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The global proliferation of high-containment biological laboratories: understanding the phenomenon and its implications

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Abstract

Disease-causing pathogens have been with humanity for as long as the species has existed, but the world has changed. The human population is increasing and becoming more globalised. Meanwhile, the international system remains unstable and biotechnology is advancing at a breakneck speed. Humans are coming into contact with new and re-emerging pathogens as they spread into previously uninhabited environments. Pathogens play an increasingly global role, and infectious disease is becoming less confined by geographical or climatic boundaries. In order to meet these new challenges, both states and the private sector have been building an increasing number of high-containment biological laboratories (HCBLs) that work with biosafety level (BSL) 3 and 4 pathogens. This rate has increased sharply since 11 September 2011, and most states that have the means to build such laboratories do so. Pathogens do not stop at borders, and the more prepared a state is to deal with them, the better for its national security. Although there is information available on the world's BSL-4 laboratories, none of it includes the proliferation of BSL-3 laboratories. This paper attempts to create a working database of the state of global HCBL proliferation. It seeks to analyse the data and to understand how we are dealing with this phenomenon, the risks involved, and the possible measures to be taken. The information is inevitably complex and certainly far from complete, but it is the author's hope that it will provide a sufficient basis from which to make useful, actionable inferences.
Rev. Sci. Tech. Off. Int. Epiz., 2018, 37 (3), 857-883
The global proliferation of high-containment
biological laboratories: understanding the
phenomenon and its implications
A. Peters
Infection Control Programme and World Health Organization (WHO) Collaborating Centre on Patient Safety,
University of Geneva Hospitals and Faculty of Medicine, Rue Gabrielle-Perret-Gentil 4, 1211 Geneva 14,
Switzerland
E-mail: alexandra.peters@hcuge.ch
Summary
Disease-causing pathogens have been with humanity for as long as the species
has existed, but the world has changed. The human population is increasing
and becoming more globalised. Meanwhile, the international system remains
unstable and biotechnology is advancing at a breakneck speed. Humans are
coming into contact with new and re-emerging pathogens as they spread into
previously uninhabited environments. Pathogens play an increasingly global role,
and infectious disease is becoming less confined by geographical or climatic
boundaries.
In order to meet these new challenges, both states and the private sector have
been building an increasing number of high-containment biological laboratories
(HCBLs) that work with biosafety level (BSL) 3 and 4 pathogens. This rate has
increased sharply since 11 September 2011, and most states that have the means
to build such laboratories do so. Pathogens do not stop at borders, and the more
prepared a state is to deal with them, the better for its national security. Although
there is information available on the world’s BSL-4 laboratories, none of it includes
the proliferation of BSL-3 laboratories.
This paper attempts to create a working database of the state of global HCBL
proliferation. It seeks to analyse the data and to understand how we are dealing
with this phenomenon, the risks involved, and the possible measures to be taken.
The information is inevitably complex and certainly far from complete, but it is
the author’s hope that it will provide a sufficient basis from which to make useful,
actionable inferences.
Keywords
Biosecurity – Bioterrorism – Epidemic – International security – Laboratory – Pathogen –
Proliferation – Public health.
Introduction
Disease-causing pathogens have been with humanity for as
long as the species has existed. We live in an age where the
world’s population is growing exponentially and humans
are in constant contact with each other, with animals,
and with the environment. The possibility of an epidemic
travelling around the world at an unprecedented rate is
becoming increasingly likely.
This interconnectivity, coupled with rapid advances in
biotechnology and the emergence of violent extremist
groups, makes for an increased biological threat to humanity.
Some violent extremist groups have expressed direct interest
in acquiring biological weapons, or have already tried to
implement programmes for their development (see the
section ‘Bioterrorism: the threat posed by non-state actors’).
High-containment biological laboratories (HCBLs) have
become an indispensable part of many national security
programmes because they can help counter the three types of
biological insecurity: natural epidemics, intentional misuse,
and accidental dissemination. The term refers to biosafety
level (BSL) 3 and 4 laboratories, which are specifically
designed to prevent pathogenic or infectious organisms from
coming into contact with the environment, and to protect
doi: 10.20506/37.3.2892
858 Rev. Sci. Tech. Off. Int. Epiz., 37 (3)
the people working with them. Most developed nations
have such facilities, though their very existence raises
important security issues. There is insufficient international
oversight of the research conducted, and little research on
the threat that these facilities and their contents pose. Both
governments and industry hold stakes in researching high-
containment agents. Most states operate within a complex
matrix of external and internal pressures, including the
information that governments receive, how they use it, and
their people’s interests and fears.
Since 11 September 2011 (9/11), there has been a
marked proliferation of these laboratories worldwide (see
Appendix 1). This proliferation increases the ability to
understand and treat disease, and helps protect humans
against pathogens. Paradoxically, this phenomenon also
increases insecurity. The possibility of accidents, thefts or
diversions, or malicious use of pathogens multiplies with
every additional laboratory built. The more labs we build
to protect ourselves, the more ostensibly unstable the
situation becomes. While it is difficult to analyse precisely
the increased risk of this proliferation in the context of the
benefits to society, it is important to raise these questions
before building new laboratories or when deciding where
to allocate increased security measures. An increase in
the number of HCBLs without improving standards for
safety and oversight leads to an increased risk both for
accidents in facilities and for potential pathogen diversion
or recruitment of laboratory personnel by non-state actors
(NSAs). An overview of HCBLs globally is useful both for
analysis of the current situation and as a starting point for
further research.
Currently, most states that can build laboratories do so.
This has resulted in something akin to a free-for-all of
construction without any systematic oversight – there is
no comprehensive list of how many HCBLs exist globally.
Although some of these issues are beginning to be explored,
analysis is generally lacking both in scope and in depth,
largely due to a lack of organised data. Information remains
incomplete about the rate and extent of HCBL proliferation,
the location of facilities, and their functions. This makes it
difficult for measures to be taken on national or international
levels, and for governments to focus on the most important
issues such as national oversight, international standards
for HCBL construction and maintenance, and screening
and training of personnel. Addressing these issues would go
a long way towards preventing both accidents and possible
diversions of pathogens.
The recent global increase in the number of HCBLs has
been driven by a ‘perfect storm’ of factors: a global increase
in violent extremism, fear of biological weapon (BW) use by
NSAs, the emergence of new diseases, and the re-emergence
of previously known diseases in new geographical areas. The
global human population has more than doubled since 1960
(1), and increased population density and mobility have led
to the ‘globalisation of diseases’ (2), enabling epidemics
to spread much farther and faster than they could before
(3, 4). Diseases such as cholera, tuberculosis, diphtheria,
plague, yellow fever and dengue are reappearing (5). By
having contact with previously uninhabited environments,
humans can be exposed to zoonotic diseases with which
they had no prior contact (6).
The HCBLs provide the safest possible environment to
identify and research these pathogens. They are instrumental
in preventing and responding to natural outbreaks, and offer
the hope of better response to the threat of bioterrorism
(7). However, their proliferation is a paradox: the more
labs we build to protect ourselves, the more precarious the
environment becomes. Although research on pathogens
saves lives, something as small as a faulty air vent could
create a global health crisis. Though they play a critical
role in the study of emerging diseases and in biodefence
efforts, HCBLs remain vulnerable to accidents, and could
conceivably increase the risk of terrorist BW use by acting
as a possible source of pathogens or knowledge. This paper
seeks to synthesise a body of data on HCBL proliferation,
analyse its implications, and offer policy recommendations.
Data collection for the paper
The main body of research consists of Appendix 1, which
lists 86 states that possess or are currently building HCBLs,
the number of laboratories known in these states, whether
they had bioweapons programmes, and other relevant
information where available (8). Where there is a gap in
reliable data, it is marked in the Appendix with ‘N/A’ (not
available).
An effort was made to gather as much information about
the laboratories as possible in order to be able to accurately
identify and assess patterns of proliferation. This information
can help policy-makers make informed decisions to reduce
vulnerabilities.
It is worth noting that many of the world’s HCBLs belong
to private or academic institutions, many of which are
not subject to governmental oversight. The information
available varies significantly from state to state: often, facility
location, activities and ownership are unknown, even to the
government of the state in which the laboratory is located.
The author cannot claim that the Appendix is complete; in
fact, it is guaranteed not to be, owing to the vast differences in
reporting and the growing number of HCBLs (9). Although
many countries seem to be quite forthcoming about their
activities, one cannot assume that this is universally the case.
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Rev. Sci. Tech. Off. Int. Epiz., 37 (3)
High-containment biological
laboratories
The genesis of HCBLs is rooted in United States
military research during the Second World War. Before
biocontainment evolved, there was no reliable way to protect
a researcher working with biological agents. Therefore,
HCBLs became a necessary structure in which to research
the most dangerous pathogens. They eventually came into
use in hospitals, private industry and universities. They also
remained in use for BWs programmes. In most countries,
laboratories are assigned a BSL between 1 and 4. The higher
the number, the better the laboratory is equipped to work
with the most virulent and infectious organisms. As used
here, the term HCBL includes BSL-3 and BSL-4 laboratories
only. The BSL-3 laboratories are designed to house
organisms (usually viruses or bacteria) that infect humans
through inhalation (aerosol) and can be lethal (10, 11). The
BSL-4 laboratories house agents that transmit disease either
by aerosol or in an unknown way, which are often fatal
to humans, and for which there are generally no known
treatments or vaccines (11). The laboratories themselves are
subject to complex safety measures (10) and certifications
(12), and are very expensive to build and maintain (12, 13).
Biosafety, biosecurity and biodefence
It is important to distinguish among biosafety, biosecurity
and biodefence. Biosafety mainly concerns the safety of
people working in a laboratory, and how well its containment
functions (14). It includes equipment, and the construction
of the laboratory itself, as well as the practices used by
workers (15). Biosecurity is the protection of facilities or
laboratories against theft or diversion of agents that could
be used for bioterrorism or to proliferate BWs (15).
Biodefence is the science, technology and policy of how
to protect against both natural epidemics and those due
to bioterrorism. However, individual states’ definitions of
biosecurity vary significantly: while some countries consider
certain activities to be biodefence, others do not, and
thus do not report them as such. Biodefence programmes
range from mostly civilian to mostly military. Japan and
Switzerland, for instance, have ‘mostly civilian’ biodefence
activities; those of the United States of America (USA),
Germany, India and South Africa are ‘to a greater extent
civilian’; and those of the United Kingdom (UK) are ‘to a
greater extent military’ (8). In the Appendix, any activities
or programmes considered by the state to be biodefence
are labelled as such, but the difference in scope among the
programmes can be significant, and this should be taken
into consideration.
High-containment biological laboratories
and biological weapons
While a state bioweapons programme needs an HCBL, there
are instances of crude low-tech BWs use by NSAs that did
not necessarily use BSL-3 or -4 pathogens and were prepared
without an HCBL. The HCBLs are developed for a number
of legitimate reasons including studying endemic disease
and potential epidemics, defence against bioterrorism,
studying animal and plant pathogens, producing vaccines
and working with genetically modified organisms (GMOs).
The laboratories can exist in national centres, academic and
private institutions, and hospitals.
Biological weapon production has three components: agent
production, weaponisation, and storage. Of these, only
weaponisation presupposes specialised technology and
processes that are rarely used for legitimate purposes (16,
17). All other processes and equipment necessary in BW
production are dual-use (18). Pathogens can be found in
nature, and can be grown in petri dishes, in fermentation
vats (bacteria) or in hosts (viruses). Toxins can also be
produced artificially, by adding the DNA coding for the
toxin to bacteria that produce it when they multiply (19).
Technology now allows the synthesis of viruses based on
their genome, and genetic engineering can increase the
pathogenicity of a bacterium or shorten the incubation
period of a disease (19). Synthetic biology, where DNA is
created ‘from scratch’, is also advancing rapidly. Purifying
and storing pathogens is as useful for BW stockpiles as it
is for vaccines. As far as the laboratories are concerned,
the deciding factor between a state BWs programme and
legitimate research is the intent behind it.
Because HCBLs are necessary for a state weapons
programme, it is expected that states with former weapons
programmes will have them. This does not mean, however,
that these labs are currently used for BW/defence research.
It is true that if the targets are plants or animals (which
could cause a great deal of disruption and economic loss)
then not all state BWs programmes would need HCBLs as
many of those pathogens are not considered dangerous
enough to humans to necessitate an HCBL. The states that
had such programmes (USA, UK, Germany, Russia, Canada,
the People’s Republic of China [China], South Africa and
France) contain the bulk of the world’s HCBLs: together
they have at least 2,595 such laboratories of the more than
3,204 worldwide. However, there are states without former
weapons programmes that have a relatively large number of
HCBLs: Sweden is an example.
Technically, a government biodefence HCBL could rather
quickly be converted into an offensive BWs programme.
States with advanced biodefence programmes could be
considered to have a latent BW capability, regardless of their
intentions. The technology needed to disperse or weaponise
860 Rev. Sci. Tech. Off. Int. Epiz., 37 (3)
such agents is often not very advanced and is used in other
industries for perfectly normal applications.
Since the Biological Weapons Convention (BWC) was
opened for signing in 1972, the overwhelming number of
signatories made it clear that most countries were against
the use of BWs as a legitimate tool of war (20). By the time
it went into effect, Canada, France, Germany, the UK and
the USA had already unilaterally dismantled their offensive
BWs programmes. In the 1990s Russia and South Africa
followed suit (21, 22). The author cannot rule out the
existence of some offensive programmes (see Appendix 1),
but the shared ethical norm that prevents state BWs use
may influence why governments are more concerned about
BWs use by NSAs than by states.
An analysis of the current
situation
Although some information concerning dates of
construction is incomplete, one can see a distinct pattern
of global proliferation of HCBLs. States are often quite open
about their laboratories. The notable exception is Israel,
which does not confirm possession of HCBLs, although
it regularly publishes defensive BWs research (23). The
Appendix shows that these laboratories are proliferating
both horizontally and vertically: more states are building
them, and the states that have them are building more of
them. Of the 86 states analysed, close to 40 have explicitly
described recent HCBL construction. Anecdotal evidence
of new construction exists for numerous additional
states, as does the expansion of existing programmes
(see Appendix 1). For the remaining states that did not
mention the dates of construction, the sources were recent,
implying that the HCBLs were recent too. For example, in
the USA, the number of HCBLs registered with the Centers
for Disease Control and Prevention (CDC) tripled between
2004 and 2008 (this number does not include the
laboratories working with pathogens that are dangerous
but do not require registration, such as tuberculosis and
severe acute respiratory syndrome [SARS]) (24). No
states deliberately declare that they do not want any more
laboratories, although Ireland maintains that no BSL-4
laboratories are planned, and Japan does not allow its
BSL-4 facilities to operate at that level because of public
opposition.
Issues with oversight: case study of the United
States of America
The initial aim in compiling a table showing the proliferation
of HCBLs was to list the numbers of BSL-3 and BSL-4
facilities in each country, permitting an exact analysis of
the scope of HCBLs globally. Although this information is
available for some states, exact numbers are unavailable
for others, often due to a lack of national oversight. The
most glaring example is the USA, which has well over
1,600 labs – by far the world’s highest number of HCBLs (see
Appendix 1). In 2007, the US Government Accountability
Office (GAO) admitted to ‘a major proliferation of high-
containment BSL-3 and BSL-4 laboratories’ (25). According
to the GAO investigation, no agency of the 12 interviewed
tracks the number of HCBLs in the USA, and ‘consequently
no agency is responsible for determining the risks associated
with the proliferation of these laboratories’ (25).
Although the facilities that are federally funded or work with
select agents (as listed in the CDC and US Department of
Agriculture’s Select Agents Program) are documented, many
laboratories fall outside this group (26). According to the
GAO report, while the USA had only five BSL-4 laboratories
before 9/11, by 2007 they had 15, including at least one
still being planned (25). According to the Federation of
American Scientists (FAS), documentation exists for only
12 of them, two of which have an unconfirmed status, and
three of which are under construction (27). Gronvall et al.’s
2007 list of BSL-4 laboratories stated that there were 11,
including four that were due to be completed in 2008
(28). A 2008 GAO report to the Congressional Committee
is titled, ‘Perimeter Security Assessment of the Nation’s
Five BSL-4 Laboratories’. It is not made clear why in this
later GAO report only five laboratories are mentioned.
On page one of the report, reference is made to the 2007
GAO report, but the number of BSL-4 laboratories in the
2008 report is one-third of the number given in 2007 (26).
Despite the fact that all these BSL-4 facilities are known to
the government through the Select Agents Program, there
are major discrepancies in the reporting.
According to the latest (2015) GAO report (29) the situation
has yet to be remedied. There is still no federal agency with
comprehensive oversight of HCBLs, and the CDC’s new
Laboratory Science and Safety Office had, as of 2015, not
yet fully implemented the GAO’s earlier recommendations.
The official estimates for the numbers of BSL-3 laboratories
vary even more, with discrepancies of up to 100% in 2005
(28). It is important to note the USA is not alone in its lack
of oversight, it just has the largest number of HCBLs and
easily available information regarding them.
High-containment biological laboratories and
levels of economic development
To explore the connection between economics and HCBLs,
the states in the Appendix were compared to those in the
Financial Times Stock Exchange (FTSE) Global Equity
Index Series. All of the 24 ‘developed nations’, 11 ‘advanced
emerging nations’, and 12 ‘secondary emerging nations’
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have HCBLs (Hong Kong is listed separately from China
by the FTSE, but not in the Appendix to this paper) (30).
Although correlation does not prove causation, it seems
that most states with the financial means to build these
laboratories do so. The HCBLs can also generate substantial
income: for some states, biotechnology has been a boon to
their economies (31, 32, 33, 34). The number of HCBLs
owned by private institutions further illustrates their
lucrativeness.
Threat
Threat is defined here as danger to the well-being of people
or to the integrity of a state. In its most basic interpretation,
threat concerns the release of a dangerous HCBL agent into
an environment outside the laboratory. There are three ways
in which this can occur: accidents, theft/diversions, and
events that compromise the structural integrity of the HCBL
(both natural disasters and intentional attacks) (35). The
HCBL proliferation in and of itself also constitutes a threat:
increased lab numbers mean more vulnerabilities.
Biological weapons: the threat posed by states
There are historical accounts of states using biological
agents since ancient times (36, 37), but these were hardly
what we would consider a BW today (36). In the First
World War, covert German operations in Romania infected
livestock that were intended for export to Russia with
anthrax and glanders (38). After the First World War, the
Geneva Protocol attempted to prohibit poisonous gases
and biological warfare, and all the great powers except
for the USA and Japan signed it (39). Japan conducted
numerous operations in China, spraying agents causing
cholera, salmonella, anthrax and plague from aircraft. These
activities had various degrees of success (including infecting
the Japanese troops themselves), but about 10,000 cholera
cases in China were attributed to their activities (36).
Besides these Japanese ‘field trials’, there is no other proven
incident of a state using BWs against another state (40, 41).
Although the stated reasons for building HCBLs are not
necessarily the only reasons for building them, it is worth
mentioning that no state has explicitly justified their
biodefence programmes as a precaution against the threat
of state-deployed BWs. The use of BWs is considered
illegitimate by most states (20), although some state-
sponsored BWs programmes allegedly could still exist.
There are a number of good reasons for a state to avoid
using BWs against another state. Because BWs are almost
universally perceived as illegitimate, and compliance with
the BWC has been very high, retaliation against a state
using BWs might be stronger than if it used conventional
weapons. Furthermore, BWs use could endanger a state’s
own army through either direct contamination or contagion.
Considering these drawbacks, state access to conventional
weaponry, and historical precedent, it is unlikely that states
will use BWs against each other.
Bioterrorism: the threat posed by non-state
actors
At least 32 of the 78 states analysed possess some sort of
biodefence programme. There are some states for which
information is unavailable, but they are likely to have a
biodefence programme if they have been accused of offensive
research (see Appendix 1). Finland, Japan, the Republic of
Korea, Switzerland, the Philippines, the UK and the USA
have all explicitly mentioned bioterrorism as reasons for
their biodefence programmes (42). There are isolated cases
in which individuals and NSAs have attempted to deploy
biological agents (43), and only two in which they have
been weaponised (put into a form or delivery vehicle for
use as a BW) and deployed – both with little success. The
Rajneeshee cult infected salad bars with salmonella in 1984,
and Aum Shinrikyo attempted to cause an inhalational
anthrax epidemic in 1993, but neither event resulted in
any casualties (43). The 1993 event in particular raised
states’ awareness of the threat of terrorist use of weapons of
mass destruction (WMD) (44), but these events happened
too early and were of too little human significance (in that
there were no casualties) to explain the extent of states’
preoccupation with bioterrorism.
This focus can be traced to two particular incidents in
2001. The first is 9/11, and the second is the anthrax
letter attacks. Although 9/11 was an act of conventional
terrorism, it demonstrated that even a nation like the USA
was vulnerable to attack on its own soil. This significantly
increased awareness of all types of terrorism, including
bioterrorism (45). Islamic terrorist groups have openly
declared their intention to pursue BWs capability (46,
47) and have developed rudimentary programmes (48).
Although these efforts have been ‘largely unsuccessful’, they
have been taken very seriously (49).
The anthrax attacks in 2001 were of limited scope,
and there were only five casualties (50). Scientist Bruce
Ivins was the primary suspect of the Federal Bureau of
Investigation (FBI), based on circumstantial evidence,
and the case was closed after he committed suicide. The
inability to definitively resolve the question of who had sent
the letters was alarming for two reasons. Firstly, efforts were
unsuccessful despite the significant resources expended.
Secondly, the fact that the bacterial strain was domestic
meant the government had ready access to facilities and
staff, which would not have been the case had the strain
been foreign in origin. The failure to resolve this case was a
global wake-up call to the inadequacy of current biodefence
resources (42, 49, 51, 52).
862 Rev. Sci. Tech. Off. Int. Epiz., 37 (3)
In 1988, terrorism expert Brian Jenkins speculated that
terrorists ‘want a lot of people watching, not a lot of people
dead’, and that terrorist groups avoid causing too much
public revulsion for fear of alienating their constituents
and inviting government retaliation (53). Although this
may often still hold true, terrorism has evolved. In 2002,
Islamic terrorist group spokesman Sulayman Abu Ghayth
al-Libi claimed that his group’s fatwa is to kill four million
Americans, and that it justified the use of WMD (47). If
terrorist ambitions have indeed shifted towards wanting a
large number of people dead, then we need to re-examine
our understanding of terrorist behaviour. Unlike a state,
these groups do not have large conventional armies at their
disposal, so pursuing WMD (including BWs) could become
a logical option. Currently, it is still easier and cheaper for
terrorists to use conventional weapons, and they seem to
be putting most of their resources into those. However,
the psychological effect and mass panic that would ensue
if a population were subjected to biological attack may
be a motivator to pursue BWs. In any case, bioterrorism
has become a global concern; the US State Department
considers potential terrorist WMD use to be one of the
“gravest threats” to the security of the United States and
its allies’ (54).
The HCBLs play a dual role in bioterrorism: they can
function both as its source and as the primary line of defence
against it. For terrorists to be successful in developing BWs,
they need access to at least a rudimentary version of an
HCBL (or at the very least a BSL-2 lab), either for studying
pathogens, or for producing the desired quantity. All known
pathogens except for smallpox and the 1918 influenza
pandemic virus are present in the environment. Attempts to
make BWs, presumably without the correct facilities, have
not worked well in the past: in 2009, a 40-member terror
cell working on BWs was killed by bubonic plague (48). In
the future, it is logical that the terrorist organisation would
recruit trained scientists and use facilities already in place
rather than trying to develop their own.
In order to have a pathogen viable for weaponisation, a
terrorist group must either try to isolate a pathogen from
nature or divert one that is already identified, purified
and growing in a lab. When isolating from nature there
may be fewer agents available, and the process may
require additional technical resources or experience in
order to isolate, culture and purify the desired pathogen.
Furthermore, not all strains of a certain pathogen are
equally virulent, as was seen when Aum Shinrikyo used the
wrong strain of anthrax and consequently failed to achieve
their objective (55). Since diversion is typically easier than
isolation, biosecurity and personnel reliability programmes
in laboratories are essential to protect pathogens. The
HCBLs also play a crucial role in combating bioterrorism,
since much of the world’s biodefence focuses on pathogen
identification, treatment development and vaccine
production. A US Government assessment concluded that
most accidents are due to human error. It found that people
working in these laboratories can pose a risk, and that it
is difficult to control inventories of biological agents with
the technology available (56). Making it more difficult for
employees to divert pathogens and making sure that the
personnel working in the labs are highly trained and reliable
are paramount to maintaining security.
Threats posed by accidents and natural
disasters
Accidents and disasters happen, even among reputable
scientists working in state-of-the-art laboratories (57).
The fact that many labs have been built in areas of high
population density further raises the stakes in case of
a mishap (58). It is believed that a large percentage of
accidents in HCBLs go unreported, especially if there are no
serious consequences (56, 59).
Examples
In 2006, at a Texas A&M BSL-3 laboratory, a worker
became infected with Brucella after working on aerosolising
the bacterium. She had neither the training nor the
authorisation to work with that particular pathogen, and
was diagnosed more than two months after exposure. The
laboratory did not have the authorisation to aerosolise
brucellosis and did not report the incident to the CDC. It
was later also discovered that some vials of Brucella as well
as some diseased laboratory animals had gone missing from
the same lab (25). More recently, there were US government
incidents involving the mishandling of anthrax in both
2014 (60) and 2015 (61). In 2014, the USA also discovered
over 300 previously unknown vials of agents that had been
kept undocumented in their storage facilities for decades;
some of these included smallpox (62).
On a nationwide scale, the lack of oversight and reporting
is even more evident: under the Federal Select Agent
Program, US labs are required to report any accidents or
accidental releases of specific agents. This programme
oversees approximately 300 laboratories in the USA. It is
unclear who oversees the rest (63), but oversight is probably
privatised. Between 2006 and 2013, federal regulators were
notified of approximately 1,500 incidents involving select
agents, 800 of which required some medical evaluation or
treatment (63). Incidents like these are surely not isolated
and are probably underreported globally, especially in
countries that do not have as clear a protocol on laboratory
regulations and accident reporting as the USA does.
Sometimes the threat of accidental release lies in the physical
structure of the laboratory. Depending on the regulations and
financial means of a country, the building’s structure may be
more or less secure. Even if built to international standards,
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Rev. Sci. Tech. Off. Int. Epiz., 37 (3)
operational and annual maintenance must be done. Air filters
need to be changed, and equipment becomes less reliable
with age: seals can crack, and mechanical systems can fail.
A UK outbreak of foot and mouth disease in 2007 originated
from contaminated wastewater, which had leaked from a
damaged drainage system at the Pirbright HCBL (25). An
investigation of the facility found evidence of a leaking
drainage system, damaged pipes, displaced joints, debris
build-up and damage from tree roots. It is thought that the
disease spread via vehicles driving through contaminated
mud and carrying the pathogen off site (25). A previous
outbreak of the disease in the UK in 2001 led to the culling
of six million animals, and cost taxpayers over £3 billion
and private enterprise £5 billion (64).
Laboratories in zones where natural disasters are
common are particularly at risk. In June 2007 the
CDC’s newest BSL-4 laboratory in Atlanta suffered a
thunder storm and experienced a power outage whereby
both its primary and back-up energy systems failed. The
power outage also shut down the negative air-pressure
system (although this is not the only measure used in labs
to keep a pathogen contained). Luckily, the facility had just
been completed and there were no pathogens stored there
at the time (25).
Accidents with mutated or genetically engineered pathogens
can be even worse, as well-intentioned research is capable of
producing virulent or transmissible organisms that do not
exist in nature; for example, the US Government funded
research on influenza that led to two papers written in 2012
on aerosol-transmissible mutations of the avian flu virus
H5N1. Some argue that such research should never have
been conducted, while others maintain that more must be
done to correctly understand the disease (which naturally
mutates on its own) (65). Since that time, a number of
other papers have also been published on this topic and
additional studies have been conducted.
As researchers and universities compete for recognition and
funding, it is difficult to draw the line between what should
and what should not be studied and published. Numerous
governments have developed guidelines concerning the
regulation of dual-use research, in an effort to balance
prioritising research on pandemic and emerging diseases
with regulations for responsible science.
The threat posed by the proliferation of high-
containment biological laboratories
More laboratories mean that there are more places where
failure can occur or from which agents can be diverted. One
must assess whether it is safer to build HCBL facilities in
fewer places with more laboratories in each, or whether it is
safer to disperse them.
It could be more difficult for governments to oversee and
protect many separate facilities. Fewer facilities could mean
better oversight; putting more laboratories in the same
buildings would lower costs, possibly leaving more of the
budget for additional security measures. Some states tend
to do this: Canada, for instance, has over 35 individual
BSL-3 laboratories at just one of their facilities. Romania and
Belgium also have the majority of their BSL-3 laboratories
housed together (see Appendix 1). On the other hand, if a
natural disaster impacts a facility holding a large number of
laboratories, the consequences could be worse than if the
same event were to strike a smaller facility.
Another pertinent issue caused by HCBL proliferation
concerns the competency of scientists working in them.
Because the number of HCBLs is rising, more people are
needed to staff them. In the USA, 8,335 individuals had
clearance to work in HCBLs in 2004, and by 2008 that
number had increased to 10,365 (59). What used to be a
small group of the world’s top scientists has now broadened
to include people who are less educated or experienced:
top scientists cannot be educated fast enough to meet the
increasing demand. This is probably an even bigger issue in
countries that do not have the infrastructure to train their
own scientists. This may force laboratories to hire less well-
qualified people, who may be more susceptible to human
error than their more educated or experienced counterparts.
The dramatic increase in trained HCBL scientists may also
present a larger pool from which terrorists can recruit.
Having access to researchers with a background of work in
high-containment facilities would be a boon to any terrorist
BWs programme.
Each person working in an HCBL is an independent
variable whose actions cannot be guaranteed by even the
most stringent and redundant biosecurity measures. More
scientists mean that there is a greater probability that one
of them could have malicious intent, or be psychologically
unstable. Background checks, psychological tests and
certification may reduce these risks, but it is unclear how
many countries implement these measures when hiring
personnel. States may have limited control over laboratories
that are not state run. Obliging them to comply with all the
safety regulations is difficult in the first place; making them
accountable for guaranteeing the intentions of each one of
their researchers is impossible.
Measures taken thus far
Globally, there are 37 national and regional members of the
International Federation of Biosafety Associations, and as
864 Rev. Sci. Tech. Off. Int. Epiz., 37 (3)
many again have ‘observer’ status (66, 67). A few examples
are detailed below to show the range of situations and
approaches regarding threat management.
Institutional level
Biosafety measures are the first line of defence against
accidents and diversions. Most HCBLs have an extensive
number of physical security measures in place, such as
alarms, fences, cameras, etc. (68). Some have armed
guards, or require that researchers are never alone in the
laboratory. Institutions often voluntarily decide on extra
security measures individually (59). Although biosafety
measures are required for official laboratory certification,
there is always the risk that some laboratories will work
with pathogens that they are not certified for.
National level
The levels of standardisation and national oversight of
HCBLs vary greatly from state to state. Many base their
biosafety and biosecurity programmes on directives and
guidelines issued by international organisations. The World
Health Organization (WHO), the World Organisation
for Animal Health (OIE) and the Food and Agriculture
Organization of the United Nations (FAO) have all
published such guidelines (9). Some states have protocols
and standards to vet the personnel in governmental HCBLs,
but others appear not to.
There are major problems with every national system
examined (9, 56, 69, 70, 71, 72). Available information
on the biosafety and biosecurity measures of most states is
lacking, although many have some degree of government
oversight (see Appendix 1). This obviously requires more
resources for states with many HCBLs than for states with
fewer. Biosecurity protocols may be more rudimentary in
states with less experience or less funding. Many states with
former BWs programmes or the states working closely with
them seem to have more developed guidelines concerning
biosecurity, perhaps because they have a longer history of
working with these agents. More research needs to be done
to determine the degree of correlation and its significance.
No country examined currently has adequate oversight of
its HCBLs.
Regional and international levels
Along with the guidelines written by the aforementioned
international organisations, there is a growing level of
cooperation between states concerning biosafety and
biosecurity. Some of these measures directly affect HCBLs,
and others seem as though they should, but do not. Both
broad international agreements as well as a few regional
initiatives are examined briefly below.
All of the relevant international agreements concern BWs,
yet none addresses HCBLs specifically. The BWC has been
a factor in reducing mistrust between nations and creating
an international norm against state BWs programmes
(73, 74). There is nothing in the convention to monitor
the proliferation of HCBLs or to make them safer. Article X
even reaffirms its support for ‘the fullest possible exchange
of equipment, materials and scientific and technological
information for the use of bacteriological (biological) agents
and toxins for peaceful purposes’ (75).
The Australia Group’s main objective is to control exports of
certain chemicals, biological agents and equipment to ensure
that they avoid both ‘direct’ and ‘inadvertent involvement’
in the spread of chemical and biological weapons (CBWs)
(76). The Australia Group consists of 41 states, the majority
of which have HCBLs (77). Although this may make
Member States less likely to sell sensitive agents to states or
groups that might misuse such agents, the Australia Group
does not really have an impact on legitimate research being
done in HCBLs.
United Nations (UN) Resolution 1540 goes a step further.
Although it is concerned with preventing the spread of
CBWs, it focuses on the spread of agents and delivery
systems to NSAs. Per the 2004 resolution, states are called
to ‘establish appropriate domestic controls over related
materials to prevent their illicit trafficking’ (78). Domestic
controls for secure production, use and transport, physical
protection measures and law enforcement against trafficking
of agents are covered by the resolution (79). Licensing
personnel, registration and certification of all pertinent
facilities, as well as measures to ensure personnel reliability,
although not expressly stated, could be considered
measures that pertain to the resolution (80). It would be a
major step forward if UN resolution 1540 were to be fully
implemented by all states with HCBLs.
There have also been regional initiatives to increase
cooperation and knowledge-sharing, and to standardise
practices and procedures. In Europe, the European
Cooperation in Science and Technology (COST) Action
B28 was enacted ‘to increase knowledge on BSL3 and
BSL4 agents in order to support the development of
more accurate diagnostics, vaccines and therapeutics, and
to better understand the epidemiology of these highly
pathogenic microorganisms’ (42). The original impetus
for COST had its roots in the unpreparedness of European
laboratories at the time of the 2001 anthrax letters event.
After realising that most of the dangerous pathogen research
was in the USA and, because most of it was classified, ‘of
little use for the European Union’, the European Union
(EU) decided to launch a collaborative effort to be globally
competitive (42). Because the EU’s HCBLs are distributed
over a number of smaller states, they maximise productivity
through collaboration.
865
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The Middle East and North African (MENA) countries have
formed the coalition of Region Network High Containment
Laboratories (RNCL) in order to implement biosafety and
biosecurity strategies at the national and regional levels,
improve the infrastructure of laboratories and emphasise
staff training. Their work addresses the threats of both
natural pandemics and human-made risks (81). Coalitions
can identify measures for improvement but lack the power
of governments to implement them.
Recommendations: practical
and political
Proliferation of HCBLs will undoubtedly continue, but one
must ask how many of these laboratories the world needs.
Recently, the USA has begun thinking about reducing lab
numbers. Human ambition and error are dangerous in even
the most structurally sound laboratories. Terrorists will seek
the easiest way to make BWs, so oversight, background
checks and redundant security systems are vital. Natural
disasters or freak occurrences happen, and no laboratory
can ever be completely prepared.
Biosecurity measures must be implemented and verified.
Only laboratories that have been certified should house
dangerous pathogens, and each state should have a single
government agency responsible for monitoring and
certifying all their HCBLs, including private laboratories.
This could be done through a mandatory certification
and inspection process, where the government has access
to the relevant information on the type of research being
conducted, although this could pose issues for companies
working on proprietary research. Laboratories should be
checked frequently for equipment failures, and be required
to recertify periodically.
There must be clear protocols in place for emergency
response procedures. All mishaps should be reported
immediately to a single government agency, which should be
responsible for documenting and responding to accidents,
when needed. The governing state should know exactly what
types of research are being carried out where, regardless of
whether the laboratory is privately run or not. The intangible
aspects of security must be addressed as well, including
personnel background checks and psychological evaluations.
In general, governments and biorisk associations have
researched what needs to be done; the problem lies in the
implementation of their findings. Government action often
takes years, depending on the political system and the level
of priority attached to HCBL safety.
Because of financial constraints, many developing states
have difficulties building adequate HCBLs to study endemic
diseases that affect their populations directly. It is imperative
that these diseases are researched only in laboratories
equipped for the dangers they pose. Although accidents
can happen anywhere, they are likely to happen less often
and have less severe consequences in adequate facilities.
Because states seem to be the least dangerous actors with
regard to the use of BWs, it would be wise to increase inter-
state cooperation and knowledge-sharing.
Concerning HCBL oversight, states must embrace
a paradigm shift. Instead of viewing these labs solely as a
question of national security, they should recognise them as
a matter of global security. Increased cooperative measures
may also discourage states that are still conducting
questionable research, which may be done as much out of
habit or political determinism as out of a perceived need for
BWs. The era when a significant group of states felt that they
needed BWs seems to be drawing to a close. Standards for
biosafety and biosecurity in HCBLs must be internationally
agreed upon, standardised and implemented.
Although important, this goal represents a major policy
obstacle. Sharing oversight and/or ownership of research is
not only expensive and difficult to implement, but it also
raises issues of national sovereignty in this particular arena.
In order to foster oversight, countries with possibly different
values, priorities and research agendas are expected to share
their information, and give up a degree of their control to an
international body.
Asking the right question
The BSL-4 facilities have more government and international
oversight than BSL-3 facilities. However, although the
latter are too numerous to oversee easily, the majority of
potential BW pathogens are BLS-3 agents (82). Of all the
states that have ever had BWs programmes, only the former
Soviet Union and the USA have done any known research
on or weaponisation of BSL-4 agents (83). In all the
aforementioned instances of bioterrorism and attempted
bioterrorism, no individual or NSA has ever weaponised or
attempted to weaponise a BSL-4 agent.
Given the extremely virulent nature of BSL-4 agents, they
are difficult to work with, and thus rather self-protecting
(84, 85). It would be nearly impossible to safely freeze-dry,
mill and weaponise such a pathogen without an appropriate
facility. The BSL-4 agents are not necessarily more contagious
than their BSL-3 counterparts; they do, however, tend to
have fewer countermeasures and/or vaccines developed
to protect those working with them from exposure. The
danger of an agent depends not only on how lethal it is, but
how well it transmits from person to person. States should
keep this in mind when deciding on security features for
HCBLs.
866 Rev. Sci. Tech. Off. Int. Epiz., 37 (3)
For these reasons, it is important to be vigilant of
BSL-3 facilities in respect to bioterrorism. The pathogens
they contain can be just as deadly, and are far easier to work
with. Only approximately 2% of the world’s HCBLs are
BSL-4, and it is crucial that governments and international
organisations shift their attention to the other 98%.
Conclusions
In order to accurately analyse the threats HCBL proliferation
poses and minimise its risk, it is crucial to have an overview
of what types of laboratories are proliferating in which
states, and what types of research they are conducting.
Numerous states and interest groups are beginning to
demand better oversight of their HCBL facilities, and there
has been an increase in international cooperation as well as
some attempt at standardisation of practices and facilities.
Unfortunately, the measures that have been taken so far are
not yet adequate, and the degree of oversight and control
that states exert over their HCBLs varies considerably.
Going forward it is important for states to implement
strict national standards for safety and security, as well as
working with each other to foster increased international
trust, cooperation and oversight. Existing measures must
be strengthened and new ones developed for both national
and private laboratories. Pathogens do not recognise
borders, and states must regard HCBL proliferation as the
global issue it is.
Appendix 1
State BSL-4 laboratories BSL-3 laboratories BW/BDP (85) Activities/additional information
Algeria N/A 1 in 2014 (86) Evidence of past offensive
research, but not of production
(83)
Virology in association with Institut Pasteur (86)
Argentina 1 (87) 1 in 1998 (88) and between 2
and 9 now (89, 90)
N/A Human pathogens (89)
Australia 3 (82) More than 40 (91) BDP (92) Epidemics, tuberculosis (93)
Austria 1 under discussion as of
2009 (94)
At least 1 (95) BDP (42, 96) The BSL-3 lab specialises in prion diseases (95)
Azerbaijan N/A 1 under construction (97) N/A Disease surveillance, United States support (97)
Bangladesh 0 1 in 2010 (98) N/A Uses CDC guidelines. Endemic diseases (TB,
HIV, influenza) with IP (99)
Belarus 1 (28, 100) N/A N/A HIV, virus research and genetic research (101)
Belgium 0 4, with multiple BSL-3s at one
facility (102)
BDP (96) Animal and human pathogens (102)
Bolivia 0 1 planned (89) N/A Planned construction of BSL-3 with ANLIS
Laboratory in Argentina (89)
Brazil Ongoing discussion (70) 12 Public Health Laboratories
and 8 Agricultural Laboratories
(70, 89)
N/A Zoonotic disease including avian influenza IP
support (70, 103)
Bulgaria 0 Probably 1; the NRLIARD was
constructing a BSL-3 facility
(104)
BDP (96, 105) Influenza, hepatitis, other viruses (106)
Cameroon 0 1 in 2003 (86) N/A Centre Pasteur, public health and national
reference laboratory (86)
Canada 1 (4 BSL-4 laboratories in
the same facility) (107)
More than 3 facilities and at
least 32 BSL-3 laboratories in
one facility (98,107). Latest built
in 2012 (108)
Former offensive programme
(ended 1945) (83). Biodefence
programme (92)
Public health, disease prevention and control
(109)
Central African
Republic
0 1 in 2011 (86) N/A Arbovirus, haemorrhagic fever viruses with IP
(86)
Chile 0 1 (pre-1998) (88, 89) N/A Emerging diseases (89)
867
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State BSL-4 laboratories BSL-3 laboratories BW/BDP (85) Activities/additional information
China (People’s
Republic of)
1 (27); plan to build 5–7
more by 2025 (110)
10 before SARS, many more
after (111). Currently around 30
are certified (112, 113)
BDP, likely maintains an
offensive capability. Allegations
that some research has
breached the BWC (114, 115)
Public health, vaccines (110). WHO involvement
in lab construction (111). Economic incentives
(31)
Chinese Taipei 2: 1 confirmed, 1
unconfirmed (27, 116)
3 before 2003, 20 by 2005.
Prior to 2003, all HCBLs were
foreign-built; later domestically
with foreign advisors (116)
Possible research programme
(83, 114).
Communicable diseases, SARS a priority (116)
Colombia 1 level 3/4 in planning
(117)
1 in 2003 (117) N/A Public health (117)
Côte d’Ivoire N/A 1 (118) N/A Tuberculosis (118)
Croatia 0 At least 1 (112) BDP (119) Human pathogens; there is much international
cooperation, partly because of sample analysis
costs (112)
Cuba A few at a single facility
that have never been
used as such (120, 121)
5 (121) Probable offensive research
(83, 122)
HIV vaccine research (122)
Czech Republic 1 (27) N/A BDP (96, 105), biopreparedness
(106)
Vaccines (106)
Democratic
People’s
Republic of
Korea
N/A N/A Offensive research with
possible production of agents
(83, 123)
Endemic tuberculosis and malaria (124)
Denmark 0 At least 5 in 2009 (125) BDP (96) Zoonotic disease (swine flu) (126)
Egypt 1 BSL 3–4 as part of US
DoD (11, 127)
A few planned, unclear how
many are built (112)
Possible former offensive
programme. Not BWC member
(128), but seems compliant
(114)
To produce vaccines for endemic diseases
(112). USA involved in lab construction (11,
127)
Ethiopia 0 2: 1 with USA in 2010 (129), 1
mobile with WHO (130)
N/A Endemic animal diseases (129)
Finland 0 At least 13, 6 of which are
BSL-3+ (131, 132)
BDP (132) Focus on terrorism and infectious diseases
(132)
France 2 (98, 133) More than 12 BSL-3 (134).
Recent construction (135)
Former offensive programme
(indigenous programme ended
in 1934, and programme under
German occupation ended in
1945) (83). BDP (96)
Infectious diseases, host–pathogen
interactions (133, 135)
Gabon 1 (27, 94) First built in1982 (later became
the BSL-4 facility) (112).
Probably more, but N/A
No evidence of BDP (112) Endemic and emerging diseases, public health,
parasitology, etc. (112)
Georgia 0 At least 1 with US support,
probably a few in same
building (136)
N/A Infectious diseases, both animal and human
(136)
Germany 6: 4 are operational, 1
planned, and 1 under
construction (27). 8 self-
reported (9)
At least 97 (8), in 2007 there
were 8 in Berlin alone (137)
Former offensive programme
(138). BDP, military biodefence
budget has doubled in the last
decade (8)
Ranks fifth globally and first in Western Europe
for life sciences and biotechnology (8)
Ghana 0 1 in 1999 (86) N/A Emerging pathogens (86)
Greece 0 2 (98) BD (96) Both BSL-3 laboratories are in hospitals, they
are likely to specialise in human pathogens (98)
Hungary 1, but operated under
BSL-3 conditions (139); 2
self-reported (9)
Unclear. 8 NRLs that would
require BSL-3 facilities (139)
BDP (105) Emergence and re-emergence of pathogens.
Staff often trained in other EU laboratories
(139)
868 Rev. Sci. Tech. Off. Int. Epiz., 37 (3)
State BSL-4 laboratories BSL-3 laboratories BW/BDP (85) Activities/additional information
India 4 (27, 140, 141) Approximately 6 (8). Private
company offering turnkey
laboratory construction (142)
BDP (140) One of the biggest global vaccine producers (8)
Indonesia 0 2 for zoonotic diseases (first
in 2007) (143), plans to build
‘numerous research facilities’
(31)
N/A Tuberculosis and avian influenza are endemic;
the BSL-2 laboratories were proving insufficient
(143)
Iran 0 Probably a few, but none listed
as such (144)
Probable BDP. Dual-use R&D,
no evidence of BWC non-
compliance (114)
Tuberculosis is a high priority (144)
Iraq 1 former (145) N/A, but most likely none
(unlikely following US
involvement)
Former offensive programme,
dismantled before 2003 (114)
Production of foot and mouth disease vaccine,
later for BW agent production (146)
Ireland 0, and none is planned
(147)
Approximately 34 (147) Possible former programme.
No BDP, but the Department of
Defence undertakes training on
BW protection (147)
Public health and monitoring for marine
biotoxins (147)
Israel N/A, but probably the
IIBR (148)
1 for animal diseases, but no
further information (149)
Offensive research programme
with possible production (83).
BDP (23). Not a member of the
BWC (128)
Vaccine production, disease detection, etc.
Much joint research with the USA, including
the CDC and US Army Medical Research and
Development Command (148)
Italy 2 (27, 94) 5 within one of their BSL-4
facilities, at least 2 more;
information is lacking (150)
BDP (96) Research on human illnesses and vaccines
(151)
Japan 2 that do not operate on
BSL-4 level due to public
opposition (27)
Approximately 200 (8) Former BWs programme
(36,152). BDP (8)
One of the biggest global vaccine producers,
sees bioterrorism as a major threat (8, 153)
Kenya 0 Approximately 6 (8) No BDP (8) Malaria and AIDS, and animal vaccine
production, USA involved in lab construction (8)
Libya N/A N/A Former offensive programme,
ended 2003 (83, 114)
N/A
Luxembourg 0 At least 1, which opened in
2007 (154)
BDP (96) Specifically focused on the H5N1 influenza
threat (154)
Madagascar 0 1 in 2008 (86) N/A Virology with IP (86)
Malaysia Indication that they might
build a BSL-4 in the
future (155)
At least 3 with more planned
(155)
BDP (156) Economic incentive through biotechnology
investment (31)
Mali 0 1 in 2005 (157) N/A Built with IP support, for infectious endemic
disease (157)
Mexico 0 4, and 14 small ones in the
same facility (89)
In cooperation with Pan-
American biodefence, no
evidence of own programme
(158)
Biomedical research and some institutes
especially for respiratory diseases (89)
Morocco 0 At least 3 (159) N/A Public health, endemic disease (160)
Netherlands 1 (58) A few are mentioned but
no total numbers; at least 1
mobile (161) and currently
building an ‘extensive suite’ of
them (162)
BDP (96) Biopreparedness and response to outbreaks,
especially emerging diseases (161)
New Zealand 0 At least 1 (163) N/A Mostly focused on pests and diseases in plants
(163)
Nigeria 0 1 built in 2010 (164) N/A Endemic disease, especially TB (164)
869
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State BSL-4 laboratories BSL-3 laboratories BW/BDP (85) Activities/additional information
Norway 0 At least 2 before 2009 (125) N/A N/A
Pakistan 0 2 current and more planned
(72)
Possible (83) Diagnosing and treating endemic diseases such
as TB (72)
Panama 0 2 (89) N/A N/A
Peru 1 BSL-3–4 as part of US
DoD (11)
3 (89, 165) N/A Especially diseases that may threaten military
operations in the region. USA involved in
laboratory construction. The report also
describes ‘disease surveillance programs’ in 10
South American nations (11)
Philippines 0 1 (46) N/A Public health and concerned about bioterrorism.
(Mujahedeen Poisons Handbook identifying
possible BWs was found in Mindanao,
the Philippines) (46)
Poland 0 1 (166) BDP (105) Human pathogens (166)
Portugal 0 At least 1 (167) N/A Public health, especially TB and HIV (167)
Republic of Korea 1 ready to open in 2017
(168). Some BSL-3–4s (3+)
in conjunction with the
IVI (169)
At least 1 officially validated by
the Korean Centers for Disease
Control and Prevention in 2006
(170)
BDP (171) Economic, through biotechnology investment
(31), agent identification (170), and endemic
diseases and vaccination production (169). Very
concerned with bioterrorism (171)
Romania 0 At least 1 facility (172) BDP (96, 105) Diagnostic and applied research for public
health (172)
Russia 3 (69) 84 regional offices and Hygienic
and Epidemiological Centres,
29 research institutes, 14 anti-
plague control stations (173). 19
are WHO Collaborating Centres.
Difference in the Russian
classification system, but many
are equivalent of BSL-3 (69)
Former offensive (ended
1992). BDP. Likely that some
current research goes beyond
‘legitimate defence activities’
(83)
Public health (173)
Senegal 0 1 in 2000 (86) Virology laboratory with IP (86)
Serbia-
Montenegro
0 At least 1 (174) BDP (96) Zoonotic diseases, including swine flu (174)
Singapore 1 (27). A 2011 article
states that Singapore’s
BSL-4 Defense Science
Organization was a
BSL-3 operating at BSL-4
standards (152)
10, proliferation is recent (113) N/A Economic, through biotechnology investment
(31)
Slovak Republic 0 1 (175) BDP (105) Zoonotic viruses, especially tick- and rodent-
borne (175)
Slovenia 1 BSL-3+ (176) N/A N/A Epidemiology and immunopathogenesis studies
(176)
South Africa 1 (27) Approximately 6 (8) Former offensive (ended 1993)
(88); BDP (8)
Public health and endemic diseases including
‘respiratory and diarrheal diseases, meningitis,
HIV/AIDS, TB, and malaria’ (177)
Spain 1 (28,178), although the
lab claims it is 3+ (179)
More than 7 for the Ministry of
Defence (180). Only 3 BSL-3s
mentioned (181, 182)
BDP; 9/11 and biosecurity cited
as reasons (96, 180)
The BSL-4 lab is a veterinary lab focusing on
animal and zoonotic diseases (178)
Sudan 0 N/A Possible interest in offensive
research (83)
N/A
870 Rev. Sci. Tech. Off. Int. Epiz., 37 (3)
State BSL-4 laboratories BSL-3 laboratories BW/BDP (85) Activities/additional information
Sweden 1 (27) 40 (125, 183) BDP (184) To monitor, protect and prevent against
communicable diseases (185)
Switzerland 3, one is a glove box (27,
186, 187). There is also an
additional BSL-3Ag facility
(188)
At least 26 (8) BDP (189,190) Biodefence and public health (191)
Syria N/A N/A. Syrian Scientific Research
Council seems to oversee
sensitive biological research
(192)
Offensive research programme
with possible agent production.
Non-compliant with BWC (83).
Not a BWC member state and
President Assad hinted at BWs
capability in 2010 (128)
May have help from Russia (and previously from
the USSR), Democratic People’s Republic of
Korea, Iran and the former regime in Iraq (192)
Tajikistan 0 1 (193) N/A TB, built with IP (193)
Tanzania 0 1 (194) N/A TB and haemorrhagic fevers (194)
Thailand 1 BSL 3–4 as part of US
DoD (11)
23 human health laboratories
(including 7 mobile units), and 4
animal laboratories (71)
N/A USA involvement in lab construction (11)
Trinidad and
Tobago
0 1 (195) N/A Endemic diseases such as chikungunya, global
threats such as Ebola and MERS (195)
Tunisia 0 1 (196) N/A IP support (196)
Turkey 0 7 (197) BDP (96) GMOs, agricultural and veterinary issues,
disease surveillance and prevention (197)
Uganda 0 1 (198) N/A TB (198)
Ukraine 0 3 have BSL-3 certification (199).
Unclear how many work with
BSL-3 and -4 agents. Legally,
2 may work with ‘group 1’
pathogens and 402 can work
with group 2. Technically these
are different criteria, but they
may work with the same or
similar agents
Has participated in proposals
for European CBRN projects,
but no evidence of involvement
or of own programme (119)
Human pathogens (in cooperation with the
USA), food and agriculture laboratories (199)
United Arab
Emirates
0 A few built in 2010 at
DuBiotech for pharmaceutical
companies (200)
N/A Biotech industry, research (200)
United Kingdom 9 (201) Approximately 600. 150 are
operated by research institutes,
150 by universities, 75 by
private companies, 170 by the
NHS (201). Other figures are
lower (8)
Former offensive programme
(ended 1956) (83). Two BDPs
(civilian and military) (8)
‘Existing and emergent infectious diseases of
both humans and animals’ (202). Concerned
about bioterrorism (203)
United States 15: 14 operational, 1
under construction.
According to the US
Research Council Staff
there are 6 operational
and 6 planned or under
construction as of
September 2011 (27, 38,
204, 205, 206, 207, 208)
1,643 as of 2008 (56) Former offensive programme
(ended 1969), BDP (7).
Allegations of questionable
biodefence research, including
the Jefferson Project, Project
Bacchus and Project Clear
Vision (209)
National safety, vaccines, medication
development, anti-BW terrorism (205). One of
the biggest global vaccine producers
Vietnam 0 At least 2 (one under
construction in 2011) (155)
N/A Japan is helping with their second BSL-3 lab
(155, 210)
AIDS: acquired immune deficiency syndrome
ANLIS: National Laboratories and Health Institutes Administration
BDP: biodefence programme
BSL: biosafety level
BW: biological weapon
BWC: Biological Weapons Convention
CBRN: chemical, biological, radiological and nuclear risk mitigation
CDC: Centers for Disease Control and Prevention
871
Rev. Sci. Tech. Off. Int. Epiz., 37 (3)
EU: European Union
GMO: genetically modified organism
HCBL: high-containment biological laboratory
HIV: human immunodeficiency virus
IIBR: Israeli Institute for Biological Research
IP: Institut Pasteur
IVI: International Vaccine Institute
MERS: Middle East respiratory syndrome
N/A: information not available
NHS: National Health Service (UK)
NRL: national reference laboratory
NRLIARD: National Reference Laboratory for Influenza and Acute Respiratory Diseases
R&D: research and development
SARS: severe acute respiratory syndrome
TB: tuberculosis
US DoD: United States Department of Defense
USA: United States of America
USSR: Union of Soviet Socialist Republics
WHO: World Health Organization
La prolifération des laboratoires biologiques de confinement
à haute sécurité dans le monde : comprendre le phénomène
et ses conséquences
A. Peters
Résumé
Si les maladies infectieuses sont présentes depuis que l’humanité existe, le
monde, lui, a beaucoup changé. La population humaine ne cesse de s’accroître
et les échanges sont de plus en plus mondialisés. Entretemps, le système
international devient instable et les biotechnologies évoluent à une vitesse
impressionnante. Les humains sont désormais exposés à un grand nombre
d’agents pathogènes nouveaux et ré-émergents à mesure que ceux-ci se
propagent dans des milieux précédemment inhabités. La dimension mondiale de
l’impact des agents pathogènes s’accroît et les maladies infectieuses sont de
moins en moins contenues par les barrières géographiques ou climatiques.
Afin de répondre à ces nouveaux défis, les gouvernements tout comme le secteur
privé se sont lancés dans la création d’un nombre croissant de laboratoires de
confinement, dont ceux à haute sécurité, c’est-à-dire les laboratoires de niveau
de sécurité biologique 3 et 4 (BSL 3 et 4) qui sont autorisés à manipuler des agents
pathogènes présentant respectivement un risque biologique de niveau 3 et 4. La
proportion de ces laboratoires a fortement augmenté depuis les attentats du
11 septembre 2001 et la plupart des pays qui en ont les moyens se sont dotés
de tels laboratoires. Les agents pathogènes ne s’arrêtant pas aux frontières, la
sécurité nationale des pays est d’autant mieux protégée que les pays se sont bien
préparés à y faire face. Des informations sont disponibles sur les laboratoires
de confinement à haute sécurité (BSL-4) dans le monde mais aucune de ces
informations n’analyse la prolifération des laboratoires BSL-3.
L’auteur a entrepris de créer une base de données de travail afin de faire le point
sur l’état actuel de prolifération des laboratoires biologiques de confinement
à haute sécurité dans le monde. L’article analyse les données réunies et tente
d’appréhender la manière de traiter ce phénomène, ainsi que les risques qui lui
sont associés et les mesures éventuelles à envisager. Les informations présentées
sont à la fois inévitablement complexes et certainement très incomplètes ;
néanmoins, l’auteur espère qu’elles fourniront une base suffisante pour que des
conclusions utiles puissent en être tirées et être traduites par des actes.
Mots-clés
Agent pathogène – Biosûreté – Bioterrorisme – Épidémie – Laboratoire – Prolifération –
Santé publique – Sécurité internationale.
872 Rev. Sci. Tech. Off. Int. Epiz., 37 (3)
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La proliferación en el mundo de laboratorios biológicos de alta
contención: comprensión del fenómeno y sus consecuencias
A. Peters
Resumen
Las enfermedades infeciosas son tan o más antiguas que la humanidad, pero el
mundo ha cambiado. La población humana va en aumento y coloniza casi todos los
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muy incompleta, pero el autor espera que siente una base lo bastante sólida
como para extraer de ella conclusiones útiles, que puedan conducir a acciones
concretas.
Palabras clave
Epidemia – Laboratorio – Patógeno – Proliferación – Salud pública – Seguridad biológica
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... Many of the facilities in the list include two or more independent units, and sometimes few adaptations are sufficient to upgrade a lower-level laboratory into one with high-containment capacity. 17 Furthermore, they are sometimes hidden under some layer of secrecy, as could be the case for some of those managed by the military (that operate 20% of the facilities 18 ), connected with industrial property protection or considered easily amenable to misuse by clandestine operators. 19 Recent estimates 17 Once built, the running costs, often not anticipated when the lab is built, easily reaches 10 million USD per year. ...
... 17 Furthermore, they are sometimes hidden under some layer of secrecy, as could be the case for some of those managed by the military (that operate 20% of the facilities 18 ), connected with industrial property protection or considered easily amenable to misuse by clandestine operators. 19 Recent estimates 17 Once built, the running costs, often not anticipated when the lab is built, easily reaches 10 million USD per year. 21 This is due to both the continuing running expenses and the necessity to keep the personnel technically proficient, to avoid losing skills. ...
... The specific projects performed in high-containment laboratories worldwide are partially unknown, an issue that questions democracy and societal control, and potentially involves the military sector, as it is estimated that 20% of known BSL-4 facilities are defense-related. 17 However, in case of accident, it is society that will pay the consequences, especially if the unavoidable accident happens in populated areas. A good understanding of the work performed in the laboratories, which organisms are used and their associated diseases, details of risk assessment, external auditing, and other measures, would be useful in mitigating the consequences of accidental release, thus limiting the danger to some extent. ...
Article
Full-text available
Advancements in the biological sciences have made it possible to manipulate life forms in unprecedented ways. Recognizing the possible dangers connected with this activity, as well as with work involving natural pathogens, countries have promoted the building of High Safety and High Containment Laboratories, classified as Biological Safety Levels 3 and 4. In this article I briefly summarize the major features of these laboratories, exemplify some of the research that they host, highlight the possible dangers, and argue for the opportunity of a reduction of possibly dangerous research, and for more transparency and openness about activities that imply risks not only for those involved, but for human and environmental health as well.
... The concept of HCLs originated from military research by the United States during World War II. 13 HCLs include a wide variety of safety features that enable scientists to work in a safe and secure environment while handling and analyzing laboratory samples and protect the surrounding environment. With the growing threat of infectious diseases and bioterrorism, the need for research on HCLs to understand the classification, transmission, and pathology of these diseases and to develop diagnostics, vaccines, and therapeutics is greater than ever. ...
... 2,17 Globally, there are 86 states that possess or are currently building HCLs, and the numbers of BSL-4 and BSL-3 labs are around 60 and 3000, respectively, most of which are located in countries including Australia (40), Canada (30), China (80), France (20), Germany (100), Ireland (34), Japan (200), Russia (100), Sweden (40), Switzerland (30), Thailand (25), the United Kingdom (600), and the United States (1650). 13,22 The construction and deployment of HCLs and ongoing capacity-building in response to public health emergencies enabled Chinese scientists to complete the isolation, identification, and whole-genome sequencing of the causative agent underlying COVID-19 within 1 week in the early stages of the pandemic, and then to promptly construct in vitro and in vivo infection models. 15,25 These achievements provided a solid basis for the develop-ment of diagnostics, vaccines, and therapeutics, and gave the world time to develop measures designed to control the spread of the virus. ...
Article
Full-text available
Biological threats, whether naturally occurring or accidentally or deliberately released, have the potential to endanger lives and disrupt economies worldwide. Thus, high-containment protective measures should be implemented when handling bio-agents that can cause serious, highly contagious diseases, otherwise devastating pandemics can occur. In the fields of scientific investigation, healthcare, and product development, high-containment facilities play a critical role in preventing, detecting, and responding promptly and effectively to threats to global health security. In this paper, we present a summary of the main types of high-containment facilities, as well as their applications, challenges, and suggestions for the future.
... At its core, biological containment refers to primary containment such as equipment such as biosafety cabinets (BSC) used in HCBLs to prevent contamination of the sample of interest and protect the people handling those materials and secondary containment related to infrastructure (2, 3. High containment biological laboratories (HCBL) refer to the biosafety level-3 (BSL-3) and -4 (BSL-4) laboratories which are designed to contain pathogens to prevent their release into the environment and provide a safe setting to protect those working with these pathogens (Peters, 2018). Although the World Health Organization (WHO) and the United States (US) Centers for Disease Control and Prevention (CDC) biosafety guidelines are widely accepted, there is no standard oversight and efforts have focused on harmonizing national safety guidelines for working with pathogens (Stavskiy et al., 2003). ...
... The number of HCBLs continues to increase, that trend will likely continue with COVID-19 worldwide as countries and states will choose to prioritize and build them. Since many academic and private laboratories are not under their governmental oversight, it is difficult to obtain accurate counts of HCBLs (Peters, 2018). In our references, we also noted inconsistencies in the HCBLs especially those listed in the BSL-3 category. ...
Article
Full-text available
High containment biological laboratories (HCBL) are required for work on Risk Group 3 and 4 agents across the spectrum of basic, applied, and translational research. These laboratories include biosafety level (BSL)-3, BSL-4, animal BSL (ABSL)-3, BSL-3-Ag (agriculture livestock), and ABSL-4 laboratories. While SARS-CoV-2 is classified as a Risk Group 3 biological agent, routine diagnostic can be handled at BSL-2. Scenarios involving virus culture, potential exposure to aerosols, divergent high transmissible variants, and zoonosis from laboratory animals require higher BSL-3 measures. Establishing HCBLs especially those at BSL-4 is costly and needs continual investments of resources and funding to sustain labor, equipment, infrastructure, certifications, and operational needs. There are now over 50 BSL-4 laboratories and numerous BSL-3 laboratories worldwide. Besides technical and funding challenges, there are biosecurity and dual-use risks, and local community issues to contend with in order to sustain operations. Here, we describe case histories for distinct HCBLs: representative national centers for diagnostic and reference, nonprofit organizations. Case histories describe capabilities and assess activities during COVID-19 and include capacities, gaps, successes, and summary of lessons learned for future practice.
... Furthermore, the last decade saw a sharp increase in the number of high-containment biological laboratories in order to do more research on and improve our understanding of new and re-emerging dangerous pathogens (Lentzos and Koblentz, 2021). However the possibility of accidents, thefts or malicious use increases with each additional laboratory and the degree of oversight and control varies (Peters, 2018). The current COVID-19 pandemic leads to even more international attention to examine pathogens with pandemic potential (Grange et al., 2021) and causes Gain-of-Function experiments to be reconsidered (Imperiale and Casadevall, 2020). ...
Article
Full-text available
Research on pathogenic organisms is crucial for medical, biological and agricultural developments. However, biological agents as well as associated knowledge and techniques, can also be misused, for example for the development of biological weapons. Potential malicious use of well-intended research, referred to as “dual-use research”, poses a threat to public health and the environment. There are various international resources providing frameworks to assess dual-use potential of the research concerned. However, concrete instructions for researchers on how to perform a dual-use risk assessment is largely lacking. The international need for practical dual-use monitoring and risk assessment instructions, in addition to the need to raise awareness among scientists about potential dual-use aspects of their research has been identified over the last years by the Netherlands Biosecurity Office, through consulting national and international biorisk stakeholders. We identified that Biorisk Management Advisors and researchers need a practical tool to facilitate a dual-use assessment on their specific research. Therefore, the Netherlands Biosecurity Office developed a web-based Dual-Use Quickscan (www.dualusequickscan.com), that can be used periodically by researchers working with microorganisms to assess potential dual-use risks of their research by answering a set of fifteen yes/no questions. The questions for the tool were extracted from existing international open resources, and categorized into three themes: characteristics of the biological agent, knowledge and technology about the biological agent, and consequences of misuse. The results of the Quickscan provide the researcher with an indication of the dual-use potential of the research and can be used as a basis for further discussions with a Biorisk Management Advisor. The Dual-Use Quickscan can be embedded in a broader system of biosafety and biosecurity that includes dual-use monitoring and awareness within organizations. Increased international attention to examine pathogens with pandemic potential has been enhanced by the current COVID-19 pandemic, hence monitoring of dual-use potential urgently needs to be encouraged.
... Significativamente, está dirigida por el antiguo presidente de la GlaxoSmithKliner junto a generales del Ejército (Kime, 2020). No hay que olvidar tampoco que la mayoría de la materia prima para la industria de vacunas proviene de laboratorios militares de alta seguridad que conservan, crían y modifican virus (Peters, 2018). ...
Article
Full-text available
Resumen. El covid-19 ha sido la causa inmediata de la más profunda crisis de la sociedad moderna. Este artículo trata de un aspecto de esta crisis: el papel de la me-dicina capitalista hegemónica. El enfoque no es técnico sino social; no se refiere a la eficacia del diagnóstico o sus medicamentos, sino a la trayectoria teórica y meto-dológica de largo alcance. El objetivo es llamar la atención sobre cómo la medicina capitalista hegemónica ha roto radicalmente con las tradiciones médicas precapita-listas, sin considerar oportunidades en ciencia y tecnología que podrían resultar más eficientes para atender la salud de la población, pero desechadas por seleccionar un camino más rentable para la industria farmacéutica.
... These were labs at the level of B3 and B4-highly restricted labs-some of which were military, others private and many not under the control of any State. Current estimate suggests the existence of more than 2,300 such labs (Peters 2018). ...
Article
The past, present and likely future of “pandemic perspectives” are here briefly examined: as embedded in the contemporary structure of speculative-based production, unsustainable path-dependent dynamics augur a difficult future of enhanced ecological ruptures under the current regime of accumulation. This has hastened pandemic moments, now including COVID-19 in 2020. Of particular note is the striking case of the wallowing US beset by multiple “market failures” all along its medical supply chain and an absence of state capacity. Such historic conjunctures have tested the apparatuses of social reproduction: they can force profound restructuring, altering the path of accumulation along with the underlying societal order. This was the case in Western Europe as the ravages of the Black Death (1346–1353) contributed to the destabilization feudalism. However, in its wake, the “second serfdom” flourished in Eastern Europe. Here we analyze, in three linked sections, some aspects of the political economy of infectious disease.
... There has been a proliferation of such HCBLs in recent years because they have become indispensable in national security programs and the preparation against epidemics, accidental spread, and intentional misuse. A recent study found that more than 80 countries have or are now building HCBLs, with an estimate of 60 BSL-4 facilities and more than 3000 BSL-3 laboratories worldwide (21). ...
Article
Full-text available
The world was unprepared for the COVID-19 pandemic, and recovery is likely to be a long process. Robots have long been heralded to take on dangerous, dull, and dirty jobs, often in environments that are unsuitable for humans. Could robots be used to fight future pandemics? We review the fundamental requirements for robotics for infectious disease management and outline how robotic technologies can be used in different scenarios, including disease prevention and monitoring, clinical care, laboratory automation, logistics, and maintenance of socioeconomic activities. We also address some of the open challenges for developing advanced robots that are application oriented, reliable, safe, and rapidly deployable when needed. Last, we look at the ethical use of robots and call for globally sustained efforts in order for robots to be ready for future outbreaks.
Technical Report
Biosecurity and/or biohazard events of global significance are predicted to occur in the future that will compromise human security, including food and health security of nations. Due to the rise of biohazards and biosecurity threats that trigger systemic risks that leads to deaths, multi-dimension crises, including global public health crisis and political instability in the last 20 years, countries are expected to develop and strengthen their resilience to biosecurity threats by comprehensively developing institutional mechanism and human resource development. The onset of Covid-19 in early 2020 till today indicates that systematically anticipating biosecurity risk in a coordinated manner is no longer an option but a must. The National Disaster Management Agency (BNPB) in Indonesia has a unique advantage because national legislation provides multi-hazard mandates for the agency that can be scalable and extended to manage, lead or at least coordinate national scale crisis management related to transboundary hazards and non-traditional security threats. COVID-19 is one example where by default, BNPB has expanded its mandates and domains of crisis management or disaster response. In the current context - a public health and biosecurity crisis on a pandemic scale requires a more comprehensive and multi-sector crisis management model. The main problem of biosafety/biorisk governance in Indonesia is the institutional uncertainty, complexity and polycentric nature of its operational landscape. The central point for dealing with biosafety lies at a multitude of loci at various levels in so many domains. For example, Indonesia has signed the Cartagena Protocol on Biosafety of the Convention on Biodiversity through Law 21/2004. At the same time, there are many regulations related to public health, agriculture, medicine, industry, and so on that are pertinent to governing biosafety or biological risk and material security in Indonesia. Thus, an immense scale of homework is related to an integrated and coordinated institutional design and operational framework. This study is based on a literature review. As an initial need assessment study of biosecurity (or biohazard or biodefense or biosafety) for Indonesia, this report aims to support the BNPB Training Center in conducting benchmarking studies related to mapping technical competencies related to biological threats and other internationally recognized material threats. Benchmarking is carried out not only by comparing institutions in other countries that are similar to BNPB (such as FEMA in the United States, NEMA in New Zealand and BKK in Germany) but a broader benchmarking effort is carried out by the authors by studying both of competence and capability of various countries that have been considered successful in reforming their biosecurity and biosafety/biorisk policies. This includes the management of biological threats (within the framework of biohazard, biosecurity, biorisk (biological risk) and material threats) carried out by various disaster management and national security agencies, United Nations, other international institutions, related industries and related private institutions.
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This is the third part of a series of reports based on our previously unpublished investigations into the origins of SARS-COV-2. We wish to thank all of the independent researchers who have contributed to this investigation, especially members of the DRASTIC Collective, many of whom wish to remain anonymous for reasons of security and privacy (PDF) 3. WUHAN LABORATORIES, BAT RESEARCH AND BIOSAFETY.
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