Environmental Risk Assessment:

Environmental risk assessment can be a significant area of regulatory activity: any business or enterprise that deals with, or involves any of the above substances, may be liable to various statutory and other legal requirements, mandates and obligations. The governing legislative provisions are contained in the Gene Technology Act 2000 (Cth) and the Gene Technology Regulations 2001 (Cth). Dr. Sue Meek, Gene Technology Regulator of the government’s Department of Health and Aging writes in her introductory comments to the “Risk Assessment Framework”:

Gene technology embraces a wide range of potential applications including medical and vaccine research, diagnosis and treatment of disease, environmental remediation, and the modification of plants and animals to incorporate new growth and compositional characteristics [1]

Permits are required for the use of genetically modified organisms (GMO). This is because the introduction of a GMO into the environment can potentially have devastating consequences for the rest of the local ecology. Because a GMO has come about as a result of an artificial process of genetic modification, not as a consequence of the natural process of evolution, it may cause a disequilibrium within the local ecology when released and result in the destruction of naturally occurring species. For this reason, an environmental risk assessment is completed before any such license can be granted, and often such license will include strict conditions as to the use of the GMO. Dr. Meek continues:

The principles of risk analysis are simple, but the differences between a hazard and a risk are often confused, and the level of complexity can vary depending upon disciplines involved.  Gene technology is a relatively new and rapidly evolving area.  Therefore the methodology for analysing risks from gene technology may appear different from long established methodologies, for example those used to assess hazardous chemicals or mechanical failure [2]

The “Risk Assessment Framework” is a guidance document for the Gene Technology regulator and its staff. It outlines the approach to risk assessment under the legislative scheme by:

• Guiding the rational and approach of assessment;
• Enabling consistency in risk assessment and license evaluation;
• Clarifies the legislative provisions in relation to risk assessment and risk management;
• Ensures transparency in the administrative processes of the Gene Technology Regulator.

The environmental risk assessment system is relatively new in Australia, and parts of it can be very confusing to businesses dealing with genetically modified organisms. In the event that a business owner believes that such substances may be in use in its processes, it may be prudent to seek legal advice in relation to the business’ rights and liabilities under the law.

The use of a GMO without a license can give rise to very serious liabilities, especially if the use causes damage to the environment. If a business owner suspects that he or she may potentially be in breach of any legislative or regulatory provisions, Navado Lawyers and Solicitors can assist in providing legal advice and any necessary representation before the Gene Technology Regulator or a Court.

Businesses and individuals who deal with genetically modified products and substances may also wish to see our section on “Biodiversity Law”, “Environmental Impact Assessment”, “Species Impact Statement” and “Native Species Legislation”. 

[1] Dr Sue D Meek, “Risk Analysis Framework” Commonwealth Department of the Health and Aging – Office of the Gene Technology Regulator (January 2005) p 1

[2] Ibid