THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Biosafety Protocol stalled on risk assessment
Kuala Lumpur, 22 December (Lim Li Lin) – Further work on biosafety risk assessment which is a key pillar under the Cartagena Protocol on Biosafety has received a setback at the United Nations Biodiversity Conference which ended on 17 December in Cancun, Mexico.
The 8th meeting of the Conference of the Parties serving as the Meeting of the Parties (COP-MOP) to the Cartagena Protocol on Biosafety came to a close after two weeks of often rancorous negotiations. The 13th meeting of the Conference of the Parties (COP) to the Convention on Biological Diversity (CBD) and the 2nd meeting of the COP-MOP to the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits from their Utilisation also met concurrently from 4 to 17 December. The two Protocols are under the CBD.
The issue of risk assessment proved to be the most divisive issue, pitting developing countries requesting for risk assessment guidance against many developed countries and some developing countries with biotechnology and trade interests.
At stake was a guidance document (Guidance on Risk Assessment on Living Modified Organisms and Monitoring in the Context of Risk Assessment), which was developed, revised and improved by the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management over the last 8 years.
Most developing countries have continually asked for capacity building and tools for conducting risk assessment in order to implement their obligations under the Cartagena Protocol. Risk assessment is a central pillar of the Protocol, as the key step in its procedure for decision making on importing genetically modified organisim (GMOs) or living modified organisms (LMOs) as they are known in the Protocol.
The AHTEG was set up in 2008 by COP-MOP 4 to address the need for further guidance on specific aspects of risk assessment and risk management. However, the Guidance has yet to be approved or endorsed by the COP-MOP because of continued disagreement over it at every meeting.
Countries with strong biotechnology and trade interests have effectively blocked endorsement of the Guidance, and have continually insisted on having it reviewed and tested. As such, over the last 8 years, the Guidance has been scientifically reviewed and tested extensively, including through online discussion forums, regional online conferences and face-to-face meetings.
After COP-MOP 6 in 2012, the Guidance was tested with regards to practicality, usefulness and consistency with the Cartagena Protocol, taking into account past and present experiences. Analysis of the testing showed overwhelming support for the Guidance, particularly from developing countries.
Also under discussion in Cancun was the fate of the AHTEG itself as well as future work by it on specific risk assessment guidance, in particular on synthetic biology and living modified fish.
One issue that dominated the discussion, and which soured the tone of the negotiations, was the fact that the Secretariat of the CBD had published the Guidance as part of its Biosafety Technical Series.
Leading the attack, Brazil and Colombia used this as a reason to argue against the Guidance as well as against the continuation of the AHTEG and any further work by it on risk assessment, as they accused the Secretariat and the AHTEG of violating their trust in the process. Joined by Honduras, Paraguay, Iran, the Philippines, New Zealand, Canada and others, the tone of the discussions was unusually discourteous and antagonistic for UN negotiations.
These countries also wanted the Guidance retracted from Biosafety Technical Series No.4, arguing that its publication had not been approved by the COP-MOP. This was despite the fact that the Technical Series documents are published by the Secretariat and none have ever been approved by the COP-MOP.
The Secretariat also clarified that the last COP-MOP had requested the Executive Secretary of the CBD to use the Guidance in capacity building, and there have been numerous requests by Parties and those who participated in the testing of the Guidance to present it in a user-friendly format.
According to one Party opposed to the Guidance, the Guidance takes an “excessively precautionary approach” which will “limit the approval of [genetically modified] products” and “would amount to market restrictions and technical barriers to trade”.
In addition, another Party opposed to the Guidance opined that the views of “those with experience” in the AHTEG were disregarded because they were non-Parties, while “those who had little experience” considered the Guidance to be good. The non-Parties who were represented in the AHTEG were the United States, Australia, Argentina and Canada, which are GMO producing and exporting countries.
Despite pleas by other developing and developed country Parties to separate the discussion about process (the publication by the Secretariat of the Guidance) from the content of the Guidance, this line of attack continued to the end. It was also pointed out that during the review process (where all countries could participate) every single comment was taken into account, and that most of the countries critical of the Guidance had nominated experts who were part of the AHTEG, including Brazil, Colombia, Honduras, New Zealand, India, Kenya, Japan and South Africa.
During the course of the negotiations, the countries that were critical of the Guidance sought to introduce language that would relegate the Guidance to merely one of many other guidance documents and national approaches on risk assessment. Other developing country Parties pointed out that the Guidance is unique as it is designed to assist Parties to implement their risk assessment obligations in accordance with the Cartagena Protocol. As such, the Guidance specifically addresses Annex III of the Protocol which is on risk assessment.
African countries in particular, led by Mauritania and Uganda, fought an uphill battle to have the Guidance endorsed, as well as to continue the AHTEG in order for it to develop further specific guidance. The European Union, Norway and Switzerland also supported these efforts.
In the end, the final COP-MOP decision on risk assesment and risk management merely “takes note” of the “voluntary Guidance”, despite the fact that a previous COP-MOP decision has already “welcomed” it.
(In UN parlance, “takes note” is non-committal as opposed to “welcomes” which signals acceptance.)
The fate of further work on risk assessement by a possible new AHTEG will be decided by the next COP-MOP in 2018. This means that the current AHTEG is terminated, and any further specfic risk assessment guidance will only be available, if at all, in another four years.
An extended multi-stage process will now take place. As a first step, Parties are invited to submit to the Executive Secretary of the CBD “(a) information on their needs and priorities for further guidance on specific topis of risk assessment of LMOs, (b) proposals on criteria, including the technical justification, that may facilitate the selection of topics for the development of further guidance, and (c) views on perceived gaps in existing guidance materials”.
This means that the further specific risk assessment guidance on living modified fish and LMOs produced through synthetic biology, even though requested by Parties and recommended by the AHTEG, will no longer be automatically considered for further work.
In addition, the 20th meeting of the Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA) in April 2016 had recommended that the general principles and methodology for risk assessment under the Cartagena Protocol may need to be updated and adapted for current and future developments and applications of synthetic biology, that scientific and technological developments and information in the field of synthetic biology need to be reviewed regularly to ensure that regulatory oversight and risk assessment methodologies remain up to date, and that coordination is needed among current and future processes under the Convention and its Protocols, including with the AHTEG on Risk Assessment and Risk Management.
Despite all this and the extensive decisions by the COP of the CBD and the COP-MOP of the Nagoya Protocol on synthetic biology, the development of specific risk assessment guidance on LMOs produced through synthetic biology remains in doubt, and will not be developed over the next two years as was initially anticipated.
In parallel, the Online Forum on Risk Assessment and Risk Management will continue “to exchange experiences on risk assessment, provide information and views on, and perceived gaps in existing guidance materials, and proposals to address any gaps identified”.
The COP-MOP Bureau will appoint a lead moderator for the online discussions and reporting on discussions, for the next intersessional period, ensuring regional rotation. A Party opposed to the Guidance had initially proposed naming the delegate from India to be the lead moderator, and insisted that there should only be one moderator.
The decision futher requests the Executive Secretary of the CBD to assist the lead moderator of the online discussions to prepare a report of the online discussions and submit it for peer review by the online forum before final presentation, to compile the views submitted by Parties, and to submit all this to the SBSTTA, which will meet prior to the next COP-MOP in 2018.
Following this, the SBSTTA will 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”.
The COP-MOP in Cancun also adopted other decisions including on socio-economic considerations, the Biosafety Clearing House, public awareness, education and participation, unintentional transbounday movements and emergency measures, transit and contained use of LMOs, and capacity building.
On the issue of socio-economic considerations, the mandate of the AHTEG on Socio-Economic Considerations is extended to work on the guidelines regarding socio-economic considerations of LMOs. A face-to-face meeting of the AHTEG, subject to the availability of funds, will do this work, and submt its report to the next COP-MOP in 2018. Importantly, the AHTEG will now be extended to include a representative from indigenous peoples and local communities.