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Opening of discussion: Working definitions [#6491]
Dear Forum Participants,
Thank you all for your valuable input into the previous online discussion on “Current definitions and uses of the terms ‘unintentional transboundary movement’ and ‘illegal transboundary movement’ of LMOs”. You have raised many important issues on this multifaceted topic and we welcome your views on the matter.

Recalling the request of the COP-MOP, in decision BS-VII/10, for views on “what constitutes an unintentional transboundary movement in contrast with an illegal transboundary movement” for consideration by the Protocol’s Compliance Committee, the following are some of the emerging ideas that came out of the previous discussion that could facilitate the way forward.

• “Illegal transboundary movement” refers to the import of a given LMO into a country  that has not been approved by the regulatory system of that country;
• The movement of an LMO from one country to another is illegal if it is carried out without implementation of regulations secured in the domestic legislation of the country of import (e.g. labelling, packaging requirements, supplementary documents that must be submitted under the national law of the countries of transboundary movement);
• The term “illegal” may, in some cases, be used to describe a use that is not authorised by the relevant domestic regulatory authorities, including the import for direct use as food, feed, or for processing, or the release into the environment.
• The term “unintentional transboundary movement” includes cases where imported conventional agricultural commodities (seeds, products) contain a small quantity of LMOs, via botanical impurities or contamination of the commodity during shipping or depositing;
• “Unintentional transboundary movements” may also occur when non-LM products are accidentally/involuntarily contaminated with LMOs, which are present in quantities that are below analytical limits of detection;
• Whether or not a transboundary movement of an LMO was carried out with or without intention is the key to determining whether a transboundary movement is “illegal” or “unintentional”.

Thus, according to the views posted, “illegal” is closely linked to the approval or authorization status of an LMO in a given country, while the understanding of “unintentional” seems to be a more complex term encompassing not only the lack of intent that led to the presence of a given LMO, but also linked to the LMO being present in small amounts in a mixture with non-LM material (or approved LMOs?) and the consequences that the small presence may have to the detection of the LMO.

Based on your postings, it may be possible to draw parallels between the terms used in the Protocol and those used in other regulatory systems. For instance, it seems that the term “illegal transboundary movement”, as defined in the Protocol, is often referred to as “unauthorized” import by some countries, whereas the term “unintentional transboundary movement”, as per the Protocol, may be intrinsically related to terms such as “low level presence” and “adventitious presence” (see some links to these terms below).

It was also noted during the last discussion that detection laboratories are not in a position to express legal opinions regarding the results of their testing processes and that the terms “illegal” and “unintentional” are not often used in the laboratory context but rather in the regulatory context. While we are in full agreement with this notion, given your practical expertise in the field of LMO detection, we believe this is an opportunity for the scientific community to influence and make recommendations to the appropriate regulatory bodies on this issue.

The points raised above lead to several questions, such as: What parallels can be drawn between the terms used in the Protocol, i.e. “illegal transboundary movement” and “unintentional transboundary movement”, and terms used by other bodies and regulatory systems? Is intent the only distinguishing factor between and illegal and an unintentional transboundary movement? Is the low presence of an unauthorized LMO necessary to constitute an “unintentional transboundary movement” or could, for example, an entire shipment be subject to unintentional transboundary movement? Can the terms “illegal” and “unauthorized” be used interchangeably in the context of transboundary movements or are they distinct? 

With a view to assisting the Compliance Committee during its 13th meeting, in the present discussion, taking into account the above, you are invited to submit concrete text proposals that aim at clarifying what constitutes an “unintentional transboundary movement” in contrast with an “illegal transboundary movement”.

We look forward to your input and active participation!
Thanks and best regards,
Dina

Relevant definitions and information on “low level presence” and “adventitious presence” by other bodies can be found here:
http://europa.eu/rapid/press-release_MEMO-11-451_en.htm
https://croplife.org/plant-biotechnology/regulatory-2/asynchronous-approvalslow-level-presence/
http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono%282013%2919&doclanguage=en
http://www.fao.org/fileadmin/user_upload/agns/topics/LLP/AGD803_3_Final_En.pdf
http://www.fao.org/fileadmin/user_upload/gmfp/docs/CAC.GL_45_2003.pdf
http://www.aphis.usda.gov/publications/biotechnology/content/printable_version/fs_llppolicy3-2007.pdf
(edited on 2015-02-16 16:08 UTC by Dina Abdelhakim)
posted on 2015-02-16 01:44 UTC by Dina Abdelhakim, SCBD
This is a reply to 6491 RE: Opening of discussion: Working definitions [#6494]
Dear Dina, Dear All,

Thank you Dina for a very good synthetic summary of the previous discussion. It helps us to go on with the next step of clarification of the distinction between these two terms and actions that is very important for many of us.

I thank you also for the relevant reference sources you attached in clarifying the use of therms by different international organizations.

I am trying to make an attempt to propose some kind of definitions for both terms that are concluded from the discussed  cases.  

The term “Illegal transboundary movement” – refers for the movement of an LMO from one country to another country of import that is not authorized by the relevant domestic regulatory authorities, including the import for direct use as food, feed, or for processing, or the release into the environment and is carried out without implementation of regulations secured in the domestic legislation of the country of import (e.g. labelling, packaging requirements, supplementary documents that must be submitted under the national law of the countries of transboundary movement).

The term “unintentional transboundary movement” includes cases where imported conventional agricultural commodities (seeds, products) contain a small quantity of LMOs, via botanical impurities or contamination of the commodity during shipping or depositing; or may also occur when non-LM products are accidentally/involuntarily contaminated with LMOs, which are present in quantities that are below analytical limits of detection.

I understand there are too long definitions and I hope colleagues will contribute to make them shorter and clear.

All the best,

Angela

Dr.Angela Lozan
MD
posted on 2015-02-20 08:51 UTC by Ms. Angela Lozan, Republic of Moldova
This is a reply to 6491 RE: Opening of discussion: Working definitions [#6496]
Thank you Angela for sharing your constructive views and attempting to capture the elements that were discussed in the draft definitions that you contributed.

I invite forum participants to comment on the proposed definitions and share their own text proposals. The views gathered during this discussion are in preparation for our upcoming workshop and, as such, your expert opinions on the matter will greatly contribute to a substantive face-to-face meeting.

Furthermore, as indicated in the opening message, you are also kindly invited to consider some of the following questions:

1. What parallels can be drawn between the terms used in the Protocol, i.e. “illegal transboundary movement” and “unintentional transboundary movement”, and terms used by other bodies and regulatory systems?
2. Is intent the only distinguishing factor between and illegal and an unintentional transboundary movement?
3. Is the low presence of an unauthorized LMO necessary to constitute an “unintentional transboundary movement” or could, for example, an entire shipment be subject to unintentional transboundary movement?

I look forward to your contributions and a lively discussion!
Kindest regards,
Dina
(edited on 2015-02-21 03:13 UTC by Dina Abdelhakim)
posted on 2015-02-21 03:06 UTC by Dina Abdelhakim, SCBD
This is a reply to 6494 RE: Opening of discussion: Working definitions [#6497]
Dear Dina,
Many thanks to you for the summary of our previous discussion.
And to Dr. Angela Lozan for the definitions proposed.
It seems to me that it is good formulation of the term «illegal transboundary movement». The only thing I would like to change in the definition to emphasize that this process could be violated in both countries of the transboundary movement « movement of an LMO from one country to another country of import that is not authorized by the relevant domestic regulatory authorities, including the import for direct use as food, feed, or for processing, or the release into the environment and is carried out without implementation of regulations secured in the domestic legislation of the countries of transboundary movement (e.g. labelling, packaging requirements, supplementary documents that must be submitted under the national law of the countries of transboundary movement)».
At the first glance the term «unintentional transboundary movement» proposed seems comprehensive. From the other hand it seems to me that it is more complex, because Low presence of LMO in agricultural commodities imported to the country is not always the attribute of the unintentional movement. It could happened for example if individual person carry seeds, shoots, etc. and even doesn`t know that commodity is LMO, or if there is no appropriate method for particular LMO detection. I hope the colleagues make contribution to clarify the definition.
With my best wishes, Galina.
(edited on 2015-02-23 08:04 UTC by Dr. Galina Mozgova)
posted on 2015-02-23 08:01 UTC by Dr. Galina Mozgova, Belarus
This is a reply to 6494 RE: Opening of discussion: Working definitions [#6502]
Dear participants,

I had a talk with some colleagues from Ministry of Agriculture of Brazil about this topic.  I work at the Ministry of Agriculture Official Lab in Brasil and I thank you for the opportunity to present our comments on this topic.

About the discussion of the concept of illegal and unintentional we think it is not our task due to three main reasons: 

- As presented by most of the participants in the previous forum the terms illegal and unintentional are the interpretation of a lab result and the lab is not responsible for this interpretation in a regulatory context;

- The Decision BS-V/9 states that the objective of lab network was “to facilitate the identification of LMO as well as the sharing of information and experiences”;

- The Decision BS-VII/10 clearly invites Parties and other Government (and not the lab Network) “to submit views on what constitutes unintentional transboundary movements in contrast with illegal transboundary movements” and requests the lab Network “to continue working on issues relevant to the detection and identification of LMO”;

So the logicall step would be to have a common concept between Parties of the terms illegal and unintentional and than to work on the guidance to assist Parties according to the objective 1.8 (if necessary and if indicated by the Parties as we already have diferente available guidances elaborated by international bodies - OECD, FAO, CODEX etc)

We do not see that “this is an opportunity for the scientific community to influence and make recommendations to the appropriate regulatory bodies on this issue”. We see that given your pratical expertise this is the opportunity to work in the topics already definied at the “Summary of the activities under the eletronic network (2012-2014)” document UNEP/CBD/BS/COP-MOP/7/INF/9 relevant to LMO detection and identification.

All the best,

Regina Melo Sartori Coelho
Offcial Laboratory
Ministry of Agriculture, Livestock and Food Supply of Brazil
regina.sartori@agricultura.gov.br
posted on 2015-02-24 11:04 UTC by Miss Regina M. Sartori Coelho, Ministry of Agriculture, Livestock and Supply (MAPA)
This is a reply to 6502 RE: Opening of discussion: Working definitions [#6507]
Thank you, Galina and Regina, for your contributions and sharing your views in the discussion. While we have some emerging consensus, we also have  some diverging views both with regard to the process as well as substance. 

We are in full agreement on the need to reach a common concept between Parties of the terms illegal and unintentional transboundary movements. In accordance with decision BS-VII/10, a notification (http://www.cbd.int/doc/notifications/2015/ntf-2015-002-bs-en.pdf) was issued inviting Parties and other Governments to submit views on this issue to facilitate the work of the Compliance Committee. Furthermore, we are also collecting views from different stakeholders, such as the Network, based on the best scientific understanding to provide the Compliance Committee with a comprehensive overview of the issue.

We very much appreciate your openness in sharing these views and invite more participants to contribute to the discussion.

Kind regards,
Dina
posted on 2015-02-24 21:56 UTC by Dina Abdelhakim, SCBD
This is a reply to 6491 RE: Opening of discussion: Working definitions [#6515]
Dear Dina and colleagues of the Forum,

Thank you the Secretariat for summarizing the first round discussion and thanks also for comments by colleagues in the network.

I agree whether being authorized or not by domestic legislation of the importing country is a key for the definition of “illegal”. It includes approval of an LMO itself as well as approval of its use such as use for foods, feeds and processing, or commercial cultivation, as previous comments pointed out.

I also agree that the understanding of the “unintentional” is a more complex term. The reason is probably because most of us do not have, need or use such term in detection laboratories as well as in regulatory systems.

In the opening remarks of this round by Dina, we can find “small amounts”, “small presence”, “low level presence” in the context of “unintentional”. It may be possible that unintentional transboundary movement can result in such a small presence; but it also may result in LMO being present in large amounts in some cases. Therefore, I don’t think the quantity matters with the term “unintentional”.

> Is the low presence of an unauthorized LMO necessary to constitute an “unintentional transboundary movement”?
No. I don’t think we need to consider the quantity in the definition of the term “unintentional” as I commented above. Moreover, an “unauthorized” LMO is illegal; so I don’t think this provides us distinction between “illegal” and “unintentional”.

I hope my comments contribute to help move things forward in some way.

Best regards,

Ayako YOSHIO
posted on 2015-02-26 07:53 UTC by Ms. Ayako Yoshio, Japan
This is a reply to 6515 RE: Opening of discussion: Working definitions [#6516]
I would like to thank Dina for the clear summary of our previous discussions and for bringing the existing definitions and information on “low level presence” and “adventitious presence” by other bodies.

I would also like to highlight that although detection laboratories might not be in a position to express legal opinions regarding the results of their testing processes, they might be requested to perform a detection analysis based on these terms. The participation of the Network is, therefore, highly relevant due to their direct and practical interpretation of such terms.

I am in agreement with the definition proposed by Angela, Galina and Ayako regarding the term “illegal TM”. I would also emphasize the words of Ayako on the non-authorization of a LMO event itself and/or its intended use. For example, in a trade relationship, in which an exporter is exporting non-authorized LMO in large amounts, it will be considered “illegal TM”. If it is exporting in LLP non-authorized LMO it might or might not be considered “illegal TM” depending on the threshold rules of each importing country. Not all Parties accept LLP definitions. There is then an intrinsic intention of the exporter and it should follow its obligation under Article 18.

It seems now that the term “unintentional TM” needs further discussion though. I would like to express some of my ideas on the term before I can actually suggest a definition.

Recalling Article 17 (Unintentional Transboundary Movements and Emergency Measures): “1. Each Party shall take appropriate measures to notify affected or potentially affected States, the Biosafety Clearing-House and, where appropriate, relevant international organizations, when it knows of an occurrence under its jurisdiction resulting in a release that leads, or may lead, to an unintentional transboundary movement of a living modified organism that is likely to have significant adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health in such States. The notification shall be provided as soon as the Party knows of the above situation. […]”

To my understanding, this article is less related to a trade action and more related to an environmental spread. There are several plausible scenarios of “unintentional TM” in that sense: scape from contained use, scape from field trials and scape from commercial plantings, etc. It is clear that the LMO in question is not authorized in the receiving/affected/potentially-affected State.

Therefore, in order to ensure compliance to Article 17, the definitions of the term “unintentional TM” should not be restricted to an amount (i.e. low level presence or adventitious presence). “Unintentional TM” definition should be broader and take into account the potential risks that this TM might pose.  In that sense, even LLP of certain LMOs might pose significant risks (e.g. pharmaceuticals LMOs). I understand that Galina agrees to that when she says that LLP is not always the attribute of the “unintentional TM”. Similarly, Ayako stated that “unintentional TM” may result in LMO being present in large amounts in some cases.

In addition, the term “unintentional transboundary movement” should not be confused to “unintentional mixing” or “unintentional presence” of LMOs, which would be more related to the definition proposed by Angela. Neither should it be confused to "unintended effects" or restricted to a risk assessment scenario. An "unintentional TM" event can happen years after the approval of an LMO (post-marketing) from country A to a country B that has not approved any LMOs.

Furthermore, I have not seen a clear link between the term “unintentional TM” and the terms “low level presence” and “adventitious presence” used in the documents of other bodies, neither in the CP. For instance, paragraph 3 of Article 17 specifies the minimum information that any notification to affected or potentially affected States should contain. This includes information not only related to the quantities but also to particular characteristics of the LMO concerned, and the circumstances surrounding the occurrence leading to the unintentional transboundary movement. In addition, information should be provided on the possible adverse effects and possible related risk management measures. Paragraph 3(d) provides a ‘catch all’, requiring the provision of “any other relevant information”.

Regarding the questions proposed by Dina:

- What parallels can be drawn between the terms used in the Protocol, i.e. “illegal transboundary movement” and “unintentional transboundary movement”, and terms used by other bodies and regulatory systems?
Illegal – non-authorized
Unintentional – accidental. Important to note that these terms should not be interpreted as exempt from the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress when there is damage or sufficient likelihood of damage. Response measures, which are to be determined by the competent authority, and taken by the operator or in the event the operator fails to do so, by the competent authority, could be the same or complementary to the action envisaged under Article 17.

- Is intent the only distinguishing factor between and illegal and an unintentional transboundary movement?
I am not sure. Although there seems to be no intrinsic “intention” to that of “unintentional TM”, there could cases of environmental spread where violation of CP are intentional and those should follow obligations/provisions under the Nagoya Protocol.

- Is the low presence of an unauthorized LMO necessary to constitute an “unintentional transboundary movement” or could, for example, an entire shipment be subject to unintentional transboundary movement?
LLP does not necessarily constitute an “unintentional TM”. “Unintentional TM” is much broader. LLP could be part of it, but it also includes other ways by which LMO spread happens.

- Can the terms “illegal” and “unauthorized” be used interchangeably in the context of transboundary movements or are they distinct?
They are distinct.

I am very sorry for my long post!

Regards,

Sarah
posted on 2015-02-26 18:42 UTC by Ms. Sarah Agapito-Tenfen, Brazil
This is a reply to 6491 RE: Opening of discussion: Working definitions [#6521]
Thank you Dina for the summary of the previous discussion and the relevant references that you posted at the beginning of this discussion, an also our participants for their contributions.

Taking into account that it was noted by many participants during the discussion of question 1 that detection laboratories are not in a position to express legal opinions regarding the results of their testing processes and that the terms “illegal” and “unintentional” are not often used in the laboratory context but rather in the regulatory context, the GIC appreciates the opportunity to comment on the terms “illegal” and “unintentional in the context of clarifying what constitutes an “unintentional transboundary movement” in contrast with an “illegal transboundary movement”. 

We note that Brazil has also supported the view that this Laboratory Network may not be the most applicable forum to pose the question, that in particular Decision BS-V/9 states that the objective of lab network was “to facilitate the identification of LMO as well as the sharing of information and experiences”, and that Decision BS-VII/10 clearly invites Parties and other Government (and not the lab Network) “to submit views on what constitutes unintentional transboundary movements in contrast with illegal transboundary movements”.

We support the effort of Regina Melo Sartori Coelho of Brazil to consult with colleagues on this matter, and have followed this model in also consulting with our experts on this topic.

We also wish to remind the participants that the language of Article 17 defines the scope of unintentional transboundary movements that are relevant to the Protocol: those that are “likely to have significant adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health” in the receiving country. Thus, the Protocol is not concerned with every unintentional transboundary movement of LMOs that might occur, and what constitutes risk will also vary by receiving country and environment.

We also note that Japan has pointed out that there is no definition for “unintentional” transboundary movement in the Protocol.

1. What parallels can be drawn between the terms used in the Protocol, i.e. “illegal transboundary movement” and “unintentional transboundary movement”, and terms used by other bodies and regulatory systems? 
We recognise that during the previous discussions, there was no consensus but most, if not all, Parties indicated that these terms are not used directly within their local regulatory systems, and thus no parallel can be drawn with regulatory systems.  We also recognize that there is no clear parallel with terms used by other bodies or in other international fora, especially in terms of those transboundary movements that are “likely to have significant adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health”. 

2. Is intent the only distinguishing factor between an illegal and an unintentional transboundary movement?
GIC believes that ”illegal” and “unintentional” are two different concepts in the context of the Protocol.

While intent is inherent in “unintentional”, whether a transboundary movement is illegal or not requires contravention of the domestic measures the receiving country has implemented pursuant to the Protocol. This is the language of Article 25, which refers to “illegal transboundary movements” as those “carried out in contravention of its domestic measures to implement this Protocol”
Both intentional and unintentional transboundary movements could be illegal, and what is illegal one country may not be in another country.


3. Is the low presence of an unauthorized LMO necessary to constitute an “unintentional transboundary movement” or could, for example, an entire shipment be subject to unintentional transboundary movement?

This question does not address the key limiting factor in this discussion, which is that Article 17.1 limits the discussion concerning unintentional transboundary movements to LMOs that are “likely to have significant adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health”. 
The issue here is not whether the presence is “low”, but whether the LMO in question has been identified the Parties to the Protocol as an LMO that is likely to have significant adverse effects on the conservation and sustainable use of biological diversity (paragraph 5(a) of Article 16).
Attempting to define the quantity of LMO that may constitute an unintentional transboundary movement is inconsistent with Article 17.  This language does not suggest that a certain quantity of the LMO is required in order to be relevant (i.e. it is not limited to “low” situations) and which would therefore constitute an unintentional transboundary movement.
The comment in the last paragraph of Dr. Galina Mozgova also supports the position that the concentration (or quantity) of unintentional transboundary movement is not relevant.


We trust that these comments can clarify the definition of the terms and contribute to the discussion.
Dr. Ray Shillito (on behalf of the GIC)
posted on 2015-02-27 15:56 UTC by Dr Raymond Shillito, Bayer CropScience
This is a reply to 6507 RE: Opening of discussion: Working definitions [#6522]
Thank you Ayako, Sarah and Ray for your insightful contributions to the discussion.

We would like to remind participants that the forum will remain open for 2 more days. You are all kindly invited to post your views on this issue before the forum closes.

I look forward to your interventions and once again thank you all for openness and constructive contributions.

Kindest regards,
Dina
posted on 2015-02-27 21:07 UTC by Dina Abdelhakim, SCBD

   
   
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