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29.11.04

The concept of biosafety as it is used under the Cartagena Protocol on Biosafety specifies those legal actions that an importing country is entitled to take under international environmental law with the aim of protecting the biological diversity of its conventional plants and animals against the risk of contamination through imported varieties or species consisting of so-called Living Modified Organisms. These actions consist primarily in preventive or precautionary trade measures. Such restrictions or bans include the elaboration, negotiation and implementation of pertinent standards, and the institutionalization and international harmonization of the related regulatory framework and procedures. They also take into consideration the legally less clearly circumscribed concerns over related public health issues and socio-economic considerations. All these provisions aim at a non-hierarchical and mutually supportive relationship with other international agreements, especially with WTO law, with the Codex Alimentarius, and with the International Plant Protection Convention.

See also the definition provided by the Biosafety Division/CBD Secretariat.

“The distinction between the preventive principle and the precautionary principle rests on a difference of degree in the understanding of risk. Prevention is based on certainties: it rests on cumulative experience concerning the degree of risk posed by an activity (Russian roulette, for example, involves a predictable one-in-six chance of death). Therefore, prevention presupposes science, technical control, and the notion of an objective assessment of risks in order to reduce the probability of their occurrence. Preventive measures are thus intended to avert risks for which the cause-and-effect relationship is already known (…)

Precaution, in contrast, comes into play when the probability of a suspected risk cannot be irrefutably demonstrated. The distinction between the two principles is thus the degree of uncertainty surrounding the probability of risk. The lower the margin of uncertainty, the greater the justification for intervention as a means of prevention, rather than in the name of precaution. By contrast,  precaution is used when scientific research has not yet reached a stage that allows the veil of uncertainty to be lifted.”

de Sadeleer, Nicolas. 2002. Environmental Principles: From Political Slogans to Legal Rules. Oxford, UK: Oxford University Press, 434 p. (74-75).

Translation

Could we imagine that risk assessment by itself represents a first phase after which one would pass definitely across a certain demarcation line in order to engage the second phase, i.e. risk management? Such an explanation is not very convincing because it would be disconnected from the concrete reality of scientific and political work processes. Science and politics in fact are far from constituting two linear fields of action that follow each other, and where the second could only enter into function once the first one is terminated.

…

In the real world risk assessment and risk management are overlapping, they are characterized by a process which moves back and forth constantly. The assessment of a risk is often the fruit of a managerial decision. In the same vein, new risk assessments are often undertaken the moment that a managerial measure has been adopted. As a matter of fact it is actually the law that imposes often, especially when scientific uncertainties remain, to accompany risk management with new assessments which may in the end allow an adjustment of risk management to the evolution of knowledge. There may well be a separation between the two processes, however this separation is everything but impermeable and we can see even that this would not be desirable. This is why some institutions such as the Codex Alimentarius on one hand describe the separation between risk assessment and risk management at a functional level, while on the other hand they fully recognize that certain interactions between the two phases are indispensable for a pragmatic approach.

Original text

« ... l'évaluation peut-elle constituer à elle seule une première étape, après quoi l'on passerait définitivement de l'autre côté de la frontière pour se consacrer à une seconde étape, la gestion? Une telle justification est peu convaincante car elle se trouve déconnectée de la réalité concrète du travail scientifique et politique. Science et politique sont loin en effet de pouvoir constituer deux actions linéaires qui se suivraient chronologiquement, la seconde ne pouvant ‘prendre ses fonctions’ qu’une fois la première terminée.

…

 Car dans la réalité, évaluation et gestion se chevauchent, se caractérisent par un va-et-vient permanent dans le temps. L’évaluation d’un risque est souvent le fruit d’une décision de gestion. De la même manière, de nouvelles évaluations sont souvent entreprises alors même qu’une mesure de gestion vient d’être adoptée. C’est du reste le droit lui-même qui impose souvent, notamment lorsque des incertitudes scientifiques demeurent, d’accompagner la gestion de nouvelles évaluations qui permettront éventuellement de l’adapter à l’évolution des connaissances. Aussi bien, si séparation il y a, elle n’a rien d’étanche et l’on voit même qu’il n’est pas souhaitable qu’elle le soit. C’est pourquoi tout en prônant une séparation fonctionnelle entre l’évaluation et la gestion des risques, certaines institutions comme le Codex Alimentarius énoncent que certaines interactions sont indispensables à une approche pragmatique. »