TWN Info Service on Biodiversity/TK and Biosafety
13 November 2024
Third World Network
www.twn.my
Biosafety Protocol’s guidance on LMOs containing engineered gene drives welcomed despite evident flaws
London, 12 Nov (Eva Sirinathsinghji and Lim Li Ching) – Parties to the Cartagena Protocol on Biosafety have welcomed voluntary guidance materials for assessing the risks of living modified organisms containing engineered gene drives.
This is despite concerns raised by civil society that the guidance materials are not precautionary enough and, moreover, were beset by questions over potential conflicts of interest.
Parties to the Cartagena Protocol met in Cali, Colombia at their 11th Conference of the Parties serving as the meeting of the Parties (CP MOP11), from 21 October to 1 November. CP MOP11 was held concurrently with the 16th Conference of the Parties (COP16) to the Convention on Biological Diversity (CBD). The Cartagena Protocol is a legally binding agreement under the CBD – the latter is known as the “parent Convention”.
Engineered gene drives are highly experimental new genetic technologies that have generated significant controversy due to their self-spreading design intended for the engineering and/or eradication of wild populations. Their conceptual and biological novelties raise an array of biosafety, socio-economic, ethical, cultural and biosecurity concerns.
Moreover, their explicit design intention for spread and persistence into wild populations deviates significantly from the vast majority of living modified organisms (LMOs) released to date. Most LMOs are designed for annual commodity crops that are harvested each year, for which spread and persistence is an established risk to be avoided and mitigated against, rather than being an integral and explicit design intention.
As such, there are new risks and heightened uncertainties associated with EGD-LMOs, as well as challenges in the ability to perform robust and reliable risk assessments. Compounding this is the inability to recall or reverse a gene drive release should the technology go awry.
The self-spreading nature of gene drives also fundamentally challenges current consent procedures and makes transboundary movement a near inevitability. This potentially affects the application of the Cartagena Protocol’s advance informed agreement procedure.
Parties to the Cartagena Protocol had therefore agreed at their last meeting in 2022 to develop additional voluntary guidance materials on risk assessment of living modified organisms containing engineered gene drives (EGD-LMOs). They established an Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment to carry out this task.
This follows from previous decisions under the CBD, the parent Convention to the Cartagena Protocol, that a precautionary approach should be applied to EGD-LMOs.
A previous AHTEG, which recommended that the guidance materials be developed, had noted that the biological novelties and associated risks and uncertainties of EGD-LMOs raise fundamental challenges to current risk assessment protocols. These include uncertainties with the gene drive systems themselves, significant knowledge gaps with regard to receiving environments and target organisms, methodological limitations, and the lack of management plans or proven strategies to control spread.
Developers and their investors have, however, spent years behind the scenes, within regulatory, media, policy and research spaces, attempting to drum up support for EGD-LMOs. They have advocated for permissive regulations on EGD-LMOs, which go against consistent calls by environmental and human rights groups for a moratorium on their release, at least until appropriately precautionary oversight is in place.
These interests have found their way into the guidance materials which were being considered by Parties to the Cartagena Protocol at CP MOP11. The document contains two main sections: (A) general methodological guidance for risk assessment, and (B) guidance specific to risk aspects pertaining to EGD-LMO mosquitoes. It reflects the diverging perspectives within the AHTEG.
While the materials maintain an explicit requirement to follow a precautionary approach and include a comprehensive list of risks with regard to specific EGD-LMO mosquito applications, there is an inconsistency between the well-identified risks and uncertainties, and the method introduced to assess them.
The approach that is used in the guidance materials (‘pathways to harm’ under a ‘problem formulation approach’) narrows the risk assessment framing and scope, minimises data requirements for assessing risks and fails to address the central and most controversial risks and uncertainties of EGD-LMOs – their uncontrolled spread and persistence.
As such, civil society and independent scientists have questioned the alignment of the guidance materials with specific aspects of the Cartagena Protocol on Biosafety.
Instead, the approach appears to align with industry methods of streamlining risk assessments that it has long promoted for LMOs. Moreover, it represents a conceptual shift towards proving harm, rather than detecting risks, while encouraging a selective approach that minimises data requirements and neglects potential unintended effects.
The guidance materials may thus not be well equipped to deal with the risks and uncertainties associated with EGD-LMOs.
Adding further concern is the fact that civil society raised questions regarding a potential conflict of interest involving an AHTEG member, due to the active role of an expert who has affiliation with an entity which manages a research project that had relevance to the subject matter addressed by the AHTEG.
That expert advocated for the approach now used in the guidance materials, as well as played a lead role in the early drafting of the section relating specifically to EGD-LMOs mosquitoes, the target organism being investigated by the affiliated project.
This regrettably casts doubt over the reliability of the guidance materials, which will likely be used by Parties to assist them in future risk assessments of EGD-LMOs.
At CP MOP11, when Working Group II took up the agenda item, Parties discussed future work under the Protocol, including whether or not to develop further risk assessment guidance for living modified fish, and to consider further guidance development for living modified ‘self-limiting insects’, that had been recommended by the CBD’s multidisciplinary AHTEG on Synthetic Biology to Support the Process for Broad and Regular Horizon Scanning, Monitoring and Assessment.
Few Parties gave strong support to either proposal, except for Norway which has consistently advocated for guidance on living modified fish. Most Parties stated that neither topic was a priority for future work.
Instead, several Parties expressed that there is a need to reevaluate how prioritisation of work is requested or evaluated, and/or to use a next AHTEG to establish what the priorities are for Parties, with regard to any potential future work.
Moreover, the EU expressed explicit support for the use of ‘problem formulation’ methods to be adopted in any future risk assessment guidance materials.
A contact group was established to further the discussions. It was co-chaired by Marja Ruohonen-Lehto (Finland) and Martha Kandawa-Schulz (Namibia), and met only once. A non-paper was produced by the co-chairs, and was the basis of the negotiations.
Under discussion was whether to endorse, welcome or acknowledge the guidance materials on risk assessment of EGD-LMOs. The majority of Parties wanted to endorse the guidance materials, while numerous other Parties, presumably with concerns over the materials, wanted to merely acknowledge them.
Parties thus settled on a compromise to “welcome” the guidance materials. Calls for an independent review to allow for further work to improve and refine the guidance materials, as demanded by civil society, were however not taken on board.
Nonetheless, the conflicts of interest concerns in the risk assessment process, as raised by civil society, have led to the adoption in Cali of decisions to improve the procedure for avoiding or managing conflicts of interests within expert groups, for the CBD and its Protocols.
This includes an amendment to the interest disclosure form, adding a declaration to recuse oneself from relevant discussion or decision-making, in the event a conflict of interest is established.
Measures to enhance the application of the procedure were also adopted. The Secretariat should disclose to other members of the expert group and at the beginning of any meeting of an expert group, significant interests that have been declared by a particular member. It should also publish all declarations made and actions taken to manage any actual or potential conflicts of interest in the report of the meeting and any other outcome of an expert group.
Furthermore, COP decision 14/19, which called for Parties and other Governments to only consider introducing EGD-LMOs into the environment, including for experimental releases and research and development purposes, when certain precautionary conditions are met, still applies.
These conditions relate to (i) carrying out scientifically-sound risk assessments; (ii) having in place risk management measures; and (iii) obtaining the free, prior and informed consent (or equivalent at national level) of potentially affected indigenous people and local communities.
The decision on risk assessment also invites Parties to submit detailed information on their needs and priorities for further guidance materials on specific topics of risk assessment.
An AHTEG on risk assessment has been established to evaluate the needs and priorities, for the consideration of CP MOP12, as to what additional issues may need guidance materials on risk assessment.
The earlier request to develop further guidance materials for living modified fish was rejected, despite the topic being identified as a priority by several Parties. Also dropped was the recommendation of the multidisciplinary AHTEG on Synthetic Biology to Support the Process for Broad and Regular Horizon Scanning, Monitoring and Assessment to consider self-limiting insects as a potential topic for further risk assessment guidance.
Nonetheless, the risk assessment work, central to the implementation of the Cartagena Protocol, has been extended, despite efforts to stymie this. Furthermore, the potential for future work is maintained with the continuation of the process. +