Reboot on GMO Risk Assessment Work Under Biosafety Protocol



Reboot on GMO risk assessment work under Biosafety Protocol

Montreal, 11 Jul (Lim Li Ching) — Parties to the Cartagena Protocol on Biosafety, at a subsidiary meeting in Montreal, have breathed some life back into the risk assessment work that is critical to the implementation of the Protocol.

The Cartagena Protocol, which is a Protocol to the Convention on Biological Diversity (CBD), is the only international treaty that specifically regulates genetic engineering and genetically modified organisms (GMOs) or living modified organisms (LMOs), as they are known in the Protocol.

The twenty-second meeting of the Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA-22), took place from 2-7 July 2018, in Montreal, Canada.

Risk assessment is the central pillar of the Protocol, necessary to assess the effects of LMOs on the conservation and sustainable use of biological diversity, taking also into account risks to human health.

It is the key step in the Protocol’s procedure for decision-making on importing LMOs.

At the Eighth meeting of the Conference of the Parties serving as the Meeting of the Parties (COP-MOP) to the Cartagena Protocol on Biosafety, held in December 2016 in Cancun, Mexico, the issue of risk assessment proved to be the most divisive one, pitting developing countries requesting for further risk assessment guidance against many developed countries and some developing countries with biotechnology and trade interests.

Led by a cabal of the latter interests, COP-MOP 8 failed to endorse the Guidance on Risk Assessment on Living Modified Organisms and Monitoring in the Context of Risk Assessment, that had been developed, revised and improved by the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management since it was first set up in 2008 by COP-MOP 4.

It also terminated the AHTEG, and proposed further work on specific risk assessment guidance on living modified fish and LMOs produced through synthetic biology was not recommended, as was initially anticipated.

This, despite the fact that the AHTEG had already developed outlines on those topics, which Parties had previously identified as priorities.

The fate of further work on risk assessment by a possible new AHTEG will be decided by COP-MOP 9, which will be held in November 2018 in Sharm El-Sheikh, Egypt.

An extended multi-stage process involving submissions by Parties, discussions in the Online Forum on Risk Assessment and Risk Management and subsequent peer review of the report of the online discussions has been carried out thus far.

SBSTTA-22 was tasked to review the information provided and "recommend a way forward to address the needs, priorities and gaps identified by Parties" for consideration of COP-MOP 9, "including the possible establishment of a new AHTEG, with the understanding that new guidance proposals should only be presented upon approval by the COP-MOP".

Parties therefore came to SBSTTA-22 with some trepidation, given the strong opposition at COP-MOP 8 to the furthering of risk assessment work and an AHTEG to do so.

At stake was literally the heartbeat of the Protocol itself.

The draft recommendations before SBSTTA comprised the following essential elements:

(a) A comprehensive study regarding the potential adverse effects to the conservation and sustainable use of biodiversity, taking into account human health, and including considerations that are relevant to the risk assessment of (i) organisms produced through genome editing and organisms containing engineered gene drives, and (ii) living modified fish, in order to inform further consideration of whether there is a need for the development of additional guidance materials on risk assessment for these organisms;

(b) A process for the identification and prioritization of specific issues of risk assessment of LMOs that may warrant future consideration by the COP-MOP, taking into account elements listed in an annex; and

(c) The establishment of an AHTEG to work on the issues above, with the extension of the online forum on risk assessment and risk management to assist the AHTEG.

Views remained polarized, with some Parties such as the Philippines, supported by a non-Party to the Protocol (Canada), opposed to further discussion on risk assessment guidance or a new AHTEG.

Others such as New Zealand wanted a process for the identification and prioritization of specific issues of risk assessment, but saw no need for an AHTEG or a comprehensive study at this stage.

Still others, such as India, felt that neither a process, nor a study, were helpful.

On the other hand, many other developing countries and countries in the Central and Eastern European region were supportive of the whole package, with Parties such as Rwanda and Bolivia making forceful arguments for the process to be speeded up and for the SBSTTA to recommend work on additional guidance for the three topics directly, given the previous work that had been done on the issue.

The European countries (who at SBSTTA negotiate as individual countries and not as a bloc) forged a third way; led by Finland, they sought to link the process and the comprehensive study so that both could move forward in tandem, in order to ensure that the end goal of further guidance for the specific topics is eventually met.

They feared that if only a process for the identification and prioritization of specific issues of risk assessment was established, without a comprehensive study, this could further cause delay as there would be no specific topic to focus on and hence no substantive work.

The European countries, however, did not want to include organisms produced through genome editing in the study, and preferred to focus only on organisms containing engineered gene drives and living modified fish.

A Contact Group was established to work through these divergent views, chaired by Timothy Strabala of New Zealand.

Extensive discussions over three sessions and the production of a non-paper culminated in the Contact Group stretching to the early hours of Friday morning (6 July) in order to be able to send an agreed outcome back to the Plenary.

The draft decision finally adopted by SBSTTA-22 to be sent to COP-MOP 9 requests the Executive Secretary to commission a study that would inform the process of identification and prioritization of specific issues of risk assessment, by focusing on LMOs containing engineered gene drives and living modified fish.

Text referring to LMOs produced through genome editing remains in square brackets, indicating that there is no agreement on this topic, which will have to be decided by Parties at COP-MOP 9.

At the same time, it is recommended that a process be established for the identification and prioritization of specific issues of risk assessment of LMOs for consideration by COP-MOP, for the development of further guidance on risk assessment.

The text further recommends the establishment of an AHTEG to review the study and analyse the two, or possible three, topics according to issues that were elaborated in an Annex.

These issues are to be considered when trying to identify and prioritise specific issues of risk assessment of LMOs that may warrant consideration by the COP-MOP.

The AHTEG is also asked to consider the needs and priorities identified previously by Parties for further guidance, and gaps in existing guidance with regard to other specific topics of risk assessment, and prepare an analysis on that.

The AHTEG is then expected to make recommendations on the need for guidance to be developed on risk assessment on the two, or possibly three, topics and any adjustments to the issues to take into account when trying to identify and prioritise specific issues of risk assessment of LMOs, and prepare its report for consideration by SBSTTA, which would in turn make its recommendation to COP-MOP 10.

The topic of LMOs containing engineered gene drives has received a great deal of attention under a parallel process of the Convention on synthetic biology.

Both the risk assessment and synthetic biology processes recognize that specific guidance on risk assessment may be useful before such organisms are considered for release into the environment, given their potential adverse effects.

However, the road ahead is still long, with an extended timeline that will only see consideration of further guidance on risk assessment for the two or three topics in two years’ time at COP-MOP 10, with the possibility of actual guidance actually being presented only at COP-MOP 11 in 2022.

Since COP-MOP 8 in Cancun, this is thus an effective six-year delay in the development of guidance on risk assessment, which is unconscionable, given the urgent needs and priorities that developing country Parties have previously identified.

Yet, there was a sense of relief among Parties that the risk assessment work of the Protocol was at least back on track, albeit on a slow train. +

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