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Opening of the discussion: Experience and case studies on detection and identification [#5604]
Dear Forum Participants,

Welcome to the second round of discussions of the Network of laboratories for the Detection and Identification of LMOs. This discussion will focus on the topic of compiling examples of "Experiences and case studies on detection and identification".

Case studies can be used as an important tool for Parties to obtain an overview of how others have integrated the technical aspects of LMO detection and identification into their national Biosafety regulatory framework. This information can provide an important blueprint and different perspectives to Parties that are looking to establish new laboratories or update their existing capabilities. Furthermore case studies on how individual laboratories approached situations where there was suspected presence of unauthorised or unintentional LMO would also provide laboratories with ideas on how to design an appropriate strategy in the event they are faced with a similar situation.

Participants are invited to contribute to the collection of case studies on how their Party implemented the detection and identification of LMOs into their national contexts as well as scenarios where they dealt with unauthorised or unintentional LMO presence with both positive and negative outcomes.

Best regards,
Dina
posted on 2014-01-20 00:36 UTC by Dina Abdelhakim, SCBD
This is a reply to 5604 RE: Opening of the discussion: Experience and case studies on detection and identification [#5610]
Dear Forum Participants,
The process of detection and identification of LMOs exists within the national regulatory context developed by each Party. The development of a national policy for dealing with unintentional and unauthorized LMOs depends on several factors and the sharing of case studies that outline how various Parties approached the development of such policies can help guide those who are developing capacity in the area.

The paper "Developing a Policy for Low-Level Presence (LLP): A Canadian Case Study" (http://agbioforum.org/v16n1/v16n1a04-tranberg.pdf) is one such example that iterates various considerations that can be taken into account when considering unintentional and unauthorized LMOs and their subsequent detection and identification.

Participants are invited to share examples of experiences or case studies on the development of methods for the detection of unauthorized LMO or LMOs unintentionally introduced into the environment, the development of strategies for the detection and identification of LMOs and discussions on ways forward towards the development of such strategies.

Best regards,
Dina
posted on 2014-02-04 20:35 UTC by Dina Abdelhakim, SCBD
This is a reply to 5610 RE: Opening of the discussion: Experience and case studies on detection and identification [#5612]
POSTED ON BEHALF OF BOLDIZSÁR VAJDA
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Dear Dina,

In the EU exists a Regulation (619/2011) on Low Level Presence. A guidance document for the laboratories on the execution of thet LLP Regulation was developed by the EURL GMFF ( http://gmo-crl.jrc.ec.europa.eu/doc/Technical%20Guidance%20from%20EURL%20on%20LLP.pdf ).
And also exists a document developed by the ENGL on UGMs "Overview on the detection, interpretation and reporting on the presence of unauthorised genetically modified materials" (http://gmo-crl.jrc.ec.europa.eu/doc/2011-12-12%20ENGL%20UGM%20WG%20Publication.pdf ).

Best regards,

Boldizsár Vajda
posted on 2014-02-05 14:36 UTC by Dina Abdelhakim, SCBD
This is a reply to 5610 RE: Opening of the discussion: Experience and case studies on detection and identification [#5623]
Dear Forum Participants,

I would like to draw your attention to a recently published notification (http://www.cbd.int/doc/notifications/2014/ntf-2014-020-bs-en.pdf).

The notification is requesting the submission of views and information to the Executive Secretary on any challenges and experiences relating to the implementation of Article 17 of the Protocol, on Unintentional transboundary movements of living modified organisms, and on the scope and elements of possible guidance or tools that may facilitate appropriate responses by Parties to unintentional transboundary movements of living modified organisms.

We encourage you to forward to your National Focal Point information and your experiences on the unintentional transboundary movements of living modified organisms and elements of possible guidance or tools that may facilitate appropriate responses.

Best regards and looking forward to your continued support to the work of the network and your contributions to the discussions.

Dina
posted on 2014-02-17 21:11 UTC by Dina Abdelhakim, SCBD
This is a reply to 5623 RE: Opening of the discussion: Experience and case studies on detection and identification [#5627]
Dear Forum Participants,

Further to the resources that have been shared on this forum I would like to also share the OECD document "Low Level Presence of Transgenic Plants in Seed and Grain Commodities: Environmental Risk/Safety Assessment, and Availability and Use of Information"

The document covers a situations where seed contains low levels of transgenic seed that have been reviewed for environmental risk/safety and received authorization for commercial cultivation (unconfined release) in one or more countries but not in the country of import. It also includes the results of a survey on several countries' experiences with LLP situations.

I hope you find this information useful and I am looking forward to further contributions from participants.

Dina
posted on 2014-02-21 15:41 UTC by Dina Abdelhakim, SCBD
This is a reply to 5604 RE: Opening of the discussion: Experience and case studies on detection and identification [#5628]
POSTED ON BEHALF OF GURINDER RANDHAWA
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Dear Participants,

The sharing of experiences and case studies on detection and Identification as per topic mentioned below was rather very slow except 2-3 participants sharing the related links so far we have not received any other inputs in this regard.
I would encourage you all please share the reports/documents/related web pages or even your laboratory or country's experiences in this regard.
It is not only that you would share the success stories you can shares all the hardships and challenges your laboratories faced while working in this this very fast evolving area.

In this discussion, participants were invited to contribute to a compilation of case studies detailing (i) how countries implement their national regulatory requirements with regards to the detection and identification of LMOs including information on the choice of methods used, and (ii) actual examples of how unauthorized LMOs or LMOs unintentionally introduced into the environment 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. 

Topic 4: Experience and case studies on detection and identification

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 (e.g. http://www.coextra.eu/pdf/report1457.pdf; http://bit.ly/1juG0Pb).

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 (e.g. http://bit.ly/1eqpo5E).

Waiting for inputs in this regard from you all, please spare some of your precious time to send out valuable information. So that an excellent compilation could be brought out which would of great use to all parties.

Kind Regards.
Gurinder
(edited on 2014-02-24 20:27 UTC by Dina Abdelhakim)
posted on 2014-02-21 15:44 UTC by Dina Abdelhakim, SCBD
This is a reply to 5604 RE: Opening of the discussion: Experience and case studies on detection and identification [#5630]
Dear Forum participants,

Here you can find the OECD published paper A Scientific Framework for Assessing Transgenic Organisms in the Environment  http://www.oecd.org/science/biotrack/31778752.pdf.
The articles provide us with the examples for LMOs samplings methods and testing as part of monitoring and environmental risk assessment.

Best regards,
Angela
posted on 2014-02-23 22:06 UTC by Ms. Angela Lozan, Republic of Moldova
This is a reply to 5604 RE: Opening of the discussion: Experience and case studies on detection and identification [#5632]
POSTED ON BEHALF OF GURINDER RANDHAWA
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Dear Participants,

I am sharing with you two reports with URL links and pdf copies of the published papers which may be of some use

Developing Detection Methods for Unapproved GM rice detected in imports from China in EU
Babekova R,  Funk T,  Pecoraro S , Engel K H, Busch U (2008) Development of an event-specific Real-time PCR detection method for the transgenic Bt rice line KMD1. Eur Food Res Technol DOI 10.1007/s00217-008-0981-0

Unauthorised rice line Shanyou 63 (BT63) was detected in the import from China in the food chain during 2007- 2008. Hence event specific real time PCR based detection method was developed by the research group (Babekova et al 2008) for transgenic Chinese Bt rice line Kemingdao 1 (KMD1) which was at that time in the stage of extensive field trials in China. Due to the lack of information of sequence of genetic construct in KMD1, site-finding PCR method was used. This technique allowed the amplification of unknown DNA sequences and the characterization of DNA flanking the insertion site of newly introduced gene construct. The DNA sequence data obtained were user for development of event specific real time PCR method for KMD1.
URL:     http://www.yoluka.eu/index_htm_files/Event%20specific%20real%20time%20method%20for%20kmd1%20detection.pdf

Developing Detection Methods for Unapproved GM rice detected in vermicelli products imported from China in Korea
Akiyama H, Sasaki N,  Ohmori K,  Sakata K,  Toyota A, Kikuchi Y,  Watanabe T,  Furui S, Kitta K,  Maitani T (2007) Indicated detection of two unapproved transgenic rice lines contaminating vermicelli products. J Agric Food Chem 55.15: 5942-5947.

No developed Bt rice has yet been authorization for food use in the Korea. In 2007, a research group (Akiyama et al 2007) analyzed DNA fragments extracted from four rice vermicelli products and detected two lines of unauthorized Bt rice harboring 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 1. A detection system was developed by the research group to monitor these Bt rice lines using a real-time PCR method.
URL:    http://www.aseanfood.info/Articles/11022034.pdf

Kind Regards.
Gurinder
posted on 2014-02-24 15:32 UTC by Dina Abdelhakim, SCBD
This is a reply to 5604 RE: Opening of the discussion: Experience and case studies on detection and identification [#5634]
Dear participants,

It is appreciated that some very useful documents have been shared in this forum.
In terms of the development of the strategy of the detection or identification of LMOs, especially for the setting of allowance levels or sampling plan, I think it would be important to consider the intended use of each LMO. (Because the risk of each LMO on biological diversity would differ between FFP use and seed use.)

I believe that many countries have been undertaking the inspection of LMOs (seeds) in the context of preventing unintentional or illegal transboundary movement of LMOs. At the starting point of such inspection, a certain detection method has to be selected. I think the selection of the detection method depends on the availability of information about the LMO.

The categorization of LMOs by knowledge level presented in EU guideline – “Overview of the detection, interpretation and reporting on the process of unauthorized genetically modified materials” - are very clear and useful to understand what type of LMO we are treating. I think that if we classify the LMOs in the unintentional or illegal transboundary movement cases according to the categorization, we could understand difficulties in the selection/development of detection method experienced in each case.

For example, most of the all LMOs (seeds) which have been inspected in my country are classified to “Knowledge level 2”. At the starting point of the inspection of these LMOs, the detection method is usually available from developers or other countries.
On the other hands, the GM papaya (PRSV-YK-resistant strain) would be classified to “Knowledge level 3”. The difficulty in the selection/development of detection method in the case was that there had been no information on the GM papaya from developers or other countries. Furthermore, in this case, as not only seeds but also plants in the field had to be inspected, the detection method specific to the plants had to be developed.

I would like to expect further accumulation of concrete individual cases of the selection/development of detection method, with the information of the above mentioned knowledge level.

Best regards,
Ayako Yoshio
posted on 2014-02-25 03:07 UTC by Ms. Ayako Yoshio, Japan
This is a reply to 5604 RE: Opening of the discussion: Experience and case studies on detection and identification [#5637]
POSTED ON BEHALF OF GURINDER RANDHAWA
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Dear Participants,

I am sharing with you all a report on Experiences in developing detection methods for unapproved GM canola detected in imports from Canada in EU, the full pdf version is attached herewith, the brief summary from the attached report is as below:

On September 8, 2009, Germany issued an EU-wide Rapid Alert notification confirming the presence of GM-flax in some samples of flax imports from Canada. Imports of Canadian flax were embargoed until Canadian exporters could satisfy the EU regulators that shipments conformed to EU standards. The process of satisfying EU regulators entailed the development of a detailed sampling and testing regime. The GM-flax product that co-mingled with non GM-flax is the variety known as CDC2 Triffid. The EU market was closed to Canadian flaxseed. The Canadian Grain Commission (CGC) initiated its own testing which confirmed the presence of trace amounts of Triffid material in some Canadian flaxseed shipments. A Protocol was developed by CGC in consultation with the Flax Council of Canada  and DG SANCO, the European Commission Directorate for Health and Consumer Affairs. The Protocol puts in place a mechanism for documenting, sampling and testing for the presence of Triffid flax in the supply chain of Canadian flaxseed destined for the EU. The Protocol satisfies the zero tolerance policy for LLP GMOs as currently interpreted in the EU, i.e. maximum acceptable level of risk of CDC Triffid is at the 0.01 percent level. The 0.01 percent detection level established by the Protocol is linked to a level that can be accurately and reliably detected by the Triffid-specific test. However, the threshold represents a very high commercial risk as it has proven nearly impossible for the grain storing and handling companies to achieve it and, thus, is of considerable economic importance.

In terms of sampling, the protocol specifies that three samples of flaxseeds must be collected at different levels of the supply chain: by the grain handling company from each producer delivery (sample retained for at least six months from the delivery date); before loading the railcar, with each railcar being sampled and the composition of samples comprised of not more than five railcars; and at the terminal elevators prior to loading on ships by CGC12 personnel. If the composite sample tests positive for the presence of FP967 at the grain handling level, all railcars that tested positive are removed from the aggregate flaxseed shipment destined for export to the EU and the list of railcars that tested negative is transmitted to CGC. The CGC samples all railcars carrying flax destined for the EU, monitors the unloading of each railcar in a designated silo, then seals and records the silo and seal number. A 2.5 kg composite sample is prepared from each silo and sent to an ISO 17025 accredited laboratory for testing.

Regards.
Gurinder
posted on 2014-02-25 16:11 UTC by Dina Abdelhakim, SCBD
This is a reply to 5604 RE: Opening of the discussion: Experience and case studies on detection and identification [#5720]
Dear Members of the Forum,

Please find attached recently published results of the FAO survey on low levels of genetically modified (GM) crops in international food and feed trade.

This survey outlines international experiences and responses to incidents of unauthorised and unintended LMO presence.

This publication comes ahead of their meeting on "Technical Consultation on Low Levels of Genetically Modified (GM) Crops in International Food and Feed Trade" the results of which we will be following closely.

Their press release outlining the results of the survey can also be found here http://www.fao.org/news/story/en/item/216311/icode/

Best regards,
Dina
posted on 2014-03-13 20:53 UTC by Dina Abdelhakim, SCBD
This is a reply to 5604 RE: Opening of the discussion: Experience and case studies on detection and identification [#5726]
Dear Members of the Forum,

Attached is a paper entitled "Detecting adventitious transgenic events in a maize center of diversity" which 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.

I hope participants find this information useful and continue to contribute their experiences and case studies on detection and identification.

Best regards,
Dina
posted on 2014-03-31 16:06 UTC by Dina Abdelhakim, SCBD
This is a reply to 5720 RE: Opening of the discussion: Experience and case studies on detection and identification [#5727]
Dear Forum Participants,

Further to the message previously posted regarding the FAO's  meeting on "Technical Consultation on Low Levels of Genetically Modified (GM) Crops in International Food and Feed Trade" we would like to direct participants to the meeting's webpage (http://www.fao.org/food/food-safety-quality/a-z-index/biotechnology/LLP/en/) which has been updated to include interesting presentations on relevant topics as well as presentations from a few countries on their experiences with low levels of GM crops.

Best regards,
Dina
posted on 2014-03-31 16:30 UTC by Dina Abdelhakim, SCBD
This is a reply to 5604 RE: Opening of the discussion: Experience and case studies on detection and identification [#5731]
Dear Forum Participants,

Please find attached a paper outlining experiences detecting GMOs in samples from Malaysia and Vietnam.

Participants are invited to share examples of experiences or case studies on the development of methods for the detection of unauthorized LMO or LMOs unintentionally introduced into the environment in the upcoming final days of the forum.

Best regards,
Dina
posted on 2014-04-03 20:19 UTC by Dina Abdelhakim, SCBD
This is a reply to 5731 RE: Opening of the discussion: Experience and case studies on detection and identification [#5733]
Dear colleagues,

I would recommend for your attention the publication on LMO testing Report by Danish colleagues http://www.sns.dk/erhvogadm/biotek/REPORT_rev_maj.pdf . It contains the description of sampling methods, overview of methods for detection of GMOs - EU approved and non EU approved GMOs, the low technological methods, high technological methods, validation and standardization of methods.

Best wishes,
Angela
posted on 2014-04-03 20:56 UTC by Ms. Angela Lozan, Republic of Moldova
This is a reply to 5733 RE: Opening of the discussion: Experience and case studies on detection and identification [#5735]
Dear Colleagues

It is a nice report mentioned above but one have to be aware that it is written more than 10 years ago. There is no date on it, but the newest reference is from 2001. Som of the content is fine and som is very old.
The document "Overview on the detection, interpretation and reporting on the presence of unauthorised genetically modified materials" from The european network of GMO laboratories has updated informations. (http://gmo-crl.jrc.ec.europa.eu/doc/2011-12-12%20ENGL%20UGM%20WG%20Publication.pdf).
Other guidance document is also avalible from http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm

Best wishes,
Lotte
posted on 2014-04-04 09:01 UTC by Ph.D. Lotte Hougs, Danish Veterinary and Food Administration