Throwing precaution to the wind: the government's attempts to thwart the regulation of synthetic biology

Louise Sales

From Chain Reaction #122, Nov 2014, www.foe.org.au/chain-reaction

What is synbio? Synthetic biology (synbio) is an extreme version of genetic engineering. Instead of swapping genes from one species to another (as in genetic engineering), synthetic biology creates entirely new forms of life − or reprograms organisms to do things that would not naturally occur. Synbio uses a variety of techniques, including constructing synthetic (human made) DNA.

Since it was first proposed that synthetic biology be looked at as a new and emerging issue under the Convention for Biological Diversity (CBD), the Australian Government − under both the ALP and the Coalition − has consistently attempted to destroy any prospect of international regulations governing this new and potentially dangerous technology. Doubtless the government's behaviour at the Convention meeting (COP12) in South Korea from 6−17 October will be no exception.

The CBD entered into force on 29 December 1993. Its key objectives are the conservation of biological diversity, the sustainable use of the components of biological diversity and the fair and equitable sharing of the benefits arising out of the utilisation of genetic resources.1

It was first proposed that synthetic biology be considered as new an emerging issue by the CBD's Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA) in 2010.2

A SBSTTA delegate from the Philippines urged the 195 countries that are members of the CBD to develop an international agreement with a strong precautionary approach regarding "living organisms produced by synthetic biology" arguing that "there should be no field release of synthetic life, cell or genome into the environment until thorough scientific assessments have been conducted in an open, transparent and participatory process involving all parties (members), indigenous and local communities."3

The Philippines' calls were backed by a number of African countries, including Cameroon, Kenya, Liberia and South Africa. In Latin America, Bolivia and the Dominican Republic also supported a precautionary approach.4

Australia however flatly rejected the proposal for a moratorium and even opposed synthetic biology being looked at as a new and emerging issue by SBSTTA.5

Australia was by no means alone in its opposition to synbio even being discussed by the SBSTTA. Canada, New Zealand the UK and the European Commission have all adopted similar tactics – opposing a precautionary approach, attempting to water down the text of any agreements, and calling for more information to stall for time. The US has also played an active role in attempting to hijack proceedings – despite not even being a Party to the Convention.6

Despite the wrecking tactics of these countries, at the CBD's eleventh meeting of the Conference of the Parties (COP11) in Hyderabad, India in October 2012 there was an agreement that: "urges parties to take a precautionary approach ... when addressing threats of significant reduction or loss of biodiversity posed by organisms, components and products resulting from synthetic biology, in accordance with domestic legislation and other relevant international obligations."7

There was also an agreement that information be gathered to inform the decision as to whether synbio should be looked at by the SBSTTA as a new and emerging issue. Two peer-reviewed reports by the SBSTTA Secretariat were produced − looking at the potential impacts of synbio and their relevance to the Convention. At the last CBD SBSTTA meeting in June, the Parties that were pro-synbio (Australia, Canada, the European Commission and the UK) expressed their displeasure with the peer-reviewed reports and called for another round of peer review8 – presumably to give the synbio industry an opportunity to rubbish the reports.

There are also ongoing attempts to remove the reference to a 'precautionary approach' from the decision text.9

It is disturbing that the Australian government appears not to have learnt from any of the lessons of the past in racing to embrace new technologies. PCBs, thalidomide and asbestos all seemed like great ideas at the time – until they caused untold damage and had to be recalled. Only in the case of synthetic organisms the stakes are significantly higher. Synthetic biologists are creating new organisms that have never existed before in nature and there is currently no way of predicting what their impacts on human health, biodiversity and the environment will be.

From listening to some of the hype associated with the emerging field of synbio, you'd be forgiven for thinking that synbio is straight-forward and predictable. Surely all you need to do is to isolate the gene you need to create the molecule you want, model it on a computer, print it, insert it into your organism of a choice – be it an algae, bacteria or plant − and you can churn out as much of your chosen molecule as you want – with no unintended consequences. However, these kinds of descriptions of synthetic biology fail to adequately convey the massive knowledge gaps that exist when it comes to how life works and the unpredictability of living organisms, particularly within complex systems.

Earlier this year the Wilson Center and MIT published a report that outlines the research that is needed if we are to understand the potential ecological effects associated with the release of organisms modified or created using synthetic biology.10 The report, which was funded by the US National Science Foundation, is the US government's first attempt to draw up a research agenda that outlines the major unanswered ecological questions about synbio. However, it is just a list of serious questions about ecological risks − actually funding and conducting the research, and arguing about and applying the results, is all in the future.

It is disturbing that the same US government agency which has been promoting the rapid development of synbio for years has only just funded an attempt to come up with a comparable research agenda to explore the ecological impacts of synbio. The rational conclusion, given the gravity of the concerns and the major data gaps that exist, is that it's premature to be pursuing commercialisation.

Industry traditionally claims that pre-market safety testing constitutes unnecessary regulation and will kill innovation. Unfortunately these views now appear to have been institutionalised by the Australian government and have led to them viewing critical regulation to protect human health and the environment as 'red tape' and 'barriers to innovation'.

However, a recent report by the European Environment Agency investigated the extent to which regulators respond to early warnings with over-regulation. It rarely happens and when there is early regulatory intervention "contrary to conventional perception, preventive measures do not strangle innovation." We are far more likely to see lack of response to early and late warnings, often with severe and costly consequences.11

Friends of the Earth supports the precautionary approach adopted by COP11 and recommends that Parties at COP12 establish a moratorium on the environmental and commercial release of Synthetically Modified Organisms.

Louise Sales is the coordinator of Friends of the Earth's Emerging Tech Project.

www.emergingtech.foe.org.au, louise.sales@foe.org.au

References:

1. CBD (1993) Article 1. Objectives, available at: www.cbd.int/convention/articles/default.shtml?a=cbd-01

2. CBD (2010) SBSTTA 14 Recommendation XIV/16. New and emerging issues www.cbd.int/recommendation/sbstta/default.shtml?id=12263

3. Leahy, S. (2010) UN urges caution on synthetic life forms, Brunei Times www.bt.com.bn/science-technology/2010/05/26/un-urges-caution-synthetic-l...

4. Sharma, Y. (2012) Developing countries face up to synthetic biology challenges www.scidev.net/global/pollution/feature/developing-countries-face-up-to-...

5. pers. comm, anonymous SBSTTA participant

6. Ibid.

7. COP 11 Decision XI/11. New and emerging issues relating to the conservation and sustainable use of biodiversity www.cbd.int/decision/cop/default.shtml?id=1317

8. pers. comm, anonymous SBSTTA participant

9. Ibid.

10. Wilson Center & MIT (20140 Creating a research agenda for the ecological implications of synthetic biology, http://web.mit.edu/cis/Publications/SYNBIO_res_agenda.pdf

11. Hanson, SF. (2014) Late Lessons from Early Warnings: Is it impossible to learn from history http://emergingtech.foe.org.au/late-lessons-from-early-warnings-is-it-im...

STOP PRESS: 194 Countries call for the regulation of synthetic biology

In a unanimous decision of 194 countries, the United Nation's Convention on Biological Diversity (CBD) has formally urged nation states to regulate synthetic biology. The landmark decision follows 10 days of hard-fought negotiations between developing countries and a small group of wealthy biotech-friendly economies. Until now, synthetic organisms have been developed and commercialised without international regulations and increasing numbers of synbio products are making their way to market. The CBD's decision is regarded as a "starting signal" for governments to begin establishing formal oversight for this exploding and controversial field.

Many of the diplomats negotiating at the UN Convention had instructions to establish a moratorium on the release of synthetically modified organisms. However, they faced stiff opposition from a small group of wealthy countries with strong biotech industries, particularly Brazil, Canada, New Zealand, Australia and the UK.

Global South representatives raised concerns that synbio products intended to replace agricultural commodities could devastate their economies and degrade biodiversity. Many delegates were also concerned that synthetically modified organisms could create biosafety risks – e.g. the possibility of synthetic algae escaping into waterways, producing a solar-powered oil spill.

A network of international organisations including Friends of the Earth, ETC Group, Econexus and the Federation of German Scientists has been closely monitoring the negotiations and providing input for over four years.

The CBD decision urges all member countries to:

  • Follow a precautionary approach to synthetic biology.
  • Set up systems to regulate the environmental release of any synthetic biology organisms or products. These regulations must ensure that activities in one country cannot harm the environment of another. (Article 3 of the CBD)
  • Ensure that no synthetic biology organisms are released for field trials without a process of formal prior risk assessment.
  • Submit synthetic biology organisms, components and products to scientific assessments that consider risks to conservation and sustainable use of biodiversity as well as human health, food security and socio-economic considerations.
  • Encourage research funds to assess the safety of synthetic biology as well the socio-economic impacts of the technology.
  • Support developing countries to develop their capacity to assess synthetic biology.

The decision also:

  • Establishes an expert group to develop a definition of synthetic biology and identify whether existing governance arrangements are adequate.
  • Invites other UN bodies to consider the issue of synthetic biology as it relates to their mandates.