Research Paper 17 2000-01

Genetically Modified Governance Issues

Rosemary Polya
Science, Technology, Environment and Resources Group
6 February 2001

Contents

Major Issues
1-Introduction
2-What GE Products are Being Used in Australia?

Glossary

Artificially Selected

Conventional plant breeding techniques such as cross fertilisation, progeny selection and backcrossing

Biotechnology

Using biological systems for industrial purposes

Chimera (adj. Chimeric)

An organism composed of two or more genetically distinct tissues

Clone

An organism developed from a single ancestor

Genetic Engineering

Manipulation of genetic material to achieve changed functions in living organisms; e.g. increased production of a metabolite

Genetically Modified/Genetically Modified Organism

An organism that has been changed by using genetic engineering techniques at the molecular level

Genetically Modified Food

A food which has been derived from an organism which has been modified by gene technology

Governance

The way authoritative control is exerted ie through power, regulation, management, direction, command, system of government etc.

Metabolite

An organic compound, e.g. a sugar, produced in metabolism

Policy Principles

Disallowable instruments for the purposes of section 46A of the Acts Interpretation Act 1901 (Gene Technology Bill proposed section 21(4))

Precautionary Principle

Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environment degradation (Principle 15, 1992 Rio Declaration).

Recombinant Organism

An organism formed by genetic engineering techniques where the artificial combination of DNA molecules of different origins takes place, and hence there has been manipulation of genes or genetic material

Somatic Cells

Any plant or animal cell other than sex cells or their precursors

Substantially Equivalent

When a genetically modified food is deemed to have the same safety status as its conventional food counterpart

Transgenic Organism

An organism that has been altered through the insertion of foreign genetic material

Further Information

Useful biotechnology dictionaries may be found at:

http://biotech.icmb.utexas.edu/search/dict-search.html or http://biotechterms.org/

Acronyms

Major Issues

The creation of genetically modified organisms (GMOs), especially those used for the production of foods, has stirred up considerable controversy about who is minding the food store. Those involved in developing the technology or commercialising it for food or therapeutic uses are caught in a bind trying to assess, in the context of local and international trade perspectives, how their particular industry should proceed. There has been increasing attention paid to regulatory solutions both within Australia and overseas. Some guidance can be obtained by observing the pathways that other governments have taken to work towards management frameworks for GMOs. The Interim Office of the Gene Technology Regulator (IOGTR) has listed existing regulatory systems of other countries and their findings, along with a summary of national regulations in their submission to the Gene Technology Bill Inquiry.⁽¹⁾

Because the establishment of a legislatively based Australian regulatory framework for GMOs is in train, at Commonwealth and State levels, this paper aims to provide a summary of the major issues involved in the context of authoritative control or governance of the technology, genetic engineering (GE). The uptake of science based information, and the way it may be used in the governance process is of particular interest.

Different viewpoints of protagonists and antagonists in the GE debate may attract the attention of the media. However, the debate should now have moved on to the central issue, the way forward, namely: how can GMOs be appropriately regulated for in a manner in keeping with the democratic tenets of our society? The sting in the tail of economic rationalism and globalisation, although initially slowly understood, has now been acknowledged widely, the market does decide; consumer choice and the right to know are critical factors in the uptake of biotechnology. Governments have responded with upgraded or, in the case of Australia, new legislation.

Negative environmental and economic consequences due to introduced weeds and feral animals, e.g. prickly pear and rabbits, are common knowledge in Australia. In hindsight, attendant losses could have been prevented if there had been appropriate governmental oversight. Weeds alone are estimated to cost Australia $3.3 billion per annum in control costs, lost production and contamination⁽²⁾. Genetic engineering can be viewed simultaneously as a risk as well as a solution to such problems. A major difference between the recognition of the impacts of feral incursions in the first half of the twentieth century, and risks arising from genetic engineering technology, is that the general population is now better educated and informed thanks to extensive public education systems and the Internet. Additionally, there are better vehicles for the public expression of viewpoints.

At this stage, there appears to be more evidence about environmental than health based risks. However, in both cases, concerned national and international bodies agree that both vigilance and further research are required. Governments have different ways of managing for risk, the EU favouring the Precautionary Principle while the United States is wary of trade implications if such an approach was adopted internationally. Australia has included the Precautionary Principle, Principle 15 of the Rio Declaration, in the Gene Technology 2000 Act.

The genetic engineering era has coincided with a trend to smaller government and increased encouragement for the private sector to fill the void through mechanisms such as contracting out or self regulation. There is a trend towards reduced employment of experts, namely, scientists and technical specialists in government agencies. This is happening when the products of sophisticated technologies require extensive scrutiny so as to prevent health and environmental mistakes. There has been a corresponding adoption of the concept 'acceptable risk' rather than 'zero risk' in public policy design, e.g. in quarantine policy.⁽³⁾ Containment of escalating scrutinising costs has been a major driver of this policy direction. Lack of concrete data to assess risk in a scientifically adequate manner is a significant problem.

GM food was marketed prior to the comprehensive development of appropriate testing technologies and protocols. Resolution of toxicology issues has lagged behind the marketing of GM foods. Some objections to GM foods have arisen, not because of a Luddite reaction to the technology or a refusal to consider the benefits that biotechnology may offer, but because the cart was placed before the horse in terms of safety assessment. As exemplified by the recent UK inquiry into Aventis' GM fodder maize, Chardon LL, that the UK Government had proposed for addition to the UK's National List (of permitted seeds) in March 2000, the adequacy of data as presented by applicants has fuelled consumer unease. Lack of credible management frameworks and communications has contributed to consumer wariness.

Smaller government may place increasing pressures and responsibilities on local governments. Local level concerns about GM crops were expressed by local councils in a number of Australian states during 2000. The Gene Technology Act 2000 provides for the recognition of designated areas under State laws for preserving the identity of GM crops or non-GM crops for marketing purposes, but this may not necessarily resolve local government level GMO related administrative and financial matters.

At a grass roots level, consumer groups are demanding a coherent and transparent framework to control burgeoning biotechnology industries. Those in therapeutic and food related industries realise that there are benefits to be derived from regulatory certainty. Nations growing and trading GM crops have perceived that there is a need to balance both consumer and industry demands.

1-Introduction

This paper updates a 1999 precis of genetic engineering (GE) issues, Genetically Modified Foods-Are We Worried Yet?,⁽⁴⁾ as well as examining various themes and obstacles pertinent to the governance of this technology. Since 1999, the need for governance of genetic engineering technologies has become more pressing for trade, consumer, environmental, ethical and health reasons. This is exemplified by Australia's first attempt to establish a national legislative framework for genetically modified organisms (GMOs), the Gene Technology Act 2000 (GT Act). The Gene Technology Bill⁽⁵⁾ was introduced to the Australian Parliament on 22 June 2000 and was passed in December 2000, after some amendments arising from the Senate Inquiry into the GT Bill⁽⁶⁾ were taken on board. Further amendments on human cloning and experiments involving combinations of human and animal cells (section 192) that do not pertain to genetic modification as defined by the GT Act (section 10.1) were also included. Addition of the human cloning amendments to the Act serves as a recent example, that not only illustrates one of the threads in this paper, namely, difficulties involved in the governance of science based issues, but also highlights differing views about which organisms are covered by the GT Act.

Genetic engineering raises questions about the governance of science based issues generally, and lessons learnt from the GE debate can be applied to other technology governance issues. Firstly, it is difficult for a science based issue to be publicly debated if concepts are not understood, whether the concept "science" itself, or more narrowly, what meaning is agreed to for terms such as "genetic engineering" or "genetically modified organisms".

Unfortunately, the word 'science' carries an unjustified mystique that can discourage vital debate about science based issues. This may perturb the way science based decisions are reached by governments. 'Science' is merely a shorthand way of describing knowledge that has been acquired by observation and deduction, and is collected incrementally. Science can be viewed as a type of history. Sometimes 'scientific facts' may have been arrived at from incomplete observations or from faulty deductions. 'Science' is not necessarily an exact discipline. The European Commission's (EC) communication on the Precautionary Principle states:

Risks arising from simple or complex technologies require management through regulation. When governments regulate for a science based issue, such as genetic engineering, apart from definitional uncertainties for terms such as 'genetically modified', they are grappling with an incomplete body of knowledge. For this reason, the degree of risk that society is prepared to manage must be gauged, in terms of whether low, medium or high chances for hazardous, dangerous or injurious outcomes are likely to arise. If risks are not enumerated, communicated and evaluated adequately, a major consequence may be limited legislative management with potential consequences not only to public health and the environment but also for national prosperity. After some debate, the issue of scientific uncertainty was addressed in Australia's Gene Technology Act 2000 (section 4aa), using the precautionary approach of Principle 15 of the Rio Declaration⁽⁸⁾:

Central to the GE debate is the need for legislative approaches for the creation of national GE regulatory frameworks. In keeping with democratic tenets, in progressing government regulation, both the Interim Office of the Gene Technology Regulator (IOGTR) and the Australia and New Zealand Food Authority (ANZFA) have undertaken considerable public consultation processes before final or draft documentation has been submitted for consideration by elected government representatives. Of course there are other considerations that may mould final outcomes, for example, the tussle between industry and consumer concerns.

Necessity for public engagement is acknowledged in Australia's National Biotechnology Strategy, released in July 2000,⁽⁹⁾ with an introduction by the Commonwealth Biotechnology Ministerial Council and the advisory body from research and business sectors, the Biotechnology Consultative Group. Biotechnology Australia reports to the Biotechnology Ministerial Council and co-ordinates non-regulatory aspects of the government's activities such as public awareness and the National Biotechnology Strategy. Some may view the interface between science and government as being as problematic as insufficient public education about genetic engineering issues in the past, weakness in the interface contributing to a less than adequate public communications process. The Dutch science writer and philosopher Ad van Dommelen points out in Hazard Identification of Agricultural Biotechnology that:

Furthermore

The passage from community consultation to the development of regulatory mechanisms for managing GMOs has been characterised by controversy globally. Biotechnology lobbyists may be seen as pioneers of a new era where gene technologies can solve previously unsolvable problems, especially health and food security issues. Genetic engineering has been directed to managing weed and feral incursions that limit agricultural productivity. This paper examines some obstacles to this vision. For example, insufficient legislative instruments may hinder further take-up of GE crops. In Australia's case, the Senate Inquiry into the Gene Technology Bill, A Cautionary Tale: Fish Don't Lay Tomatoes,⁽¹¹⁾ including minority reports, provided recommendations to refine the Gene Technology 2000 Bill. Although grounds for further alterations and additions to the GT Bill were identified, most recommendations were not included in the GT Act. The GT Act represents a beginning and holds the promise of further developments in GE regulation in the future in response to international and national requirements.

While Australia has elected to take a legislative and regulatory pathway with the passage of the GT Act, Dr Richard Jefferson of the Centre for the Application of Molecular Biology to International Agriculture (CAMBIA) takes the view that over-regulation may hinder research and innovation. Also, it could increase the power of multi-national companies because they have the financial resources to pay for regulatory costs.⁽¹²⁾

As Australia develops a regulatory framework, a number of unknowns need to be considered. Issues relating to the following questions are discussed in the paper, but it is for the reader to decide on their preferred answers.

Questions about the contested aspects of the technology include:

• What constitutes adequate environmental and health safeguards for this technology?
• What constitutes 'acceptable scientific certainty' and 'acceptable risk'?

Questions about matters that are currently unfolding include:

• What level of regulation will voters and industry tolerate?
• Will consumers refuse to buy GM foods, whether for ethical, political or science based reasons?
• How will the GMO issue impact on local and international trade?
• How successful will the administration of the domestic regulatory framework be? (ie. re crop trials and commercialisation of crops, medical uses, control of feral animal populations, GM food labelling)
• What are the limitations of the framework?
• How will Commonwealth, State and Territory and Local governments respond?
• Will the regulations be flexible enough to cater for new GMO information and developments, especially environmental and health effects?
• What communication strategies are and will be employed, who will undertake them and what are the likely respective biases?
• How will the trading blocs respond?
• How will international level trade in GMOs proceed?
• How will the World Trade Organisation/Cartagena Protocol on Biosafety interaction proceed and how will this affect Australia?
• The extent of the acceptance, rejection and influence of the Precautionary Principle by governments?

The recent EU-US Biotechnology Consultative Forum Report, commissioned by the Presidents Clinton and Prodi, succinctly identified contextual elements that must be considered when considering regulation of new technologies, the far reaching effects of new technologies, globalisation, the role of the citizen and safeguarding the future⁽¹³⁾.

Please note that this paper was completed in mid January 2001. For subsequent developments, check pertinent web sites provided in the bibliography. Please note that some documentation may have been withdrawn from specified web sites.

2-What GE Products are Being Used in Australia?

Food

Many foods on sale in Australia contain genetically modified (GM) ingredients. However, until GM labelling regulations come into force on 7 December 2001 it will not be clear to the consumer if foods contain GM ingredients or not. The Australia New Zealand Food Standards Authority (ANZFA) envisages that a leaflet explaining GM labelling requirements will be made available at supermarket outlets in 2001.

The Table to Clause 2 of Standard A18 - Food produced using Gene Technology now lists 7 approved GM foods, various lines of canola, cotton and soybean⁽¹⁴⁾. When the Australia New Zealand Food Standards Council (ANZFSC) approves further GM foods they will also be listed. Two GM staples that were previously given interim approval in 1999 were approved for use by the ANZFSC on July 28 2000: Monsanto's Roundup Ready soybean and Ingard cottonseed oil. The ANZFSC approved insect protected corn, glyphosate-tolerant cotton, glyphosate-tolerant corn, glyphosate-tolerant canola and high oleic acid soybeans at their 24 November 2000 meeting.⁽¹⁵⁾ The advantage of high oleic acid soybeans is that they have lower saturated fat levels than conventional soybeans. By the beginning of October 2000, ANZFA had released a total of twelve GM food assessments for public comment. These include the imported GM corn lines, Bt-176 and Bt-11, and a number of Monsanto's New Leaf GM potato lines that ANZFA has declared safe for human consumption. Further assessment reports are expected to be released soon. At this time, it appears that various GM soybean, canola, corn, cotton, sugar beet and potato lines, included in many food stuffs,⁽¹⁶⁾ are likely to be assessed favourably.

Trials and Commercial Releases

The extent of experimental GM crop trials currently under way in Australia is uncertain. The Genetic Manipulation Advisory Committee's (GMAC) web site⁽¹⁷⁾ provides a list of crops being trialled, and has listed the location and size of some trials, but the exact lines (specific genetically modified crops - eg potato line RBMT15-101) are not stipulated. GMAC also lists current proposals separately. GMAC has guidelines for crop trials, but different conditions apply depending on risks involved for each successful application.⁽¹⁸⁾ The lack of transparency about the location of GM trial crops caused a flurry of press commentary in March 2000 about extensive GM canola trials where locations were not revealed because of commercial-in-confidence reasons⁽¹⁹⁾. Under the GT Act (section 185.2A), the Regulator must disclose information about GMO field trials unless this might 'involve significant risks to health and safety'. If locations cannot be revealed, the Regulator is obliged to explain the decision in a publicly available statement (section 185.3A).

At present, although the GMAC web site contains a considerable amount of information, it would be relatively difficult for a farmer to establish a locational list of GM trials, e.g. in the Wagga district. (In their first Information Bulletin the Interim Office of the Gene Technology Regulator (IOGTR) announced new measures for disseminating GMO information at their web site, requesting ideas for improvements in the process).

The GMAC Secretariat provided the following statistics to the Department of the Parliamentary Library:

There have been 30 new proposals since February 2000. Since 63 per cent of the trials are being undertaken by government rather than the multi-national companies, this has significant consequences for any future liability actions. Government bodies may be positioned between those that own the technologies and any adverse consequences. Patrick Holden from UK's Soil Association claimed that Australia was being used as an international laboratory for developing GM crops. On the other hand, the Grains Council of Australia counselled that it would be to Australia's detriment, not to take advantage of the food technology benefits to be derived from the use of agricultural biotechnology. ⁽²⁰⁾

The National Registration Authority (NRA) released a GM pesticide in 1989 and a salmonella vaccine in 1992.⁽²¹⁾ The Genetic Manipulation Advisory Committee (GMAC) has approved a carnation and Ingard cotton. The latter is a Bt cotton, that is, it contains a gene for one of the toxins produced by Bacillus thuringiensis, a bacterium traditionally used by organic farmers to kill insect pests. Monsanto's Roundup Ready cotton, resistant to the weed killer, glyphosate, was approved for commercial use in September 2000, along with Roundup Ready/Ingard cotton.⁽²²⁾ The latter carries the herbicide resistance of Roundup Ready cotton along with the Bt gene derived toxin of Ingard cotton.⁽²³⁾

Concerns have arisen because of claims that GM seed grown in Australian trials were intended for export to the US and Canada for commercial seed production. If seed is transferred between companies' Australian and American branches, and is non-commercial in Australia, there are no export controls.⁽²⁴⁾ In December 2000, GMAC announced Aventis' proposal to grow 1100 hectares of GM canola in WA, SA, Queensland and Victoria to obtain seed for a Canadian trial⁽²⁵⁾.

Therapeutics

A range of drugs is produced through genetic engineering: insulin, hepatitis B vaccine, human growth hormones and blood-clotting agents. Professor Shine, head of the Garvan Institute of Medical Research, pointed out recently that the advantage GM medicines had over GM foods in terms of acceptability was that the medicines were derived from human genes. Labelling GE drugs as such does not seem to present a problem to drug companies⁽²⁶⁾ while there has been considerable reluctance on the part of food manufacturers to do so.

3-Surveys

Australian surveys have served to communicate a range of community perceptions about genetic engineering. The author's previous paper⁽²⁷⁾ summarised some public reporting of genetically modified (GM) food surveys up to May 1999, the conclusion being that there were considerable differences between the findings. This is still the case.

Public reports of some more recent Australian surveys are listed at Appendix A. They demonstrate a galvanising of opinions about GM foods. However, surveys are often privately commissioned, for commercial and/or public relations reasons, and reports of these surveys in the press may be only summaries derived from press releases of the commissioners. In the case of the Biotechnology Australia July 2000 survey cited in Appendix A, the results were derived from a press release. While it is understood that in this instance there was considerable data generated, the actual survey report is not in the public domain and so accurate contextual evaluation is restricted. Consequently, the number of surveys undertaken reveal that there is considerable interest in the issue, however, without examining the surveys themselves, it is difficult to reach a concrete conclusion about the reported results.

4-Regulation

Australia

It was recognised by the mid-1970s that some form of guidance for those using biotechnology was needed. For example, there were concerns for laboratory workers conducting experiments with GM Escherichia coli in the US. In 1975, both Australia and the US produced GE research guidelines. This was followed by the creation of the Recombinant DNA Advisory Committees⁽²⁸⁾ of the US National Institute of Health. By 1981, Australia had a voluntary regime established by a Recombinant DNA Monitoring Committee. Their 1986 five year review indicated the view that existing State and Commonwealth agencies had legal responsibility for releases of novel agents and that specific gene technology legislation was not needed.⁽²⁹⁾ The US first regulated for biotechnology⁽³⁰⁾ in 1986 with the Co-ordinated Framework for Regulation of Biotechnology involving the USDA (Department of Agriculture), the EPA (the Environment Protection Agency) and the DHHS (the Department of Health and Human Services).

In Australia, the Genetic Manipulation Advisory Committee (GMAC) was established in 1987, in addition to a Group of Officials on Biotechnology Regulations. It was not until 1992 that a legislative approach was proposed in response to the House of Representatives Standing Committee on Industry, Science and Technology Report, Genetic Manipulation: The Threat or the Glory?.⁽³¹⁾ The prospective establishment of the Gene Technology Office (GTO), along with legislation to ensure uniform laws and compliance, was not announced until October 1997.⁽³²⁾ The establishment of the Interim Office of the Gene Technology Regulator (IOGTR), within the Therapeutic Goods Administration (TGA), to begin drafting GE legislation and undertake necessary consultation process, was announced in the 1999-2000 Commonwealth Budget. The instrument needed to achieve the creation of the Gene Technology Office and a Commonwealth legislative framework, the Gene Technology Act 2000 (GT Act), was passed by the Australian Parliament in December 2000.

The difficulty in arriving at an agreed regulatory regime, in Australia, is exacerbated by Australia's federal structure and the number of departments and agencies necessarily involved. The Biotechnology Ministerial Council comprises the five pertinent ministers, the Ministers for the Environment and Heritage; Agriculture Fisheries and Forestry; Health and Aged Care; Education, Training and Youth Affairs; and the Minister for Industry Science and Resources, who is also Chairman. Areas of regulatory and administrative control are under the aegis of a number of agencies within these Ministries, along with the Department of Foreign Affairs and Trade. A recent summary of Government biotechnology activities is provided in Australian Biotechnology. Progress & Achievements⁽³³⁾. The extensive number of agencies involved can be found at Appendix B. The GT Act will be administered by the Minister of Health and Aged Care when it comes into force on 20 June 2001.

Uncertainty about Australia's regulatory situation was exemplified by Tasmanian moves in 2000 to implement a year long moratorium on the growing of GM crops under their Plant Quarantine Act 1997. Unless legally tested by the Commonwealth, the validity of respective State actions was viewed as uncertain. Use of planning powers of local governments (derived from State legislation) to block GE trials were variously being explored. (See the Gene Technology Bill 2000 Bills Digest for an amplification of legal issues⁽³⁴⁾ as well as the IOGTR submission to the Inquiry into the GT Bill⁽³⁵⁾). The GT Act allows for the recognition of designated areas under State laws which then will enable the States and Territories to preserve the identity of GM crops or non-GM crops for marketing purposes (section 21aa).

The sheer communications complexity involved between intra-State, intra-Commonwealth and State/Commonwealth agencies promises misunderstandings and confusion at the very least. At each jurisdictional level, at a minimum, environment, health and agriculture agencies, along with premiers' departments are involved. While encompassing many jurisdictional agencies, negotiations to establish a consistent national regulatory scheme proceeded at a Premier's department (or equivalent) and Cabinet levels. When the GT Bill was placed before Parliament, the Draft Gene Technology Regulations were not yet in the public arena, making it difficult to readily identify the devil in the detail. The Draft Regulations were available⁽³⁶⁾ when the GT Bill was debated in December 2000 and the revised Draft Regulations were released in January 2001. However, the Draft Intergovernmental Agreement between the States, Territories and the Commonwealth was not a public document when the Gene Technology Act 2000 was passed by the Australian Parliament. The Draft Intergovernmental Agreement is still not in the public domain.

Management of GMO issues at a local government level do not appear to have been fully explored and may well prove to be problematic. For example, the audit of Aventis Crop Science Pty Ltd, which includes consideration of the recent dumping of GE waste of an Aventis canola with resistance to the 'Liberty' herbicide, glufosinate ammonium, at a Mount Gambier tip, found that there was a risk of uncontrolled seed dispersal. The possibility of weeds acquiring the traits from the GM canola was also viewed with concern.⁽³⁷⁾,⁽³⁸⁾ This breach of GMAC conditions also reminds us of the potential for a considerable gap to exist between in practice and theoretical management of GMOs at this time. While IOGTR found that the breaches did not increase human health risks and environmental risks were low, they identified that Aventis did not always comply with GMAC recommendations, namely:

• Always establishing a 15 metre buffer zone of non-transgenic canola around plantings at summer trial sites to minimise pollen escape
• Monitoring of a 50 metre zone for all sexually compatible species
• Monitoring for, and removal of, volunteer plants after the trials; and compliance with the procedures for the transport and disposal of field trash.⁽³⁹⁾

While the GT Act represents the first steps along a GE legislative track, at this stage, it does not necessarily hold the promise of resolving such issues or supporting local government requirements.

Overseas Regulation

Australia has lagged behind some major players in the development of a GE regulatory framework; both the European Union (EU) and the US have not only had regulations in place for years but are in the process of re-assessing their management of GMOs. For instance:

The United States had the Co-ordinated Framework for Regulation of Biotechnology in place by June 1986, the participants being the three departments: US Department of Agriculture (USDA), the DHHS (the Department of Health and Human Services) and the USEPA (the Environment Protection Agency). The International Consumers for Civil Society have issued a summary of current US regulation of agricultural biotechnology.⁽⁴⁰⁾ The USFDA's (Food and Drug Administration - an agency of the DHHS) May 1992 policy required that GM foods should be labelled as such if there were significant compositional differences from regular equivalent foods.⁽⁴¹⁾ Draft voluntary guidelines for GM labelling were issued in January 2001.⁽⁴²⁾ By 1990, the USFDA had their first food related regulation for a substance derived from the use of recombinant DNA techniques, chymosin, a milk-clotting enzyme used to make cheese.⁽⁴³⁾ (Note that the USFDA's powers are derived from the Federal Food, Drug, and Cosmetic Act 1906).

The EU has had a range of GE Directives in place for up to a decade.⁽⁴⁴⁾ Amendments to one of its GE Directives, namely, Directive 90/220/EE of 23 April 1990 on the deliberate release into the environment of genetically modified organisms⁽⁴⁵⁾ are yet to be finalised. The amended Directive is expected to be in force in 2001. The EC's Communication to the European Parliament on 3 November 2000 briefly describes the history of Directive 90/220/EC along with amendments that have been accepted, either totally, partially or in principle.⁽⁴⁶⁾ Interim measures now allow EU member states to test sugar beet, maize, rapeseed, soybean, cotton and tomato seeds if GM presence is suspected. A 0.5 per cent contamination level is permitted for seeds covered by EU authorisation, those seeds without authorisation have a zero threshold for GM material. Legislation will follow.⁽⁴⁷⁾ European Commissioner Byrne recently described an interim approach, beyond Directive 90/220/EEC, looking at the whole regulatory framework for GMOs, including traceability and labelling, introducing legislation on novel feed, and updating seed and food legislation.⁽⁴⁸⁾

GE decisions of other nations, trading blocks and international bodies are influencing Australia's course of action. The EU/US disagreements are of particular importance. The EU/US have not reached an agreed position at the Codex Alimentarius Commission (CAC) level (international food standards setting body) about what 'scientific certainty' means in the context of living modified organisms (LMOs) and it appears increasingly unlikely that they will do so. Other likely impacts on future international regulatory and trade directions may stem from meetings of the Intergovernmental Committee for the Cartagena Protocol on Biosafety (Biosafety Protocol). At their December meeting, signatories agreed to set up an international biosafety information centre, while the next meeting, in October 2001, will examine the decision making process and how Protocol commitments will be met.⁽⁴⁹⁾

In December 2000, the EU-US Biotechnology Consultative Forum established by President Bill Clinton and the European Commission's President Romano Prodi, established a number of recommendations designed to restore public confidence in agricultural biotechnology. Both Presidents agreed to pursue a co-operative approach and to consider the recommendations.⁽⁵⁰⁾ Of particular interest is the EU-US Biotechnology Forum's Recommendation 19 that biosafety principles in the Protocol should be forwarded. The new US administration's response, if any, to Recommendation 12, which is on the role of precaution and managing 'substantive uncertainties' is awaited. The Forum's rational for Recommendation 13, on regulation, that 'a rush to judgement [of GMOs] will be self-defeating to both the public and industry', is a salutary but belated warning.

5-Australian GE decisions

In late 2000 two major Australian GE decisions were taken. Firstly, the gene technology legislation: namely, the Gene Technology Act 2000, Gene Technology (Licence Charges) Act 2000 and Gene Technology (Consequential Amendments) Act 2000, was passed. Secondly, the GM food labelling specifics, namely: Standard A18 - Food Produced Using Gene Technology, in the Food Standards Code, was gazetted.

Australia has not as yet indicated when, or whether, they will sign the Cartagena Protocol on Biosafety.

Gene Technology Act 2000

The object of the Gene Technology Act 2000 (section 3) is:

The GT Act provides for the establishment of the Office of the Gene Technology Regulator (OGTR) and the Gene Technology Regulator (GTR). The GTR's functions include making decisions about GMO licences and drafting policy principles and policy guidelines as requested by the Ministerial Council. Other roles include informing and providing advice to other regulatory agencies and the public, undertaking or commissioning GMO risk assessment and biosafety research, as well as harmonising risk assessments for GMOs and GM products (section 28). The aim of the government is to have the OGTR operational by 20 June 2001. A Ministerial Council will set policy principles (section 21).

Science/Government Interface

The GT Act demonstrates difficulties encountered with the interface between science and government. The GTR and the Ministerial Council are to obtain their advice from the same source, GTTAC (Gene Technology Technical Advisory Committee). Beyond concerns about the selection process for GTTAC scientists, and despite the intention to co-opt additional scientists when needed, it can be argued that the proposed circular model could limit access to a range of scientific opinions. Given that advice provided may be in the realm of 'contested science expertise' and that GMAC has attracted some criticism, the way scientific advice is provided to governments is fundamental to the governance issue.

If it was the intention of the Interim Office of the Gene Technology Regulator to separate process and decision making from policy matters, when drafting the GT Bill, there were at least two potential obstacles to this in the GT Bill. Amendments have partially corrected this in the GT Act.

The GTR (the decision maker) can be constrained by the Act's 'policy principles' that are issued by the Ministerial Council (the policy makers) (section 21). Policy principles are disallowable instruments, that is, they may be rescinded by Parliament and they may be related to ethical issues or regulations. The impact of the regulations is not known at this time. For instance, it is unclear at this stage what potential there is for the decision maker, the GTR, to be constrained by the policy makers, the Ministerial Council, and, further to this, what impact this could have on GMO administration in Australia.

The second potential problem was resolved by an amendment to the GT Bill (section 100.7a). The three committees proposed in the Bill (GTTAC, the Gene Technology Community Consultative Group (GTCCG) and the Gene Technology Ethics Committee (GTEC) cover ethical, societal and scientific concerns. Under section 101, only the science based committee, the GTTAC, could be directly involved in providing advice on GMO licences and other applications. In the GT Bill, GTTAC was not to include a member of either the consultative or ethics committees, but, an amendment (section100.7a) ensures that the community and ethical input of these committees are to be represented on GTTAC. (Note that a further amendment in the GT Act formally upgraded the GTCCG, a group, to a committee, the Gene Technology Consultative Committee (GTCCC)).

The Minister of the Department of Health and Aged Care will appoint GTTAC members, the major constraint on the Minister being that the majority of jurisdictions (ie States, Territories and Commonwealth) agree to each appointment. It could be argued that there is potential for the development of a perception that the science/politics divide could be muddied at State, Territory or Commonwealth levels. On the other hand, the selection of GTTAC members by the GTR (the decision maker) could hold the potential for accusations about bureaucratic dominance and lack of transparency. The Regulations do require conflict of interest and disclosure of interest requirements.⁽⁵¹⁾

Whether the principle of separating science and politics is a given, or if a continuum between science and policy is seen as preferable, other models for the selection of scientists for GTTAC could perhaps have been considered. For example, in order to build in a wider range of participation and expertise, scientists could have been nominated by the range of professional organisations with subject expertise areas as specified at section 100 in the GT Act. The Minister then could have selected from the changing pool of professional organisations. For example, the Australian Research Council (ARC) and the Rural Research and Development Corporations (RDCs) have recently recommended the formation of a National Biotechnology Network of Scientists to serve as a reference group for emerging science and technologies including commercial and environmental perspectives. If formed, it would be a useful organisation to draw upon.⁽⁵²⁾

Organisms Covered by the Act

Human cloning is covered by the GT Act even though the replacement of the whole nucleus is involved rather than 'genetic modification', ie the modification or insertion of a gene or genes. Also, the GT Act covers instances where human cells have been introduced into animal embryos, in the case of Amrad's recently acquired patent for mixed embryos.⁽⁵³⁾ On the other hand, transgenic goats, with a human gene to enable the production of human albumin in their milk, were and are within the intended scope of the Act⁽⁵⁴⁾, namely, genetically modified organisms.

Until additional regulations are written for the Senate's section 192 amendment to the Gene Technology Bill 2000, there will be some uncertainty about what organisms are covered by the GT Act. The Act has a broad definition of gene technology (section 10.1) that covers modification of genes or other genetic material but excludes:

That is, human cloning is not specifically covered in section 10.1.

Under the GT Act 'genetically modified organism' means:

Issues covered by section 192 are human cloning (ie duplicating a whole human being as defined by the GT Act (section 192), the insertion of a combination of human and animal cells into a human uterus, or putting human cells or a combination of human and animal cells into animal eggs. These processes were not specified in the Gene Technology Bill 2000. These important matters were not given the in depth examination that was given by Interim Office of the Gene Technology Regulator's (IOGTR) to other issues covered in the development of the draft Bill. The amendments (section 192) are certain to require clarification though additional regulations and may well require additional legislation in the future. Given the intention to roll back powers to the States, clarity may be obtained in the States' cloning legislation.

As Nicholas Tonti-Filippini has pointed out, section 192 was formulated hastily⁽⁵⁵⁾ and fails to address the complexities involved. Section 192 deals with biotechnological manipulation at the human cellular/subcellular levels rather than at the molecular level that pertains to the modification of genes or other genetic material. For example, there is room for doubt about whether or not the insertion of human genetic material from the 'initial organism' into an enucleated human cell is necessarily covered by these provisions, especially if the result is not an exact duplicate whole human being. When seeking clarification from the IOGTR on this point it appeared that the National Health and Medical Research Council (NHMRC) will be advising the IOGTR and the States about the implications of section 192. This lack of clarity serves as a cogent example of pitfalls in the governance of issues that deserve, not only an extensive examination of scientific and ethical parameters, but also, an informed public debate about them.

Environmental and/or Health and/or Agriculture Watchdog?

Power vested in one person, the GTR, could also be seen as potentially problematic. While the GTR's role is to make individual decisions about GMOs, the cumulative effects of the GTR's individual decisions will have an extraordinary influence on the way GMOs are managed in Australia. It should be noted that while the GTR will be advised by scientists, the GTR may not necessarily be science trained. For example, the Interim Regulator has legal qualifications. The GT Bill 2000 Inquiry's recommendation that the Regulator should be a statutory authority consisting of three people was not taken up.⁽⁵⁶⁾

Each jurisdiction will contribute a minister to the Ministerial Council and it will be up to each State or Territory to decide whether to send an environment, health, industry or agriculture minister to the Council. Consequently, this Ministerial Council may operate differently from other government models. For example, the National Environment Protection Council (NEPC) comprises jurisdictional environment ministers and the Murray Darling Basin Ministerial Council includes ministers from environment and agricultural (or their equivalent) departments from each State or Territory. While ANZFSC currently comprises all jurisdictional health ministers (including New Zealand), the November 2000 Food Regulation Agreement provides for a replacement council, the Australia and New Zealand Food Regulation Ministerial Council, comprising health ministers as well as ministers from other portfolios.⁽⁵⁷⁾ It is arguable whether competing environment, health and agricultural agendas could hinder or enhance the objectives of the GT Act. The chair of the Ministerial Council will initially be the Commonwealth Minister for Health and Aged Care because this portfolio will administer the GT Act. It is anticipated that the chair will rotate. Some see a Trans Tasman approach, perhaps along the same lines as ANZFSC, as desirable, given close trading ties and the Trans Tasman Mutual Obligation Agreement. At this stage, New Zealand is not a participant. Since Australia has not as yet signed the Cartagena Protocol on Biosafety, and New Zealand has, some administrative adjustments of arrangements between the two countries may be required, if the Protocol comes into force.

There is an international trend for the creation of single, centralised, food safety agencies, e.g. UK, the EU and Canada. Although this approach was advocated by the US National Academy of Sciences in order to avoid jurisdictional disputes,⁽⁵⁸⁾ the suggestion has not been taken up. In Australia, it is intended that ANZFA will be replaced by Food Standards Australia New Zealand (FSANZ). It is not clear how food science, public health, trade and food industry interests will be accommodated within the new agency. In Europe, the peak biotechnology industry body, EuropaBio,⁽⁵⁹⁾ has advocated that the forthcoming European Food Safety Authority should have the final say about GM food safety matters.

In Australia, the administration of gene technology will not be so clear cut under the proposed arrangements because the Gene Technology Regulator (GTR) is only responsible for those areas where there are existing regulatory gaps (e.g. where existing regulators ANZFA, the NRA, the TGA and AQIS currently have no control). An array of circumstances may arise where the GTR will not have sole responsibility for biosafety issues. In practice, there lies a potential for the type of relationship that exists in the US between the three major Federal government players, with competing interests, namely, health, environment and agriculture.

Biotechnology public awareness communication is enshrined in Australia's National Biotechnology Strategy, launched by the Biotechnology Ministerial Council and chaired by the Minister for Industry Science and Resources. Because much consumer concern about gene technology relates to food safety and consumer choice, an overarching health communication strategy could be seen as preferable. While it is important that Biotechnology Australia (BA) and the Bureau of Resource Sciences do provide biotechnology communications to the public, both have industry facilitation roles. It could be also argued that the dual GT Act objectives of health and environmental safety could prove to be onerous and conflicting burdens for the GTR.

Dissimilar GMO management approaches by various Australian agencies may lead to mishaps or oversights. The Bills Digest also suggests that the delegation powers of the GTR to other agencies could also lead to problems.⁽⁶⁰⁾

Gene Technology Act 2000 Gaps

Because the draft Intergovernmental Agreement (the draft Gene Technology Agreement (GTA - the agreement between States, Territories and the Commonwealth Government)) is not publicly available, the workability of the GT Act holds some uncertainties. Those making submissions to the Inquiry into the GT Bill did not have access to the draft GTA or the Draft Gene Technology Regulations and so were unable to comment in the full context of the proposed gene technology regulatory framework. The GTA is not expected to be publicly available until it is signed early in 2001.

It is likely that States and Territories will have different legislative responses, complementary rather than mirror legislation used by NEPC, for example. As States and Territories introduce their legislation the Commonwealth will wind back pertinent responsibilities. All jurisdictions appear to have reached agreement about the GTA.

Opting Out

Tasmania was unwilling to sign the GTA without the inclusion of opting out mechanisms⁽⁶¹⁾ and in early November 2000 the Commonwealth agreed to grant Tasmania opt out rights.⁽⁶²⁾ While is understood that a 'policy principle' will be developed to cover this situation, the section 21aa amendment, previously mentioned on p.9, caters for Tasmania's GM-free marketing concerns. Tasmania is currently exploring their future position on the issue through a GMO inquiry. Previously, at the Commonwealth's GT Bill Inquiry, an IOGTR adviser had suggested that there were a number of ways that could be explored to accommodate Tasmania's needs. If there were health and environmental risks the GTR could disallow the release of a GMO. If Tasmania wanted to create a GM-free image a possible solution would be for 'policy principles' to be developed by the Ministerial Council that entailed 'protecting Australia's diverse farming practices' that might lead to the declaration of GM-free zones in various areas in Australia. States and Territories could also use their own legislation 'whether land planning legislation or, in Tasmania's current case, plant quarantine legislation'.⁽⁶³⁾

Despite section 21aa, Mr Kim Chance, the Western Australian Opposition agriculture spokesman, indicated that although Labor would work in the system, wider opt-out provisions for the States would have been preferable, and that a WA Labor government would test these provisions.⁽⁶⁴⁾

Problematic Matters

The Gene Technology Bill 2000 Bills Digest discusses the Bill in detail. Some unclear areas in the Bill include:

• Fines may be imposed for offences against the GT Act but it appears that Common Law is the only vehicle for a third party to bring an action against an offender
• For an offender to be successfully prosecuted for an aggravated offence under the GT Act (section 38) it must be proved that they:

• Uncertainty about liability if the industry applicant has complied with OGTR's conditions
• Commercial-in-confidence rights will limit transparency
• The operational relationship between the Environment Minister and the Gene Technology Regulator (GTR) and lack of the right of veto over GMOs, apart from with respect to matters of national environmental significance, are cause for concern. The GTR 'must take into account' the Environment Minister's advice re risk assessment and risk management plans for the intentional release of GMOs into the environment (section 50(3)), but as the decision maker, the GTR isn't obliged to take the advice. The GTR is answerable to Parliament however. The Environment Minister could commission scientific studies on the impact of GMO releases but they would have no force in law. There are those that argue that intervention by the Environment Minister may threaten the independence of the GTR. The success of some of the environmental aspects of the GT Act is dependent on successful communication lines between the Environment Minister and the GTR, a chancy scenario that holds the promise of misunderstandings at the very least.
• The Organic Federation of Australia wanted the GT Act to include provisions for tracking GM grain sales and a compensation fund for farmers if contamination occurs from an unknown source.⁽⁶⁵⁾ (Bristow was of the opinion that the OGTR may have the right to impose insurance or assurance bond provisions under the GT Bill).⁽⁶⁶⁾ Although the ANZFSC ministers' announcement about GM food labelling revealed that it would be pertinent for food manufacturers to have a paper trail to protect themselves if there are claims that their food labelling is misleading, the GT Act does not make provision for tracking GM grain sales. In Europe, while this has been proposed, in the recent grain contamination scare the agrobiotech industry was quick to point out that, in fact, their sector was able to track the contamination back to its source. The EC have issued an advance working document on traceability and labelling of GMOs and products derived from GMOs.⁽⁶⁷⁾ Will the Australian private sector be able to achieve a workable tracking system for both products and grains under protocols, guidelines or codes of practice? Some funding was allocated for the examination of tracking when Australia's Biotechnology Strategy was released.
• The GTR is obliged to consult 'appropriate' local councils but it is by no means certain what standing the word 'appropriate' has (section 50(3e)). Even if a local council is consulted, while the GTR 'must take into account' their advice, the GTR is, again, not obliged to take their advice. Neither is it clear who will pay local councils for costs incurred due to administrative business arising from GE applications within their jurisdictions. (The Naracoorte-Lucindale Council, South Australia, is an example of a local government authority that has expressed reservations about GM trials in their area).⁽⁶⁸⁾
• The GT Act requires (section 138) that the Record (of GMO and GM Product Dealings) - be kept for all notifiable low risk dealings, and, included in this a description of each dealing on the GMO Register. It is intended that the GMO Register will list GMOs that have no licencing requirements. It is not known how quickly the information will be made available on the OGTR's web site. While the GTR 'may consult' States and Territories about items proposed for the GMO list, he or she is not obliged to do so. Neither is the GTR obliged to notify States and Territories about GMOs that have been included in the Register. States and Territories can of course check the Register for new additions but it would appear that a notification system would be preferable.
• The financial impact of the GT Act on agencies other than the OGTR is an unknown at this stage. The KPMG OGTR costings study questioned the likelihood of OGTR achieving full cost recovery in the next three to five years.⁽⁶⁹⁾

Biosafety Protocol

Senator Robert Hill, the Minister for Environment and Heritage, issued a press release in a supportive response to the international agreement to the text of the Cartagena Protocol on Biosafety in January 2000⁽⁷⁰⁾ but has since been reported to have reservations. Signatories to the Protocol will agree to provide advanced informed consent (AIA), in some cases, about the transport of LMOs (living modified organisms) across national boundaries. Importing countries will be able to use the Precautionary Principle to refuse to accept LMO imports but may have obligations to cooperate with further risk assessments. The relationship between the World Trade Organisation (WTO) and the Protocol rules are as yet untested. At ABARE's Outlook Conference on 2 March 2000, the Australian Ambassador for the Environment cautiously indicated Australia's position. He stated:

• The future production and export of LMO commodities in Australia;
• Our own domestic arrangements for the environment and human health regulation of genetically modified organisms, including for export;
• The regulation of LMO commodities in our key export markets, including under the Protocol; and
• The uncertainties as described above, that is, how the Protocol will operate in relation to the WTO, the references to the precautionary approach and the key issues that have been left for further negotiation.⁽⁷¹⁾

Whether Australia will or will not sign and/or ratify the Protocol in the near future is uncertain, albeit unlikely, there being a considerable tussle at Cabinet level on the issue. A backbench committee has commenced informal hearings.⁽⁷²⁾ Either way, implications derived from the implementation of the Protocol by some trading partners will need to be addressed by Australia. In May 2000, at Nairobi, the Protocol was opened for signature and at least 81 countries have signed at the time of writing, including the European Community and New Zealand. As yet, only two countries have ratified the Protocol, Bulgaria and Trinidad and Tobago.⁽⁷³⁾

Food Labelling

On 28 July 2000, the Australian and New Zealand health ministers, ANZFSC, considered the Inter-Government Taskforce's recommendations on the labelling of genetically modified foods in Standard 18 of the Food Standards Code.⁽⁷⁴⁾ ANZFSC opted for:

• labelling of food and food ingredients where novel components such as DNA and protein is present in the final food
• where food has altered characteristics

Exemptions include:

• highly refined foods where the effect of the refining process is to remove novel DNA and /or protein
• flavours which are present in a concentration less than or equal to 0.1 per cent in the final food, and
• food prepared at the point of sale.

The Standard allows:

• an ingredient to contain up to 1 per cent of unintended presence of genetically modified product.⁽⁷⁵⁾

A report, commissioned in October 1999, from a consortia comprising KPMG, Harley Juffs & Associates, Millward Brown and AgriQuality New Zealand,⁽⁷⁶⁾ proposed more moderate costing estimates for the labelling of GM foods (circa $300 million per year) than the previous report produced by KPMG ($3 billion per year).

The lack of GM food testing facilities in Australia will hamper compliance strategies. The Protocol of Compliance is expected to clarify the way that industry can demonstrate due diligence, using tools such as audit trails and testing. The GM food labelling as specified in the Standard A18 (which will become Standard 1.5.2 in the Joint Australia New Zealand Food Standards Code) will not be in force until 7 December 2001, that is, twelve months after gazettal of the Standard. Three years after gazettal, ANZFA is required to report on the implementation of the Standard.

On 26 May 2000, it was announced that the Food Standards Code will be examined in the light of National Competition Policy principles (i.e. whether it restricts competition, imposes costs or confers benefits on business). This may further impact on the gene technology food standard.

Deregulation in the food industry has attracted criticism from both sides of the fence. The Australian Consumers' Association (ACA) has claimed that ANZFA has failed 'to ensure the primacy of consumer interests in food regulation', asserting that ANZFA has lowered standards to match those of international agencies and that 'public interest has been progressively subordinated to the interests of the food industry'. It has also reported that 'Cadbury Schweppes and Golden Circle have warned that further deregulation of food standards could deceive consumers and create severe health risks'.⁽⁷⁷⁾

When developing the draft GT Bill issues such as the Biosafety Protocol, industry and trade concerns and food labelling matters had to be taken into consideration. Some guidance can be obtained by observing the pathways that other governments have taken to work towards management frameworks for GMOs. IOGTR has listed existing regulatory systems of other countries and listed their findings, along with a summary of national regulations.⁽⁷⁸⁾ Various national attempts to regulate for GMO food related issues are also included in the OECD's June 2000 Compendium of National Food Safety Systems.⁽⁷⁹⁾ National biotechnology regulatory schemes may also be found at the OECD's web site.

6-What Obstacles Require Solutions?

For the promise of gene technology to be realised, it is likely that not only will adequate consumer information, including reliable identification of GM derived products be required but potential or identified environmental and health hazards will also need to be noted and managed by governments. Of particular importance are adequate testing, assessment and monitoring regimes.

Health Fears

GMO Assessments

Australian assessment of GE crops and foods is largely a paper exercise involving scrutiny of data supplied by each applicant because neither GMAC nor ANZFA have laboratories. The report of the Strategic Review of Australian Government Analytical Laboratories is due shortly. The industry body, the Australian Biotechnology Association, argues affirmatively, in their submission to the Strategic Review's question: should Government be in the business of running analytical laboratories?:

Because OGTR will be self-funding, although it will be within the GTR's aegis to commission data, it remains to be seen to what extent they will be able to commission original research and from whom they commission research. ANZFA's recent announcement about the creation of ten ANZFA scientific fellows later this year, 'to complement ANZFA's own internal expertise'⁽⁸¹⁾ could be seen as a response to the need to bolster its science base. However, it is not known whether the expertise of the fellows will be used to produce original work. There are dangers inherent in reliance on externally generated data and procedures.

For instance, it was reported in May 2000 that Monsanto had recently realised that when they reported to the US regulators in 1993 that the GE, Roundup Ready soybean, contained a single new strand of DNA, they were wrong. There were, in fact, two 'rogue' fragments of DNA in the soybean. Monsanto has been informing regulatory agencies about this, describing the fragments as 'inactive' and arguing that since the Roundup Ready soybeans were found to be safe in 1993 their conclusion still stands.⁽⁸²⁾ While this could well be so, the case highlights the dangers of accepting an applicant's data at face value and the lack of peer review of what could be commercial-in-confidence information.

• While the GTA includes provisions (section 65) that oblige licence holders to inform the GTR if there is additional information about a GMO relating to health or environmental risks or unintended effects, if these conditions do not apply, then the Regulator does not have to be informed. That is, using the Monsanto case, there is no obligation for the licence holder to inform the Regulator that the GMO that has been released, as described to him or her, is actually different in some way. The danger is that there may be a possibility, albeit however slight, that health and environmental effects may be detected in the future and the Regulator will not have a record of the exact nature of the GMO in question.
• The other potential problem pertains to the licence holder. The licence holder may be the farmer, the seed supplier or the overseas importer. They may not be informed by the seed developer about new information about a particular GMO with which they are 'dealing'. The overseas GMO seed developer has no obligations to do so under the GT Act unless they are the overseas importer.

Benchmarks and assessment tools appear to be primarily derived from overseas agencies. In 1999, it was noted at an OECD meeting that safety assessment practices were insufficient, and a new approach was required.⁽⁸³⁾ This being the case, assurance by ANZFA that they have used 'principles developed by the World Health Organisation, the Food and Agriculture Organisation and the OECD'⁽⁸⁴⁾ in their safety assessments does not necessarily promote public confidence in GMOs. There is a difference between efficiencies that can be gained where nations share knowledge and safety approaches, and dependency on international approaches because of national infrastructure problems, such as the lack of a national Australian agency that caters for all food safety and health issues. This year, the report of the OECD's Working Group on Harmonisation of Regulatory Oversight further warned that 'while different authorities may use similar information and similar assessment procedures, they sometimes arrive at different conclusions'.⁽⁸⁵⁾

GM food was marketed in Australia, and elsewhere, prior to the comprehensive development of appropriate testing technologies and protocols. In particular, resolution of toxicology issues has lagged behind the marketing of GM foods. Some objections to GM foods have arisen, not because of a Luddite reaction to the technology or a refusal to consider the benefits that biotechnology may offer, but because the cart was placed before the horse in terms of safety assessment. Factors such as wariness about data presented by applicants along with the lack of credible management frameworks and communications have fuelled consumer unease.

A consortium of European scientists recently argued that it is difficult to assess risks arising from GM foods. They note that it is far easier to detect adverse effects from pharmaceuticals than GM foods, and even then, about 3 per cent of pharmaceuticals are withdrawn from sale because harmful effects have been detected.⁽⁸⁶⁾ While there are notable exceptions, eg thalilomide, diethylstilbestrol (DES) etc, harm arising from the use of inappropriate pharmaceuticals is largely confined to the individual taking the medication. Unwarranted GM crops approvals may carry risks of unremediable ecological harm.

There is limited knowledge about health benefits or risks arising from specific chemicals in non GM foods and synergistic effects of compounds in non GM foods. Genetic engineering adds another level of complexity and highlights the need for further research into foods generally, whether foods that contain beneficial compounds e.g. anti-cancer compounds in the brassicas, or, those that carry risks if eaten excessively e.g. comfrey, or, those that contain novel proteins or novel synergies induced by genetic engineering.

The recent UK inquiry into Aventis' GM fodder maize, Chardon LL, that the UK Government had proposed for addition to the UK's National List (of permitted seeds) in March 2000, provides an example of scientists raising questions about the adequacy of the applicant's data. One expert witness, the director of the International Feed Resource Unit in Aberdeen, Professor Bob Orskov, indicated that the data submitted by Aventis was inadequate, the animal feed had not been tested on cattle, only rats and chickens. Another expert witness had concluded after analysing Aventis' safety data that there were significant statistical differences between the GM and non-GM varieties with respect to fat, protein and fibre composition.⁽⁸⁷⁾

The Public Health Association of Australia (PHAA) raised concerns about the adequacy of testing for Monsanto's Roundup Ready soybeans as a result of a paper by Dr J Carman.⁽⁸⁸⁾ A subsequent scientific study on three further ANZFA GM crops assessments (two corn and one canola line) conducted for the PHAA, raised further concerns about and the adequacy of the data submitted to ANZFA as well as the assessment process. Concerns included the up to 16 per cent liver enlargement of rats fed the GM canola, non disclosure of information because of 'commercial in confidence' reasons, small test sample sizes and the lack of independent scientific scrutiny of Monsanto and Optimum Quality Grains data.⁽⁸⁹⁾

A report by EcoStrat GmbH, commissioned by Greenpeace International, examined a range of company studies on GM crops with a particular focus on methodologies used. The report is based on both laboratory and field based studies. Previously, the UK's ACRE (The Advisory Committee on Releases to the Environment) had examined the work of one of the authors, Angelika Hilbeck, from the Swiss Federal Research Station for Agroecology and Agriculture. Her experiments had established increased mortality of lacewings fed with Novartis Bt maize. While her report was found to be balanced and reasonable, the Committee found insufficient evidence to justify a ban on Novartis Bt maize. Hilbeck et al indicated since their work was laboratory based, conclusions about field effects could not be drawn. ACRE recognised the need for further research on the effects of GM crops on non-target organisms.⁽⁹⁰⁾

In brief, the EcoStrat GmbH report concluded that the requirement for company application packages submitted to regulatory agencies to provide test results for acute ecotoxicological effects of the insecticidal protein for a range of Bt crops, on non-target species, was insufficient. The report maintained that, in addition to the acute toxicity data, chronic lethal and sublethal toxicity parameters in the testing procedures should have been provided. Of interest was the request by two of the eight scientists involved for anonymity,⁽⁹¹⁾ perhaps anecdotal evidence about pressures that GE scientists may be experiencing.

A recent Scientific Steering Committee of the European Commission report on risk assessment of genetically modified plants (GMP) can be used to summarise limitations of the process.

GM foods

ANZFSC's 28 July decision to label foods with GM ingredients on sale in supermarkets, and the gazettal of the standard, Standard A18 on 7 December 2000 will provide some certainty for consumers and guidelines for businesses.

The major regulatory gap pertains to food preparation outlets which were not included in the ANZFSC decision. Since there is evidence that Australians are increasingly either eating out or buying takeaways, this omission is inconsistent with a consumer choice rationale for GM food labelling. However, it could be argued that food preparation outlets could voluntarily advertise that they either do or do not use GM ingredients and/or insist that their wholesale suppliers indicate the GM or non-GM status of foods they sell.

Standard A18 explicitly does not regulate for food derived from animals fed with GM fodder. This issue is gaining attention in the EU, especially in the UK where the public is mindful of the BSE/CJD (Bovine Spongiform Encephopathy/Creutzfeldt Jakob Disease) debacle originating from meat and bone meal animal fodder.

Also exempted from prohibited sale are GM foods covered by applications made on or before 30 April 1999 to ANZFA, under section 13 of the Australia New Zealand Food Authority Act 1991. The provisos include the stipulation that there is evidence that the food is lawfully permitted by a national food regulatory agency of one country other than Australia or New Zealand and that the ANZFSC is not aware of any significant risk to public health and safety.

The health ministers' GM food labelling decision will not take effect until 7 December 2001. The Standard, which was agreed to at the ANZFSC 24 November 2000 meeting also refers to a draft compliance guide to assist businesses that has been issued for public comment. The Standard provides the following labelling examples:⁽⁹³⁾

For single ingredient GM foods:

• soy-'genetically modified' or 'from genetically modified soya beans'

For GM food ingredients in a food:⁽⁹⁴⁾

• Soy Protein Isolate (genetically modified)

Labelling for non GM foods:

• No statement required

Negative Claims for non-GM foods:

Claims must not be misleading or deceptive, and the Draft Guidelines suggest that since absolute negative claims such as 'GM free' have been tested in court such a claim must be supported by evidence. The negative claim example 'Best endeavours to use non-genetically modified food ingredients' is provided.

Compliance and Enforcement

The establishment of a GM standard in the Food Standards Code is one thing, enforcement and compliance is another. To what extent will the GM standard be just words? While the onus is on food manufacturers and suppliers to provide documentation for audit trails, if queried, who will be checking for compliance? States and Territories have the responsibility for this.

With widespread governmental down-sizing and out-sourcing trends there is no reason to believe that the ability of States and Territories to adequately enforce food standards has improved since the 1995 Office of Regulation Review survey. The Review found that while most government food agencies in the survey agreed that it was their policy to enforce all food provisions, over half the agencies indicated that they were unable to do so in practice.⁽⁹⁵⁾

Similarly, recognition of the regulations, and compliance with the GT Act, could be an issue. In New Zealand, it was reported in July 2000 that 18 per cent of GMO research projects had not been correctly authorised.⁽⁹⁶⁾ As Peter Pockley, Australian science writer and broadcaster, states 'the Environmental Risk Management Authority did not begin to flex its muscles until last April'. In fact, 152 out of 1065 GM experiments had not been approved. The application fee of $3000 per project may have been a contributory factor.⁽⁹⁷⁾ In Australia, breaches are reported to GMAC and are listed in their annual reports. When the GT Act is in force there are provisions that require quarterly reporting of GMO licences issues, breaches of GMO licences and auditing of monitoring activities (section 136A.2) to the Minister. But mindful of possible recognition and compliance shortfalls, Recommendation 1 of the Primary Producer Access to Gene Technology Report was for constant and cautious monitoring, and public reporting.⁽⁹⁸⁾ And the GT Bill 2000 Inquiry recommended that:

In the EU, despite Directives for genetically modified foods and crops, successful implementation is some time away because of the lack of testing methodologies, facilities and inspectors.⁽¹⁰⁰⁾ For example:

• The British Working Party on Food Authenticity, while agreeing that Real Time PCR (Polymerase Chain Reaction) techniques made it possible to differentiate between GM and non-GM soya there are problems below 1 per cent GM content of an ingredient.⁽¹⁰¹⁾ (PCR tests for novel DNA sequences and ELISA (Enzyme Linked ImmunoSorbent Assay) tests for novel proteins. The EC has compiled costings which include: PCR tests take from 1-3 days, cost 104 - 310 euros per test and have been estimated to be 99.9% accurate. ELISA tests take between 2-8 hours, at 10 euros per test, and are 95% accurate. Another simpler ELISA test takes 5-10 minutes at 3.6 euros per test.⁽¹⁰²⁾) GeneScan Australia Pty Ltd, with links to an overseas testing laboratory, is an example of an Australian company that has the capacity to provide a GM food testing service.⁽¹⁰³⁾ However, a recent UK government performance check for GM soy on 80 laboratories in 19 European countries found that 20 per cent of laboratories failed to detect GMO presence in foods, and 60 per cent of the sample reported a GMO presence when there was none.⁽¹⁰⁴⁾
• A recent German survey found that over a third of tested food products contained GM corn or soya, 31 out of the 81 having less than 1 per cent GM content. That is, food manufacturers were not necessarily always complying. The surveyors were lobbying for the 1 per cent GM contamination threshold to be reduced to 0.5 per cent.⁽¹⁰⁵⁾

In the US, the recent detection of Starlink GM maize (corn) in supermarket foods, including some Kraft and Taco Bell products, has also highlighted the ease with which non-approved GM products can be included in human foods. Starlink has been only approved for animal use because the pesticide Cry9 it contains may cause nausea and allergic reactions in humans.⁽¹⁰⁶⁾ Aventis has subsequently submitted new data to the USEPA, applying to allow Starlink to be permitted for human consumption for a limited period⁽¹⁰⁷⁾ of up to four years. The Starlink scare extends beyond US borders:

• Japan has detected traces of Starlink corn in imported US products
• New Zealand has stopped imports of products that could contain the GM corn⁽¹⁰⁸⁾
• ANZFA, AQIS and the USFDA are investigating the Australian situation and at this stage, because Kelloggs (the distributor for Taco Bell) use local corn for their products, ANZFA considers that it is unlikely that Starlink has entered the human food chain in Australia. However, it is not known whether Starlink corn has been used in imported processed foods from the US. It is also not known whether Starlink has been imported as animal feed. Although Starlink is illegal in Australia, at the time of writing, it does not appear that any government agency is testing for its presence in foods intended for human consumption.

Antibiotic resistance

Antibiotic resistance marker genes are used to detect whether desired genes have been successfully inserted in cells. For example, genes may be inserted to confer desired properties e.g. production of a particular protein toxic to predators of the particular crop involved. The antibiotic resistant marker genes remain in some GM foods. The major question is: can antibiotic resistance genes transfer from GM foods to gut microorganisms and consequently be expressed in transformed cells?

The 1999 UK House of Lords Inquiry called for an end to the use of antibiotic marker genes⁽¹⁰⁹⁾ and Sir Robert May, the then UK Chief Scientist, and Professor Liam Donaldson, the UK Government Chief Medical Officer, supported the use of alternatives.⁽¹¹⁰⁾ In 2000, the EU stopped short of banning them. While risks from antibiotic marker genes are deemed low, caution has been called for. Beyond the gene technology issue, there is concern about increased resistance to antibiotics generally. Unnecessary use of antibiotics is seen as unwise, whether as veterinary antibiotics administered to farm animals, or, in genetically modified organisms where antibiotic resistance marker genes are employed. A recent WHO/FAO report on the safety aspects of GM foods concluded that:

This is qualified by:

In this light, IOGTR's statement about antibiotic-resistance genes in their risk analysis of Roundup Ready and Roundup Ready/Ingard cotton is somewhat surprising:

While some dispute that antibiotic resistance genes, used as markers, could be transferred to gut microorganisms, it has been reported that foreign DNA can survive transiently in the gastrointestinal tract of mice and enter the blood stream. The 1992 USFDA Draft Guidance stated that it would be unlikely tha