There is broad international agreement that food safety standards and related guidelines must have an objective basis in science. It is also widely evident that risk analysis, and especially risk management, requires the consideration of many more subjective and value-laden variables, to determine the appropriate level of protection and to choose the optimal risk-management option(s). The scientific community has developed ways to resolve disagreements over scientific facts, but disagreements over the value and ethical components of food safety decisions are often much harder to sort out.
One reason for this difficulty is that value choices and ethical assumptions in debates about food safety tend to be implied, rather than explicit. Traditionally, it has been unusual for the scientists and risk managers who most often carry out the key risk analysis steps to communicate openly about their value judgements and ethical choices. Decisions usually are defended as based on "science," and sometimes on economic costs and benefits as well, which offer seemingly objective, verifiable evidence that the policy choice is "correct". Decisions explicitly based on ethical principles and value preferences can be just as defensible, if society agrees broadly on the ethical assumptions used to make policy. However, applying divergent ethical perspectives often precludes consensus on a single "correct" outcome. In such situations, risk managers tend to shy away from openly explaining the ethical judgements underlying their decision.
The emphasis on science and the exclusion of ethical argument as the basis for decisions may polarize the scientific debate. Stakeholders who find that risk managers will not entertain a serious discussion of, for example, their right to avoid consuming a food they believe is not safe enough, may argue instead that the food is not safe, exacerbating technical disagreements about inherently ambiguous evidence of risks.
To increase understanding of the values implicit in decisions about food safety, the Expert Consultation identified five groupings of values: the right to adequate food, trust, optimization, informed consent and equity. The first is fundamental to food safety policy considerations because it responds to the universal human right to safe and nutritious food, and because it encompasses other human rights such as the right to information, culture and human dignity. Its basic, fundamental component, the right to freedom from hunger, is generally highlighted in situations of food shortage and food insecurity. The other values are specifically relevant within the risk analysis framework. They are therefore examined first, here; the right to food and its relationship with food safety will be taken up again later (see p. 16).
In theory, a fully informed consumer might decide which food-related risks to take and which to avoid. But in the real world, average citizens cannot collect detailed information about the wide array of food safety issues and make their own decisions. For the most part, these decisions are delegated to responsible authorities in government agencies and the food industries. From an ethical standpoint, when one delegates decisions, especially decisions affecting personal safety, one must trust the entities responsible for these decisions. The food safety system therefore must be able both to manage risks and inspire trust.
There are important distinctions between trusting and risk-taking. Risk-taking and trust operate on different levels. Risk-taking involves making a decision after weighing the pros and cons and deciding that the positive outcomes are more likely or greater than the negative outcomes. With sufficient information about specific risks, we can build on past experiences with similar risks and determine whether or not to accept the new risk.
Trust, on the other hand, is primarily a dimension of a human relationship, rather than an action. To delegate responsibility for risk-related decision-making, trust between the decision-maker and those affected is essential. Trust requires a belief in the inherent competence of the decision-makers as well as in their integrity. In a trustful relationship, all parties regard each other's concerns, interests and wishes seriously. To trust a person or an institution means - essentially - to expect that they will handle problems in the same way one would have done oneself. Risk-taking involves acting on the basis of a decision in which pros and cons are weighed, but trust is an aspect of a relationship built up over time.
Because of some recent food safety failures, trust has been eroded in certain expert authorities, and some sectors of the public, in at least some parts of the world, are now reconsidering their level of comfort with this traditional delegation.
The growing gap between traditional food-related behaviours and current reality can put trust at risk. The need to make explicit the role of ethics in food safety policy development is driven, in part, by the increasing distance in today's world between the producer and the consumer. Hence, the "farm to fork" concept that food safety is best managed as a continuum has gained great importance in recent years. This concept recognizes that knowledge of the linkages between the consumer at one end of the supply chain and the producer at the other end is lacking, or is coloured by traditional understandings rather than reality. Popular images of the food system often do not correspond to the reality of modern food production systems, its increasing mechanization and the use of new technologies. Similarly, we seldom pause to consider that the food system is driven by matters other than production as an end in itself (e.g. minimization of chemical use, concern for welfare of animals, geographic origin).
While the phenomenon of the "growing gap" is most acute in the developed world, it also exists in the developing world where, through rapid urbanization, people are becoming less directly engaged in agricultural production and increasingly rely on others for their food. This gap can develop in a short time, even within a single generation. However, the values and images underpinning decision-making are not keeping pace with the changing reality of production systems. Furthermore, in developing countries, social and political conditions often limit people's awareness of food safety issues and their opportunities to engage with the institutions entrusted with making decisions on their behalf.
Two conceptual frameworks are often applied to evaluating ethical issues associated with risk and safety.
The framework commonly used in public health stresses optimization of the balance between the costs and the benefits associated with policies and actions intended to reduce or manage risk. Optimization relies on a series of trade-offs. The application of this framework to food safety is conceptually straightforward, even if its execution in any particular instance can involve technically complex analysis and data collection. With the optimization framework, policies are not justified unless they produce more benefit than cost, and the decision-maker who sets policy is obligated to implement policies that deliver an optimal ratio of benefit to cost. With respect to food safety, benefits are defined as reductions in historical rates of mortality and morbidity associated with food-borne pathogens; in the case of some other hazards, benefits correspond to reductions of exposure and avoidance of risks predicted from animal testing. These must be weighed against the administrative costs of implementing a policy, as well as any collateral impact that the policy may have on mortality and morbidity or on public economic and social welfare. For example, increases in the cost or scarcity of food owing to a policy intended to reduce pathogens could cause mortality and morbidity associated with hunger that would offset any benefit attributable to the reduction in pathogens. The optimization perspective interprets ethically sound policy-making as an exercise in weighing these trade-offs.
Informed consent framework
The other framework, which has a long history in contracts and has recently become especially important for medical ethics and for the ethics of research on human subjects, puts central importance on informed consent in making decisions. Informed consent approaches the ethics of risk as the challenge of ensuring that people who bear risk do so knowingly and voluntarily. Advocates of the informed consent perspective criticize optimization, because some basic individual rights are seen as overriding, and it is not acceptable to trade them off against other values. For example, principles underpinning the International Declaration of Human Rights clearly override policy trade-offs where the trade-off may adversely affect a vulnerable group.
Under the final grouping of values, the value of equity was considered to be useful in understanding the relationship and the tension between optimization and informed consent.
Equity, or fairness, in policy-making and in the final distribution of opportunity and wellbeing, is an ethical issue that cuts across both the optimization and informed consent frameworks for food safety. Equity concerns arise in the national context, with respect to the distribution of risks, costs and benefits of a particular food safety decision. Equity is also a concern in the context of a number of issues in international food safety policy that are associated with the unequal distribution of power, wealth and knowledge among the world's peoples. Thus, for example, food safety decision-making may favour the interests of more powerful developed states by restricting the access of producers from less developed regions to international markets. In some cases, local producers in these less developed regions are displaced, and markets disrupted, by the influx of food from countries in which a numbers of factors converge to give them a pronounced competitive advantage. These factors include a better infrastructure, greater economies of scale, higher levels of direct and indirect government support, access to advanced technologies, and greater financial and technical resources to facilitate adaptation to international food safety norms. Conformity with internationally accepted food safety regulations often requires a re-organization of local production systems, with considerable and abrupt social and economic impact on populations that have traditionally relied on agriculture for their livelihoods.
In addition, available scientific data and expertise on food safety and risk analysis disproportionately reflect the experience of more industrialized systems of food production and manufacture. International food safety standards and other food safety regulations are therefore skewed towards a developed country perspective. This general ethical concern arises in virtually all areas of policy, not only policy relating to risk and food safety.
Equity from the optimization and informed consent perspectives
The issue of equity tends to be interpreted and addressed somewhat differently depending on whether the goal is optimization of outcomes or rights through participation and consent.
The optimization framework has typically approached equity as a problem of ensuring that the interests of all affected parties are addressed, and that equivalent interests are given equal weight in calculating benefits and harm. Thus, a food safety policy that fails to consider the impact on specific groups such as women and children is, from this perspective, inequitable because it fails to incorporate the full range of policy consequences into its comparison of benefit and harm. A food safety policy might also be inequitable because it fails to recognize that an increase in the price of food has relatively greater impact on the well-being of poor people. The price of food can mean the difference between life and death. So, in this case, a policy that inadequately addressed the question of market access as fundamental for poverty alleviation and economic development in the global south would be inequitable. The principle of equity does not imply an equal policy for all; it can identify a suboptimal policy outcome measured in terms of impacts on health, wealth and well-being.
The informed consent framework tends to emphasize the role of equal and universal human rights. Thus, a policy is unfair or inequitable when people lack effective means to claim goods or opportunities to which they are believed to be entitled by right. The opportunities to participate equally in decision-making or to give or withhold consent to risk exposures are protected by rights. Within the equity framework, this leads to an examination of the structural aspects of a social setting (e.g. the legal protections, technological capabilities and opportunities afforded to all parties). Inequality or unfairness is understood primarily as a problem of denial of access to these protections, capabilities and opportunities.
Although people base their decision-making on different values, these values may converge on a common position. The approach that is ultimately applied, however, can lead to important differences in practical outcomes. The participation and consent approach is more resistant to trade-offs that sacrifice the rights of individuals and minority groups, while the optimization approach is more amenable to seeing gains in well-being for the majority as offsetting the loss of opportunity or right that might be experienced by the few.