Annex 5

EXAMPLES OF RISK-MANAGEMENT MEASURES FOR CONTROLLED RELEASES

Risk management is employed during the development and evaluation of an organism in a systematic fashion, for example from the laboratory, through stages of field testing, to commercialization. The number and forms of these stages are not fixed, but depend on the outcome of risk assessment at the different stages. Progression through the appropriate developmental stages, in order to gain knowledge, generally entails a reduction in control and possibly in monitoring, while often increasing in scale.

Appropriate risk management measures for releases will vary considerably from case to case. They will be determined by the risk assessment, the organisms involved and the way that they will be released. In addition to general precautions to control releases, risk management measures often focus on the control of the dissemination of the released organisms and control of the gene flow from the released organisms.

The type of risk-management measures to be employed should be commensurate with the risks identified. Therefore, there might be cases where very few, if any, risk management measures will be necessary. Consequently, not all of the examples given below are likely to be relevant for any given controlled release.

Examples of risk-management measures for controlled releases include:

General precautions

• Appropriate information and training is provided for those involved in handling the organisms;
• Monitoring procedures are applied in such a way that appropriate measures can be taken in case of unexpected effects during or after the release;
• The dissemination of the released organisms and/or gene flow from the released organisms are controlled;
• Controlling access to the release site.

For plants

• Applying reproductive isolation, by:
  - spatial separation;
  - temporal separation: use of plants that will flower either earlier or later than plants of nearby reproductively compatible species;
  - biological prevention of flowering (e.g. by omitting vernalisation);
  - removal of the male or female reproductive structures;
  - bagging of flowers;
  - making use of sterility.
• Controlling the persistence or dispersal of reproductive structures such as propagules or seeds.
• Destroying volunteer plants after harvest; control of volunteers may be necessary during longer periods, depending on the species.

For animals

• Confining by appropriate means such as fences, filters, islands, ponds;
• Applying reproductive isolation by using sterile animals;
• Isolation from feral animals of the same species.
• Controlling the persistence or dispersal of reproductive structures such as larvae or eggs.

For micro-organisms

• Using organisms with impaired ability to grow or persist in the environment;
• Minimizing gene transfer by:
  - using organisms that do not contain known self-transmissible mobilizable or transposable genetic elements;
  - ensuring that introduced traits are stably located on the chromosome.

These measures will often not be applicable once an organism with novel traits, such as a modified crop plant, is at the stage of being marketed as a product if, as a result of testing during research and development, it has been shown that the risks are acceptably low.