Synthetic biology debate ahead of biodiversity treaty’s top meeting
Austin, USA, 6 May (Edward Hammond*) – Synthetic biology, a controversial and fast-advancing technology, will be one of the key topics at the meeting of Parties to the Convention on Biological Diversity (CBD) that will meet in December in Cancun, Mexico.
There was considerable discussion when the CBD’s Subsidiary Body on Science, Technology and Technological Advice (SBSTTA) met the week of 25 April in Montreal, Canada.
Weighing the impacts of synthetic biology, delegates considered a draft recommendation for the CBD Conference of the Parties (COP) to decide upon in Cancun. The draft was prepared on the basis of the report of the CBD's Ad Hoc Technical Expert Group (AHTEG) on Synthetic Biology, which itself was previously convened pursuant to Decision XII/24, taken at the COP's last meeting in South Korea in October 2014.
The SBSTTA initially considered synthetic biology in a plenary session on Tuesday 26 April. The plenary was followed by a contact group that met Tuesday, Wednesday, and Thursday – at times late into the night. Its recommendation to COP adopted by SBSTTA on Saturday the 28th, foresees continuing the CBD's work on synthetic biology in the existing AHTEG, and drawing on work in the CBD's Cartagena Protocol on Biosafety, but leaves several important issues in brackets to be decided at the end of the year in Cancun.
Key issues that were contended include the operational definition of synthetic biology, access and benefit sharing for digital genetic sequence data, and how to proceed with work on socio-economic, social, and ethical issues surrounding synthetic biology.
A few countries also tried to call into question a key AHTEG outcome that the components (e.g. DNA strands) and products (e.g. bio-chemicals produced by synthetically modified bacteria) of synthetic biology fall within the scope of the Convention. (The AHTEG divided synthetic biology into “organisms, components and products” and concluded, and most countries agree, that for the time being the majority of synthetic biology organisms fall within the Cartagena Protocol’s definition of ‘living modified organisms’.)
Also raised were calls by non-governmental organizations (NGOs) for urgent action on gene drives, a powerful synthetic biology technique capable of changing the genetic makeup of an entire species. Many NGOs and some scientists believe a moratorium on use of gene drives would be wise, given the power of the technology and limited understanding of its implications.
Meanwhile, a small group of developed countries, led by Australia, question if synthetic biology has met the criteria of being a “new and emerging issue” under the CBD, and seek more reconsideration of this question. If synthetic biology is not deemed by all to be a “new and emerging issue”, they argue, then a CBD programme of work on the subject cannot be established.
Opponents of this view, including many developing countries and civil society observers at the SBSTTA meeting, point to the extensive and peer-reviewed analyses produced to date (including a paper in the CBD Secretariat's technical series). They consider Australia's demand to be an attempt to lock the synthetic biology AHTEG in a “death spiral” of repeatedly reconsidering the same question, one that most countries, apart from Australia and its supporters, consider to be settled.
(Privately, many delegates admit that this is a wider problem that the CBD needs to address. The identification of “new and emerging” issues involves weighing a new topic against a number of criteria related to biodiversity impact. These criteria are spelled out in resolution IX/29, but there's no guidance on how to apply them. For example, must they all be met? Few existing programmes of work under the Convention would pass such a test. If an issue needs to only meet some criteria, how many does it need to meet to be considered “new and emerging”, and at what point is the matter settled?)
During the Plenary session to discuss the issue, Ethiopia, speaking for Africa, emphasized the need to update existing biotechnology risk assessment and risk management approaches to account for synthetic biology. Citing potential displacement of African vanilla and shea butter producers, it expressed concern about synthetic biology impacts on sustainable use of biodiversity and socio-economic consequences.
Developing countries (excepting Brazil) and European countries, albeit more blandly, supported the broad operational definition of synthetic biology endorsed by the AHTEG, with some noting that revision of the definition may be necessary in the future to address technological and/or legal developments.
Practically all countries favoured a continuation of the AHTEG in principle, but reserved their final approval pending detailed discussion of the group's terms of reference.
Mexico emphasized the need for deeper discussion of the impacts of the products and components of synthetic biology and called upon the CBD to address the question of genetic sequence data in relation to access and benefit sharing.
Namibia, Bolivia, China, and other developing countries also mentioned the need for digital sequence data to be addressed in the Convention and/or its Nagoya Protocol on Access and Benefit- Sharing, reflecting concern that technological changes in gene sequencing and gene synthesis means that genetic resources can now be transferred electronically – as data – and that without physical transfer of materials (i.e. biodiversity samples), synthetic biology could undermine the material transfer agreements on which many access and benefit sharing approaches are predicated.
European countries and developed countries more generally, however, especially Japan and Belgium, were adamant that references to digital sequence information be deleted in their entirety.
Third World Network (TWN) responded to European opponents of work on digital genetic sequence data by noting that manipulating sequence information is intrinsic to synthetic biology and that it is scientifically nonsensical to reject reference to it. The AHTEG should, TWN stressed, analyse the combination of genome sequencing and gene editing technologies and their potential to enable biopiracy, to facilitate the CBD addressing the impacts of synthetic biology on access and benefit sharing.
The ETC Group recalled the CBD de facto moratorium on Terminator Technology (also called “GURTs” – genetic use restriction technologies) and said the threat from gene drives was even greater. It called for a moratorium on gene drives. The Federation of German Scientists raised concerns about gene editing technologies, particularly CRISPR (“lustered regularly interspaced short palindromic repeats”, a gene editing technology), and called for the Convention to address them.
The ensuing contact group focused on resolving the key outstanding issues identified in plenary, including the operational definition, digital sequence data, AHTEG terms of reference (TOR), socio-economic considerations, the Australian-led effort to lock the AHTEG in a repetitive cycle on “new and emerging” issues, and efforts by Switzerland, sometimes with support from Canada, to derail CBD work on the components and products of synthetic biology.
Despite the fact that the AHTEG's operational definition of synthetic biology is closely derived from a European proposal, many European countries were equivocal in their support for it in the contact group. (In the corridors, it was posited that Europe has become hesitant to clearly define synthetic biology because some see the issue as linked to secret discussions on a trans-Atlantic trade agreement.)
Allied with other developed countries, some European countries, including the United Kingdom and Belgium, sought to weaken the definition by suggesting its possible reconsideration by the AHTEG and text proposals that would reduce or preclude the definition's future practical use.
On the other side, most developing countries and some others in Europe, notably Norway and Austria, favoured ensuring that the operational definition can be used forthwith.
Over the course of discussion, the language on the operational definition in the draft recommendation for COP became weakened and convoluted, and the text was bracketed near the end of the contact group at the request of The Philippines, whose position was consistent with that of many other developing countries (though time for further detailed discussion was not available at that late juncture).
On digital sequence data, the European Commission Co-Chair opened discussions in the contact group by moving to delete the item from the AHTEG draft TOR, leaving only a recommendation to COP that it invites the Nagoya Protocol to consider the issue. Such an outcome would preclude the AHTEG from addressing what is essentially an integral synthetic biology issue, with no guarantee that the Nagoya Protocol Parties would take the issue up, leaving a huge unaddressed gap.
This move to delete proved premature, however, when the item came up for more detailed discussion, and developing countries voiced support for sequence data to remain under consideration by the AHTEG. A compromise “two-step process” emerged wherein the AHTEG would consider digital sequence information in the short run, and then later forward recommendations through the COP to the Nagoya Protocol for consideration at the latter’s 3rd or 4th meetings in 2018 and 2020 respetively).
Developing countries including China, Brazil, Mexico, Malaysia and Ethiopa, as well as Norway, were satisfied with the two-step process, while European and other developed countries were roundly opposed. Japan went a step further, saying it believed that sequence information was entirely beyond the scope of the CBD, and insisted it needed to consult Tokyo before even endorsing the European position, which was to eliminate consideration of sequence data from the AHTEG TOR and to quickly dispatch the issue to the Nagoya Protocol.
Toward the end of the contact group, Japan reported back that, on consultation with “headquarters” (i.e. capital), it could reluctantly agree to Europe's position to refer the issue to the Nagoya Protocol, a concession that drew thanks from the European Commission Co-Chair.
This momentarily aligned the North (except Norway) behind Europe's position. But then Canada intervened, saying that it too had consulted “headquarters” and was adamantly against any reference to digital sequence information in the draft recommendation whatsoever. If it was not deleted entirely, it must be bracketed, Canada rather stridently insisted.
That prompted Malaysia, which had also consulted capital, to say that it had instruction to ensure that the full two-step process appears in the text; in other words, that work on sequence data should also be part of the AHTEG TOR. Mexico immediately supported Malaysia as other countries prepared to join the discussion. But the contact group's time was at an end for the evening, and the Co-Chair adjourned with both parts of the two-step process bracketed in the text.
As with the definition, the bracketed text on digital sequence data remained untouched through the adoption of the draft recommendation by the final plenary.
The final contact group session on Friday morning (29 April) saw discussion on Australia's insistence with respect to “new and emerging” issues (see above), and an attempt by Switzerland to raise questions about the AHTEG's inclusion of components and products of synthetic biology within the scope of the Convention. Members of the AHTEG in attendance at the contact group did not agree with Switzerland's assertion that the AHTEG did not consider “the scope question as such” in relation to synthetic biology components and products.
The contact group also considered compromise language on consideration of socio-economic, cultural, and ethical considerations that was proposed by Austria. The compromise had support from Bolivia, Norway, Malaysia, Finland and others. But it wound up in brackets due to opposition from Brazil and Canada, with the United Kingdom, Belgium and Japan offering modifications to Austria's proposal that augured towards Canada's position, that considering socio-economic, cultural, and ethical considerations of synthetic biology would constitute “mandate creep” of the CBD, despite the objectives of the CBD and prior decisions specifically supporting such work.
The draft recommendation on synthetic biology that was finally adopted by SBSTTA (UNEP/CBD/SBSTTA/20/L.16), will be forwarded with brackets for consideration by the CBD COP at its 13th meeting in Cancun, Mexico to be held on 4 to 17 December.
While it is agreed that the CBD's work on synthetic biology will continue in the AHTEG and that, for many synthetic biology aspects regarding living modified organisms, also in the Cartagena Protocol and its AHTEGs, specifically the Cartagena AHTEG on risk assessment and risk management and the AHTEG on socioeconomic considerations, COP will have to take decisions on key issues. In particular, the TOR of the synthetic biology AHTEG will, in the view of many developing countries, need to be strengthened and agreed to ensure AHTEG work begins on digital sequence data.
Further, given the threats to sustainable use of biodiversity by small farmers that may be arising due to synthetic biology (e.g. vanilla farmers), the tenuous position of socio-economic, cultural, and ethical position in the CBD's synthetic biology work needs strengthening. Finally, gene-editing techniques, particularly in gene drive applications, merit a more rapid and specific response from the COP. On gene drives, a number of civil society organizations have proposed a moratorium, a discussion that can be renewed in Cancun.
(*Edward Hammond is Director of Prickly Research, a USA-based policy research organization. He participated at the SBSTTA meeting in April.)