Technical Tools and Guidance for the Detection and Identification of LMOs

Experience and case studies on detection and identification

By: Gurinder Randhawa and Ayako Yoshio

Detection and identification of living modified organisms (LMOs) is cross-cutting and relevant to a number of biosafety-related issues, such as risk assessment and management, detection of unauthorized or illegal LMOs, detection of unintentional introductions into the environment, and liability and redress. Thus, the capacity to detect and identify LMOs is arguably one of the main pillars for the effective implementation of the provisions of the Cartagena Protocol on Biosafety and national biosafety legislation. Nevertheless, monitoring, detecting and identifying LMOs remain a challenge to many Parties.

Unauthorised and/or unintentional transboundary movements of LMOs often found in shipments and products traded in the global market. There may be incidents of deliberate or accidental introduction of unauthorised LMOs into the environment. As the development of LMOs expands in both number and geographic area, their different approval status in individual countries leads to “asynchronous approvals” where, for example, a particular LMO may be approved for introduction into the environment in one country, as food or feed in another country, while not being authorized in other countries. The analytically-based detection of unauthorised LMOs in consignments and of LMOs unintentionally introduced into the environment is a challenge due to the sheer volume of material, which may also include authorized LMOs and non-LMOs. The detection of any LMO is dependent on the availability of suitable detection method(s) and control materials to validate the method(s). Other information, e.g. describing the novel trait or introduced genetic elements, may also facilitate the detection, verification and identification of an LMO.

Depending on national biosafety policies and regulations, requirements for the detection and identification of LMOs may range from qualitative “yes/no” tests that detect the presence of an LMO, to more complex tests that allow for the identification of the LMO, to tests that are capable of quantifying an LMO. Further differentiation between different classes of unauthorised LMOs are sometimes referred to as low-level presence (LLP), where the LM product has been approved in at least one country, or adventitious presence (AP), occurring when the LM product is not approved in any market (i.e. is an experimental product or is cultivated under confined field trials).

The aim of this section is to provide laboratories with strategies and guidelines on how to handle unauthorised LMOs, as well as to interpret and report analytical results and related information to the competent authorities. It also captures the experience of some countries in addressing the presence of unauthorised transboundary movements and unintentional introduction into the environment using a scientific approach.

Examples on how countries establish the scope of their requirements relating to unauthorised transboundary movements and unintentional introductions into the environment can provide a blueprint of different options to Parties that are in the process of establishing new laboratories or updating their existing facilities. Additionally case studies providing examples of relevant technical and analytical issues, ranging from the setting up of laboratories to the actual sampling, detection and identification of LMOs, can be important tools for Parties that are currently building their capacities in this area.