Past activities 2012 - 2014

In line with the Network's calender of activities we are pleased to invite participants to a discussion on the Network's recommendations to the Conference of the Parties serving as the meeting of the Parties to the Protocol.

A background document to assist and guide the discussion, consists of the recommendations put forward by the participants of the Workshop of the Network of Laboratories for the Detection and Identification of Living Modified Organisms” which was held in Ispra, Italy, from 25 to 27 November 2013.

The recommendations from the workshop were proposed with the view to facilitate future actions on the detection and identification of LMOs on the basis of moving toward achieving operational objectives 1.6, 1.8 and 2.3 of the Strategic Plan for the Cartagena Protocol on Biosafety and the the implementation strategy developed during the workshop as outlined in the report of the workshop.

Participants of the Network are invited to review the background document and provide suggestions that build on these recommendations with the view to further achieving the relevant operational objectives of the Strategic Plan.

Topic 1: Overview of available detection methods, including validated methods

Moderators: Chris Viljoen, Sarah Agapito-Tenfen, and Gretta Abou-Sleymane
Discussions will open: 20 January 2014
Discussions open and close at 1:00 a.m. GMT

A number of methodologies and techniques are available to detect, identify and quantify living modified organisms (LMOs) ranging from fast and more cost-effective protocols, such as lateral flow tests and endpoint PCR, to those that can be more complex, such as quantitative real-time PCR.

In working towards setting up a laboratory for the detection and identification of LMOs a choice must be made regarding which methodologies and protocols will be adopted. For service-oriented laboratories, particularly those servicing regulatory authorities, the selection of methods is guided by, amongst other things, the country’s specific regulatory requirements in accordance with national biosafety laws. The methodologies may therefore range from qualitative methods to detect the presence of LMOs, to tests that identify individual LMOs, to quantitative tests that measure the percentage of LMOs present in a sample.

Thus, the aim of this forum is to produce a comprehensive compilation of methodologies for the sampling, detection, identification and quantification of LMOs that reflect the diversity of options for analytical methods that are available for use. Participants are invited to share and upload relevant methodologies that are currently in use, either in their laboratories or elsewhere, and comment on the appropriateness of using a particular method in the context of the specific level of analysis that is required within their national framework. Methodologies for both DNA and protein based detection at different levels of qualitative and quantitative detection are welcome.

These protocols will be compiled in a single and accessible place to facilitate the availability of relevant information to national laboratories that are in the process of developing capacity in this field such that they can establish standard operating procedures that are satisfactory to their needs for the detection and identification of LMOs. These methodologies may include, for instance, sampling, extraction methods (e.g. as indicated in this article), lateral flow or ELISA tests, end-point PCR, and quantitative real-time PCR, as well as various other used in detection laboratories.

Topic 2: Overview of available databases for methods and sequence information, and available screening matrices (e.g. Waiblinger table)

Moderators: Bjom Spilsberg, and Petra Heinze
Discussions will open: 20 January 2014
Discussions open and close at 1:00 a.m. GMT

Databases containing accurate and reliable information on methods, reference materials and DNA sequences are an important tool to enable countries to effectively detect and identify LMOs. To be useful, such databases must, at a minimum, be available online, be open to the public, contain accurate and up-to-date information, and have user-friendly mechanisms for searching and retrieving information. The scope of the database may vary in the type of methods (e.g. DNA and/or protein; validated or not), type of LMOs (e.g. crops, vaccines, etc) or geographic area (e.g. local or global), etc. Examples of well-known databases of methods for LM crops are the “EU Database of Reference Methods for GMO Analysis” maintained by the Joint Research Center of the European Commission, the “GMO Detection Method Database” maintained by the GMO Detection Laboratory at Shanghai Jiao Tong University and the “The CropLife International Detection Methods Database” maintained by the plant biotechnology industry. In addition there is a considerable body of knowledge in the scientific literature that contains valuable information on strategies that have been developed for the identification of LMOs. While this information may not already be contained in a well-known and established database, it nevertheless provides useful resources and can potentially be structured into a database format.

A cost efficient alternative to using individual event-specific methods to detect the potential presence of an LMO in a sample is to use a screening approach which employs a series of element specific tests in combination with a "screening matrix". A screening matrix is defined as “a relational representation of the correspondence between GMOs and their corresponding species on the one hand and the response to specific tests on the other hand… is applied in the detection of GMO presence typically using tests that target elements common to various GMOs” (ref). Screening relies on tests targeting specific nucleotide sequences representing commonly used genetic elements, such as the Cry1ab, P-35S and T-nos (ref). "Screening matrices" list which elements can be detected with a particular method in each LMO and are used to interpret results. “Screening matrices” can be integrated into a software program that combines and compares the results of individual tests and can be used as a tool to assist in predicting the identity of an LMO that may be present in a sample.

Sharing of information on available databases and matrices is a first step to increasing access to these technologies by countries, which are developing their capacity to detect and identify LMOs. In November 2013, participants of a workshop of the Network for the Detection and Identification of LMOs agreed to compile information on databases and matrices and to make this information available to countries through the Biosafety Clearing House (BCH).

In this forum, participants of the Network are invited to share information on databases of detection methods, sequences of inserts in LMOs, reference materials, as well as on LMO matrices with the view to compiling this information, through the BCH, for easy access to countries. The type of information may refer to LMOs already in existence or under development, including LMOs that are locally developed. Your feedback may also include, for example, comments on:

1. Type of information found in the database:
   1. LMOs that can be detected
   2. Type of methods (DNA- or protein-based)
   3. Sequences (whole constructs, coding sequence, regulatory sequences, insertion points)
   4. Reference materials (LMO or non-LMO, certified or not, etc)
2. Quality and completion of information
3. User-friendliness
4. Whether the methods and sequences are validated or not and, if so, how or by whom.
5. Type of matrix, what LMOs can be detected, accessibility to the matrix by other laboratories, etc.

Topic 3: Minimum performance criteria for sample handling, extraction, detection and identification methodology

Moderators: Natalhie Campos Reales Pineda, and Mojca Milavec
Discussions will open: 20 January 2014
Discussions open and close at 1:00 a.m. GMT

Laboratories that perform detection and identification of LMOs for regulatory purposes must maintain quality management and assurance systems to ensure accuracy and reproducibility of their test results on an ongoing basis. Quality assurance activities focus on sample handling, record keeping, maintenance of equipment, reporting of results, etc.

There are numerous DNA and protein based analytical methods that laboratories can choose from. The choice of methods will depend on, among other things, each country’s specific regulatory requirements, operational costs, infrastructure, technical capability, and may range from qualitative methods to detect the presence of LMOs, to tests that identify individual LMOs, to more complex quantitative tests that measure the amount of LMOs present in a sample. Regardless of the choice of analytical method, they must still be validated, either within each laboratory or ideally through inter-laboratory comparisons to ensure that they meet minimum performance criteria and the accuracy of results.

The performance of the selected methods is crucial for the production of reliable and reproducible data. The performance of an analytical method encompasses measuring, amongst other things, its robustness, precision, trueness, sensitivity and specificity. A number of quality control measures can be applied including the use of (certified) reference materials, control samples and duplicates to monitor the performance of a method and ensure the validity of analytical results. Understanding these parameters and being able to detect any deviations from set criteria during routine testing ensures that results are consistent and remain within acceptable ranges of variability.

The exchange of information is a valuable tool for laboratories that are building up capacity in this area; therefore, it is particularly important the availability of technical guidelines on how quality assurance activities can be implemented and how the performance of analytical methods can be measured. This information can, for example, include either reports on how to internally validate a particular method within a laboratory or more comprehensive approaches such as inter-laboratory collaborative testing.

Participants are invited to contribute to a compilation of information and examples of minimum performance criteria of methods for sample handling, extraction, detection and identification of LMOs. The expected contributions may range from general information on good practices and quality assurance guidelines on the topic of minimum performance criteria to other useful guidelines that can explain methodological specification on how to validate a specific analytical method. Access to this information will assist countries and laboratories in setting up and improving their routine methodologies for sampling, extracting, detecting and identifying LMOs that are based on sound and acceptable criteria.

Topic 4: Experience and case studies on detection and identification

Moderators: Gurinder Randhawa, and Ayako Yoshio
Discussions will open: 20 January 2014
Discussions open and close at 1:00 a.m. GMT

Detection and identification of living modified organisms (LMOs) is cross-cutting and relevant to a number of biosafety-related issues, such as risk 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 as a core requirement for the effective implementation of the provisions of the Cartagena Protocol on Biosafety and national biosafety frameworks remains a challenge to Parties.

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.

Depending on national biosafety policies and regulations, requirements for the detection and identification of LMOs may range from qualitative tests to detect the presence of an LMO to more complex tests for the identification or even quantification of an LMO. Examples on how countries are implementing requirements in their national biosafety regulations can provide an important blueprint of different options to Parties that are in the process of establishing new laboratories or updating their existing facilities.

Likewise, a number of examples are available describing how countries have detected an unauthorized or illegal LMO, for instance in a shipment, or an unintentional introduction into the environment. Sharing experiences of how laboratories approached such situations from an analytical perspective, as well as how the related administrative and regulatory processes were put in place to respond to such occurrences, are also valuable tools to countries that are developing capacity in this area.

In this online discussion, participants of the Online Network are invited to submit and comment on their experience with the following;

• Experiences or case studies on the development of methods for the detection of unauthorized LMO or LMOs unintentionally introduced into the environment, including actual examples of how they were sampled, detected, identified and/or quantified, as appropriate, including success stories, lessons learnt and identified gaps, that could assist other countries and laboratories in designing an appropriate strategy when faced with a similar situation (An example of such an experience from Japan can be found here).
• How countries developed appropriate strategies for the sampling, detection and identification of LMOs, including their choice of methodologies, and highlights of the decision making process that lead to its implementation in the context of their national regulatory framework;
• For Parties building capacity in this area, what kind of information or documents would effectively support the process of developing an appropriate strategy to respond to an unauthorized LMO or unintentional release, especially in the context of developing a detection and identification method.