OGTR 2013 Risk Analysis Framework Overview: Attention
to Context
David Tribe 2023
Next post in this series: Gene technology regulations Part 3: Enhanced International Standards Bolster Biotechnology Risk Management
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.
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Next post in this series: Gene technology regulations Part 3: Enhanced International Standards Bolster Biotechnology Risk Management
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