Declaration calls for Precautionary Oversight of Synthetic Biology

By Jeff Conant, for Climate Connections

Today a broad coalition of 111 organizations from around the world released The Principles for the Oversight of Synthetic Biology, the first global civil society declaration to outline principles that must be adopted to protect public health and the environment from the risks posed by synthetic biology, and to address the field’s economic, social and ethical challenges. Until these governance principles are in place, the coalition calls for a moratorium on the release and commercial use of synthetic organisms and products.

As part of our ongoing coverage of synthetic biology, and in conjunction with our upcoming event, Unmasking the Bay Area Bio-Lab and Synthetic Biology, Climate Connections interviewed Eric Hoffman, Food and Technology Policy Campaigner at Friends of the Earth U.S., one of the authors of the Principles.

 

Jeff Conant: What prompted you to draft The Principles for the Oversight of Synthetic Biology?

 

Eric Hoffman: We started writing the principles in response to constant calls for self-regulation, coming from the synthetic biology industry itself, and also from the President’s Commission on Bioethics in December 2010 (see NYTimes article here).  When the President’s Commission recommended self-regulation by synthetic biologists, this gave the okay for business as usual.

 

At Friends of the Earth, ETC Group, and the International Center for Technology Assessment, we grew tired of simply raising awareness of the need for proper regulation. We asked ourselves, what would appropriate regulations for synthetic biology look like, to prevent negative social and environmental impacts? Over the course of a year we collaborated on the principles, and have just finalized them now.

 

The principles we urge are the following:

1) Employ the Precautionary Principle

2)    Require mandatory synthetic biology-specific regulations

3)    Protect public health and worker safety

4)    Protect the environment

5)    Guarantee the right-to-know and democratic participation

6)    Require corporate accountability and manufacturer liability

7)    Protect economic and environmental justice

 

JC: And, the document calls for a moratorium on synthetic biology?

EH: The 111 signatories to the document call for a moratorium on the release and commercial use of synthetic organisms. We believe that in order to establish proper oversight, we need a moratorium limiting synthetic biology to work in the laboratory, until we have a guarantee that organisms can’t get out. Anything that can get out, including commercial release, needs to wait until we can develop proper oversight. We know that organisms escape all the time – the story of Becky McClain [a molecular biologist injured by an escaped organism in a Pfizer-owned lab, and later dismissed from her job for filing a complaint – ed.] is an example of the high cost of accidental release.  Current practices around biotechnology have major holes, and the current regulations are not enough, which is why a moratorium if necessary.

 

JC: Has there been such a call before, for a moratorium on commercial releases of synthetic biology products?

EH: This is the first document of its kind – the first time civil society has come together to say what needs to happen with synthetic biology. When we first called for oversight a few years ago, 40 groups signed on. The next year, 58 groups signed on. Now we have 111. This shows that we’re seeing increased concern, and increased awareness that synthetic biology is the next level of evolution of the dangerous arc of biotechnology.

 

JC: We are hosting an event in Berkeley later this month to draw attention to concerns about the new Lawrence Berkeley lab site proposed for Richmond, California – the lab will be doing synthetic biology, and no one seems to be aware of it, because LBNL is framing it simply as “renewable energy research.” Some comments have arrived to the synbiowatch website, where we are promoting the conference, that we are being ‘one-sided,’ and even ‘irresponsible,’ by not having the leaders of the synthetic biology field on our panels. How would you respond to that?

 

EH: Synthetic biology events hosted by industry happen all the time, and civil society is not invited to present. Some of the groups that endorsed the principles have tried to present at industry conferences and been shut out. None of the public meetings around the new campus of the Lawrence Berkeley lab even mentioned synthetic biology. If we want to have an open debate, lets do it; the purpose of this meeting on March 29 is to raise these concerns and to start a dialogue. The event is intended to push back on the lack of responsible oversight of synthetic biology.

 

To their credit, many synthetic biologists are thinking about the ethics of the industry – but largely without democratic participation. We shouldn’t just let them tell us how they want to be regulated. If the industry is as important as it claims to be, we need public governance. It’s not enough to have Synthetic Genomics founder Craig Venter tell us to trust him. [Venter is one of the leaders in the field, founder of Synthetic Genomics, a firm dedicated to using modified microorganisms to produce biochemicals, and the recipient of $600 million collaborative funding from ExxonMobil. – ed.]

 

Yet, Venter has a large grant to look at governance gaps – that is, to research why the public isn’t involved. Why is a leader in the field receiving a grant to research why his efforts are not well-known, let alone well-regulated?

 

JC: Do you see a debate within the scientific community on the merits of synthetic biology?

EH: Certainly there is a debate on the risks, but also on whether it will work. Numerous scientists say the field is, by and large, just a show to get more money from investors, when much of what these companies are doing is not much different from conventional genetic engineering. A lot of it is just hype. And there are serious questions about risks to health and the environment.

 

The question of whether the technologies of synthetic biology can reach the scale promised by the industry is key. Amyris [a Bay Area based company founded by UC Berkeley alum Jay Keasling with a $42 million grant from the Gates Foundation and significant inputs from the fossil fuel industry – ed] offers a clear example of the false promise of biofuels. They’ve been seeing themselves as a biofuels company from the beginning – but when they failed to reach the scale of production needed to make profits, they offloaded their biofuels line and moved into producing high-end cosmetic oils. To say now, as they have, that they do not want to be in biofuels, flies in the face of their pronouncements from the beginning that they are challenging the fossil fuel regime. Are they going to do this by getting into high-end oils for cosmetics – I don’t think so. If your goal is to promote alternatives to fossil fuel for energy, you don’t do it by making expensive face cream, which is what they’re doing now.

 

JC: If the dangers associated with synthetic biology are so grave, why a moratorium? Why not a ban?

EH: The reason is that the science is still quite new. We’re very concerned about applications, but the science behind synthetic biology could, potentially, be useful in limited fields – for looking at how DNA and living systems work, at how life began, for example. It does have possibilities for better understanding genetics and biological systems.

 

The reason we call for a moratorium is that we see this field moving forward too quickly without proper safeguards in place – which applications we want and which we don’t; which ones may be worth the risk, which ones are not. If, through that, society says it wants a ban, I think that would be fine to come to a ban through democratic deliberation. In fact, we do call for a ban on synthetic biology to alter the human genome. Scientists such as George Church and Drew Ende, for example, are calling for license to create re-engineered humans. We think the risks and the ethical concerns associated with this are far too great.

 

JC: What do you hope will happen with the principles?

EH: Today I’ll be bringing them to the Congressional Caucus on Synthetic Biology, which is made up of two people, Representative Moran of Virginia and Representative Bilbray of California. The caucus was created, we believe, at the request of Craig Venter, and we hope that the caucus will serve as a forum for critical look, and not just for PR for the industry.

 

Beyond that, we hope they’ll be taken up at the Convention on Biological Diversity, COP11 in India in October, as a moratorium on synthetic biology releases. We also hope that the City of Richmond will use these principles as a starting point to think about how to regulate synthetic biology in their community, following our event on March 29.

 

For the full report from FOE, ETC, and CTA, go to:www.foe.org/principles-for-synthetic-biology

 

Following is the announcement forwarded to Climate Connections about the report:

 

New declaration calls for precautionary oversight for the emerging field of synthetic biology

 

WASHINGTON, D.C. — Today a broad coalition of 111 organizations from around the world released The Principles for the Oversight of Synthetic Biology, the first global civil society declaration to outline principles that must be adopted to protect public health and the environment from the risks posed by synthetic biology, and to address the field’s economic, social and ethical challenges.  Until these governance principles are in place, the coalition calls for a moratorium on the release and commercial use of synthetic organisms and products.

 

The synthetic biology industry is expanding rapidly, with a market value in 2011 of over $1.6 billion that is expected to reach $10.8 billion by 2016. However, there has been little to no governance of the industry or assessment of the novel risks posed by synthetic organisms. Synthetic biology is “extreme genetic engineering” — not just reading and rearranging genetic code, but writing it to create new genes, genetic traits and possibly entire life forms from scratch.

 

The global coalition calls for the following seven principles to be established to safeguard public health and the environment from the novel risks of synthetic biology and to ensure open, meaningful and full public participation in decisions regarding its uses:

 

1.            I.         Employ the Precautionary Principle
2.          II.         Require mandatory synthetic biology-specific regulations
3.        III.         Protect public health and worker safety
4.        IV.         Protect the environment
5.          V.         Guarantee the right-to-know and democratic participation
6.        VI.         Require corporate accountability and manufacturer liability
7.      VII.         Protect economic and environmental justice

 

“The Principles for the Oversight of Synthetic Biology marks an important milestone in the debate around synthetic biology, as it is the first document from a global coalition of civil society organizations that outlines how synthetic biology should be regulated,” said Eric Hoffman, Food and Technology Policy Campaigner at Friends of the Earth U.S. “This diverse coalition of 111 groups from around the world, including environmental, religious, consumer, scientific, worker safety and human rights groups, has come together to call for the proper governance of synthetic biology. Our recommendations are rooted in the guiding principle of placing the health of people and the environment above corporate profits.”

 

“Self-regulation of the synthetic biology industry simply won’t work. Current laws and regulations around biotechnology are outdated and inadequate to deal with the novel risks posed by synthetic biology technologies and their products,” said Andy Kimbrell, Executive Director of the International Center for Technology Assessment. “These principles outline the positive role local and national governments, as well as international laws, can play in protecting communities from the novel risks posed by synthetic biology.”

 

“In addition to the risks synthetic biology poses to human health and the environment, this technology may also deepen global social and economic injustices,” explained Silvia Ribeiro, Latin American Director of ETC Group. “Novel organisms tailored to break down biomass will enable a new bio-economy in which land, water and fertilizers used to produce food for communities in the global South will be diverted for producing biomass feed for synthetic organisms in order to produce fuels, chemicals and other high-end products for wealthy nations.”

 

“We are calling for a global moratorium on the release and commercial use of synthetic organisms until we have established a public interest research agenda, examined alternatives, developed the proper regulations and put into place rigorous biosafety measures,” said Carolyn Raffensperger, Executive Director of the Science and Environmental Health Network. “It is our obligation to safeguard the future, to be wise in our development and use of technologies which could threaten humans and the Earth.”

 

Contact:

Eric Hoffman, Friends of the Earth U.S., 202-222-0747, ehoffman@foe.org

Jaydee Hanson, International Center for Technology Assessment, 202-547-9359,jhanson@icta.org

Jim Thomas, ETC Group, 1-514-273-9994, jim@etcgroup.org

Silvia Ribeiro, ETC Group, +52 55 5563 2664, silvia@etcgroup.org

Carolyn Raffensperger, Science and Environmental Health Network,

515-268-0600, raffenspergerc@cs.com