Future Work on Risk Assessment Under the Biosafety Protocol Threatened

TWN Info Service on Biodiversity and TK, and Biosafety
13 December 2016
Third World Network


Future work on risk assessment under the Biosafety Protocol threatened

Cancún, 12 Dec (Lim Li Ching*) – As the meetings of the United Nations Biodiversity Conference in Cancún reached their halfway mark, the issue of the continued work on risk assessment under the Cartagena Protocol on Biosafety remained threatened.

The Cartagena Protocol on Biosafety, 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. Meetings of Parties to the CBD and the Cartagena Protocol are taking place in Cancun from 4 to 17 December.

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.

Operational objective 1.3 of the Strategic Plan for the Cartagena Protocol on Biosafety for the Period 2011-2020 envisages the development and implementation of scientific tools on common approaches to risk assessment and risk management for Parties. As such the outcomes include “guidance on risk assessment and risk management including guidance on new developments in modern biotechnology”.

At this, the 8th Conference of the Parties serving as the Meeting of the Parties (COP-MOP8) to the Protocol, views were sharply divergent on risk assessment.

COP-MOP4 first established the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management in 2008, to develop a ‘roadmap’ on the necessary steps to conduct a risk assessment in accordance with Annex III to the Protocol. It was also mandated to prioritize the need for further guidance on specific aspects of risk assessment.

In 2012, the AHTEG was re-established by COP-MOP6 with a balance of old and new members, and in 2014, it was extended with expanded membership by COP-MOP7. The AHTEG has therefore worked on risk assessment and risk management for the last 8 years.

This work has been supported by discussions in the Open Ended Online Forum on Risk Assessment and Risk Management, which involves a wide range of experts from Parties, non-Parties, academia, industry and civil society.

The resulting ‘Guidance on Risk Assessment of Living Modified Organisms and Monitoring in the context of Risk Assessment’ is the product of many years of work and the expertise of experts nominated by Parties to serve on the AHTEG. The Guidance comprises a Roadmap for Risk Assessment, as well as provides guidance on specific topics, as identified by Parties according to their needs and priorities. It has undergone numerous rounds of peer review, testing, revision and improvement.

At the COP-MOP8 Working Group I discussion on the agenda item on 8 December, there was however, strident opposition to the Guidance as well as to the continuation of the AHTEG to develop further guidance on specific topics of risk assessment.

Also at issue for some of the Parties was what they viewed as ‘premature’ the publication of the Guidance as Biosafety Technical Series 04, before any endorsement of the Guidance by the COP-MOP. (The Technical Series is published by the Secretariat of the Convention on Biological Diversity and comprise technical documents that are not usually endorsed by Parties).

The hostility to the Guidance, led by Colombia, Brazil, the Philippines, Honduras and Iran, threatens the widespread use of the Guidance, both in conducting risk assessment and in capacity building on risk assessment.

The discontinuation of the AHTEG would also stymie the process of developing further guidance on specific topics of risk assessment, which have already been identified and prioritized by Parties.

A Contact Group was set up to try and resolve the disagreements. Co-chaired by Helmut Gaugitsch of Austria and Wadzi Mandivenyiof South Africa, it met in the afternoon of 9 December and again for the whole day of 10 December.

At the first meeting of the Contact Group, those Parties that were against the Guidance repeated their opposition to it, some with barely disguised contempt. They only wanted to ‘acknowledge’ or ‘take note’ of the Guidance. On the other hand, Parties such as Mauritania, Uganda, Mexico, the European Union, Switzerland and Norway were in favour of endorsing the Guidance.

Expressing discomfort with the judgements being made on the Guidance, and by extension the experts who had worked on it, many of whom were nominated by the same Parties now vehemently opposing it, Mexico reminded the Contact Group about the uniqueness of the Guidance in building on Annex III of the Protocol (on risk assessment) and focusing on the impacts of LMOs to the conservation and sustainable use of biological diversity.

Nonetheless, some Parties, and Brazil in particular, were adamant that the Guidance should not set the standard, and should only be considered as one of many other guidance documents and national approaches to risk assessment.

The Guidance is not prescriptive and does not impose any obligations on Parties. This understanding is recorded in Decision BS-V1/12 and recalled in Decision BS-VII/12. However, the Parties that were opposed to the Guidance insisted that any reference to the Guidance be preceded by the term ‘voluntary’ and that it was a ‘voluntary’ tool.

At the second meeting of the Contact Group, a non-paper from the Co-Chairs was issued, which attempted to bridge the divide among Parties. Following a proposal from Mauritania, the Contact Group began separating the issue of the Guidance from that of other guidance documents and national approaches to risk assessment. They left aside, for the time being, the issue of whether to endorse the Guidance or not.

A compromise was struck, to invite interested Parties, other Governments and relevant organizations to take the Guidance into account as a voluntary tool to assist in conducting risk assessment in accordance with the Cartagena Protocol, at the same time recognizing or acknowledging that other guidance documents and national approaches could also assist in conducting risk assessment in accordance with the Protocol.

There was relatively quick agreement on text inviting interested Parties, other Governments and relevant organisations that have used the Guidance and/or other guidance documents and national approaches to share an assessment of their applicability and usefulness through the Biosafety Clearing-house.

Discussion on whether to ask the Global Environment Facility to provide funding for a global capacity-building project on risk assessment and risk management centred on whether or not there should be an explicit link with the Guidance. No agreement could be found on this and the entire paragraph remains in square brackets.

Preliminary agreement was however reached on a paragraph requesting the CBD’s Executive Secretary to convene, subject to the availability of resources, and upon the invitation by Parties, regional and subregional capacity-building activities on risk assessment of LMOs.

The final major issue of contention was whether or not to extend the AHTEG to work on the development of specific guidance, based on two outlines already developed by the AHTEG: on risk assessment of living modified fish, and on LMOs developed through synthetic biology, as well as to take into account additional topics, including those identified by Parties in their submissions and by the AHTEG. These issues were included in the elements for a draft decision on risk assessment and risk management, for the consideration of Parties.

The issue of synthetic biology is being considered at the current Conference of the Parties to the CBD, and a coordinated approach between the Convention and the Cartagena Protocol has been recommended. (See separate article on “Genetic Sequence Data And Benefit Sharing Under Consideration”.)

This is especially relevant for the issue of risk assessment. The CBD’s Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA), at its 20th meeting in April 2016, noted that the general principles and methodologies for risk assessment under the Protocol and existing biosafety frameworks provide a good basis for risk assessment regarding living organisms that are in current and advanced stages of development of synthetic biology, but that such methodologies may need to be updated and adapted for current and future developments and applications. This makes the development of guidance on this topic critical.

The Co-Chairs’ non-paper of 10 December however, in reflecting the differing views on the continuation of the AHTEG and development of guidance, only foresees online discussions of the Open-ended Online Expert Forum, to identify possible gaps in existing guidance on risk assessment of LMOs, and, where gaps are identified, for the Executive Secretary to assess the need for guidance to address such gaps. Following this, an analysis of the outcomes of the online discussions would be forwarded for consideration by COP-MOP9 in 2018, with the view to assessing the need for further guidance.

Mauritania, supported by Uganda, the EU, Norway and Switzerland, argued for the AHTEG to be continued, to work on further guidance on risk assessment, including on living modified fish and LMOs developed through synthetic biology. They preferred the original text in the draft decision and requested that this be reinstated.

This was strongly opposed by Brazil. Other Parties such as South Africa, the Philippines and Japan wondered if it would be more productive to compile views on available guidance and gaps and to present these for consideration by COP-MOP9.

Due to the inability to resolve the conflict, the texts from both the original draft decision and the Co-Chairs’ non-paper remain bracketed. The Contact Group is expected to resume early this week, when it will continue its outstanding discussions.

(* With inputs from Lim Li Lin.)


articles post