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Technical Tools and Guidance for the Detection and Identification of LMOs

Background

By: Joachim Kreysa, Angela Lozan, Lilian Odongo, and Nisreen Al-Hmoud

Since its invention, the genetic engineering of plants has led to an increasing number of Living Modified Organisms (LMOs) (commonly known as Genetically Modified Organisms or GMOs) being developed. Currently, there are more than 300 LMOs in the research and development pipeline with more than 100 having entered the global market and/or been released into the environment.

In 2000, the Conference of the Parties to the Convention on Biological Diversity (CBD) adopted the Cartagena Protocol on Biosafety (CPB) as an international legally binding instrument that sets the minimum requirements for regulating the transboundary movement of LMOs. The Cartagena Protocol came into force in 2003 and, by May 2014, it was ratified or accessioned by 167 countries . Its objective is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.

In addition to their obligations vis-à-vis the Protocol, Parties require the capacity to monitor, detect and identify LMOs in such a manner that enables them to meet the requirements of trade agreements, as appropriate.

At its fifth meeting, the Conference of the Parties serving as the Meeting of the Parties to the Protocol (COP-MOP) acknowledged the importance of the detection and identification of LMOs by including the following three outcomes in the Strategic Plan for the Cartagena Protocol on Biosafety to be achieved by 2020:
  • Easy to use and reliable technical tools are available for the detection of unauthorized LMOs;
  • Guidance is available to assist Parties to detect and take measures to respond to unintentional releases of LMOs; and
  • Personnel is trained and equipped for sampling, detection and identification of LMOs.

At its fifth meeting, in decision BS-V/9, the COP-MOP requested the establishment, through the Biosafety Clearing-House (BCH), of an electronic network of laboratories involved in the detection and identification of LMOs and the organization of workshops for heads of detection laboratories. The COP-MOP also requested Parties and encouraged other Governments and relevant organizations to make available to the BCH, inter alia, methods for the detection and identification of LMOs.

To implement the above, the Network of Laboratories for the Detection and Identification of Living Modified Organisms, which was launched through the BCH. The Network held several series of online discussions on various topics that are relevant to the detection and identification of the unintentional transboundary movement of LMOs with the view to facilitate the sharing of information and experiences, identifying challenges in the identification of LMOs and to make progress toward the implementation of the Strategic Plan for the Cartagena Protocol on Biosafety for the period 2011 2020. Furthermore, based on these discussions, a workshop was held in November 2013 and focused on the following objectives:
  1. A detailed implementation strategy for the detection and identification of LMOs consisting of a plan of action to assist Parties in making progress toward each of the outcomes in the Strategic Plan for the Cartagena Protocol on Biosafety for the period 2011-2020; and
  2. A set of recommendations identifying possible key players and specific activities to assist in the implementation of the plan of action in (a) above.

The outcomes of the workshop include a list of topics for the compilation of technical tools and guidance to facilitate the detection and identification of LMOs in the context of the Protocol. Participants of the workshop prioritized five of the topics from the list and agreed to develop the technical tools and guidance on these topics prior to the seventh meeting of the COP-MOP. They also agreed that the remaining technical tools and guidance could be addressed after the seventh meeting of the COP-MOP, as appropriate. In addition, the workshop also put forward a set of recommendations for consideration by the COP-MOP at its seventh meeting.

The resources in this portal build on the outcomes of the workshop with the aim to provide Parties with a set of tools and technical guidelines to facilitate the implementation of their obligations vis-a-vis the Protocol and their national regulatory requirements regarding the detection and identification of LMOs.

Introduction

A strategy for an efficient sampling, detection and identification of LMOs may start by defining:
  1. The national monitoring and control objectives/targets;
    Possible targets include the monitoring of (transboundary) movements of authorised LMOs and/or the detection and control of unauthorised LMOs.

  2. The perceived, potential, or known parameter that shall be monitored and controlled;
    Possible parameters include maintaining a paper trail of any (trans-boundary) movement of material that could be LMO or contain (traces of) LMOs. Details of this paper trial can be agreed upon at the international level. In addition, or alternatively, the parameter of interest could also be the presence or absence of LMO material in sampled consignments. This would require first an appropriate capability of statistically representative sampling and second an appropriate capability to analyse the samples. Depending on the intended control level, the required analytical capability may be qualitative (presence/absence) or quantitative (e.g. if certain threshold require different measures.) The main text of this report relates to the issue of adequate analytical capability – assuming that representative samples of good quality reach the laboratories.

  3. The resources (financial, human) that can be made available in the foreseeable future.
    Besides the resources required for laboratory testing capacities, countries also need to develop adequate capacities to sample LMOs, including training of their border control officers and field inspectors. The role of sampling is critical in that it determines the quality of the results and the overall outcomes of a system to monitor, detect and identify LMOs. Taking the importance of sampling into account, where resources are limited, efforts may be more efficiently allocated if focused on sound field sampling combined with basic, qualitative laboratory capacities.

In facilitating Parties’ implementation of the relevant objectives of the Strategic Plan for the Cartagena Protocol on Biosafety the Network of Laboratories for the Detection and Identification of LMOs agreed to develop a set of technical tools and guidance for the detection of unauthorized LMOs and unintentional releases. This involves a living compilation of resources on four prioritised topics, specifically:

  1. Overview of available detection methods, including validated methods;
  2. Overview of available databases for methods and sequence information, and available screening matrices;
  3. Minimum performance criteria for sample handling, extraction, detection and identification methodology;
  4. Experience and case studies on detection and identification with the view to assist Parties that are currently building their capacities in this area.