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Over the past couple of months, there has been a cascade of proposals for — or at least discussions about — regulating synthetic biology, and they are beginning to be noticed. It’s about time!

The technology is edging into the marketplace, at least as proof of concept, and various stakeholders are establishing positions. Some kind of regulation will eventually happen, but we can expect some major struggles first. For instance, if our present institutions are less than adequate to oversee the new processes — and all but the most starry-eyed boosters agree that they are — should they be replaced or expanded? In the U.S. context, what legislation will be required, and how will it get through Congress?

Perhaps most critically, from the point of view of those of us who are skeptical about utopian promises, how can we ensure that social, economic, ethical and other factors are considered? For too long safety has been very narrowly interpreted, and substantial equivalence far too broadly assumed. Will those definitions really be retained when it comes to governing completely novel organisms whose...