby, Andrew "Hobart argues for a new approach", Sydney Morning Herald, 25 July 2000.
  67. It is unclear whether the Regulator may be appointed for a subsequent fixed term (p. 11). The Regulator is only required to report annually, not more frequently (p. 12). Policy guidelines made by the Ministerial Council are not disallowable instruments and do not have a mandatory consultation process (p. 13). The advisory committees will only be consulted in the development of policy if requested by the Regulator or Ministerial Council (p. 14). No provision for disclosure of the interests of committee members is required by the Bill (p. 14). It may be difficult to prove the commission of an aggravated offence, causing significant damage to the human health and safety or to the environment (p. 21).
  68. Probably the majority of dealings with GMOs may need to be evaluated to consider whether they may cause the spread of pests or disease. This is covered by the Commonwealth's quarantine power (section 51(ix) of the Constitution). Dealings that might not pose a risk of the spread of pests or disease could include therapeutic goods such as medicines and vaccines, organisms which are modified to enhance taste or for health reasons (such as sweeter tomatoes or vitamin-enhanced rice), and genetically modified bacteria (such as those used in the production of human growth hormone). Of those dealings, the Commonwealth can still regulate the activities of Commonwealth departments and authorities, trading, financial and foreign corporations (section 51(xx)), and any activities conducted in the course of interstate or international trade and commerce (section 51(i)).
  69. Activities which may fall outside Commonwealth power include contained research with GMOs conducted by State government agencies, such as State Departments of Agriculture. Field trials of GM crops conducted by State government bodies would presumably fall within Commonwealth power, because of the risk of spread of pests or disease. Contained research or release of risk-free GMOs (such as some pharmaceuticals) conducted by individuals, partnerships, research institutes and perhaps universities may also fall outside Commonwealth power.
  70. Making a regulation gives the Bill the maximum constitutionally permitted coverage, and excludes the operation of the non-corresponding State laws to the extent they are inconsistent with the Bill, by operation of section 109 of the Constitution. In proposed section 16, the Commonwealth has stated its intention not to 'cover the field', that is, to preserve the operation of State law as far as is consistent with the Bill. However, once a regulation is made in respect of a State law, the Commonwealth's intention is reversed, that is, it intends to cover the field and constitutionally exclude the operation of that named State law. Although the Commonwealth has no constitutional power to preclude the operation of State legislation in areas which it has no power to regulate, the operation of this provision would be restricted to be within Commonwealth power.
  71. See discussion in 'Opt Out' in the Concluding Comments section of this Digest.
  72. Explanatory Memorandum to the Gene Technology Bill 2000, pp. 14-15.
  73. Byrnes v The Queen; Hopwood v The Queen (1999) 73 ALJR 1292; Bond v The Queen (2000) 74 ALJR 597.
  74. [2000] HCA 22; (2000) 74 ALJR 802 at 809-810.
  75. A case raising some of the unresolved issues in respect of the powers conferred by State law on the Australian Securities and Investment Commission, GPS First Mortgage, is apparently listed for argument before the High Court later in the year.
  76. [2000] HCA 22; (2000) 74 ALJR 802 at 812.
  77. In R v Hughes [2000] HCA 22; (2000) 74 ALJR 802, a duty was implied from the mere power to prosecute, because of the circumstance that the State Director of Public Prosecutions was not to exercise any functions or powers conferred on the Commonwealth Director of Public Prosecutions. In effect, this imposed a duty on the Commonwealth Director of Public Prosecutions to exercise the power to conduct prosecutions, because no other body was able to exercise the power.
  78. Either through becoming a signatory to an international treaty dealing in detail with gene technology, through a reference of powers from the States to the Commonwealth, or by constitutional alteration through referendum.
  79. Explanatory Memorandum to the Gene Technology (Licence Charges) Bill 2000, p. 1.
  80. See IOGTR, Explanatory Guide to the Gene Technology Bill 2000, (July 2000) p. 75.
  81. See section 73B of the Income Tax Assessment Act 1936, which provides for tax concessions of 100%, 125% and 150% in relation to certain costs associated with research and development.
  82. See, for example, Work in Progress: Proceed with Caution, op. cit. note 13, p. 140; IOGTR, Explanatory Guide to the Gene Technology Bill 2000, (July 2000) p. 75.
  83. Stevenson, Andrew, "Farmer puts his faith in science and necessity", Sydney Morning Herald, 18 July 2000.
  84. The issue of the cost of GM seed varieties was briefly addressed in Work in Progress: Proceed with Caution, op. cit. note 55, pp. 89-91.
  85. IOGTR, Explanatory Guide to the Gene Technology Bill 2000, (July 2000) p. 76.
  86. Explanatory Memorandum to the Gene Technology Bill 2000, p. 11.
  87. Proposed subsection 27(l) of the Gene Technology Bill 2000.
  88. Explanatory Memorandum to the Gene Technology (Consequential Amendments) Bill 2000, p. 7.
  89. See comments of Australian GeneEthics Network, Organic Federation of Australia, Senator Natasha Stott-Despoja, summarised in Work in Progress: Proceed with Caution, op. cit. note 55, p. 128.
  90. See submissions of Environment Australia, CSIRO and the Western Australian government, ibid., p. 152.
  91. Ibid., p. 141.
  92. For example, under the Protection of the Environment Operations Act 1997 (NSW) the penalties for individuals who cause water and air pollution are $120,000 and $60,000 for each day the offence continues (sections 123, 132).
  93. For example, the Environment Protection and Biodiversity Conservation Act 1999 (Cth) prescribes gaol terms of up to 2 years for offences relating to endangered or threatened species (sections 196, 196B, 196D), listed migratory species (sections 211, 211B, 211D), whales (sections 229, 229B, 229D, 230) and listed marine species (sections 254, 254B, 254D). The maximum fine payable for these offences is 1000 penalty units. Under the Protection of the Environment Operations Act 1997 (NSW) the maximum penalty for wilfully or negligently causing harm to the environment by disposal of waste, leaks or spillage, or emission of ozone depleting substances is $250,000 or 7 years imprisonment (section 119).
  94. Proposed sections 175, 187 and 192. See discussion in the Main Provisions section of this Digest under the heading "Offences".
  95. See Work in Progress: Proceed with Caution, op. cit. note 13, p. 129.
  96. Including Senator Natasha Stott-Despoja of the Australian Democrats, "Democrats back farmers concerns on GMOs", AAP, 20 July 2000.
  97. IOGTR, Discussion Paper: Proposed national regulatory system for genetically modified organisms: How should it work? (October 1999), p 29.
  98. Section 92 of the Constitution provides, relevantly, that "trade, commerce, and intercourse among the States... shall be absolutely free."
  99. For example, a State law which prohibited growing GMO crops in field trials or commercial release would clearly be a law for an impermissible protectionist purpose if its purpose was to protect local agriculture and enable local growers to market themselves as "GMO free". It would also infringe section 92 if it was intended to protect the local environment, but the restriction went further than necessary to achieve the environmental aim. A State law prohibiting the sale of GMOs and GM products in a particular State might also infringe section 92 if no local businesses in that State manufactured or sold GMOs or GM products, as the sole burden of the law would fall on interstate traders.
  100. However, there have been no cases on section 99 of the Constitution since the 1960s. Accordingly, it is unclear if the narrow interpretation would continue to be applied today, particularly in light of the substantive and purposive interpretation now given to section 92. There have been suggestions that section 99, like section 92, is one of a series of constitutional provisions giving effect to the creation and maintenance of a free trade area throughout the Commonwealth: Capital Duplicators Pty Ltd v Australian Capital Territory (1992) 177 CLR 248 at 276-277 per Brennan, Deane and Toohey JJ. It may then be seen as a source of an individual right not to be treated differently in matters of trade and commerce merely on the basis of a person's State of residence. If this interpretation were to be adopted, it raises some doubts as to the constitutional validity of a Commonwealth "opt out" clause.
  101. Elliott v Commonwealth (1936) 54 CLR 657.
  102. IOGTR, Explanatory Guide to the Gene Technology Bill 2000, (July 2000) p. 29. Section 391.
  103. Buglass, Dan, 'GM Cash deal fair, says NFU President', 6 July 2000 http://www.scotsman.com/taf/farming.taf.
  104. See Kleiner, Kurt "Blowing in the wind", New Scientist, 14 August 1999, p. 18; Steinke, Darren, "Round one starts in farmer's GM fight with Monsanto", Reuters News Service, 5 June 2000.
  105. Evidence given by the IOGTR to the House of Representatives Standing Committee on Primary Industries and Regional Services, 5 April 2000, p. 266. There are no obvious examples of reported cases involving actions over damage caused by GMO contamination. However, it is clearly established that, under certain circumstances, the spread of dust, smells, noise or other things which restrict an occupier's enjoyment of his or her land will give rise to a suit of private nuisance.
  106. Work in Progress: Proceed with Caution, op. cit. note 13, p. 159.
  107. Lean, Geoffrey, 'Europe to act on GM pollution of organic farms', The Independent, 26 March 2000.
  108. Evans, David, 'EU Parliament Rejects GMO Liability Clause', Yahoo Science Headlines, 12 April 2000.
  109. This is clearly illustrated by a recent case involving a claim for damages for contamination, although not by GMOs. Perre v Apand Pty Ltd (1999) 164 ALR 606 involved South Australian potato farmers who were prevented from selling their crop in the lucrative Western Australian market because a neighbouring farmer's potatoes contracted blight, and their potatoes fell within the zone of quarantine. It took 7 years from the time the damage occurred before the final court decision was handed down. Judicial opinion was divided at all levels as to whether the damage was actionable at all, and whether the company that supplied the contaminated potato seed was liable. Even in the High Court, the Justices were unable to agree which of the plaintiffs were sufficiently directly affected to be able to recover for their loss.
  110. This has been done in unrelated areas such as workers' compensation. There is no precedent in other jurisdictions for the establishment of a statutory compensation scheme in relation to GMOs, and difficult questions arise as to who may be required to contribute to the scheme.
  111. Statutory liability currently exists in areas such as criminal injuries compensation and civil aviation carriers' liability, both in relation to personal injury or death and property damage. The rationale behind such schemes is that it is desirable that persons who suffer loss or damage be compensated for their loss, however, it is also desirable that the level of liability be capped. We can think of no precedent for such a scheme in relation to environmental damage or injury to human health.
  112. A useful summary of European Union policy and procedures regarding GMOs can be found in 'Facts on GMOs in the EU' Memo/00/43, 13 July 2000, at:
  113. http://europa.eu.int/comm/dgs/health_consumer/library/press/press63_en.pdf.
  114. Directive 90/219/EEC deals with 'contained' releases.
  115. The scope of Directive 90/220/EEC includes the placing on the market of GMOs and products consisting of or containing a GMO such as GM tomatoes, but does not extend to products derived from GMOs such as tomato paste: 'Facts on GMOs in the EU', op. cit. note 113.
  116. The GMOs in question were genetically modified maize and oilseed rape: 'Facts on GMOs in the EU', op. cit. note 113.
  117. To date, in all the cases so referred, the Committee decided the bans were not justified on the basis of the information provided to them: 'Facts on GMOs in the EU', op. cit. note 113.
  118. 'GM food debate continues in EU', Reuters, 20 July 2000.
  119. General information on gene technology regulation in the UK can be found at http://www.cabinet-office.gov.uk/gm-info/.
  120. Research and development are covered by the GMO (Contained Use) Regulations 1992.
  121. See http://www.dti.gov.uk/ost/ostbusiness/index.htm.
  122. See the Department of Agriculture's Biotechnology Website for more information at http://www.aphis.usda.gov/biotech/usda_biotech.html.
  123. More information can be found at http://www.fda.gov/oc/biotech/default.htm.
  124. See http://cbac.gc.ca/cbac/cbacweb.nsf/b8a5bbe305b2f7c98525681800116fd9/ddea7299beefd6fd852568e3006de0a8?OpenDocument.
  125. See http://www.ermanz.govt.nz/NewOrganisms/.
  126. Christensen, M and Williams, M 'First GMO approvals for New Zealand under New Law' (1999) 9(2) Australian Biotechnology 98; 'ERMA decision on Cattle Released', Press Release, 25 July 2000.
    See: http://www.erma.govt.nz/NewsIssues/files/PressReleases/2000/pr20000725.htm.
  127. See http://www.mfe.govt.nz/new/inquiry_into_geneticmod.htm.
  128. See http://www.ermanz.govt.nz/NewsIssues/files/PressReleases/2000/pr20000615.htm.
  129. More information can be found at http://ss.s.affrc.go.jp/docs/sentan/eintro/intro.htm

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