Last year, synthetic biology celebrated its tenth anniversary by creating a bacterium around an artificial genome. But a second milestone may have been just as important. Over the years, synthetic biologists have devoted enormous effort to identifying security risks and debating solutions. At the same time, they knew that any debate would be pointless unless it ended in practical action. In the end, members pursued two strategies. The first was traditional and asked government to write regulations. The second asked industry and academics to govern themselves. Prior to 2009- 2010, there was no way to know whether either strategy would produce useful results. Optimists and pessimists could see what they wanted. Today, we know much more, and the news is discouraging. Almost everyone agrees that the security agenda's first and most urgent task is to keep would-be terrorists from buying synthetic DNA. But just how hard should companies investigate customer orders before filling them? Mainstream security experts have long agreed that many threats do not appear on any list, let alone the US. governments list of officially regulated “Select Agents.” For the foreseeable future, the only way to detect these threats is for human experts to compare each customer request against similar published sequences that have well-known biological functions. In November 2009, gene companies around the world announced that they would indeed pay human experts to do this. One might have expected the U.S. government to endorse this result. Instead, the Department of Health and Human Services (“HHS”) announced draft guidelines that encouraged companies to adopt a weaker procedure (“Best Match”) that can only detect sequences derived from Select Agents. The guidelines became final in October of 2010. Surely, this is a modest return for ten years of effort. Worse, it signals that the U.S. government will shelter industry from strong biosecurity standards even when industry has already agreed to them. If so, synthetic biology's security agenda has been so much wasted effort. Clearly, it is time for a closer look. This Article examines what synthetic biologists have done to improve biosecurity over the past decade and asks how much additional progress can be expected. Parts I through III introduce synthetic biology, the economic and scientific forces that have driven it for the past decade, and the pressures that persuaded the community and eventually the U.S. government to promise improved biosecurity. The Article then turns to the familiar argument that attempts to regulate technology are hopeless. To the contrary, Part IV argues that many of the weapons of mass destruction (“WMD ”) technologies developed over the last century were eminently predictable and could have been blocked by policymakers. Part V reviews synthetic biologists' extended debate over when and how to control so-called “experiments of concern” that might lead to new and better weapons. Parts VI and VII review synthetic biologists' parallel debate over how to deny the field's existing technologies, including synthetic DNA, to terrorists. Part VIII reviews the community's failed attempt to implement these ideas through a combination of self-governance and formal government regulation. Part IX looks at the prospects for additional private standards and government regulation in the foreseeable future. Part X identifies practical reforms that would allow synthetic biology to revive its stalled security agenda. Part XI provides a brief conclusion. Reprinted by permission of the publisher.

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