In most countries, key food safety decisions are delegated to specialized agencies, usually those with a mission to protect public health. These decision-makers need to carry out their responsibility in an objective manner, and they rely on technical experts and science to provide the perceived requisite certainty and objectivity.
Internationally, food safety agencies also agree on the value of science as a significant tool in food safety policy-making and in developing food standards. The general policy guidelines of the Codex Alimentarius Commission contain Statements of Principle Concerning the Role of Science in the Codex Decision-Making Process and the Extent to Which Other Factors are Taken into Account.
The first two of these statements follow.
1. The food standards, guidelines and other recommendations of Codex Alimentarius shall be based on the principle of sound scientific analysis and evidence, involving a thorough review of all relevant information, in order that the standards assure the quality and safety of the food supply.
2. When elaborating and deciding upon food standards Codex Alimentarius will have regard, where appropriate, to other legitimate factors relevant for the health protection of consumers and for the promotion of fair practices in food trade.
The Codex Alimentarius Commission has further elaborated criteria for considering the "other legitimate factors" referred to in the second statement of principle listed above. The key elements in the identification of these factors follow.
Other legitimate factors relevant for health protection and promotion of fair trade practices may be identified in the risk management process, and risk managers should indicate how these factors affect the selection of risk management options and the development of standards, guidelines and related texts.
Consideration of other factors should not affect the scientific basis of risk analysis; in this process, the separation between risk assessment and risk management should be respected, in order to ensure the scientific integrity of the risk assessment.
The consideration of specific other factors in the development of risk management recommendations of the Codex Alimentarius Commission and its subsidiary bodies should be clearly documented, including the rationale for their integration, on a case-by-case basis.
The integration of other legitimate factors in risk management should not create unjustified barriers to trade; particular attention should be given to the impact on developing countries of the inclusion of such other factors.
(For the full statement as given in the Procedural Manual of the Codex Alimentarius Commission, see Annex II of this report.)
Codex policies emphasize that risk analysis should be based upon risk assessment as a scientific enterprise. Since the relationship between science and ethics is a crucial element of risk analysis, we need to clarify what is meant by "scientific". If scientific is taken to mean rigorous, impartial and with interpersonal objectivity, then this is a good description of the standard for which risk assessment should strive. If scientific is meant to imply "value free" and providing the only "right" answers in the identification, assessment and management of risks, then this is plainly wrong. Implicit in risk analysis are some - mostly uncontroversial - value judgements, which merit further analysis (see p. 16).
In the vast majority of cases, technical experts and other stakeholders widely agree about what constitutes safe food. In those situations, there is no or very limited disagreement about the value judgements made in the risk analysis process. However, in some risk analysis situations these judgements are disputed. Consider, for instance, the assessment of new technology, a new food production process or a newly identified hazard. In these cases, what is "safe" may not yet be the subject of a consensus, and risk analysis has more explicit ethical dimensions.
To make the ethical dimensions of the risk analysis process transparent, we must first understand what triggers the need for such a process. Similarly, it is not always feasible to carry out a full analysis of all risk-related issues, from the perspective both of available resources and of technical capacity. The reasoning followed in undertaking and defining the scope of a risk analysis should therefore be explicit.
While risk assessment is based on science, scientific evidence and analysis cannot always provide immediate answers. Much scientific evidence is tentative, as the established processes of science include checking and rechecking outcomes in order to attain the required level of confidence. Within any given time frame, the scientific answers provided may not solve the problems at hand. The reliability of a risk assessment is influenced by many factors, not the least of which are the appropriate framing of the questions being asked and the relative completeness of the knowledge of the risk assessors.
Scientific enquiry and the interpretation of scientific evidence are not entirely objective enterprises. They involve their own set of values and principles. While many of these are recognized and direct the scientific processes, others are obscure or inferred. The scientific values embedded in a risk analysis need to be made explicit. Doing so clarifies the relative positioning of these values against other value sets with which they intersect (e.g. political or religious values).
For example, scientific values include recognizing the inherent uncertainty of evidence and challenging or testing the veracity of accepted knowledge. This is, in fact, part of the strength that science brings to food safety policy formulation. The investigative nature of science exposes systemic weaknesses, allowing for continuous improvement of knowledge, while at the same time providing a tool for predicting consequences of actions taken. Science is the means by which alternative options for managing problems may be presented to both decision-makers and those affected by decisions. Science enhances the confidence in decisions reached by making the unknown more familiar and predictable.
