The Biosafety Protocol requires Parties to make decisions on import of LMOs for intentional introduction into the environment in accordance with scientifically sound risk assessments (
Article 15). It sets out, in
Annex III general principles, methodological steps, and points to consider in the conduct of risk assessment. The general principles include, among others, the following concepts: Risk assessment should be carried out in a scientifically sound and transparent manner; Lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk; Risks should be considered in the context of risks posed by the non-modified recipients or parental organisms; and that Risks should be assessed on a case-by-base basis.
The methodology described in Annex III of the Protocol follows the conventional risk assessment paradigm, beginning with identification of a potential hazard, such as characteristics of an LMO, which may have an adverse effect on biodiversity. Risks are then characterized based on combined evaluation of the likelihood of adverse effects, and the consequences should those effects be realized.
The Protocol, in
Article 16, requires Parties to adopt measures and strategies for preventing adverse effects and for managing and controlling risks identified by risk assessments (Articles 16.1 and 16.2). Parties are also required to take measures to prevent unintentional transboundary movements (Article 16.3); to ensure that LMOs undergo appropriate periods of observation prior to use (Article 16.4); and to cooperate in identifying LMOs and their traits that may pose risks, and in taking appropriate management measures (Article 16.5).
At its second meeting, COP-MOP considered risk assessment and risk management for the first time and adopted
decision BS-II/9. In that decision, the Executive Secretary was requested to convene, prior to the fourth meeting of the COP-MOP and subject to availability of financial resources, regional workshops on capacity-building and exchange of experiences on risk assessment and risk management of LMOs. In addition, the COP-MOP decided to establish an
Ad Hoc Technical Expert Group on Risk Assessment to further consider the nature and scope of existing approaches to risk assessment, evaluate such approaches and identify any gaps, and identify capacity-building needs.
At its third meeting, COP-MOP further considered risk assessment and risk management on the basis of the report of the expert group, information received in interim national reports under the Protocol, and submissions and guidance materials that were compiled in advance of the second meeting of the COP-MOP. In
decision BS-III/11, COP-MOP examined further measures for enhancing capacity-building in risk assessment and risk management and outlined the process for collecting and sharing available information and guidance documents in order to facilitate the consideration, at the fourth meeting, of the need for further guidance on specific aspects of risk assessment and risk management.
At its fourth meeting, the COP-MOP, in
decision BS-IV/11, established and mandated an Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management to, inter alia, (i) prepare a "roadmap", e.g. a flowchart, on steps for conducting a risk assessment in accordance with Annex III to the Protocol with examples of existing guidance documents for each of step; (ii) prioritize the identified needs for further guidance; (iii) define an action plan to produce modalities for developing guidance documents on specific aspects of risk assessment and risk management identified as priorities; and (iv) consider possible modalities for cooperation in identifying living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health. An open-ended online forum on specific aspects on risk assessment was also established, through the BCH, to provide input into the work of the AHTEG. Furthermore, COP-MOP requested the Executive Secretary to organize training activities on risk assessment and risk management, including hands-on regional or subregional training courses.
The Ad hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management held its first meeting from 20 to 24 April 2009 in Montreal, Canada. The group discussed the development of guidance documents with the view to further support countries in conducting risk assessment of living modified organisms (LMOs) in the context of the Protocol. The participants produced a draft text for a roadmap on the steps in risk assessment and established four sub-working groups to further undertake the development of the roadmap and guidance documents on specific aspects of risk assessment and risk management prior to the Group's second meeting, scheduled to be held in April 2010 in Ljubljana, Slovenia. For details see the report of the meeting in document
UNEP/CBD/BS/AHTEG-RA&RM/1/3.
The Second Meeting of the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management took place in Ljubljana, Slovenia from 20 to 23 April 2010. During the meeting, the AHTEG finalized the development of a “Guidance on Risk assessment of Living Modified Organisms” (LMOs), which includes a Roadmap for risk assessment as well as guidance on risk assessment of specific types of LMOs and traits (i.e. LMOs with stacked genes, LM crops with tolerance to abiotic stress and LM mosquitoes). The AHTEG also deliberated on possible modalities for cooperation in identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account human health. For details see the report of the meeting in document
UNEP/CBD/BS/AHTEG-RA&RM/2/5.
