S2
Phytosanitary risks that may be associated with a living modified organism (LMO) are within the scope of the International Plant Protection Convention (IPPC) and should be considered using pest risk analysis (PRA) to make decisions regarding pest risk management.
The analysis of LMOs includes consideration of the following:
- Some LMOs may present a phytosanitary risk and therefore warrant a PRA. However other LMOs will not present a phytosanitary risks beyond those posed by related non-LMOs and therefore will not warrant a complete PRA. For example, modifications to change the physiological characteristics of a plant (e.g. ripening time, storage life) may not present any phytosanitary risk. The pest risk that may be posed by an LMO is dependent on a combination of factors, including the characteristics of the donor and recipient organisms, the genetic alteration, and the specific new trait or traits. Therefore, part of the supplementary text (see Annex 3) provides guidance on how to determine if an LMO is a potential pest.
- PRA may constitute only a portion of the overall risk analysis for import and release of a LMO. For example, countries may require the assessment of risks to human or animal health, or to the environment, beyond that covered by the IPPC. This standard only relates to the assessment and management of phytosanitary risks. As with other organisms or pathways assessed by an NPPO, LMOs may present other risks not falling within the scope of the IPPC. When an NPPO discovers potential for risks that are not of phytosanitary concern it may be appropriate to notify the relevant authorities.
- Phytosanitary risks from LMOs may result from certain traits introduced into the organism, such as those that increase the potential for establishment and spread, or from inserted gene sequences that do not alter the pest characteristics of the organism but that might act independently of the organism or have unintended consequences.
- In cases of phytosanitary risks related to gene flow, the LMO is acting more as a potential vector or pathway for introduction of a genetic construct of phytosanitary concern rather than as a pest in and of itself. Therefore, the term "pest" should be understood to include the potential of an LMO to act as a vector or pathway for introduction of a gene presenting a potential phytosanitary risk.
- The risk analysis procedures of the IPPC are generally concerned with phenotypic characteristics rather than genotypic characteristics. However, genotypic characteristics may need to be considered when assessing the phytosanitary risks of LMOs.
- Potential phytosanitary risks that may be associated with LMOs could also be associated with non-LMOs. It may be useful to consider risks associated with LMOs in the context of risks posed by the non-modified recipient or parental organisms, or similar organisms, in the PRA area.
