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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 FAO defines LLP and AP as:

Low Level Presence (LLP): LLP refers to the detection of low levels of GM crops that have been approved in at least one country on the basis of a food safety assessment according to the relevant Codex guidelines. Readers should note that low level presence (LLP) is not specifically defined by Codex, however in the context of the Codex guidelines it is referred to as LLP.

Adventitious Presence (AP): AP refers to detection of the unintentional presence of GM crops that have not been approved in any countries on the basis of a food safety assessment according to the relevant Codex guidelines.

Source: The results of the FAO survey on low levels of genetically modified (GM) of the Technical Consultation on Low Levels of Genetically Modified (GM) Crops in International Food and Feed Trade Crops in International Food and Feed Trade

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.


Article provides examples for LMOs sampling methods and testing as part of monitoring and environmental risk assessment.
Describes the approach and experience of Peru in working towards an approach to detect unintended presence of transgenic events within locally grown cultivars of maize.
This study employed PCR technology for detection and direct DNA sequencing for confirmation procedures respectively. The results demonstrated for the first time the presence of GM plants with glyphosate-resistant trait led by the control of P35S promoter and NOS terminator in either Malaysian or Vietnamese feed with high frequency.
Canadian case study that iterates various considerations that can be taken into account when considering unintentional and unauthorized LMOs and their subsequent detection and identification.
Study describes an event-specific quantitative real-time PCR detection method for the transgenic rice line Kemingdao 1 (KMD1).
Identification of the transgenic vector construct generated based on resistance to infection with the papaya ringspot virus (PRSV) YK strain. A specific detection method to qualitatively monitor papaya products for contamination with the GM papaya was developed using the real-time polymerase chain reaction.
The study analysed DNA fragments extracted from four rice vermicelli products and detected two lines of unauthorized Bt rice harbouring the Bt toxin cry gene, one of which has a construct similar to the previously reported GM Shanyou 63 line (19-21) and the other is an unknown Bt rice line, which has a construct similar to the Kemingdao.
Outlines an experience of developing of detection methods for the unapproved GM papaya, imported for commercial seeds and seedlings.
The scope of this document covers low level presence situations in which seed [or certain commodities] contain low levels of transgenic seed that have been reviewed for environmental risk/safety and received authorisation for commercial cultivation (unconfined release) in one or more exporting countries but not in the country of import.
The aim of this document is to provide laboratories of the ENGL with harmonised strategies and guidelines on how to cope with unauthorised GM materials (UGM), as well as to interpret and report analytical results and related information to the competent authorities. It is the objective to facilitate detection of UGM, if present, without the requirements for a completely new detection paradigm. Therefore, the document also includes a review of presently available approaches for detection of UGM.
Several countries have requested FAO to facilitate international dialogue on the issue of trade disruptions involving low levels of GM crops in international food and feed trade.
In the EU exists a Regulation (619/2011) on Low Level Presence. This guidance document was developed for laboratories on the execution of the LLP Regulation was developed by the EURL GMFF.
This survey outlines international experiences and responses to incidents of unauthorised and unintended LMO presence.