Gene technology regulations Part 2.How to do start doing risk management

OGTR 2013 Risk Analysis Framework Overview: Attention to Context

David Tribe 2023

The Office of the Gene Technology Regulator (OGTR) 2013 Risk Analysis Framework (RAF) is a robust and comprehensive approach that outlines how the Australian government deals with risks related to the use of genetically modified organisms (GMOs). Based on the Gene Technology Act 2000 and the Gene Technology Regulations 2001, this framework delineates a clear, consistent methodology for conducting risk assessments, managing identified risks, and effectively communicating these risks to a wide array of stakeholders.

The overall RAF encompasses three main components: Risk Context, Risk Assessment, and Risk Management, each of which operates within the bounds of the legislation. The Risk Communication component is embedded within all stages of the RAF, ensuring transparency, openness, and inclusivity (see figure).

Figure. Risk analysis method for GMO licence application.

Risk context is the initial step in this process, providing a framework for understanding and categorizing potential risks. This step involves defining the scope and boundaries of the risk evaluation process, outlining key parameters such as the subject and trigger for regulation, the method for achieving protection goals, and the definitions of key terms.

The risk criteria considered range from the properties of the parent organism, the effects of genetic modification on this organism, measures for limiting GMO dissemination, to the scale of proposed dealings. The risk consequences focus on both the level and nature of potential harm to human health and safety, as well as to the environment.

One facet of the OGTR’s Risk Context is the acknowledgement of not only the physical harm posed by GMOs, but also the perception of that harm. This reflects an understanding that public attitudes and understanding are a critical component of risk management in gene technology.

The Risk Assessment Context of the RAF emphasises a case-by-case approach, recognising the unique nature of each GMO and its specific application. It takes into account not only the specifics of the GMO, proposed dealings, and the parent organism, but also the environment into which the GMO will be released. It acknowledges that these environments are dynamic and can change over time, necessitating a flexible and adaptable risk assessment.

In the Risk Management Context, the RAF outlines protocols for managing identified risks, focusing on key protection goals, legislative matters, decision-making processes, licence conditions, and provisions for audits and monitoring. It also includes risk management considerations for parent species and sanctions for non-compliance.

Finally, the Risk Communication Context details the communication and consultation procedures, underscoring the importance of open dialogue and consultation with a variety of stakeholders to ensure transparency and build trust.

For proponents of GMO technologies aiming for a successful licence application, understanding and effectively addressing the RAF’s comprehensive risk management considerations is crucial. A thorough understanding of the risk context, as described by the OGTR 2013 RAF, is fundamental to achieving this.

Applicants need to carry out rigorous and scientifically sound risk assessments, considering both the physical and perceived risks associated with the GMOs. They must take into account not only the nature of the modification and its application but also the environment in which the GMO will be released. Applicants must also propose effective risk management strategies and demonstrate how they will achieve the protection goals, comply with legislative matters, and adhere to the conditions of the licence.

Moreover, they must be prepared to engage in open dialogue and consultation, taking on board the views of a wide range of stakeholders. In particular, transparency and engagement with the public are crucial elements of the RAF and can be a critical factor in a successful license application.

In conclusion, a well-prepared application within the context of the OGTR’s Risk Analysis Framework requires a combination of solid scientific analysis, effective risk management strategies, and excellent stakeholder communication skills.

Source document

Office of the Gene Technology Regulator 2013, Department Of Health and Ageing 2013. Risk Analysis Framework 2013