Review of the Gene Technology Act 2000 (Cth) Submission from the Gene Technology Ethics Committee (gtec)

Recommendation 7: Definition of “risk”

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Recommendation 7: Definition of “risk”

GTEC recommends that the wider context of risk analysis ought to be recognised and integrated into the risk assessment, risk management and risk communication provisions of the GT Act (Recommendation 3). Consistent with Recommendation 3, GTEC also recommends that if “risk” is to be defined within the GT Act it should be given a broad definition.

Act achieving objects

2. Investigate whether the object of the Act is being achieved and whether the regulatory framework stipulated in section 4 of the Act is appropriate.

Section 4 (aa) Inclusion of Precaution in the Regulatory Framework to Achieve Object

GTEC considers that the issue of scientific uncertainty relating to the potential effects of genetically modified organisms on health and safety of people and the environment is a key concern of the regulatory regime. However, GTEC considers that the discussion of precaution in relation to scientific uncertainty, in section 4(aa) of the GT Act, does not address or specify sufficiently issues of scientific uncertainty in decision-making within the regulatory regime.
In this submission GTEC will consider this issue in two parts, dealing first with precaution (or the precautionary principle), and secondly, with the treatment of scientific uncertainty.
(i) Precaution, a Precautionary Approach or the Precautionary Principle

GTEC notes that there are multiple sources of contradiction and ambiguity about the status, meaning and operational effect of precaution within the current GT Act.

  • Firstly, the GT Act does not refer to the Precautionary Principle by name, although it does incorporate part of the text of the precautionary approach from Principle 15 of the Rio Declaration of the Environment 1992. Within the RAF (OGTR, 2nd edition, 2005) the OGTR has adopted the terminology of precaution (rather than the precautionary principle) and has referred to precaution as one of the ’pillars’ of the regulatory system.

  • Secondly, the GT Act is in sharp contrast to the EPBC Act (s 391), which lists the decisions for which it is mandatory for the Minister for the Environment to apply the “precautionary principle”. In the GT Act there is no equivalent direct obligation placed on the decision-maker to apply the precautionary principle in decision-making.

  • Thirdly, there is limited legal elaboration or further definition of the principles of precaution in Federal statutes. Australian legal precedent, such that it is, originates from the lower specialist State and Territory courts and tribunals, thus precedent on the precautionary principle could only ever be persuasive and not binding on Federal courts. Further ambiguity arises because there is also considerable uncertainty and contradiction within that body of lower court case law (Fisher, E. (2003) “Law, Precaution and Administration: The Precautionary Principle and Australian Courts 1993 – 2003”, paper presented at The Precautionary Principle and Environmental Regulation: 10 Years since Leatch, 20-21 November 2003, The Australian National University, Canberra).

  • Fourthly, the interpretation of precaution or precautionary principles in Australian statutes is, arguably, dependent upon the statutory regime into which it has been inserted, making it difficult to draw any generalisable legal conclusions about the meaning and interpretation of precaution or the precautionary principle in Australia. Thus, the precise operation of precaution will inevitably depend upon its statutory context.

The legal uncertainty about the interpretation and meaning of precaution in Australia resonates with continued debates in international law and the international academic discourse on precaution and the precautionary principle. These debates have a number of strands that include consideration of: the correct formulation or wording of the principle and its interpretation; the strength or weakness of the principle; the appropriate thresholds of scientific uncertainty for application of the principle; and the extent to which the principle is intended to operate as a scientific principle or as a non-scientific guide for decision-makers. The distinction between precaution, a precautionary approach and the precautionary principle is unclear from the international literature with no definitive terminology (see for example: the terminology of the Wingspread Statement 1998 (Raffensberger, C. Tickner, J (eds) Protecting Public Health and the Environment. Washington DC: Island Press 1999); the glossary in Sterling et al. (1999) On Science and Precaution In the Management of Technological Risk, an ESTO Project Report prepared for the European Commission ; and, more recent EC terminology in Renn et al (2003) The Application of the Precautionary Principle in the European Union: Regulatory Strategies and Research Needs to Compose and Specify a European Policy on the Application of the Precautionary Principle (PrecauPri), European Commission). Furthermore, there is also no clear distinction between the precautionary principle, a precautionary approach and precaution in Australian domestic case law.

All of these factors currently contribute to a high level of uncertainty about the legal meaning and interpretation of precaution in Australia and in the GT Act. Nonetheless, the current inclusion of precaution in section 4(aa) of the regulatory regime reasonably creates a public expectation that some notion of ‘precaution’ - or even, given that the Rio wording is used, the precautionary principle - will be adhered to in decision-making relating to gene modification of organisms. Some interest groups regard the Rio Declaration, or even the wording of section 4(aa) of the GT Act as a ‘strong version’ of the precautionary principle - without appreciating that many academics regard this form of precaution as problematic (For a critique of ‘strong’ precaution see Sunstein,C (2003), “Beyond the precautionary principle”, Pennsylvania Law Review 151, pp 1003 – 1058; and for a review of both ‘strong’ and ‘weak’ forms see Dorman, P (2005) “Evolving knowledge and the precautionary principle” Ecological Economics 53, pp 169 - 176).
GTEC also notes the inclusion of “cost-effective” within section 4 (aa), where it mimics the Rio Declaration but is inconsistent with the broader scope of the GT Act, which excludes social and economic considerations. At least one other Federal legislative formulation of precaution (eg, EPBC, s 391) excludes the words “cost-effective”. In reviewing the GT Act, GTEC recommends that section 4(aa) should be amended to improve consistency with the remainder of the statute. If social and economic considerations are to remain excluded from the GT Act then the term “cost-effective” could be removed.
The most significant issue about precaution within the GT Act probably is that it has been inserted into a statutory framework that adheres to a scientific risk assessment and risk management process. Since the Rio Declaration in 1992, the international interdisciplinary academic discourse, especially in Europe, has progressed significantly beyond the ‘strong’ versions of the principle first enunciated. Furthermore, leading European academics now consider that the relationship between precaution and a scientific approach can be “consistent and even mutually reinforcing” (Stirling, A and Gee, D. (2002) “Science, Precaution and Practice” Public Health Reports 117, pp 521 - 533). Considerable interdisciplinary research effort and expertise, such as the PrecauPri project (referred to above) has been directed towards the development and advancement of sophisticated regulatory strategies for the application of the precautionary principle. Academic consideration of the precautionary principle in terms of the role of science and risk analysis within the context of principles of ‘good’ public administration is clearly continuing (see Fisher, E (2005) “The Precautionary Principle, Administrative Constitutionalism, and European Integration”, accepted for publication in Vos, E (ed)). Furthermore, numerous re-statements of the text of the precautionary principle (for example Wingspread Statement 1998 (referred to above) and the Lowell Statement on Science and The Precautionary Principle 2001, available from: URL: (Accessed 11 July 2005)) have evolved with the current discourse on precaution. GTEC recommends that, in the course of reviewing section 4(aa) of the GT Act, consideration be given to amending either the text of section 4(aa), or some other part of the statute, to make it clear that the inevitably ‘strong’ form of precaution, sometimes historically and popularly associated with the text of Principle 15 of the Rio Declaration, is not regarded as the sole and only legitimate reference point for interpretation and application of precaution within the GT Act.
GTEC supports the science-based risk analysis process, inclusive of precaution, within the current GT Act and notes that the insertion of precaution into a broad regulatory framework, without further statutory prescription, creates potentially significant regulatory discretion as to its use and application within the GT Act. GTEC considers that since the international discourse and experience with precautionary administration is evolving, this high level of regulatory discretion is appropriate at present. GTEC also notes that the Regulator has taken steps, in the first five years of the GT Act, to increase the transparency of the application of precaution within the regulatory framework by further elaborating the OGTR’s approach to precaution within the RAF. GTEC notes that the OGTR, in its most recent RAF (OGTR, 2005, 2nd edition) has engaged with international expertise on broader forms of precaution and risk analysis as evidenced by reference to the PrecauPri project (Renn et al, 2002 (see above)) and the current academic literature (OGTR, 2005, 2nd edition, p 8 – 9. and 103 – 104).
GTEC considers that broad discretion regarding the interpretation and application of precaution is appropriate and allows the Regulator and OGTR, within its scientific risk analysis framework, to respond to international developments in interdisciplinary research on precaution and its application in science-based risk assessment especially as it might relate to regulatory design for the regulation of genetically modified organisms. GTEC has considerable capacity and expertise to advise the Regulator on matters relating to risk assessment and precaution and could develop this further. GTEC considers that the GT Act could be amended to state expressly that the function of the GTEC (s 112) and its membership (s 111 (5)), on the request of the Regulator, is to provide advice on ethical and interdisciplinary issues relating to the review and implementation of a precautionary approach to risk analysis.

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