1 Objectives of risk assessment

The objective of risk assessment is to identify and evaluate the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity and human health in the likely potential receiving environment. Risk assessment is used by competent authorities to make informed decisions regarding living modified organisms.

2 General principles of risk assessment

(1)Science-based. Risk assessment should be carried out in a scientifically sound and transparent manner;

(2) Step by Step. The development and application of a typical LMO and its products need to go through several or all phases, namely lab research, pilot testing, environmental release and commercialisation. The step-by-step principle requires the risk assessment of all phases of LMOs and their products. Data and experience of the previous phase can be used as a basis for risk assessment of next phase.

(3) Case by case. Since individual LMO and its products vary in terms of donors, vectors, recipient organisms, cloning method, intended use as well as the receiving environment, so the assessment must be made case by case, according to specific LMO.

3 General process of risk assessment

(1) An identification of any novel genotypic and phenotypic characteristics associated with the living modified organism that may have adverse effects on biological diversity and human health in the likely potential receiving environment;

(2) An evaluation of the likelihood of these adverse effects being realized, taking into account the level and kind of exposure of the likely potential receiving environment to the living modified organism;

(3) An evaluation of the consequences should these adverse effects be realized;

(4) An estimation of the overall risk posed by the living modified organism based on the evaluation of the likelihood and consequences of the identified adverse effects being realized;

(5) Identification of strategies as to whether or not the risks are acceptable or manageable.

4 Points to consider
(1) Recipient organism or parental organisms. The biological characteristics of the recipient organism or parental organisms, including information on taxonomic status, common name, origin, centres of origin and centres of genetic diversity;

(2) Donor organism or organisms. Taxonomic status and common name, source, and the relevant biological characteristics of the donor organisms;

(3) Vector. Characteristics of the vector, including its identity, source or origin, and its host range;

(4) Inserted genes and/or characteristics of modification. Genetic characteristics of the inserted nucleic acid and the function it specifies, and/or characteristics of the modification introduced;

(5) Living modified organism. Identity of the living modified organism, and the differences between the biological characteristics of the living modified organism and those of the recipient organism or parental organisms;

(6) Detection and identification of the living modified organism;

(7) Information relating to the intended use; and

(8) Receiving environment. Information on the location, geographical, climatic, ecological characteristics, biological diversity and centres of origin of the likely potential receiving environment.