Recent debates on issues such as GMOs and the review of the European chemicals policy have sparked heated discussions among stakeholders about the analysis and assessment of the underlying risks and the way in which these can be managed and communicated. Questions about the definition of risk, the objectivity of scientific information and the role that risk analysis should play in policy decisions are at the heart of the debates.
When talking about risk-based decision-making, it is important to understand the concepts this approach is based on. In particular, there is often some confusion over the terms of ‘risk’ versus ‘hazard’ as well as the concept of risk management. The following definitions are therefore essential:
Hazard is the potential to cause harm. A good example would be a chemical substance which, if in contact with humans, could cause serious health problems.
Risk on the other hand is the likelihood of harm to actually occur. This normally depends on the degree of exposure to a given hazard. For example, a very low exposure to a highly hazardous chemical may result in a low risk, while on the other hand a high exposure to a substance of very low hazard may result in a moderate or even high risk. In other words, for there to be a risk, there must be both the hazard and the exposure to the hazard.
Risk management describes the process of weighing up the policy options with regards to a controversial issue such as GMOs or chemicals in consultation with all the stakeholders. By looking at the risks involved, as well as at the risk perception of the public, policy-makers take decisions about what to do about the risk, communicate their decision, see through its implementation and evaluate the results.
Risk perception refers to the way the public and other stakeholders perceive any given risk. This can be quite different from the scientific evidence provided, such as in the case of GMOs in human food. Understanding the risk perception is crucial as it can make debate highly charged and helps determine the best ways to communicate the risk.
Risk communication is key to gain stakeholder acceptance of policy decisions. It may include economic, social and ethical values as well as the scientific facts. Policy-makers used to take a top-down approach to risk communication (from regulator to public), whereas a more modern approach encourages public and stakeholders to participate actively in the communication process through public consultations, hearings etc.
Precautionary principle : In 2000, the Commission published a communication on the so-called ‘precautionary principle’, saying that this covered "cases where scientific evidence is insufficient, inconclusive or uncertain and preliminary scientific evaluation indicates that that there are reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the high level of protection chosen by the EU". Applying the precautionary principle is a risk management policy decision.
In its 2001 White Paper on European Governance, the Commission recognised that scientific and other expert advice played an increasingly significant role in decision-making. Expert advice particularly serves to anticipate and identify potential problems and uncertainties, take decisions and ensure good risk communication.
The White Paper points out that recent food scares such as the one generated by BSE (mad cow disease) have undermined public confidence in risk-based policy-making. Furthermore, it recognises that this problem is worsened by the “opacity of the Union’s system of expert committees or the lack of information about how they work”, making it unclear who is taken the decisions, policy-makers or experts. There is also more and more mistrust in the independence of expert advice given to decision makers.
Questions such as “What is risk?”, “Who defines it?” and “Who takes the decisions?” become even more pertinent as the EU is committed to applying the precautionary principle and to conducting thorough risk analysis and risk management.
In December 2002, the Commission published a Communication on principles and guidelines on the collection and use of expertise, which stipulates that all gathering of expert advice should be underpinned by quality, openness and effectiveness.
There has been widespread debate on the advantages and disadvantages of risk analysis as a valuable tool for policy decisions. In particular, stakeholders, including industry, NGOs and academia are often at odds as to how risk analysis should be used and how much influence it should have on the decisions. One of the main points of debate concerns the objectivity of the consulting experts.
The scientific community and industry often argue in favour of a strictly risk-based policy making, saying that risk analysis is the only ‘objective scientific basis’, which can lead to more ‘rational’ decisions. According to the proponents of this approach, problems and limits of risk analysis can be overcome through thorough data collection and research, as well as strict guidelines for the consistent conduct and presentation of the results.
Others, mainly environmentalist, consumer interest groups and other NGOs, point to the danger that risk analysis tends to oversimplify the problems faced by policy-makers by focusing on one hazard and one effect at the time or on problems that are well understood. They criticise that because risk assessment methods tend to be very complex, they can be easily manipulated for political purposes. As a result, the decision-making process will be less democratic.