FEBRUARY 2016 No. 2
STRATEGIC SECURITY ANALYSIS
Synthetic Biology and ‘Amateur Science’:
Dual-use and Challenges of Regulation
by Ioana Puscas
STRATEGIC SECURITY ANALYSIS
GCSP - SYNTHETIC BIOLOGY AND ‘AMATEUR SCIENCE’: DUAL-USE AND CHALLENGES OF REGULATION
Synthetic Biology and ‘Amateur Science’:
Dual-use and Challenges of Regulation
In recent years, the phenomenon known as ‘garage
biology’ has emerged as a new area of security
concern. Garage biology refers to the relocation
of life science experimentation from established
institutions to more amateur settings.
The risks of unregulated
biotechnology are not new,
yet the advances made in life
sciences, the possibilities offered
by genetic engineering or
synthetic biology have shed new
light on risks and governance
challenges. The real scientific
possibility to make a virus or
other pathogens from scratch
and the likelihood of designing
such harmful biological material
in hidden or makeshift labs
now raises serious concerns
about risks and the urgency of
regulation.
In parallel to what is increasingly
perceived as a ‘de-skilling’
of biological research, the
decreasing costs for lab
equipment have contributed to
the scare about what amateur
biologists, or trained biologists
in amateur settings, could
potentially accomplish.1
enthusiasts from across the
world (mostly in the United
States and Europe), organised
in about 40 groups.2 The
members of the DIY community
can share information and
perform experiments in often
rudimentary labs and with
limited resources, proving that
the ranks of life sciences have
now expanded to include
nonprofessional amateurs or
‘citizen scientists’. Indeed, in
the past few years, amateur
biologists have been able to
perform genetic experiments
single-handedly, and devices
to duplicate DNA can now be
ordered online for modest (or
affordable) prices.
•There have been significant and
successive turning points in life
sciences with implications for
security policy in recent decades,
most recently marked by the advent
of synthetic biology. Synthetic
Biology allows for the creation of
biological components with novel
functions, which do not otherwise
exist in nature. Synthetic genomics
now allow scientists to create entire
genes and microbial genomes from
scratch.
•Synthetic biology is an example of
a dual-use technology: it promises
numerous beneficial applications
but it can also be used for harm.
This has led to fears that terrorists
could exploit synthetic biology to
create deadly viral agents.
•Those apprehensive of dualuse have cited enabling factors
such as an overall de-skilling and
‘democratisation’ occurring in
biology, as well as decreasing
prices of DNA synthesis and its easy
availability for purchase over the
Internet. The advent of ‘amateur
biology’, and its community of
biology enthusiasts, has led to
fears that virtually anybody could
potentially learn to use the tools of
synthetic biology, with destructive
implications.
•Concerns about the misuse of
synthetic biology by amateur
scientists were overstated as there
are numerous technical hurdles to
bioterrorism. One critical hurdle
that is often overlooked in this
debate is the role played by ‘tacit
knowledge’ in the laboratory.
The emergence of the DoIt-Yourself (DIY) community
exacerbated these fears. The
movement traces its origins
back to 2008 and it currently
gathers over 2,000 biology
1 Jonathan B. Tucker, “Could Terrorists
Exploit Synthetic Biology”, The New
Atlantis, Spring 2011, p. 69.
KEY POINTS
2 Catherine Jefferson, “The Growth of
Amateur Biology: A Dual-use Governance
Challenge?” Policy Paper 3, https://
biochemsec2030dotorg.files.wordpress.
com/2013/08/jefferson-policy-paper-3for-print.pdf 3.
•Despite the alarmist exaggerations,
the need for regulation over this
community remains important.
Unfortunately, while there have
been some steps towards selfregulation in the community of
amateur biologists, for the most
part, the issue of governance has
been insufficiently addressed.
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STRATEGIC SECURITY ANALYSIS
GCSP - SYNTHETIC BIOLOGY AND ‘AMATEUR SCIENCE’: DUAL-USE AND CHALLENGES OF REGULATION
There is little doubt that for many of the members
of the DIY community, biohacking3 is motivated
by genuine idealism. These individuals are
advocates of innovation based on open-source
knowledge sharing, scientific empowerment or
addressing inequality in access to healthcare.4
Its unique tools make synthetic biology different
from genetic engineering: unlike the latter,
premised on transferring genes from one species
to another, synbio aims to create novel microbial
genomes (from natural genes or artificial genes
synthesised from scratch).
However, soon after the movement sprouted,
it sparked concerns about DIY’s potential for
dual-use, security risks associated with amateur
biology, and the gaps in governance which will
have to be addressed. There are several types of
risks associated with the do-it-yourself scientist
operating in isolated labs, basements or garages.5
These include concerns over biosafety, the risk of
spillages and accidental releases or especially the
possibility of bioterrorism. Following experiments
that allowed the transformation of the H5N1
bird flu into mutant forms, many cautioned that
the publication of the results would lead to the
experiments being replicated in amateur settings.6
The risks posed by the ‘democratisation’ and deskilling of biology are further reinforced by the
advent of synthetic biology.
Essentially, synbio is the application of
engineering principles to biology with a view to
design new biological entities and tune them
to meet very specific performance criteria. On
the one hand, synthetic biology promises to
produce biofuels, medicines or other important
organic materials. Examples include bacteria
that eat pollution in water, cancer-fighting
microorganisms, and protosynthetic systems to
produce energy. Possibilities made available by
these novel biological systems are innumerable,
and the estimated market value of synbio by 2018
is $16 billion.8 On the other hand, synbio could
be exploited by terrorists to create viruses and
bacteria with targeted functions. While the field
of synthetic biology generates new insights into
how life works, it is not without its risks.
Synthetic Biology and
Risks of Dual Use
The discovery of the DNA structure and the
mapping of the human genome are usually
considered the two main turning points in life
sciences in the 20th century. These were followed
by a third, and more recent, revolutionary
innovation — synthetic biology. Synthetic biology
refers to the suite of techniques to fabricate
biological components with functions that do
not exist in nature. This encompasses both the
construction of new biological parts by building
living machines from off-the-shelf ingredients and
the re-designing of existing biological systems.7
3 The term “biohacking” can have negative connotations, in
association with computer hackers and cybercrime. The meaning
appropriated by the members of the DIY community is rather
benign, evoking enthusiasm in tinkering with and exploring the
potential of a technology.
4 Catherine Jefferson, “Governing Amateur Biology: Extending
Responsible Research and Innovation in Synthetic Biology to
New Actors”, Research Report for the Wellcome Trust Project on
‘Building a Sustainable Capacity in Dual-Use Bioethics’ http://
www.brad.ac.uk/bioethics/media/ssis/bioethics/docs/Jefferson_
Governing_Amateur_Biology.pdf”, 11. 5 Dustin T. Holloway, “Regulating Amateurs”, The Scientist,
1 March 2013, www.the-scientist.com/?articles.view/
articleNo/34444/title/Regulating-Amateurs/
6 Carl Zimmer, “Amateurs are New Fear in Creating Mutant
Viruses”, The New York Times, 5 March 2012, www.nytimes.
com/2012/03/06/health/amateur-biologists-are-new-fear-inmaking-a-mutant-flu-virus.html?_r=1
7 Jonathan B. Tucker and Raymond A. Zilinskas, “The Promise
and Perils of Synthetic Biology”, The New Atlantis, Spring 2006,
p. 25.
In 2003, the Human Genome Project was
completed, and was followed by successive
breakthroughs in the ability to decode DNA.
These advances have coincided with lowering
prices of DNA synthesis and a widespread
general interest in synbio.9 Such developments
raised fears that the discipline was shifting from
a specialised field toward an unregulated area
of experimentation. This fear was accentuated
further by initiatives like the annual International
Genetically Engineered Machine (iGEM), the
first synbio competition open to undergraduate
students.10 Such dissemination of knowledge has
contributed to speculations about the application
of synbio methodologies among the DIY
community.
While it is commonly understood that most of
these amateur biologists are merely pursuing a
hobby, the chance that one among their ranks
could exploit the phenomenon for bioterrorist
purposes remains a possibility. Indeed, it is
difficult to gauge the intentions of amateur
biologists. While worst-case scenarios have
crystallised around the possibilities of terrorism,
conclusions about the capacity of terrorists to
exploit synthetic biology are often overstated.
These conclusions are informed by apprehension
8 Josie Garthwaite, “Beyond GMOs: The Rise of Synthetic
Biology”, The Atlantic, 25 September 2014, www.theatlantic.
com/technology/archive/2014/09/beyond-gmos-the-rise-ofsynthetic-biology/380770/
9 Catherine Jefferson, “Governing Amateur Biology”, 12.
10 iGEM, http://igem.org/About
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STRATEGIC SECURITY ANALYSIS
GCSP - SYNTHETIC BIOLOGY AND ‘AMATEUR SCIENCE’: DUAL-USE AND CHALLENGES OF REGULATION
rather than by fact-based assessments. The
relationship between synbio and DIYBio needs
more critical review, and the threats posed by
this relationship must be examined in a rational
manner.
Between hype and
caution
The emerging narrative about the biosecurity risks
of synbio holds that synthetic biology leads to the
de-skilling of biology, making it easy for anyone
to engineer biology. Furthermore, as biology
becomes increasingly accessible to people outside
the realm of traditional scientific establishments
(public or private), rogue actors could purposefully
misuse such technologies for nefarious purposes.
The Internet has further facilitated the access to
critical knowledge. Blueprints for manufacturing
pathogens like anthrax and smallpox can be
accessed online. Yet availability of blueprints or
even access to proper tools and equipment are
not sufficient to create a bioweapon. In assessing
the risks of misuse of synthetic genomics, there
are a number of practical challenges that need to
be addressed.
Tacit vs. explicit knowledge
Scientific knowledge is not entirely based on
hard facts and formulae. Intuition and experience
play a critical role as well. Sociologists of science
identify an important distinction between two
types of technical knowledge: explicit and tacit.
Explicit knowledge refers to data and information
which can be written down, codified and passed
on impersonally, including through notes and
publications. Tacit knowledge, by contrast,
involves know-how and skills which cannot be
readily written down but are acquired through
experience. Furthermore, tacit knowledge
is conventionally divided into personal tacit
knowledge and communal tacit knowledge: the
former refers to knowledge held by individuals,
and the latter to knowledge cultivated by teams
of specialists.11 Biotechnology relies extensively
on such personal and communal knowledge and
often lengthy processes of trial and error are key
to success.
These critical aspects of scientific research are
often overlooked when assessing the entire
process of assembling biological parts into
living organisms. As ‘democratised’ as synbio
11 Tucker: 70.
has become, there are traditional bottlenecks
which confirm the importance of individual and
collective expertise developed in the course
of training and everyday challenges in the
laboratory.12
Craig Venter and his team of researchers became
famous by announcing in May 2010 that they
managed to construct an entire genetic sequence
of more than one million DNA units, knows as
nucleotides. Venter’s team also managed to
create an artificial bacterial cell, then inserted
the DNA genome inside and watched the new
organism come to live and replicate itself.13 These
achievements are revolutionary and illustrate the
unprecedented potential of synthetic genomics.
In theory at least, it is possible to produce any
desired sequence from off-the-shelf chemicals
in the laboratory and DNA synthesis machines
simplify the process: instead of using traditional
recombinant DNA techniques (and isolate
individual genes of one species and have them
spliced into the genome of another), the genetic
sequence can now be designed on a computer
and then converted into a physical strand of
custom DNA.14
While this process seems very straightforward,
both technical and social factors contributed to
synthesising genes and genomes. Venter noted
the importance of on-site observations and the
adjustment of methodologies in several phases of
the synthesis process.15
Although de-skilling has occurred in several
areas of genetic engineering, there are still
good reasons to remain reassured that amateur
biologists or citizen scientists would continue
encountering insurmountable difficulties in
creating pathogenic agents from scratch. The role
of tacit knowledge for synthetic biology cannot
be overlooked and is a major impediment to
weaponisation of biological agents, at least for
the foreseeable future.
12 Catherine Jefferson, Filippa Lentzos and Claire Marris,
“Synthetic Biology and Biosecurity: Challenging the ‘Myths’”,
Frontiers in Public Health, 2, August 2014, pp. 3-5.
13 Laurie Garrett, “Biology’s Brave New World: The Promise
and Perils of the Synbio Revolution”, Foreign Affairs November/
December 2013, www.foreignaffairs.com/articles/2013-10-15/
biologys-brave-new-world
14 Jonathan B. Tucker, “Introduction” in Jonathan B. Tucker,
ed., Innovation, Dual-Use and Security: Managing the Risks of
Emerging Biological and Chemical Technologies, MIT Press, 2012,
Cambridge, p. 4.
15 See Andrew Marshall, “The Sourcer of Synthetic
Genomics”, Nature Biotechnology 27, 2009, pp. 1121-1124,
www.nature.com/nbt/journal/v27/n12/full/nbt1209-1121.html
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STRATEGIC SECURITY ANALYSIS
GCSP - SYNTHETIC BIOLOGY AND ‘AMATEUR SCIENCE’: DUAL-USE AND CHALLENGES OF REGULATION
The value of tacit knowledge is clear when
assessing the development of weapons in
more conventional settings (involving scientists
in well-equipped labs). The techniques and
processes through which scientists acquire certain
knowledge are often not translated into any
written form. Such unarticulated know-how is
essential to work in the lab. As it is not easily
passed on to others, it poses obstacles to the
replication of the same experiment in different
places, even with the same instructions and
materials.16
Some experts on proliferation have repeatedly
flagged the issue of “intangible factors”, such
as work and structural organisation, or social
environment, which leave a mark on how
scientific knowledge is acquired and used. Sonia
Ben Ouagrham-Gormley has extensively analysed
the technical difficulties encountered in past
weapons programmes when data is shared and
transferred among states. The author uses the
example of the production of the Soviet anthrax
weapon by the Kirov bioweapons laboratory in
Russia. The Stepnogorsk plant in Kazakhstan later
attempted to produce the same weapon and it
recorded failures for two consecutive years, until
a group of 65 scientists from two Russian facilities
travelled to Kazakhstan and after three more
additional years of work on the initial protocols.17
Scientific knowledge is therefore often local and
requires adaption and adjustment when repeated
in a new setting.
Managing dual-risks
The resources, technical capabilities, know-how
and motivation needed to engage in sophisticated
biological and chemical terrorism are not
within reach for most terrorist organisations.
Furthermore, the tools needed to exploit the
advances in synthetic biology are even more
difficult to obtain. The emphasis on the threats
posed by synthetic biology usually stems from
a material approach. This takes into account
the commoditisation of biology: availability
of synthesised DNA or de-skilling of human
capital. However, as repeatedly demonstrated
in practice, numerous contingencies are key to
synbio processes and the conditions required
for replication are often very difficult to achieve,
as many experiments are accomplished in
16 Sonia Ben Ouagrham-Gormley, “Barriers to Bioweapons:
Intangible Obstacles to Proliferation”, International Security, 36,
4, Spring 2012, p. 85.
17 bid, 86-86.
very particular circumstances.18 Even in a
context of the overall de-skilling occurring
in biosciences19, most terrorist organisations
are usually conservative in their choices of
weapons, choosing to rely on standard guns and
explosives.20
The conclusions about the terrorism-related risks
of synbio are also a reflection of the existing
narratives surrounding the field of synbio. It has
been shown that a hype cycle almost inevitably
arises with new technologies, often simply
generated by the fact that scientists need to ‘big
up’ their mission and the impact of their work
to garner funding, support and legitimacy.21
Expectations are also formed because most
innovations inherently are meant to have societal
impact, and open themselves up to scrutiny from
these same societies. Furthermore, scientists
themselves can contribute to contradictory
expectations as there is a tendency to make
more generous claims “when wearing a public
entrepreneurial hat” and more cautious claims
among research peers.22 The hype generated
about the future promises of synbio also
contributed to further alarmist scenarios about
its risks, namely weaponisation and bioterrorism.
Narratives on the biosecurity implications
of synbio have carried a strong element of
technological determinism, with presumptions
that once developed, synbio will get out of
control.23
Regulatory Concerns
Mass media have overstated and sensationalised
the risks of synbio in amateur settings (often
in analogy to the famous case of the autumn
2001 Anthrax letters attacks in the United States
in the aftermath of the 11 September attacks).
Nevertheless, merely because the risks have been
highly overstated, this does not mean they do not
exist. At least in theory, ‘garage terrorism’ is not
inconceivable and there is scope for warranted
prudent reaction.
18 Kathleen Vogel “What is the Role of Tacit Knowledge in
What Malevolent Actors could Achieve?”, Workshop Report
“Synthetic Biology and Biosecurity: How Scared Should We Be”,
www.kcl.ac.uk/sspp/departments/sshm/research/Research-Labs/
CSynBI@KCL-PDFs/Jefferson-et-al-%282014%29-SyntheticBiology-and-Biosecurity.pdf, p. 25.
19 There has been a clear shift in the dependence on certain
skills due to standardisation and mechanisation, but the dynamic
of de-skilling is often wrongly understood to mean that any
layperson will become qualified to produce new organisms.
20 Tucker, “Introduction”, p. 9.
21 Mads Borup, Nik Brown, Kornelia Konrad and Harro
van Lente, “The Sociology of Expectations in Science and
Technology”, Technology Analysis & Strategic Management, 18,
¾, July-September 2006, pp. 290-291.
22 Ibid, 292.
23 Jefferson, “Synthetic Biology and Biosecurity in the Media”,
Workshop Report, p. 16.
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STRATEGIC SECURITY ANALYSIS
GCSP - SYNTHETIC BIOLOGY AND ‘AMATEUR SCIENCE’: DUAL-USE AND CHALLENGES OF REGULATION
The issue of misuse of synbio by amateur
scientists is a new challenge with regards to
regulation, having no similar precedent. At the
same time, it can certainly be argued that such
challenges do not emerge in a regulatory vacuum.
Some of the sources of regulation could fall within
existing hard and soft laws, from regimes of
export controls and customs systems that regulate
hazardous materials, to codes of conduct.
There are global regimes as well as regional and
national laws that cover the problem of misuse
of biology. The fundamental ethical norm at the
root of all these initiatives is that “toxic chemicals
and disease agents should not be used as
weapons”.24
The Geneva Protocol of 1925 (banning the use
of biological and chemical weapons in warfare),
the Biological Weapons Convention of 1972,
and the Chemical Weapons Convention of 1993
form the backbone of international law related
to the governance of dual-use technologies.25
However, even the conventions that are legally
binding have been signed and ratified by states,
and do not have the mechanisms to hold ‘rogue’
individuals or garage terrorists accountable. There
are numerous other international frameworks
that cover bioethics. For example, the Universal
Declaration on the Human Genome and Human
Rights (1998), the UNESCO Declaration on
Bioethics and Human Rights (2005) and the
World Medical’s Association’s Declaration of
Helsinki (adopted in 1964 and amended in 2008)
cover aspects related to medical research, ethics
in research in life science, while advocating for
responsibility and the respect of human dignity.26
Of course, these instruments leave many
issues unaddressed and eventually could do
little in addressing actors operating in obscure
and remote labs. There are no international
mechanisms of outreach, control and oversight for
amateur biologists. Considering the complexity of
the issue, it is difficult to expect such mechanisms
to develop in the near future. More realistic
options for regulation and surveillance are present
within national boundaries, such as in the United
States, where biosecurity governance benefits
from highly developed and extensive biosecurity
legislation, particularly following the provisions of
24 Jefferson, “Protein Engineering”, Tucker, ed., op.cit, p. 127.
25 Lori P. Knowles, “Current Dual-Use Governance Measures”,
Tucker, ed., op.cit, p. 46.
26 The European Group on Ethics in Science and New
Technologies to the European Commission, “Ethics of Synthetic
Biology” Opinion No 25, Brussels, 17 November 2009, www.
erasynbio.eu/lw_resource/datapool/_items/item_15/ege__
opinion25_en.pdf , 35.
the USA Patriot Act. This uses tools from criminal
law to combat manufacturing of biological
weapons and terrorism. Other countries, however,
are less prepared for the challenge.
There are major limitations to the governance
of an issue as complex as the use of synbio by
amateur biologists. The operational site of such
groups could go undisturbed in most countries as
it very difficult to trace the works of all individuals
working in isolated or secluded labs. Moreover,
even if some countries are better able to track
down ‘garage terrorists’, it is easy to imagine they
could simply choose to move their operations
to ‘safer’ (meaning less policed or monitored)
countries.
One obvious solution is for the community of
amateur scientists to self-regulate. The DIY
Community has taken a proactive step to prove
its commitment to responsible research. In 2011,
at a congress in London, they issued a Draft Code
of Ethics. The “Peaceful Purposes” section in the
Code clearly mentions that “biotechnology must
only be used for peaceful purposes”.27 In addition
to its purpose to promote best practices, a key
motivation for the Code was to address concerns
about security risks.
This is a timely and laudable initiative but is in no
way comprehensive. By its nature, the Code of
Ethics offers no guarantee that the commitments
of the Code will be fully implemented and
that actors outside this community will have
the same approach. Challenges remain and
dialogue is important to foster trust. The Federal
Bureau of Investigation in the US has already
engaged in dialogue with the DIY Community
and has discussed safety and security aspects of
amateur biologists’ work. Proactive engagement
is an important step in creating transparent
communication and eliminating fears of
malevolent intent.
About the author
Ioana Puscas is Research Officer in the Geopolitics
and Global Futures Programme of the Geneva
Centre for Security Policy (GCSP).
27 “Draft DIYbio Code of Ethics from European Congress”,
2011, http://diybio.org/codes/draft-diybio-code-of-ethics-fromeuropean-congress/.
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