Past Activities 2016-2018

Dear Participants,

Welcome to the online discussions of the Network of Laboratories for the Detection and Identification of Living Modified Organisms.

At their last meeting, on Decision CP VIII/16,  the Parties to the Cartagena Protocol on Biosafety requested the Executive Secretary to continue working on the draft training manual, in collaboration with the Network of Laboratories for the Detection and identification of Living Modified organisms, and make a draft version available for consideration at their ninth meeting. Accordingly, an updated version of the draft manual has been prepared by the Secretariat, in collaboration with a small group of experts from the Network, and it is available for review by all participants of the Network.

This discussion will focus on module 6 provides additional detail on laboratory documentation requirements and the reporting of testing results including important considerations on report writing.

Participants are invited to review and provide feedback on the contents for each module during the course of the next 2 weeks. We request that you review the manual from both a technical and editorial perspective focusing on edits and comments that  would provide additional clarity to the manual. In providing your comments, please refer to specific line numbers or highlight the text directly in the Word document containing the module and upload it together with your message.

We look forward to two weeks of constructive and fruitful discussions which will bring us a step closer to the goal of developing and improved version of the manual for the consideration of the COPMOP.

Kindest regards,
Secretariat

In the document adjoined it was added in line 146 units % cp/cp and in line 153 reference material for your consideration

Dear All,

I have added some remarks to the 'mx_cenam_cibiogem'-reviewed document.

Hi,
cp/cp means copies/copies, in English
it is very important to specify Units of measurement, also the Uncertainty of quantitative measurements

with kind regards

Melina

Hi,
I'm Frank Narendja, Environment Agency Austria. I have added some comments regarding the experssion of results to the "module 6_27mar18_posted_pe_msm" document:

line 147-unit of measurement mentioned is depended on the material used for determining the (relative) LOD in % - if I have used mass certified reference material the unit will be w/w, if I used a copy number based approach it can be cp/cp or if I state (absolute) LOD its copy number of target

line 153-As  GMO amount  is a relative quantity per definition I do not understand what an absolute value means ?

Kind regards
Frank

Dear All,

It would be useful to add  in the references section the following document:

European Network of GMO Laboratories (2017)Detection, Interpretation and Reporting on the presence of authorised and unauthorised genetically modified materials
available at http://gmo-crl.jrc.ec.europa.eu/ENGL/docs/WG-DIR-Final-Report.pdf

Best regards

Roberta Onori

Dear Participants and Roberta Onori,
Thank you for providing additional source material.  While there are a number of very useful documents available from the European Union, I believe that in order to maintain global relevance it is important to honor the discussions that were held in Italy and avoid just replicating the EU documents.  The EU situation is one where there are a great deal of resources applied to LMO detection, which is not necessarily the case in developing countries and small island nations, where resources may be more limited.  Moreover such document reflect the non-acceptance of LMOs in agriculture which is increasingly not the case for many other nations.   It would therefore be optimal to use these documents in advisement and provide guidance that can be used by all parties, including those that are accepting in the use of LMOs in agriculture.

thank you for your attention.

Dear Forum Participants,

I would like to thank everyone who has shared their comments on this module so far.

As previously indicated, the main objective of this discussion is to review and provide feedback on the contents of module 6 which can be accessed at http://bch.cbd.int/detectionlabs/trainingmanual/module%206_27mar18_posted.docx.

We request that you review the manual from both a technical and editorial perspective focusing on edits and comments that  would provide additional clarity to the manual. In providing your comments, please refer to specific line numbers or highlight the text directly in the Word document containing the module and upload it together with your message.

I hope you will be able to contribute to this discussion in the coming week and share your knowledge with us in order to contribute to the development of a through and comprehensive training manual.

Kindest regards
Dina

POSTED ON BEHALF OF Mr. Adugnaw Admas, ETHIOPIA
--------------------------------------------------------------
Dear Colleagues,
Thank you for you invitation to participate in this online LMO detection form.
Accordingly your  invitation to review the document,I have tried to see carefully all module, really it is interesting and also, i apperciate the module organizers for collecting best materials of LMO detection document.
module 6:
my comment
from line 1 in management section
The reporting format is very interesting for decision makers,
Also, if you give us the format with one completed document  as examples from experienced country from sampling up to data analysis
Thank You
Adugnaw Admas
Ethiopian Environment and Forest Research Institute
Biological Science Research Division Coordinator
Tell 0918561763

Dear participants,

Thank you for compiling the document on reporting.  It is important to note that there are very good guidelines in ISO17025 for reporting, and specifically for LMO’s in ISO24276.  I have added these references.

The use of the word laboratory may suggest that a test can only be performed in a laboratory, whereas certain LMO testing can be carried out for example in the field.  This needs to be made clear.   Thus I have changed this to testing organization throughout as it is a more neutral term.  Another way would be to state here (and in other modules) that a the use of the term ‘laboratory’ does not implicate a physical building but can also mean a testing organization that is operating for example in a seed or grain collection site, in the field etc.
Hence I also deleted the word laboratory from the Heading on line 30.

I replaced the request for a reference in footer 1 with a reference to module 5. “Typical quality systems are described in module 5.”

I do not believe that information about any investigation in process is appropriate in a laboratory or testing organization report (line 62 and text nearby).  A sample should be submitted with just the request for the analysis.  To do so can compromise the quality and non-biased nature of any laboratory data, even to the point of compromising any legal case. The testing organization is responsible for reporting the result of the tests, not the reasons for doing the tests.  They should be kept separate.

The use of the term Case report (lines 31-52 and subsequent sections) also links the analysis and the reason for testing the sample and thus can compromise integrity of the data and the objectivity of the results.   I have substituted with sample (after all that is what the data is about), or other suitable terms throughout.

I believe the reference: ‘United Nations Office on Drugs and Crime (UNODC); Guidance for the Implementation of a Quality Management System in Drug Testing Laboratories; 2009’ is not appropriate for this document and application.

The references are not referenced back to the text; this needs to be done in a way that is consistent through all modules.

Dear colleagues,

many thanks to the authors for writing this module as a basis for the development of training materials, which is a very good starting point.

Module 6 should provide additional details on laboratory documentation requirements and the reporting of testing results including important considerations on report writing.

There are the existing ISO standards

1) ISO 21569 Foodstuffs -- Methods of analysis for the detection of genetically modified organisms and derived products -- Qualitative nucleic acid based methods

2) ISO 21570 Foodstuffs -- Methods of analysis for the detection of genetically modified organisms and derived products -- Quantitative nucleic acid based methods

3) ISO 24276 Foodstuffs -- Methods of analysis for the detection of genetically modified organisms and derived products -- General requirements and definitions

providing harmonised and straight-forward approaches with details on the required laboratory documentation, the reporting of PCR-test results and the considerations on report writing. These concern qualitative and quantitative PCR results in LMO testing.

I recommend, that we do not need "to invent the wheel a second time", where harmonisation has been achieved since more than 10 years.

My apologies, not providing comments  to specific line numbers. I added comments and changes/additions directly in the Word document containing the module 6, which is hereby uploaded together with my message.

I am looking forward for a further and fruitful online discussion towards developing and improving the manuals for the consideration of the COPMOP. Please contact me, if further support and expertise is required.

Kind regards and have a nice weekend,
Lutz

Dear participants,

I would like to suport some comments already made by other participants:

- “The EU situation is one where there are a great deal of resources applied to LMO detection, which is not necessarily the case in developing countries and small island nations, where resources may be more limited (#9207)”

- “we do not need "to invent the wheel a second time", where harmonisation has been achieved since more than 10 years (#9214).”

For all the draft modules presented is important to describe the technical aspects of each step of a GMO analysis procedure in a neutral and generalized way. It is also important to avoid duplication of efforts or replication of guidelines applicable to some countries that are not indeed applicable to other countries.

Due to the time constraints and having these points on mind I only have comments for the "Module 6 – Reporting" in the attached file, with specific comments and suggestions directly in the text.

Thank you.

Best regards,

Luciana Ambrozevicius
Ministry of Agriculture / Brazil

Thank you Dr. Grohmann and the BVL for your comments.  We agree that the references tend towards certification, which is not the subject of this module.

Certification processes and requirements can vary widely between Parties, although many are based on certification to ISO17025.  Even though this is the case, the exact way in which methods are certified can vary, ranging from labs being certified for each event individually (which is impracticable) to flexible certification (e.g. real time PCR in all maize).

Thanks you to all who have contributed to this excellent discussion on all the modules, and I trust that we can combine all the comments to produce a useful and workable document for further review and adoption by the network of laboratories for possible presentation for review by parties at the next COP/MOP.