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Discussion opening: Recommendations to the COP-MOP [#6246]
Dear Members of the Network,

Welcome to the final round of discussions under the activities of the Network for the 2012-2014 intersessional period. This discussion will focus on the recommendations to the Conference of the Parties serving as the meeting of the Parties to the Protocol which will take place in Pyeongchang, Republic of Korea, 29 September-3 October 2014.

We invite you to review the background information outlining the recommendations from the workshop, at http://bch.cbd.int/detectionlabs/workshop_recommendations_to_the_copmop.docx, in preparation for the discussions and as a basis to build upon.

Once again I would like to thank you for your constructive and active contributions and I am looking forward to your continued support of the activities of the Network.

Best regards,
Dina
posted on 2014-06-30 13:38 UTC by Dina Abdelhakim, SCBD
This is a reply to 6246 RE: Discussion opening: Recommendations to the COP-MOP [#6247]
Dear members of The Network,

We would like to remind you that the discussion on recommendations from The Network to the COP-MOP will remain open until the 13th July and we would, once again, like to invite participants to put forward and build on the recommendations proposed at the workshop.

Furthermore we would like to draw your attention a draft of the online portal for the Technical Tools and Guidance for the Detection and Identification of LMOs which has been developed in line with the strategy for implementation that was outlined in the workshop .

The portal is available at http://bch.cbd.int/protocol/cpb_detection/toolsandguidance.shtml and you are welcome to provide your feedback on the portal.

Please note that there are still more background documents that need to be added to each section which will be done prior to 31st July, as indicated in the report of the workshop to be the deadline date for publishing the Technical Tools and Guidance.

Thank you once again for your valuable contributions to the work of the Network.
Best regards,
Dina
(edited on 2014-07-09 19:22 UTC by Dina Abdelhakim)
posted on 2014-07-04 17:43 UTC by Dina Abdelhakim, SCBD
This is a reply to 6247 RE: Discussion opening: Recommendations to the COP-MOP [#6248]
Dear colleagues

I would first like to thank the Secretariat for their efforts in organizing the online discussions of the Network as well as the Workshop.
I believe that the recommendations report prepared by the Secretariat is faithful to the discussions from the Workshop of the Network of Laboratories for the Detection and Identification of Living Modified Organisms and I would like to recommend that the report be adopted as is.

Best regards,

Sarah
posted on 2014-07-08 16:48 UTC by Ms. Sarah Agapito-Tenfen, Brazil
This is a reply to 6248 RE: Discussion opening: Recommendations to the COP-MOP [#6250]
Dear members of The Network,

We would like to remind you that the discussion on recommendations from The Network to the COP-MOP will remain open until the the end of this week, Sunday 13 July, and we continue to invite participants to post their views on the recommendations proposed at the workshop.

Best regards,
Dina
posted on 2014-07-09 19:22 UTC by Dina Abdelhakim, SCBD
This is a reply to 6250 RE: Discussion opening: Recommendations to the COP-MOP [#6251]
Dear colleagues,

I would like to thank the Secretariate for preparing the recommendation paper and colleagues for their valuable imput to the document. I consider the document reflects the discussion held during the workshop and could be submitted for adoption to the COP-MOP.

Best wishes,
Angela
(edited on 2014-07-10 00:59 UTC by Ms. Angela Lozan)
posted on 2014-07-10 00:59 UTC by Ms. Angela Lozan, Republic of Moldova
This is a reply to 6246 RE: Discussion opening: Recommendations to the COP-MOP [#6255]
POSTED ON BEHALF OF GURINDER RANDHAWA
------------------------------------------------------

Dear Dina,

I am really happy that the recommendation report prepared by the Secretariat is very informative and useful for the LMO detection laboratories working all over the globe.
If the laboratory managers/experts actively participate in this online discussion for the Network of Laboratories for the Detection and Identification of LMOs, it would be best platform to share our experiences.

I am really looking forward to hear from maximum number of participating laboratories.

With Best Wishes.
Gurinder

Dr. (Mrs.) Gurinder Jit Randhawa
Principal Scientist
Genomic Resources Division
(National Research Centre on DNA Fingerprinting)
National Bureau of Plant Genetic Resources
New Delhi-110012, INDIA
posted on 2014-07-11 13:47 UTC by Dina Abdelhakim, SCBD
This is a reply to 6246 RE: Discussion opening: Recommendations to the COP-MOP [#6258]
POSTED ON BEHALF OF LUTZ GROHMANN
-----------------------------------------------

Dear All,

I reviewed the different documents providing background information outlining the recommendations from the workshop and in general I think these are contributions very valuable for many of us. I have only a few comments.

Regarding the part “Overview of available detection methods, including validated methods” I want to comment the following.

1) Section 2.1 on “protein-based methods for LMO detection” is describing the general approach using dip-sticks and ELISA. In addition, western blotting is mentioned as a detection method. I believe that this technique is not used for routine LMO testing (at least in EU region) but eventually in R&D of LMOs, therefore I would suggest to omit the last para from section 2.1.
Protein detection methods require specific antibodies which are finitely available and need to be not produced again if used up. Different productions may cause variance in sensitivity, and more importantly, tests (ELISA or dipstick) are in available as commercial product. I would recommend mentioning this somewhere in this chapter or in section 2.3.
Finally, protein-based methods should be only applied to raw and unprocessed products; otherwise false-negative results are accepted because the LMO proteins in processed products may not be detectable (denaturation, destruction of protein structure and the epitope).

2) DNA-based methods are the preferred approach for LMO detection, and in particularly PCR methods are applied and validated according to the international accepted performance requirements and standards. If gel-electrophoresis methods are employed it should be mentioned that it is recommended and required according to ISO standard 21569 to verify the identity of the PCR product (e.g. by restriction digest, probe hybridisation or sequencing etc.).

Regarding the part “Minimum performance criteria for sample handling, extraction, detection and identification methodology” I want to comment the following:

1) In part B 3. the first sentences say that “...there are several types of analytical methods that target different analytes and use a wide variety of chemistries and strategies. For instance, for DNA based molecular methods, detection may involve the amplification of a GM event or its genetic markers by simple PCR reaction, hydrolytic probes, isothermal amplification or high resolution melting strategies amongst others either in single reaction, arrays or in a multiplex. The laboratory may select from this wide array of test methods based on, among other things, each country’s specific regulatory requirements, operational costs, infrastructure and technical capability....”
Since this chapter is describing the “minimum performance criteria for....detection and identification methodologies” it needs to be mentioned that apart from PCR, to my knowledge for none of the other methodologies validation/verification criteria and performance requirements are described in any relevant document referenced at the end of the document. Therefore, I would suggest changing the sentence accordingly and clarifying this point.

Thank you for the attention and I would be grateful if you could distribute the comments to the network or the authors of the documents,

Kind regards

Lutz
posted on 2014-07-14 13:28 UTC by Dina Abdelhakim, SCBD
This is a reply to 6246 RE: Discussion opening: Recommendations to the COP-MOP [#6260]
POSTED ON BEHALF OF RAY SHILLITO
-----------------------------------------
Dear Dina,

Thank you to the Secretariat for their efforts in organizing the online discussions of the Network and the Workshop, and for the opportunity to participate.
The Global Industry would like to add some comments to the discussion on recommendations from The Network to the COP-MOP.

In regard to the first recommendation, information on sequences of the events is generally made available to governments in submissions.  It is important that intellectual property and confidentiality considerations of such data are respected and most governments have laws in place that address this.  Such laws could conflict with making this a requirement.  Should such sequences be made available then intellectual property considerations must be respected.  Additionally, reference (control) materials are generally made available via certified reference material providers AOCS and IRMM upon or in most cases before commercial production of an event. 

7(i)
The Global Industry Coalition supports the suggestion in paragraph 7.1 to make information about appropriate control samples, including certified reference materials and other reference materials, validated methods and protocols for LMO detection, more easily findable on the BCH website.  The website information on detection laboratories (both commercial and governmental) that are operating also needs to be made more easily searchable and accessible.

We also recommend that the website include information on rapid alert networks referred to in paragraph 5 that are already in place in many parts of the world.  The BCD is the recognized source of information related to the Biosafety Protocol, and any decisions taken that would create a rapid alert system should be located on this site. 

Best regards,

Ray Shillito (GIC)
posted on 2014-07-14 15:59 UTC by Dina Abdelhakim, SCBD
This is a reply to 6246 RE: Discussion opening: Recommendations to the COP-MOP [#6261]
POSTED ON BEHALF OF RAY SHILLITO
-------------------------------------------

Dear Dina, all,

GIC appreciates the opportunity to comment on the  Technical Tools and Guidance for the Detection and Identification of LMOs and wish to support and supplement some of the statements made today by Dr. Grohmann.

Protein-based methods:
We concur with the statement that , western blotting is not used as a routine LMO testing in any region; it is indeed a research tool and it is difficult to see how it would be used effectively.

While some protein detection methods use antibodies which are finitely available (such as those produced in the plasma of animals), many of the commercial tests now being produced use monoclonal antibodies that are available in effectively infinite amounts.  
While there may be variance in sensitivity of antibodies (from different animals, or lots) , and commercial producers take great care to adjust the amount of antibodies used, or other factors, to maintain a stable testing kit performance.

We agree that protein-based methods should be in most cases only be applied to raw and unprocessed products due to denaturation, destruction of protein structure and the epitopes.in materials subjected to heat or moisture.  Minimally processed materials such as flours can be assayed using protein based methods if they are validated for that use.  There are however, a few cases where a test (e.g. for RR soy) have been produced for use in processed materials.

In addition we wish to comment on the section Comparison between protein- and DNA-based methods for LMO detection in the Overview of available detection methods, including validated methods, which was also commented on by Dr. Grohmann.

While DNA-based methods are the preferred approach for LMO detection in many jurisdictions, they are not required by the protocol.  In many cases DNA-based methods are not fast enough to be used for control, and a protein based method can offer assurance of meeting the requirements without unacceptable delay of the transport or use of materials.

Regarding use of alternative methods than PCR, we believe that while there is a significant amount of guidance available for the use of PCR, there is also guidance in the general analytical literature on the use of analytical methods, and specifically both CODEX and ISO provide guidance on the use of protein based methods.

Thank you for the opportunity to comment and I would be grateful if you could distribute the comments to the network and the authors of the documents,

Best regards,

Ray Shillito
posted on 2014-07-14 16:00 UTC by Dina Abdelhakim, SCBD