Annex 3

RISK ASSESSMENT:
EXAMPLES OF POINTS TO CONSIDER, AS APPROPRIATE

Risk assessment is based on the characteristics of the organism, the introduced trait, the characteristics of the intended use, the receiving environment, and the interaction between these. Knowledge of and experience with any and all of these provide familiarity which plays an important role in risk assessment. A relatively low degree of familiarity may be compensated for by appropriate risk-management practices. Familiarity can be increased as a result of a trial or experiment. This increased familiarity can then form a basis for future risk assessment.

Risk assessment is typically a routine and ongoing component of research and development, and testing of organisms with novel traits. It can range from a routine ad hoc judgement by the researcher to adherence to a formalized assessment.

Risk assessment requires a range of expertise which should be reflected in the competence and experience of those carrying out the assessment in a scientifically sound manner.

The different fields of expertise needed for scientifically sound risk assessment may include, as appropriate:

This list is provided as a guide to the major fields of expertise which may be required and is not intended to be comprehensive. Not all of these are likely to be relevant in each case and, as knowledge and technology advance, other fields of expertise will be important in risk assessment.

The objective of risk assessment is to answer questions related to:

• Identifying any hazards: what are the hazards, if any?
• Assessing the risks: if a hazard has been identified, what is the combined effect of the consequences and the likelihood of the hazard being realized? Can these be estimated?
• Managing the risks: To what extent can the risks be managed? 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
• How do any identified risks compare with the risks that would be posed by the use, instead, of an organism not covered by these guidelines, if this is possible, or with risks that might be posed by doing nothing.

The impacts to be considered include those on human health, agricultural production, other organisms and the quality of the environment.
Full regard should be paid to the experience gained and to the relevant literature and consultation with available experts and public authorities.
The level of risk can be minimized either by applying risk-management strategies or by deciding not to proceed with the intended use of the organism with novel traits.
The information required for a scientifically sound risk assessment could include the following, depending on the organism, the application and the receiving environment, as appropriate; in some instances, providing a scientifically convincing rationale as to why particular data are not relevant may be helpful:


INFORMATION RELATING TO THE ORGANISM WITH NOVEL TRAITS:

Characteristics of the organism from which the organism with novel traits is derived:

The relevant biological, physiological and genetic and environmental characteristics of the recipient/parental/host organism include, as appropriate:

• the name and identity of the organism;
• Pathogenicity, toxicity and allergenicity (in the case of micro-organisms, it should be noted that there are internationally accepted classification lists for human pathogens. Similar lists exist at national level for plant and animal pathogens);
• the natural habitat and the geographic origin of the organism, its distribution and its role in the environment;
• mechanisms by which the organism survives, multiplies and disseminates in the environment;
• means for transfer of genetic material to other organisms.

Characteristics of the organism(s) from which nucleic acids are obtained (the donor):

The relevant characteristics include, in particular, pathogenicity, toxicity and allergenicity.

Characteristics of the vector:

• identity, origin, natural habitat, and the relevant safety characteristics of the vector;
• the frequency at which the vector is mobilized or can transfer itself to other organisms;
• factors which would influence the ability of the vector to become established in other hosts.

Characteristics of the inserted nucleic acid (the insert):

• functions coded by the inserted nucleic acid, including any residual vector;
• information on the expression of the inserted nucleic acid and the activity of the gene product(s).

Characteristics of the organism with novel traits:

The organism with novel traits should be compared with the organism from which it is derived, examining, where relevant the following points:

• pathogenicity, toxicity and allergenicity to humans and other organisms (in the case of micro-organisms it should be noted that there are internationally accepted classification lists for human pathogens. Similar lists exist at national level for plant and animal pathogens);
• survival, persistence, competitive abilities and dissemination in the environment or other relevant interactions;
• capacity to transfer genetic material and the ways in which this might occur;
• methods for detecting the organism in the environment and for detecting the transfer of the donated nucleic acid;
• functions which might affect its ecological range;
• characterization of the product(s) of the inserted gene(s) and, where appropriate, the stability of the modification.

INFORMATION RELATING TO THE INTENDED USE


The amount of information required will vary with the characteristics of the organism and use, frequency and the scale of the intended use.

For contained uses, this can include:

• number or volume of organisms to be used;
• scale of the operation;
• proposed containment measures, including verification of their functioning;
• training and supervision of personnel carrying out the work;
• plans for waste management;
• plans for safety of the health of personnel;
• plans for handling accidents and unexpected events;
• relevant information from previous uses.

For deliberate releases, this can include:

• purpose and scale of the release;
• geographical description and location of the release;
• proximity to residences and human activities;
• method and frequency of release;
• training and supervision of personnel carrying out the work;
• likelihood of transboundary movement;
• time and duration of the release;
• expected environmental conditions during the release;
• proposed risk-management measures including verification of their functioning;
• subsequent treatment of the site and plans for waste management;
• plans for handling accidents and unexpected events/disasters;
• relevant information from any previous releases.

CHARACTERISTICS OF THE POTENTIAL RECEIVING ENVIRONMENT


The potential for an organism to cause harm is related to the environments into which it may be released and its interaction with other organisms. Relevant information can include:

• the geographical location of the site, the identity and any special features of the receiving environments that expose them to damage;
• the proximity of the site to humans and to significant biota;
• any flora, fauna and ecosystems that could be affected by the release, including keystone, rare, endangered or endemic species, potential competitive species and non-target organisms;
• the potential of any organism in the potential receiving environment to receive genes from the released organism.