II. GENERAL PRINCIPLES AND CONSIDERATIONS

18. As with any human activity, the safety of any technological application is achieved by carrying out certain sequential steps, as follows:

1. Identifying any hazards;
2. Assessing the risks: if a hazard has been identified, the combined effect of the consequences and the likelihood of the hazard being realized are estimated;
3. Managing the risks: where indicated by the results of the risk assessment, either by applying adequate management strategies, including designing procedures and methods to minimize risks and their consequences, or by deciding not to proceed. Management strategies should be commensurate with the results of the risk assessment. Therefore, there might be cases where very few, if any, risk management measures will be necessary.

19. In applying this general principle to biotechnology, which involves the use of organisms, risk assessment takes into account the following components and the interactions between these (see also Chapter III):

• The characteristics of the organisms (see Annex 2) involved, including any newly introduced traits;
• The manner in which organisms are to be used, including any management practices applied, such as provision for containment and waste treatment;
• The characteristics of the areas and other organisms that might be affected, i.e. the potential receiving environment, including humans.

20. Risk assessment and risk management can be based in part on knowledge of and experience (i.e. familiarity) with an organism, the intended application and the potential receiving environment. Risk assessment may vary from a very short process to an extensive review, depending on the extent of familiarity. Adequate familiarity does not necessarily imply that an organism is safe, but it means that known management procedures can be applied. A lack of familiarity does not mean that an organism is not safe, but it means that, until sufficient familiarity with such organisms has been acquired, risks associated with such organisms are assessed on a case by case (e.g. variety by variety or strain by strain) basis and in a step-wise manner. As experience and knowledge evolve, risk assessment may serve for a group of organisms for characteristics that are functionally equivalent on a physiological level. Greater knowledge and experience will be required for the exemption of larger groups of organisms. As a consequence, applications with certain groups of organisms may proceed under defined generic conditions, or might be exempted from oversight. The development of such generic approaches of risk assessment or exemption in one country does not necessarily mean that similar generic approaches will be applied in other countries.

21. There is generally less familiarity with the behavior of organisms whose genetic make-up is unlikely to develop naturally, such as organisms produced by modern genetic modification techniques, than with the behavior of organisms developed traditionally. This has been the reason why many countries have focused on such organisms and products containing them. In these Guidelines, such organisms are called organisms with novel traits. These Guidelines should allow the benefits of biotechnology to be realized and, at the same time, ensure that concerns about novelty are addressed. Although these Guidelines are directed to organisms with novel traits and products containing such organisms, the general principles for safety are applicable to all organisms.

22. The Guidelines provide assistance for identifying organisms whose characteristics may differ from those of the parent organisms from which they are derived in ways that would suggest additional scrutiny might be appropriate. This may be because they produce substances which are not found in the species concerned, or because there are new environmental or other risks associated with the new characteristic.

23. Experience with environmental releases to date suggests that the risks associated with organisms with novel traits, much of which has concerned well- known agricultural crop plants in well-known agricultural environments, will in most cases be the same in kind as those associated with the parent organisms, and can be dealt with satisfactorily by comparable mechanisms. It is generally anticipated that, in most cases, there will be low environmental risk from introducing into a similar environment such well-known crop plants after they have been modified by altering or adding only one or a few genes, especially when compared with the risks of introducing entirely new or alien species.

24. Monitoring can contribute significantly to gaining knowledge and experience with the use of organisms with novel traits. Monitoring may vary from a very simple observation to an extensive research programme. Monitoring can be carried out by the user and/or by an independent authority, organization or body and is often used to verify the assumptions made in a risk assessment and should be used to evaluate whether the risk-management measures used are appropriate and effective.

25. Once adequate risk-management strategies have been formulated, the effectiveness of those strategies depends partially on the user. Therefore, the primary responsibility for the safe use or transfer of organisms with novel traits lies with the user. Consequently, users should be well informed, competent and well aware of their responsibility.

26. An organism with novel traits which is considered to be harmless in one region might be potentially harmful in another region which offers different environmental conditions. Therefore, there is a need for the exchange and supply of scientific information in cases where organisms with novel traits are intended to be released into new environments and when transfer of such organisms across national boundaries is being considered, particularly in those cases in which organisms with novel traits are intended to be released in the environment.

27. In cases in which organisms with novel traits are to be transferred to their centres of origin, there is a need to pay particular attention to risk assessment and risk management, because of possible effects on related species that are present, to ensure adequate protection of genetic resources and biological diversity.