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Opening of the discussion: Current definitions and uses of the terms “unintentional transboundary movement” and “illegal transboundary movement” of LMOs [#6478]
Dear Forum Participants,

Welcome to the first round of discussions of the Network of laboratories for the Detection and Identification of LMOs to work towards the implementation of the requests of the COPMOP at their previous meeting. This discussion will focus on the topic of “Current definitions and uses of the terms “unintentional transboundary movement” and “illegal transboundary movement” of LMOs”.

As outlined in the introduction to the discussion, the Cartagena Protocol on Biosafety contains provisions related to “illegal transboundary movements” (Article 25) and “unintentional transboundary movements” (Article 17). While the Protocol defines the former as “transboundary movements of living modified organisms carried out in contravention of domestic measures of a Party to implement this Protocol”, it does not provide a definition for the latter. Having the capacity to detect and address illegal and unintentional transboundary movements of LMOs is a key element for the effective implementation of the Protocol.

Participants are invited to discuss, from the perspective of someone involved in LMO detection and identification, how the imports of LMOs that have not been authorized in your country are dealt with, particularly with regard to which terms are used to refer to these imports and what the implications are, if any, of using such terminology. For example:

• Are the terms “illegal” and “unintentional” used in the context of detection and identification of LMOs being brought into your country? Is there a distinction between these terms?
• Are there other terms that refer to similar concepts and which are used in your laboratory or national regulations? In what context are these terms used and is there a distinction between these terms and those used in the Protocol?
• What does the definition of illegal transboundary movement (“transboundary movements of living modified organisms carried out in contravention of domestic measures of a Party to implement this Protocol”) mean in practice?
• What practical consequences can the use of different terms, based on intent, legal status or quantity, have on the detection and identification of LMOs?

We are looking forward to your lively participation in this discussion.
Kind regards,
Dina
(edited on 2015-01-26 00:26 UTC by Dina Abdelhakim)
posted on 2015-01-26 00:25 UTC by Dina Abdelhakim, SCBD
This is a reply to 6478 RE: Opening of the discussion: Current definitions and uses of the terms “unintentional transboundary movement” and “illegal transboundary movement” of LMOs [#6479]
In the context of an LMO detection laboratory, the concept of an illegal LMO is determined by what events have been approved by the regulatory system of that country in terms of either environmental release (for production) and commodity use.  If an event approved for commodity use is found in the environment then it is considered "illegal".

My opinion is that the term "unintentional" is a regulatory term which can not be confirmed or tested in an LMO detection laboratory but requires an investigation as to whether the regulatory requirements for the illegal transboundary movement were adhered to or not.  However, by definition an "unintentional" transboundary movement would be considered "illegal".

I would caution that an LMO detection laboratory should never be required to express a legal opinion on the result of the testing.  That should be a regulatory function outside of the ambit of the LMO detection laboratory.  In other words, the detection laboratory should supply a result but not be responsible to interpret the result in a regulatory context.
posted on 2015-01-28 14:10 UTC by Prof. Chris Viljoen, University of the Free State
This is a reply to 6479 RE: Opening of the discussion: Current definitions and uses of the terms “unintentional transboundary movement” and “illegal transboundary movement” of LMOs [#6480]
Dear Dina, Dear Members of the Forum
My greetings and best wishes for the New Year.

Dina has suggested 4 questions, which I will reply to in order.

• Are the terms “illegal” and “unintentional” used in the context of detection and identification of LMOs being brought into your country? Is there a distinction between these terms?

Considering the literal translation of these terms to our official language, I can conclude that these terms are not commonly used and cannot be found in our regulation. Although “illegal” has been used by the Commission to report the cultivation of GM material that was either non-authorized or has been planted in a GM-exclusion zone, or even without following co-existence or any other GM rule.

• Are there other terms that refer to similar concepts and which are used in your laboratory or national regulations? In what context are these terms used and is there a distinction between these terms and those used in the Protocol?

The Biosafety Law uses the term “non-authorized” for the production, storage, transportation, marketing, import or export of GMOs and their by-products that have not been authorized in our country. This term has been also used by inspection agencies while testing imports. Normative Resolution no. 6 uses the term “accidental release” for the unintentional release of GM material from field trials.

• What does the definition of illegal transboundary movement (“transboundary movements of living modified organisms carried out in contravention of domestic measures of a Party to implement this Protocol”) mean in practice?

GM material that has been brought into our country without authorization.

• What practical consequences can the use of different terms, based on intent, legal status or quantity, have on the detection and identification of LMOs?

I must admit to being confused by the question above. I guess this is related to what Chris has previously posted.

Best regards,

sarah
posted on 2015-01-28 19:53 UTC by Ms. Sarah Agapito-Tenfen, Brazil
This is a reply to 6480 RE: Opening of the discussion: Current definitions and uses of the terms “unintentional transboundary movement” and “illegal transboundary movement” of LMOs [#6481]
Dear Dina and members of the Forum,
Glad to hear you again and I would like to reply  to the questions proposed also.

I consider that distinguishing of the terms “illegal” and “unintentional” (in our domestic legislation I have found the terms «unauthorized release» and« unauthorized import») is the matter of importance for GMO regulatory process (and those who involved in it), especially establishment of regulations on GMO monitoring and liability and redress. It seems to me that from the point of view of the regulatory bodies it is important to divide this concepts and it could be helpful for further development of the domestic legislation, that in general affects the whole process of GMO control. But I am agree also that LDGMOs are not involved in regulatory process and its` main purpose are to provide proper and reliable data to support the decision-making process. That`s why I don`t see practical consequences of using proposed terms  on the results of LMOs detection and identification.
In my opinion the definition «illegal transboundary movement» means that the movement of an LMO from one Party to the Protocol to another Party (and sometimes from one Party to non-Party) was carried out without implementation of regulations secured in domestic legislations (e.g. labeling, packaging requirements, supplementing documents that must be submitted under the national law of the countries of transboundary movement).

With my best wishes,
Galina
posted on 2015-01-29 10:45 UTC by Dr. Galina Mozgova, Belarus
This is a reply to 6478 RE: Opening of the discussion: Current definitions and uses of the terms “unintentional transboundary movement” and “illegal transboundary movement” of LMOs [#6482]
Dear Forum Participants,

I would like to thank Chris, Sarah and Galina for their contributions and raising some very interesting points of discussion and helping us move forward through this multifaceted topic.

I encourage all participants to make a contribution to the discussions such that we have many perspectives on the topic at hand as the contributions to this discussion will be vital in forming the basis of the next round of discussions during which we will be on drafting working definitions for “unintentional transboundary movement” and “illegal transboundary movement” of LMOs for consideration of the Compliance Committee.

I look forward reading your views on the matter.
Kind regards,
Dina
posted on 2015-01-30 18:25 UTC by Dina Abdelhakim, SCBD
This is a reply to 6482 RE: Opening of the discussion: Current definitions and uses of the terms “unintentional transboundary movement” and “illegal transboundary movement” of LMOs [#6483]
Dear All,

Thank you Dina for guiding questions to facilitate our discussion.

I would like to join colleagues and providing with our national regulatory context for the discussed topic.  
1. Are the terms “illegal” and “unintentional” used in the context of detection and identification of LMOs being brought into your country? Is there a distinction between these terms?
- There are both terms used in our domestic legislation. The Biosafety law requires in Art.37 application of special measures in case of illegal transboundary movement of LMOs, as well as  in Art.40 stipulate specific liability and redress actions for illegal import or domestic use of LMOs.  From the point of view of national legislation there is similarity in understanding of both terms. In my view "unintentional" LMOs can be used in case when an importer of conventional agricultural commodities (seeds, products) may also introduce in the country some small quantity of LMOs, as botanical impurity or the stack is not enough isolated from an LMOs commodity during shipping or depositing.  

• Are there other terms that refer to similar concepts and which are used in your laboratory or national regulations? In what context are these terms used and is there a distinction between these terms and those used in the Protocol?
- The distinction between both term is mostly used by regulation. The laboratory just may provide report on analysis of LMO detection, as qualitative as well as quantitative, without making conclusion about the legal status of import/export.  The legal status of LMOs import should be monitored by the inspection competent agencies and National competent authority.

Wish an excellent start of a New Year!

Best regards,

Angela
posted on 2015-02-02 15:17 UTC by Ms. Angela Lozan, Republic of Moldova
This is a reply to 6478 RE: Opening of the discussion: Current definitions and uses of the terms “unintentional transboundary movement” and “illegal transboundary movement” of LMOs [#6484]
Dear Dina and colleagues of the Forum,

Thank you very much for lots of efforts by the Secretariat to start discussions at this Forum again.
I’m glad to have an opportunity to provide my thoughts on the definitions of term “illegal” and “unintentional” transboundary movement (TM).

As defined in Article 25 of the Protocol, an “illegal” TM is a TM carried out in contravention of domestic measures. Therefore when considering the point of this term “illegal”, it is important whether an LMO in question or a way of its use is approved/ authorized in the importing country or not.

In contrast, there is no definition for “unintentional” TM in the Protocol but I believe the point here is whether TM is carried out with or without intention, literally.

In order to have clearer ideas on distinction, I try to match these two-by-two elements, that is “approved/ unapproved” and “with /without intention”, with instances. Please see the followings:

- Legal and Intentional TM: Trade of LMO which is approved in the importing country (hereinafter “approved LMO”);
- Illegal and Intentional TM: LMO which is NOT approved in the importing country (hereinafter “unapproved LMO”) is transported to the country WITH intention (e.g. Contraband trade);
- Legal and Unintentional TM: Approved LMO is transported to the country WITHOUT intention (e.g. transboundary pollen flow of approved LMO, TM of approved LMO by animals or birds unless the law prohibits such movements); and
- Illegal and Unintentional TM: Unapproved LMO is transported to the country WITHOUT intention (e.g. Unapproved LMO is accidentally commingled in trade goods).

The examples above include a hypothetical story and are not the cases in our country; but I hope they help better understanding of these terms.

In conclusion, as we see examples above, two concepts “illegal” and “unintentional” are not conflicting each other since either of them has a different meaning.

Best regards,
Ayako
posted on 2015-02-05 08:26 UTC by Ms. Ayako Yoshio, Japan
This is a reply to 6478 RE: Opening of the discussion: Current definitions and uses of the terms “unintentional transboundary movement” and “illegal transboundary movement” of LMOs [#6485]
Dear Forum Participants,

Thank you Angela and Ayako for sharing your perspective on this topic.

I would like to remind participants that this discussion forum will be open for 2 more days and would like to encourage all participants to make a contribution to the discussions in preparation for the next round of discussions during which we will be on drafting working definitions for “unintentional transboundary movement” and “illegal transboundary movement” of LMOs for consideration of the Compliance Committee.

I look forward reading your views on the matter.
Kind regards,
Dina
posted on 2015-02-06 17:31 UTC by Dina Abdelhakim, SCBD
This is a reply to 6485 RE: Discussion of current definitions and uses of the terms “unintentional transboundary movement” and “illegal transboundary movement” of LMOs [#6486]
Dear Dina and colleagues of the Forum,

The GIC appreciates the opportunity to provide our thoughts on these topics:

as to Question 1: Are “illegal” and “unintentional” used in the context of detection and identification of LMOs being brought into a country -

As stated by Brazil and others, the terms “Illegal” and “Unintentional” are not  often used in the laboratory context.   Rather, “unintentional” is used in the context of risk assessment, for example in reference to unintended effects of genetic modification (e.g. Australia/New Zealand, India, Malaysia, South Africa, European Union; see also CODEX), or to “unintentional” mistakes that may occur during the transfer of materials. It is also used in the contexts of low level presence, co-existence and food labelling (e.g. Australia/New Zealand, European Union). The term “illegal” may in some cases be used to describe use (e.g. import for FFP or release into the environment) that is not authorised by the relevant domestic regulatory authorities (i.e. it has to do with regulatory status). However the term “illegal” is more often used by organisations that are external to the regulatory regime and unrelated to the Protocol (e.g. the media).

We remind participants that several International documents regarding these issues have already been published.  In particular Codex document CAC/GL 45-2003 Annex 3 concerning low level presence in food is a useful document,  and parties can make use of the Food And Agriculture Organization (FAO) of the United Nations GM Foods Platform ( http://www.fao.org/food/food-safety-quality/gm-foods-platform/en/).  In addition the OECD document  ENV/JM/MONO(2013)19 is informative where plants and seed are concerned.

As to Question 2: Terms used in the laboratory -

The terms “Illegal” and “Unintentional” are not to be used in a laboratory situation, in that the role of a laboratory is to provide results, and not legal opinions.   To give a legal opinion would not be in compliance with ISO 17025 section 5.10 unless the laboratory has been requested to do so and “can document the basis upon which the opinions and interpretations have been made”.

As to Question 4: Practical consequences can the use of different terms -

The GIC supports the position of Prof. Chris Viljoen, Dr. Galina Mozgova, Dr. Angela Lozan, that the terms “illegal” and "unintentional" are terms which cannot be confirmed or tested in an LMO detection laboratory, and that a LDGMOs should not express a legal opinion on the result of the testing; the laboratory should supply a result but not be responsible to interpret the result in a regulatory context.   We have some concerns that Laboratory Detection Experts are being asked to answer legal questions.


We trust that these comments will be useful and contribute to the discussion.
Ray Shillito (on behalf of the GIC)
(edited on 2015-02-06 20:12 UTC by Dr Raymond Shillito)
posted on 2015-02-06 20:12 UTC by Dr Raymond Shillito, Bayer CropScience
This is a reply to 6486 RE: Discussion of current definitions and uses of the terms “unintentional transboundary movement” and “illegal transboundary movement” of LMOs [#6487]
Dear all,
We would like to thank Dina for her efforts in organizing these discussions and all the colleagues for their contributions.
As we have posted in previous discussions, although Lebanon has ratified the Cartagena protocol on Biosafety (Feb 2013), the country has not placed its GMOs regulatory measures yet. Accordingly, we don’t have official definitions for the terms “illegal” and “unintentional”, as well as for other terms related to GMOs such as “authorized” and “unauthorized”.
We believe that the term “illegal” is equal to “unauthorized” which means that this type of GMOs is not allowed to be used for one or more purposes (for example a certain GM event could be unauthorized to be used in feed and therefore its presence in feed products is illegal).
As for “unintentional”, we think that this term refers to GMOs that are not detected by a GMOs testing laboratory because they are present in an amount that is below the limit of detection of the methods used for the analysis such as non-GM products which have been accidentally/involuntarily contaminated with GMOs.
Finally, we agree with the colleagues that the terms “illegal” and “unintentional” should not be reported by a testing laboratory. Their use should be restricted to the regulatory system in the country.
Thank you.
Narmeen Mallah and Gretta Abou-Sleymane
posted on 2015-02-08 09:15 UTC by Dr Gretta Abou-Sleymane, Lebanon
This is a reply to 6478 RE: Opening of the discussion: Current definitions and uses of the terms “unintentional transboundary movement” and “illegal transboundary movement” of LMOs [#6488]
POSTED ON BEHALF OF GURINDER RANDHAWA
----------------------------------------------------

Thanks a lot to Dina and her team for arranging online discussion on this very important aspect.
In India LMO detection laboratory does not give a legal opinion on the results of the testing, that is in the purview of regulatory authority. Only results are provided by the detection laboratory interpretation of the the results taken care by regulatory body.

I totally agree with the comments of Prof. Chris, Dr. Galina, Dr. Angela and GIC, that the terms “illegal” and "unintentional" are terms which cannot be confirmed or tested in LMO detection laboratory, the laboratory should supply a result but not be responsible to interpret the result in a regulatory context. 

Kind Regards.
Gurinder
posted on 2015-02-09 16:12 UTC by Dina Abdelhakim, SCBD

   
   
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