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

Recommendation 6: Definition of “health” or “environmental health”

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Recommendation 6: Definition of “health” or “environmental health”

GTEC recommends that consistent with the narrow scope of the GT Act, “health” also should be defined narrowly and in terms of physical health, or indeed, environmental health.

Definition of “risk” and related terminology

The term “risk” is not defined in the GT Act. GTEC has previously considered that a broad definition of “risk” is appropriate to risk assessment, risk management and risk communication pursuant to the GT Act. In Managing Risk Ethically GTEC proposes a broad approach to “risk”. This paper has informed the development of the revised Risk Analysis Framework currently applied by the OGTR in the preparation of RARMPs (OGTR, RAF 2nd edition, 2005).
The RAF, in its glossary, defines key terminology underpinning risk analysis pursuant to the GT Act but that terminology is not currently defined in the GT Act. GTEC suggests that, as part of the review, the definition of key terminology relevant to risk, within the GT Act, ought to be considered. However, GTEC notes that defining risk is not straightforward as such definitions vary depending upon the context. For instance, the United States Society of Risk Analysts set up a definitions committee in 1985 and after two years of deliberating published thirteen definitions (Beer and Ziolkowski, Environmental Risk Assessment: An Australian Perspective, Commonwealth of Australia, 1995, p.21). One commonly used definition comes from toxicology: risk = hazard x likelihood of occurrence, where hazard = exposure x effects. In the OGTR’s RAF, risk is defined as “the chance of something happening that will have an undesired impact” (OGTR, 2nd edition, 2005 p.2) and risk assessment is defined as hazard identification x likelihood and severity of the consequences. This definition also incorporates uncertainty (OGTR, 2nd edition, 2005 p.18). GTEC notes that, in terms of regulatory design, the definition and explanation of risk terminology and the risk analysis processes in a document such as the RAF has considerable advantage. The accessible form and relative ease with which it may be reviewed, updated and amended by the OGTR permits the risk analysis process to remain appropriately adaptive and responsive to a complex and rapidly evolving risk discourse, as has occurred during the first five years of operation of the GT Act.
If key risk terminology is to be defined within the GT Act, GTEC recommends the adoption of a broad definition of risk and related terminology consistent with the approach taken in the RAF. In this way sections of the Act dealing with risk assessment and risk management (and any additional sections dealing with risk communication) could be universally broadened and re-framed to acknowledge the limits of technical risk analysis in a new field such as gene technology and levels of uncertainty or indeterminacy and how these are managed or taken into account in the decision to issue a licence.

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