[ExI] Fwd: Slate | Synthetic biology and Obama's bioethics commission: How can we govern the garage biologists who are tinkering with life? - By William Saletan

[Bryan Bishop]

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From: Eri Gentry <sap.ved.eri at gmail.com>
Date: Tue, Feb 1, 2011 at 7:50 PM
Subject: Slate | Synthetic biology and Obama's bioethics commission: How can
we govern the garage biologists who are tinkering with life? - By William
Saletan
To: biocurious at googlegroups.com



http://www.slate.com/id/2283324/?from=rss

 Faking Organisms How can we govern the garage biologists who are tinkering
with life?By William SaletanPosted Tuesday, Feb. 1, 2011, at 9:20 AM ET

*This article arises from Future Tense <http://www.slate.com/id/2271557/>*,
*a collaboration among Arizona State University, the New America Foundation,
and** **Slate**. A Future Tense conference on whether governments can keep
pace will scientific advances will be held at Google D.C.'s headquarters on
Feb. 3-4.* (*For more information and to sign up for the event, please visit
the****NAF Web site* <http://newamerica.net/events/2011/here_be_dragons>*.)*

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 <http://www.bioethics.gov/>, in
its report on this emerging
technology<http://www.bioethics.gov/documents/synthetic-biology/PCSBI-Synthetic-Biology-Report-12.16.10.pdf>,
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."
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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."
 Advertisement

*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<http://www.slate.com/id/2182667/>.
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.



-- 
- Bryan
http://heybryan.org/
1 512 203 0507
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