III. ASSESSMENT AND MANAGEMENT OF RISKS
28. An assessment of the risks to human health and the environment associated with
the use of organisms with novel traits is based on consideration of the following
key parameters, when applicable:
(i) The characteristics relating to the organism with novel traits, taking into account:
(ii) The intended use, i.e. the specific application of the contained use or deliberate
release or placing on the market, including the intended scale and any management
procedures and waste treatment;
(iii) The potential receiving environment.
Forecasting models could be developed in the future that may aid in these assessments.
29. Examples of the points to consider in risk assessment are given in Annex
3. These points should be used to arrive at a judgement concerning the consequences
and likelihood of hazards occurring which could cause harm to human health and/or
the environment and the effectiveness of proposed management strategies to minimize
the risk. The severity of harm might depend on the extent to which and the period
over which other organisms and their ecosystems or their components are affected.
30. If the risk assessment at first shows that the level of risk of the intended
use is not acceptable, additional risk-management measures are to be taken and assessed
until the risks have been minimized to an acceptable level. If the risk cannot be
minimized in this way, it might be concluded that the intended operation should not
proceed, or a risk/benefit analysis might be carried out to determine whether a higher
level of risk is acceptable and whether the intended operation should proceed.
31. The type of risk management to be applied depends on the organism with novel
traits and the particular application. For contained uses, the degree of containment
achieved depends primarily on the type of physical barriers and the application of
appropriate work procedures. In the case of controlled releases, different types
of barriers, such as biological, chemical, physical or temporal barriers can be used
to minimize or limit the dissemination and impacts of organisms with novel traits
and/or to provide genetic isolation, if required. Different risk-management practices
may be applied, depending on the scale of the proposed release and its duration.
Examples are given in Annex 5.
32. International databases are important sources of information for risk assessment
and risk management, because they provide detailed knowledge of and experience gained
with organisms with novel traits and aid in the development of models. They provide
a contact from which further information could usually be obtained. Countries should
be encouraged to provide information on access to their own databases. Countries,
organizations and companies should be encouraged to contribute to and coordinate
the development and maintenance of regional and international databases such as those
listed in Annex 6. Databases should be regularly updated
and, whenever possible, interlinked and made available for users.