TWN Briefings for UN Biodiversity Conference #2
13th Conference of the Parties to the Convention on Biological Diversity / 8th Conference of the Parties serving as the Meeting of the Parties to the Cartagena Protocol on Biosafety / 2nd Conference of the Parties serving as the Meeting of the Parties to the Nagoya Protocol on Access and Benefit-Sharing
4-17 December 2016, Cancún, Mexico
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Stopping the Spread: Unintentional Transboundary Movements and Emergency Measures (Article 17) and the Detection and Identification of LMOs
By Lim Li Ching, Third World Network
Article 17 of the Cartagena Protocol on Biosafety requires Parties to take appropriate measures to notify affected and potentially affected States, the Biosafety Clearing-house (BCH) and relevant international organizations when it knows of an occurrence under its jurisdiction that leads, or may lead, to an unintentional transboundary movement of a living modified organism (LMO). Notifications must be provided as soon as the Party knows of such situations, and relevant information must be communicated to the affected or potentially affected States. Consultations with affected or potentially affected States are also necessary to enable them to determine appropriate responses and initiate necessary action, including emergency measures.
The occurrence of unintentional transboundary movements circumvent the central principles of the Cartagena Protocol that preserve the right of Parties to have their prior informed consent sought, and to be able to make decisions on LMO approvals based on risk assessment and in accordance with the precautionary approach. It could also mean that untested and possibly higher-risk LM crops, e.g. those intended for production of industrial biochemicals or pharmaceuticals would enter the food and feed system, which is risky from a safety point of view. When such contamination occurs in the form of seeds or grain, which are still able to reproduce and/or transmit genetic information to other organisms, this risk could potentially spread and further contaminate food, feed, seed and wild species.
Incidents of unintentional transboundary movements of LMOs worldwide have occurred with alarming frequency. According to the GM Contamination Register (www.gmcontaminationregister.org), a total of 448 known contamination incidences and illegal releases have occurred to date since 2005, when the database was first set up. The Register is compiled from public reports and managed by Greenpeace and GeneWatch UK.
UNEP/CBD/BS/COP-MOP/8/9/Rev.1 discusses the issue of unintentional transboundary movement and emergency measures, as well as the related issues of detection and identification of LMOs. It contains a draft decision, elements of which are discussed below.
Operational definitions: Unintentional vs. illegal
In order to provide clarity as to what constitutes unintentional transboundary movements in contrast with illegal transboundary movements, Parties submitted views on the issue, a synthesis of which was provided to the Compliance Committee for consideration.
The Compliance Committee noted that an operational definition could provide Parties with useful guidance and has recommended that Parties adopt its proposed operational definitions of the terms “unintentional transboundary movement” and “illegal transboundary movement”, with a corresponding explanatory note:
“Illegal transboundary movement” is a transboundary movement carried out in contravention of the domestic measures to implement the Protocol that have been adopted by the affected Party;
“Unintentional transboundary movement” is a transboundary movement of a living modified organism that has inadvertently crossed the national borders of a Party whereby the living modified organism was released either deliberately or accidentally.
Explanatory note:
An illegal transboundary movement may include transboundary movements of living modified organisms that have not been approved for a particular use in the jurisdiction of the affected Party;
A transboundary movement can still be considered illegal if it results in a contravention of the affected Party’s domestic measures to implement the Protocol, even if the transboundary movement is unintentional.
The operational definition of “illegal transboundary movement” is derived directly from Article 25 of the Cartagena Protocol. Contravention of domestic measures to implement the Protocol could include, for example, failure to obtain approval for a transboundary movement, failure to supply all necessary information, failure to conduct a risk assessment or failure to provide an emergency response plan.
The operational definition of “unintentional transboundary movement”, by focusing on either deliberate or accidental release that inadvertently crosses borders, is broad enough to cover different possible scenarios: e.g. deliberate release of an LMO approved domestically for field trials which inadvertently enters the food chain or is exported; or accidental release of an unapproved LMO which inadvertently enters the food chain or is exported.
The explanatory note stating that an illegal transboundary movement may include transboundary movements of LMOs that have not been approved for a particular use in the jurisdiction of the affected Party, confirms that unapproved LMOs could be illegal.
The explanatory note stating that a transboundary movement can still be considered illegal if it results in a contravention of the affected Party’s domestic measures to implement the Protocol, even if the transboundary movement is unintentional, confirms that unintentional transboundary movements can also be illegal.
Given the above, Parties should adopt the operational definitions provided by the Compliance Committee. These definitions and their explanatory notes provide useful guidance to Parties in their implementation of the Cartagena Protocol and national biosafety laws.
The need for timely notification
Article 17 contains notification obligations for Parties. Notifications must be provided as soon as the Party knows of situations of unintentional transboundary movements, and relevant information must be communicated to the affected or potentially affected States.
Unfortunately, it appears that such notification does not often happen, much less in a timely manner. In contrast to the high number of incidences compiled in the GM Contamination Register, very few Parties have reported unintentional introduction of LMOs in their jurisdictions. Efforts are therefore needed to encourage, facilitate and enable Parties to take appropriate measures to notify affected or potentially affected States of an unintentional transboundary movement.
This issue is currently missing from the draft decision and should be included in order toensure that Parties take steps to facilitate and enable timely notification to affected or potentially affected States, when unintentional transboundary movements occur.
Parties should also consider setting up a regional or sub-regional rapid alert system that immediately notifies all affected and potentially affected States, if none exists.A rapid alert system would greatly assist Parties in the event that there has been unintentional transboundary movement of LMOs. In most cases, the Party into which an LMO has inadvertently crossed borders has no means to know about the transboundary movement. The EU already has such a system between its member States for food and feed, including for LMOs, whichenables information to be shared efficiently between them. It also provides a round-the-clock service to ensure that urgent notifications are sent, received and responded to collectively and efficiently. Such a system serves to ensure that food safety risks are averted before they affect consumers.
Emergency and response measures
Under paragraph 4 of Article 17, Parties from whom an unintentional transboundary movement originates are to consult the affected or potentially affected States to enable them to determine appropriate responses and initiate necessary action, including emergency measures. Paragraph 2 of Article 25 also provides some detail of action that can be taken in the case of illegal transboundary movements.
However, there is, thus far, a lack of detail and practical guidelines on emergency measures taken by Parties. The draft decision therefore urges Parties to submit to the BCH information and available guidance on the mechanisms of emergency measures in case of unintentional transboundary movements. It also requests the Executive Secretary to, based on the information submitted, commission a study to analyse possible gaps in existing standards, methods and guidance including assessing the possible need for the elaboration of standards on mechanisms for emergency measures and to make the study available for consideration by COP-MOP9. These elements in the draft decision should be supported.
It would be beneficial for Parties to learn from other national and regional mechanisms and examples of emergency measures. For example, the EU has in specific cases, adopted emergency measures when there has been unintentional (and illegal) transboundary movements of LMOs, including requiring the exporter to provide an original analytical report issued by an accredited laboratory which demonstrates that a product does not contain the LMO that has unintentionally crossed borders. In the absence of such a report, the importing company must either have the product tested or must not place it on the market.
In addition, the issue of response measures should be included. This is because in cases of unintentional transboundary movements, the issue of liability and redress may also arise if there is damage or sufficient likelihood of damage. In such cases, response measures must be taken in line with the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress. 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.
Detection and identification: Technical Tools and Guidance
The detection and identification of LMOs are key steps towards taking appropriate measures to respond to unintentional transboundary movements of LMOs. Progress has been made through the work of the Network of Laboratories for the Detection and Identification of Living Modified Organisms, as well as through capacity-building activities conducted by the Secretariat, which has also produced a draft training manual on the issue.
The draft decision shouldendorse the Technical Tools and Guidance for the Detection and Identification of LMOs and urge its widespread use. The Technical Tools and Guidance were developed by the Network of Laboratories, which has specific expertise on detection and identification. It should be endorsed and used as widely as possible as it is useful and helps meet Operational Objective 1.8 of the Strategic Plan, which is to develop tools and guidance that facilitate the implementation of the Protocol’s provisions on, inter alia, unintentional transboundary movements and emergency measures.
Under the guidance of the Network of Laboratories, a mechanism for the continued updating and elaboration of the Technical Tools and Guidance should be established. Toencourage further use of the Technical Tools and Guidance, it should betranslated into all the UN languages and made available for capacity-building workshops on sampling, detection and identification of LMOs.
The Executive Secretary, in addition to continuing to organise online discussions through the Network of Laboratories focusing on the detection and identification of LMOs, should also, where necessary, organise face-to-face meetings of the Network of Laboratories, subject to the availability of funds.
Sequence information and reference materials
Sequence information and reference materials are necessary in order for countries to be able to detect, test for and know about which LMOs are entering into the country. Without these, regulation of unintentional and illegal transboundary movements cannot be effectively enforced. Regrettably, competent authorities are often not provided such sequence information and reference materials, and this is particularly so for LMOs in field trials.
These elements should therefore be included in the draft decision: ensuring that laboratories not only receive high-quality test samples, but also sequence information and reference materials; as well as requestingParties, other Governments and relevant organizations to submit to the Biosafety Clearing-house not only the information on methods for the detection and identification of LMOs, but also including where to access the necessary sequence information and reference materials.
Gene drives can cause unintentional transboundary movement
‘Gene drives’ are an experimental genetic engineering approach to promote the inheritance of a particular gene in order to increase its prevalence in a population. They areintended to aggressively spread, over many generations, a specific genetically engineered trait among a species or population in nature and would become dominant in wild populations over a few generations. Because they can alter the traits of entire species, including eradicating them, they represent a potentially high risk to biodiversity.
Many civil society organizations are calling for Parties to the Convention on Biological Diversity to establish a moratorium on the research, development and release of such engineered gene drive systems, in line with the Precautionary Principle.
Unlike LMOs produced with ‘classical’ genetic engineering, where containment is a key issue, gene drives are deliberately designed to spreadacross entire species and ecosystems, and can do so without respect to borders. As such, the likelihood of unintentional transboundary movements occurring is very high.
Gene drives are so far experimental, and have been tested in mice, fruit flies, mosquitos, yeast and nematodes. However, as the techniques are evolving rapidly, with proponentsproposing field trial releases of gene drive organisms as early as 2020, it would be prudent to anticipate the implications of such genetically engineered gene drives as they relate to Parties’ rights and obligations under the Cartagena Protocol on Biosafety.
Thus, a request should be made to the Executive Secretary in the draft decision, to conduct a study on genetically engineered gene drives and its implications for Article 17 given the high likelihood for unintentional transboundary movement.