The Protocol calls for the characterisation of the “likely potential receiving environment” of an LMO. This encompasses both the area where the LMO will be intentionally introduced into the environment as well as any other environment which may be exposed to the LMO.
As such, during a risk assessment in accordance with the Protocol, in addition to the area where the LMO will be intentionally introduced, the likely potential receiving environment of an LMO should also be thoroughly examined with particular attention given to areas where exposure levels to the LMO will be the highest.
The characterization of the likely potential receiving environment takes into account its ecological characteristics, including physical location/geography, climate, its biological entities and their interactions. The characterization of the likely potential receiving environment will help in selecting appropriate assessment endpoints for the risk assessment (see Module 2, section 2.1) and will also affect the assessment of the potential interactions of the LMO with other organisms. To determine the likely potential receiving environment, risk assessors may consider potential pathways for dispersal of the LMO as well as the habitats where the recipient/parent organism(s) may persist or proliferate.
An analysis of possible dispersal routes and mechanisms is important when establishing the likely potential receiving environments. Different dispersal mechanisms may exist and could be inherent either to the LMO (e.g. altered seed characteristics), its intended use (e.g. shipment practices) or the receiving environment (e.g. proximity to a river). The risk assessment should take into consideration all possible dispersal mechanisms, keeping in mind the biology of the LMO and non-modified recipient or parental organism(s), in a concerted manner for each case.
Information about the likely potential receiving environment can include considerations on both large scale (e.g. climate) and small scale characteristics (e.g. microclimate) depending on the complexity of the environment. The type of information on the likely potential receiving environment and the level of detail depend on the nature of the LMO and its intended use, in accordance with the case-by-case principle. (see section 4.3).
It may not be possible or practical to consider every possible interaction between the LMO and the receiving environment. Such challenges and limitations should be acknowledged during the risk assessment process.
Below are descriptions of some physical and biological characteristics of the likely potential receiving environment(s) that can be considered in the risk assessment of LMOs. This is an indicative list thus the information required to satisfy the needs of the assessment will vary depending on the nature of the LMO and its intended use.
