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Synthetic biology—the engineering of new forms of life—is the kind of science that can freak people out. Some critics want to stop or restrict it. But President Obama’s bioethics commission, in its report on this emerging technology, advocates a subtler approach: “an ongoing process of prudent vigilance that carefully monitors, identifies, and mitigates potential and realized harms over time.”
Prudent vigilance may not be sexy, but it’s smart. It’s designed, in the commission’s words, to maximize “information, flexibility, and judgment” in the regulation of technology. Here’s how it works, as illustrated in the synthetic biology report.
1. If in doubt, don’t interfere. The commission endorses “regulatory parsimony,” i.e., “only as much oversight as is truly necessary.” You might think that emerging technologies, because they’re unformed and unpredictable, require particular restraint. That’s the conservative view. The commission draws the opposite conclusion: The evolving nature of these technologies makes them “not well suited for sharply specified limitations.”
This principle applies not just to technology, but to related fields such as law. “Intellectual property issues in synthetic biology are evolving,” says the report. Accordingly, the commission “offers no specific opinion on the effectiveness of current intellectual property practices and policies in synthetic biology.” Don’t speak until you know what to say.
Why not err on the side of intervention? Because you might make things worse. Hasty restrictions, the report warns, “may be counterproductive to security and safety by preventing researchers from developing effective safeguards.” Let the technology unfold, and see what happens. This might be the best way to learn what sort of regulation we’ll need down the road. “The aggressive pursuit of fundamental research generally results in a broader understanding of a maturing scientific field like synthetic biology,” says the report, and this “may be a particularly valuable way to prepare for the emergence of unanticipated risks that would require rapid identification and creative responses.”
2. Change is the norm. The conservative instinct is to treat the status quo as natural and defend it against change. The commission rejects this idea. The notion that “synthetic biology fails to respect the proper relationship between humans and nature” misconceives the reality of that relationship. In biology, the panel argues, defining “nature” or “natural” is tricky “in light of humans’ long history interacting with and affecting other species, humankind, and the environment.” We’ve been messing with life all along.
The status quo, in other words, is change. Yes, modern genetic manipulation is more complex than old-fashioned breeding. But it isn’t exploding. It’s “proceeding in limited and carefully controlled ways.” And while synthetic biology is at the cutting edge, it’s just “an extension of genetic engineering” and “does not necessarily raise radically new concerns or risks.”
3. Make the regulation as agile as the technology. The tricky thing about synthetic biology, according to the report, is that “the probability or magnitude of risks are high or highly uncertain, because biological organisms may evolve or change after release.” And you can’t gauge their future from their past, given the “lack of history regarding the behavior” of these organisms. So the commission keeps its judgments provisional. The words “evolve,” “evolving,” “current,” “currently,” “at present,” “at this time,” and “uncertain” appear 191 times in the report.
How can we manage such fast-moving, adaptable targets? With a fast-moving, adaptable regulatory system. The White House must “direct an ongoing review of the ability of synthetic organisms to multiply in the natural environment,” says the commission. It must “identify, as needed, reliable containment and control mechanisms.” This means constant reevaluation. A system of prudent vigilance will “identify, assess, monitor, and mitigate risks on an ongoing basis as the field matures.” The word “ongoing” appears 73 times in the report.
4. Make the regulation as diffuse as the technology. The commission notes that synthetic biology “poses some unusual potential risks” because much of it is being conducted by “do-it-yourself” amateurs. Top-down regulation of known research facilities won’t reach these garage experimenters. “It is at the individual or laboratory level where accidents will occur, material handling and transport issues will be noted, physical security will be enforced, and potential dual use intentions will most likely be detected,” says the commission. Therefore, the government should focus on “creating a culture of responsibility in the synthetic biology community.” The phrase “culture of responsibility” appears 16 times in the report.
5. Involve the government in non-restrictive ways. Given the complexity, adaptability, and diffusion of synthetic biology, the report suggests that the government “expand current oversight or engagement activities with non-institutional researchers.” This “engagement” might consist of workshops or educational programs. By collaborating with the DIY research community, the government can “monitor [its] growth and capacity,” thereby keeping abreast of the technology and its evolving risks.
The best protection against runaway synthetic organisms might come not from restricting the technology, but from harnessing it. “Suicide genes” or other self-destruction mechanisms could be built into organisms to limit their longevity. “Alternatively, engineered organisms could be made to depend on nutritional components absent outside the laboratory, such as novel amino acids, and thereby controlled in the event of release.”
How can the government encourage researchers to incorporate these safeguards and participate in responsibility-oriented training programs? By funding their work. This reverses the Bush administration’s approach to stem cells. Bush prohibited federal funding of embryo-destructive research so pro-life taxpayers wouldn’t have to support it. The Obama commission does the opposite: It recommends “public investment” to gain leverage over synthetic biologists. If the government subsidizes your research, it can attach conditions such as ethics training or suicide genes.
6. Revisit all questions. Occasionally, the Obama commission forgets its own advice and makes a risky assumption. For example, it brushes off “the synthesis of genomes for a higher order or complex species,” asserting, “There is widespread agreement that this will remain [impossible] for the foreseeable future.” But if this prediction or any other turns out to be erroneous, don’t worry. The report builds in a mechanism to correct them: future reevaluations of its conclusions.
This is more than a matter of reassessing particular technologies. It’s a commitment to rethink larger assumptions, paradigms, and ethical questions. “Discussions of moral objections to synthetic biology should be revisited periodically as research in the field advances in novel directions,” says the report. “An iterative, deliberative process … allows for the careful consideration of moral objections to synthetic biology, particularly if fundamental changes occur in the capabilities of this science.” Arguments against the technology
will surely continue as the field matures, as well they should. The question relevant to the Commission’s present review of synthetic biology is whether this field brings unique concerns that are so novel or serious that special restrictions are warranted at this time. Based on its deliberations, the Commission has concluded that special restrictions are not needed, but that prudent vigilance can and should be exercised. As this field develops and our ability to engineer higher-order genomes using synthetic biology grows, other deliberative bodies ought to revisit this conclusion. In so doing, it will be critical that future objections are widely sought, clearly defined, and carefully considered.
That’s the way good scientists think: subject your work to peer review, seek falsification, and revise hypotheses as we learn more. Every question is open to reexamination. Even the commission’s rejection of a moratorium on synthetic biology “at this time” implies the possibility of reversal. Who knows what the future will bring?
I count three specific restrictions in the commission’s interpretation of prudent vigilance. First, “Risk assessment should precede field release of the products of synthetic biology.” That’s more than monitoring. It’s a precautionary hurdle. Second, “reliable containment and control mechanisms” such as suicide genes “should be identified and required.” Third, “ethics education … should be developed and required” for synthetic biologists, as it is for medical and clinical researchers.
Beyond those three rules, prudent vigilance seems to be a matter of humility, open-mindedness, keeping an eye on things, constantly rethinking assumptions, and finding creative ways to influence an increasingly diffuse community of scientific entrepreneurs. It’s a lot of work. But it’s what we’ll have to do if we don’t want to restrict technologies preemptively or leave them unsupervised. Eternal vigilance is the price of liberty.
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