Annotated Bibliography Entry

Reference: Australian Gene Technology Bill 2000
Title: A cautionary tale: Fish don’t lay tomatoes – A report on the Gene Technology Bill 2000.
Authors: Senate Community Affairs References Committee
Publisher: Parliament of Australia, Parliament House, Canberra, ACT 2600, Australia
Publication details: November 2000.

Summary
Table of Contents

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Summary

This Senate report is very timely. There is widespread and growing community debate about gene technology and increasing concern about health and environmental issues. The community has learned to be cautious about claims by governments, corporations and scientists that things are safe for them. The benefit of DDT and, more recently, the safety of British beef during the mad cow disease episode are just two claims that have engendered considerable scepticism. The Bill is an important piece of legislation designed to protect the public health and safety of people and to protect the environment from risks associated with gene technology.

The Senate inquiry into the Gene Technology Bill 2000 has provided a great opportunity for serious discussion about this legislation and whether it will provide the protection the community wants. A broad range of interested individuals and organisations and the community generally expressed their concerns and fears about aspects of the Bill, and in particular, the adequacy of the proposed regulatory framework to address these concerns.

There were a number of features to emerge from our inquiry. One of the most important was the significant number of and qualifications of scientists opposed to, or very concerned about, gene technology, its applications and possible consequences.  A common emphasis during the inquiry was that industry and researchers cannot be relied upon to be sufficiently rigorous and objective in evaluating risk and implementing appropriate strategies to manage those risks – at least to the level where the community can feel reassured.

The importance of community consultation and community involvement in decision-making was emphasised during the inquiry. The Committee was told that there is a need for Government to listen to the community, to explain developments in the rapidly evolving gene technology area and to have regard to community concerns in this area. The Committee heard that the community has more concerns about gene technology used in food than other areas, for example pharmaceuticals, where there is significant research and testing before products are released for use.

There remains a great need for community education. While the level of concern about possible risks is growing in the community, there is still inadequate information – particularly information that is impartial, unbiased and comprehensive – available to the community and consumers to evaluate the risks associated with gene technology.

Individuals also have difficulty in assessing and processing available information to help them make informed choices. The Committee attaches great importance to ensuring that a national education campaign, by an independent source, be implemented to provide information on gene technology and its potential risks.

Many other concerns were raised during the inquiry. These include the language used - whether gene technology is the same as genetic modification, genetic manipulation, genetic engineering or transgenic processes. Modifying the language to try and assuage peoples’ concerns seemed, on the evidence to the Committee, to only add to a suspicion about what exactly the protagonists were doing.

One major area of concern was the gene crossover, sometimes described as transgenic, from one species to another. There was much less concern about wheat genes being used in wheat than bacterial genes being used in wheat for example. The use of viral promoter genes was a cause of even graver concern, in particular what might be the consequences of viral changes in subsequent generations. The Committee was told that little to no research had been done on later generation viral consequences. Assurances that there is ‘no evidence’ of harm may in fact mean no research has been done, and that worries the community. While there may be genetic exchange between species occurring in nature, genes from fish do not get into tomatoes under normal circumstances.

Other areas of concern include the importance of providing for GM-free zones, issues related to animal welfare, human genes used in animals, deficiencies in the risk assessment processes and investigative capacities of the Regulator and concerns over the cost recovery, funding measures and insurance.

Due to the wide ranging nature of the issues and concerns raised, the Committee believes that the Bill when enacted will require close supervision and ongoing assessment with a need for an independent review in three years – much sooner than the current proposed review after five years.

The Committee is concerned that the great weight of responsibility of decision making in this area should fall on more than one person – hence the Committee’s recommendation that the Regulator be a statutory authority not a single individual. Further, there should be opportunities to appeal decisions of the Regulator by third parties as well as licence applicants.

Australia needs an effective regulatory system that is open, transparent and accountable. The consequences of ‘getting it wrong’ are too grave to contemplate, especially in the longer term. The proposed regulatory regime needs to ensure that there is widespread community confidence in the system. Australia’s regulatory system should represent international best practice.

Overall, the Committee found that the Bill to introduce regulation into the gene technology area is overdue and very welcome. However, the weight of evidence supported a great deal of caution. That is why the report is called - A Cautionary Tale: Fish Don’t Lay Tomatoes.

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Table of Contents 

Membership of the Committee

List of Acronyms

Preface

Recommendations

Chapter 1 Introduction
Terms of Reference
Conduct of the inquiry
Development of the Gene Technology Bill 2000
Acknowledgments 7

Chapter 2 Background on gene technology
What is gene technology?
Genes and gene expression
Benefits associated with gene technology
Risks associated with gene technology
GMOs covered by the Gene Technology Bill 2000 23

Chapter 3 Objectives of the Gene Technology Bill
Objective of the Bill
The current regulatory regime
Measures to achieve the Bill’s objective
The precautionary principle
A precautionary approach
Risk management versus risk prevention
Environmental impact
The national interest
Human medical research
Ethical considerations
Animal welfare
Benefits of gene technology
Alternative regulatory models
Placement of a moratorium
The role of multinationals
Implications for trade competitiveness
Trial site locations
Commercial-in-confidence information
Cost recovery
Adequacy of public reporting provisions
Public confidence
Review of gene technology legislation

Chapter 4 Office of the Gene Technology Regulator 
Structure of the Office of the Gene Technology Regulator
Interface with existing regulators – ‘one-stop shop’ model
Risk assessment processes
Confidential commercial information
Powers and investigative capability of the Regulator
Cost recovery and funding measures

Chapter 5  The Expert Committees and Ministerial Council
Gene Technology Technical Advisory Committee
Gene Technology Community Consultative Group
Gene Technology Ethics Committee
The Ministerial Council
Rights of third-parties to seek review of decisions

Chapter 6  Other Issues – Liability, State Opt Out and Mount Gambier
Term of Reference (i): Liability and insurance issues relating to deliberate and accidental contamination of non-genetically modified crops by genetically-modified crops and how those issues are being addressed in international regulatory systems
Contamination
Liability and insurance
Comparisons with international regulatory systems
Concluding comments

Term of Reference (j): The validity and practicability of any proposed clause allowing individual States the right to opt out of the scheme and the implications of such an option in the context of Australia’s international trade and related obligations
Background
The Gene Technology Bill 2000
Constitutional issues
International trade obligations
The Tasmanian situation
Conclusion

Term of Reference (k): The alleged genetically-modified canola contamination in Mount Gambier and the processes followed by the Interim Office of Gene Technology in investigating and reporting on the allegations
Background
Existing system of administrative controls over genetically modified organisms
The investigation
Conclusions and outcomes from the IOGTR’s investigation
Monsanto and the release of GM cottonseeds
Issues arising from this case for the future
Concluding comment 

Minority Report by Government Senators
Australian Democrats' – Additional Comments
Supplementary Report – Australian Greens
Senator Bob Brown  

Appendix 1 ORGANISATIONS AND INDIVIDUALS WHO PRESENTED WRITTEN PUBLIC SUBMISSIONS AND SUPPLEMENTARY INFORMATION TO THE COMMITTEE 209

Appendix 2  WITNESSES WHO APPEARED BEFORE THE COMMITTEE AT PUBLIC HEARINGS

Appendix 3 REGULATION OF GENE TECHNOLOGY– INTERNATIONAL COMPARISONS

Appendix 4  SELECTED STATEMENTS OF THE PRECAUTIONARY PRINCIPLE/APPROACH

Appendix 5 APPROVAL PROCESSES FOR THE INTENTIONAL RELEASE OF GENETICALLY MODIFIED PLANTS INTO THE ENVIRONMENT

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Web site: http://www.aph.gov.au/senate/committee/clac_ctte/gene/report/index.htm