Synthetic Biology: Harbinger of an Uncertain Future?
By Malcolm Dando
Bulletin of the Atomic Scientists
16 August 2010
http://thebulletin.org/web-edition/columnists/malcolm-dando/synthetic-biology-harbinger-of-uncertain-future

It is hard to imagine that only three years ago, back in
2007, there was such a lack of awareness of dual-use and
related biosecurity issues among practicing life
scientists. Even the Biological and Toxin Weapons
Convention (BTWC) was almost unknown. For me, this brand
of unawareness was confirmed when, that year, Alexander
Kelle attended "Synthethic Biology 3.0", an
international convention on synthetic biology that was
held in Zurich, and interviewed some of the leaders in
the field on dual-use and biosecurity issues. His
conclusion? PDF

	"...only a small part of the interviewees, if
	any at all, were in a position to give an
	assessment of the various committees, reports,
	and recommendations addressed in the
	interview..."

Being a number cruncher by inclination, however, the
clincher for me was that none of the 20 people
interviewed had even heard of the report produced by the
Lemon-Relman committee, the joint-committee of the U.S.
Institute of Medicine and National Research Council.
Their influential report, published in 2006,
specifically made it very clear that concerns about the
potential misuse of the modern life sciences went well
beyond work on pathogens and toxins and certainly
included the advances being made in synthetic biology.
So it was indeed surprising that these leaders in the
field had not even heard of the report.

Yet many would agree that the synthetic biology
community, more so than any other community in the life
sciences, has really made an effort to protect against
the possible misuse of its benignly intended work. For
example, Synthetic Genomic: Options for Governance was
an illuminating study. PDF It explained different points
of intervention (gene firms, oligonucleotide
manufacturers, DNA synthesizers, users, and
organizations) and articulated various policy options
that might be applied at each point (for example,
education of the users about the risks and best
practices in their university courses). After reading
this study, it was clear to me that a serious effort was
underway to develop ideas about effective means of
protecting this science and technology from hostile
misuse.

Development of policy ideas has continued apace in
Europe and in the United States. In 2009, Kelle
suggested what he called a "5P-governance matrix" in
which possible intervention points (principle
investigator, project, premise, provider, and purchaser)
may have different potential biosecurity measures
applied, and he has suggested how these ideas might be
taken forward. Within weeks after scientists had created
a "self-replicating cell that contained an entirely
synthetic genome" in May of this year, President Barack
Obama asked the U.S. Presidential Commission for the
Study of Bioethical Issues to study the "implications of
this technology" and to provide recommendations within
six months as to what the federal government might do
"to maximize benefits and minimize risks associated with
this technology."

Meanwhile there has been considerable activity in the
industry itself, and in the U.S. government, both trying
to hammer out an effective operational system to screen
orders for DNA sequences and to minimize the possibility
of misuse. After 9/11 U.S. firms began to use computer
programs to compare the sequences ordered against a
database of DNA sequences of viruses and bacteria that
could be of concern. If an order appeared to closely
match a sequence that could be used for hostile
purposes, a company expert then investigated the
security risk before the order was accepted. In 2006 a
number of U.S. DNA synthesis firms that were applying
such systems attempted to harmonize them within the
International Consortium for Polynucleotide Synthesis.
By 2007 five German firms had formed a different
voluntary group with similar objectives, the
International Association for Synthetic Biology. Then in
2009 an international meeting between European and U.S.
experts led to a draft "Code of Conduct for Best
Practices in Gene Synthesis." All seemed to be going in
the right direction.

However, a split in the industry appeared when two of
the leading firms -- DNA2.0 in the U.S. and Geneart in
Germany -- proposed to minimize the second phase of
security screening, i.e. using a human expert, and to
rely almost entirely on the first phase of screening,
i.e. using only computers. Because a mainly computerized
system would not require the time consuming and
expensive work of an expert, it could be implemented
quickly and cheaply. However, removing the detailed
human expert examination obviously increases the
possibility that dangerous orders could get through the
screening, as the computer screening process is only as
good as the databases it calls upon. Debates and
divisions continue within the industry as to the best
approach.

The U.S. National Science Advisory Board for Biosecurity
(NSABB) also became involved in this issue, and in 2006
recommended that legally binding regulations should be
developed for the synthetic biology industry. However,
consideration within the U.S. government led instead to
the proposal that a set of voluntary guidelines should
be developed and then tested for some years. Last year
the government issued its draft Screening Framework
Guidance for Synthetic Double-Stranded DNA Providers.
Unfortunately, the government's proposal is weaker than
those proposed by the industry groups because it
involves using a more limited database of sequences in
order to carry out the screening; consequently,
dangerous orders could more easily get through the
screening. It does seem therefore that an opportunity to
rely on stronger measures developed by private industry
could be undermined.

But all may not be lost, as this global industry may be
subject to strong commercial pressures that could force
it to comply with stronger voluntary guidelines. For
example, powerful, important customers might not
purchase from a firm that cannot demonstrate that it
follows the industry's best practices. It is also
conceivable that the ongoing discussions in the U.S.
will lead to a compromise on a set of stronger
guidelines. We can all hope that events unfold in such a
constructive way, and it is important that they do.
Unfortunately, that will not solve the fundamental
problem: By the time guidelines are agreed and
implemented, the goalposts will have moved. Advances in
science and technology will in the not-too-distant
future deliver widely available bench-top synthesizers
quite capable of producing what the industry now does.
These developments will necessarily give rise to new
biosecurity concerns. Clearly then we need a
comprehensive system that will involve a continuous and
coordinated international method more capable of getting
to grips with the implications of the rapid advances in
the life sciences than is now available.

Currently, a regular review of relevant science and
technology developments at the Biological and Toxin
Weapons Convention Review Conferences, which take place
every five years, is the main mechanism available to
governments. At the Fifth Review Conference in 2001-2,
however, the UK government suggested that there was a
need to alter this system because of the rate of change
in science and technology. As the UK noted: 

	"...Given the accelerating pace in science and
	technology, the UK wonders whether it is prudent
	to maintain a five year gap between such
	assessments under the BTWC. The UK suggests that
	the upcoming Review Conference consider
	establishing a mechanism for States Parties to
	work together on a more frequent basis to
	conduct scientific and technical reviews and to
	consider any implications at the necessary level
	of expertise."

It is unfortunate, but hardly surprising, that this
suggestion did not get far in the deeply divided Fifth
Review Conference.

Yet is worth noting that the UK put forward the same
proposal in the most recent Review Conference in 2006
pointing out, in part, that "[T]he implications of new
and rapidly emerging technologies such as synthetic
biology...are difficult as yet to predict, but these are
clearly areas with vast potential for both beneficial
and detrimental applications." Again there was no
discernable movement to take up this suggestion in 2006.
It seems possible that some constructive development of
the present annual meetings systems could be agreed upon
at the next Review Conference in 2011; if so, maybe
advances in science and technology could be one of the
items given more frequent, perhaps annual, review by the
States Parties.

If some such comprehensive international mechanism of
consideration of the implications of the advances in
science and technology cannot soon be found, it seems to
me that the probable failure to effectively regulate
synthetic biology -- because we will end up dealing with
yesterday's problem -- will indeed be a harbinger of a
very uncertain future in regard to the governance of
other areas of the life sciences.

_____________________________________________

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