End of the Beginning or Beginning of the End?

Abstract

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 20092010, 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 U.S. government's 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