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Frequently Asked Questions



Definition of Biosafety

What is biosafety? The Cartagena Protocol on Biosafety which was adopted in January 2000 in Montréal interestingly does not define the term. This is not really unusual in public international law since it is a complex concept and it would be difficult to achieve a global consensus on its definition. In any case, such a definition is not necessary, it would add little or nothing to the legal functioning of the Protocol. Furthermore, member countries may even  have strategic reasons not to define the concept in order to maximize flexibility in its application.

The Protocol does, however, specify in Article 4 the scope of this agreement which is part of the Convention on Biological Diversity, administered by the United Nations Environment Programme: "This Protocol shall apply to the transboundary movement, transit, handling and use of all living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health." Contrary to the definition, the specification of the scope of an international agreement is a crucial requirement for its application, and in the case of this Protocol it was in fact one of the most difficult issues to negotiate. These difficulties were resolved by providing importing countries with much stronger rights to restrict imports of GM seeds and fish than for GM commodities destined for feed or food because the former represent a far bigger threat to the protection of biological diversity.

EcoLomics International provides the following procedural definition of biosafety in the context of the Cartagena Protocol:



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.




What is the Difference between
Precaution and Prevention?


“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).




What is the Relationship between Risk Assessment and Risk Management?




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. »



Christine Noiville et Nicolas de Sadeleer. 2001. La gestion des risques écologiques et sanitaires à l'épreuve des chiffres - le droit entre enjeux scientifiques et politiques. Revue du Droit de l'Union Européen 2: 389-450 (408).




Other Frequently Asked Questions answered by the Secretariat of the CBD/Biosafety Division


What is biosafety?

Biosafety is a term used to describe efforts to reduce and eliminate the potential risks resulting from biotechnology and its products. For the purposes of the Biosafety Protocol, this is based on the precautionary approach, whereby the lack of full scientific certainty should not be used as an excuse to postpone action when there is a threat of serious or irreversible damage (see "What is the precautionary approach?"). While developed countries that are at the center of the global biotechnology industry have established domestic biosafety regimes, many developing countries are only now starting to establish their own national systems.

For other questions on the Biosafety Protocol see:






Biosafety Protocol



Secretariat, Biosafety Division


Biosafety Clearing-House


Chatham House / Royal Institute of International Affairs,

Sustainable Development Programme / Environment, London



Environmental Research Foundation, New Brunswick, N.J.

Free electronic subscription

(Emphasizing the Precautionary Principle)



ETC Group, Ottawa


Free electronic subscription


Gene Watch UK


GRAIN, Barcelona


Free electronic subscription: Seedling


International Center for Trade and Sustainable Development, Geneva


Free electronic suscriptions:

Bridges Weekly
Bridges Trade BioRes

Bridges Monthly: on the Web and in Print
Authoritative information on trade and sustainable development

L'édition française avec Enda-Tiers monde: Passerelles



International Environmental Law Research Center, Geneva, Nairobi and New Delhi



International Institute for Sustainable Development, Winnipeg, Ottawa, New York and Geneva


Free electronic subscription:


Environmental Negotiations Bulletin

In depth daily coverage of the major environmental

multilateral negotiations


Observatoire de l'écopolitique internationale,

Université du Québec à Montréal


Objectif Terre, Bulletin de liaison du développement durable de l'espace francophone (gratuit)



Politics of Genetically Modified Organisms, Vancouver

Prof. Yves Tiberghien, University of British Columbia, Department of Political Science


RIBios - Réseau Interdisciplinaire Biosécurité, Genève

Biosafety Interdisciplinary Network, Geneva





WTO, Trade and Environment Division



WTO Analytical Index — Guide to WTO Law and Practice



WTO Documents Online