Annex III sets out the general principles and methodology for the risk assessment process.
The general principles for risk assessment under the Protocol are that:
- it must be carried out in a scientifically sound and transparent manner and on a case-by-case basis,
- 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, and
- risks of LMOs should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment.
Individual Parties use these general principles to guide the development and implementation of their own national risk assessment process (see Module 2). The following are considerations about some of the general principles for risk assessment:
Scientific soundness – The Cartagena Protocol explicitly states that risk assessments should be carried out in a scientifically sound manner. The principle of scientific soundness entails that risk assessments are to be undertaken in a systematic way on the basis of verifiability and reproducibility of information by, for example, reporting on methods and data in sufficient detail to enable others to repeat the steps of the risk assessment independently. Some countries have integrated this principle into their own procedures with specific suggestion about what type of information can be appropriately used in a risk assessment. In many cases different sources and criteria for scientifically sound information have been set, ranging from scientific literature, studies presented by the notifier and expert opinions, etc. Consultations among scientific experts may also be considered an appropriate means for gathering such information.
Transparency – Annex III states that risk assessments should be conducted in a transparent manner. Most countries with NBFs have procedures in place to ensure the transparency of risk assessments. The CNAs often show what transparency mechanism is in place to handle notifications and how the mechanism is applied in each case. The level of transparency, however, may range from public notification to broad public involvement.
Some countries, for instance, make the necessary requirements for conducting risk assessments available online and, if an approval is granted for release of an LMO into the environment, a public notification is usually done by posting the release online (see also provisions of Article 23 on “Public Participation” and Module 2 section 1.4 below on Stakeholder Participation).
Example – Transparency “ERMA New Zealand strives to be transparent as is practicable and appropriate in its processes. In general, applications for substances or organisms that can significantly affect the environment must be publicly notified, and anybody can then make a written submission - within 30 working days of public notification - and a hearing will be held if any submitter requests to be heard, or if the Authority thinks it is necessary.” Source:
ERMA NZ
