1. Risk Analysis

Risk Analysis encompasses risk assessment, risk management and risk communication. Risk is defined as the probability that exposure to a hazard will lead to a negative consequence (Sperber, 2001). The formulaic approach to risk-assessment expresses risk as simply,

Risk = Hazard x Dose (Exposure)

A hazard is any biological, chemical, mechanical, environmental or physical agent that is reasonably likely to cause harm or damage to humans, other organisms, or the environment in the absence of its control (Ropeik, 2002). In biosafety and from food safety perspective examples of Hazards include potential allergenicity, or toxicity reactions that could emanate from consuming GMO foods.

2. Risk Assessment

Risk Assessment is the measure to estimate what harm might be caused, how likely it would be to occur and the scale of the estimated damage. The objective of risk assessment under the Cartagena Protocol of Biosafety is to identify and evaluate the potential adverse effects of living modified organisms on the health and the environment. Risk Assessment is therefore inherently the most critical component of biosafety implementation and decision making (Traynor et al., 2002).

3. Guiding Principles for Risk Assessment

Five guiding principles of risk assessment include:

• That decisions on biotechnology Research and Development should be based on outcomes of a risk assessment.

• Risk assessments must be undertaken in a scientific manner based on recognized risk assessment techniques, taking into account advice and guidelines developed by relevant international organizations.

• Lack of scientific knowledge or scientific consensus must not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk.

• Risks associated with Living modified organisms (LMOs) or products thereof should be considered in the context of risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment.

• Risk assessment should be carried out on a case by case basis. (CPB, 2000)

4. Methodology for Risk Assessment

A generally accepted methodology for biotechnology risk assessment has been outlined in several documents including the UNEP International Technical Guidelines for Safety in Biotechnology (2010), the Cartagena Protocol on Biosafety (2000), EC Directive 2001/18/EEC 5, European Food Safety Authority (EFSA, 2010). Each of these include the following steps, that, together identify potential impacts and assess the risks:

• Identify potential adverse effects on human health and/or the environment also called the hazard.

• Estimate the likelihood of these adverse effects; being realized (dose or exposure).

• Evaluate the consequences should the identifiedeffects be realized (the risk).

• Consider appropriate risk-management strategies.

• Estimate the overall potential environmental and health impact, including a consideration of potential impacts that may be beneficial to human health or the environment (Traynor et al., 2010; EEC Directive, 2001; UNEP 2000; CPB, 2000, EFSA, 2010).

5. Interpreting Risk Assessment Data

• The first step in interpreting risk assessment data is to categorize the level of risk as outlined in the risk matrix below (OGTR, 2013). The figure shows possible results options obtained from risk assessment.

• In date interpretation it should be underlined that “Risk” is a product of “Hazard x Exposure”. For example you can have high “Hazard” but if the “Exposure” is low, the overall magnitude of “Risk” will be low and vice-versa.

• Where possible, a comparative risk assessment approach is used in which case risk from GMO is considered relative non-GMO parent organisms.

• Interpretation of the data will depend on the stage of biosafety in the biosafety regulatory pathway commencing from laboratory, greenhouse, confined field trials and release into environment and placing in the market. For example, during contained greenhouse experimentation- the effect of GMO on human health may be uncertain but because the exposure is low (no human or animals may be allowed to the food) the overall risk is low.

• The risk assessment may identify risks that require management; how best to manage the risk and a risk management strategy should be defined. For example, when developing a GMO in areas with cross compatible wild relatives, the applicant may be requested to do the experimentation in greenhouse with a higher biosafety level. In this case the “Hazard” is uncertain or is potential high but the “Exposure” is low (zero) so the resultant risk is minimized because of the stringent management practice.

6. Writing a risk Assessment Report

The components to include in risk assessment report will vary depending on the country and regulatory framework, the stage of the biotechnology R and D. The following components are however common in many of these reports;

• Characteristics of the GMOs and releases

• Identification of characteristics which may cause adverse effects

• Evaluation of the potential consequence of each adverse effect if it occurs

• Evaluation of the likelihood of occurrence of each potential adverse effects

• Estimation of the risk posed by each identified characteristic of the GMOs

• Application of management strategies for the risk from the deliberate release or marketing of the GMOs

• Determination of the overall risk of the GMOs

• Conclusion on the potential environmental and or food safety impact from the release or placing on the market of the GMOS (EEC 2001/18)

7. Risk Management

Where risk has been identified, appropriate measures to manage risk should be developed. Risk management selects and implements plans or actions to ensure that risk is appropriately managed. This entails preparation of a risk management plan as well as monitoring and reviewing to provide feedback on all steps in the risk analysis (OGTR, 2013). The risk management strategies should aim to reduce risk associated with GM plant to a level of no concern and should define areas of uncertainty. Risk management should be described in term of reducing the hazard and or exposure and the consequent reduction in risk should be quantified (when possible) (EFSA, 2010).

8. Risk Communication

Risk communication is the exchange of information, ideas between the regulator and the stakeholders (OGTR, 2013). It is a continual and iterative process to provide, share and obtain information and engage in dialogue with stakeholders regarding the analysis of risk within the context of legislation. The goals of risk communication are three fold- to engage internal and external stakeholders, to foster understanding of risk and to build trust and credibility in the regulator (OGTR, 2013).