Mapping Maximum Biological Containment Labs Globally
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Clinical work and scientific studies on pathogens, or disease-causing biological agents, are important for public health, biomedical advances, and disease prevention. Some of these activities, however, pose significant risks. Mapping Maximum Biological Containment Labs Globally
M A P P I N G M A X I M U M B I O LO G I C A L C O N TA I N M E N T L A B S G LO B A L LY
Mapping Maximum
Biological Containment
Labs Globally
High-risk Work with high-risk pathogens
carries substantive safety risks
The risks of work with dangerous
pathogens mean that extremely
pathogen research to laboratory workers, the wider high-levels of safety and security
society, and the environment. A lab protection must be applied and that the
worker may be accidentally infected work must be conducted responsibly.
by a pathogen, causing disease in This is especially important for work
Clinical work and scientific the individual, and potentially with pathogens that may have devastating
also in other lab workers, family consequences for local, regional, and
studies on pathogens, or members, and the wider community. global communities, if an exposure or
disease-causing biological A pathogen may also be accidentally accidental release were to occur.
agents, are important for released directly into the environment
Maximum containment laboratories,
through a lab containment breach,
public health, biomedical leading to potential spread of
commonly referred to as biosafety level
advances, and disease disease in the community.
4 (BSL4) labs, are designed and built to
work safely and securely with the most
prevention. Some of Key security risks include pathogens dangerous bacteria and viruses that can
these activities, however, or other related material being stolen cause serious diseases and for which no
pose significant risks. from a laboratory, and lab insiders treatment or vaccines exist. There is,
using their knowledge, skills, and however, currently no requirement to
access for malevolent purposes. There report these facilities internationally,
is also a risk that scientific knowledge and no international entity is mandated
and methods used by lab workers to to collect such information and provide
understand and manipulate biological oversight at a global level. Moreover,
and epidemiological properties of there are no binding international
pathogens for public health purposes standards for safe, secure, and
is repurposed by others to cause harm. responsible work on pathogens in
maximum containment labs.
High-risk pathogen work also carries
risks to peace and international security. This study provides
Increases in the number of facilities and an authoritative resource that:
researchers working with dangerous
1) m
aps BSL4 labs that are planned,
pathogens may contribute to a perception
under construction, or in operation
that capacities to weaponise biology
around the world, and
are increasing, which may provide
justification for a country to initiate 2) identifies indicators of good
or expand an offensive biological biosafety and biosecurity
warfare programme. practices in the countries
where the labs are located.
The study aims to increase public
knowledge about these specialised
facilities, and to strengthen national
and international biorisk management
policies and practices.
2M A P P I N G M A X I M U M B I O LO G I C A L C O N TA I N M E N T L A B S G LO B A L LY
59
maximum
containment
facilities
Key message 1:
3 5
BSL4 labs are booming
out
Today, there are nearly 60 maximum of
containment facilities that are
planned, under construction, or in
BSL4 labs are
operation around the world. government-run
The number of BSL4 labs being built public health
and operated has significantly increased institutions.
over the past ten years. Of the 42 labs
where foundation dates are available,
approximately half have been established
in the last decade. This means potential
risks are proliferating.
Key message 2: Less than
The facilities are spread over 23 countries. 1/5 are
The largest concentration of BSL4 labs is More public health university labs.
in Europe, which has 25 labs, in Belarus,
Czech Republic, France, Germany,
than biodefence
Less than
Hungary, Italy, the Russian Federation,
Sweden, Switzerland, and the United
1/5 are
Kingdom. Asia and North America
60 percent (36/59) of global BSL4 labs are defence labs.
government-run public health institutions.
have a roughly proportional number of
BSL4 labs. Asia has 13 labs, located in These labs serve a number of functions Only 2 labs are
China, India, Japan, Republic of Korea, including diagnosis of suspected wholly privately
Saudi Arabia, Singapore, and Taiwan. infections, scientific research to better owned.
North America has 14 labs in Canada understand the properties of pathogens,
and the United States of America. and development of new and improved The vast
Africa has three BSL4 labs in Cote vaccines, therapeutics, and diagnostics. majority focus
d’Ivoire, Gabon, and South Africa. on human health.
There are roughly proportional
Australia has four.
numbers of biodefence-related
More than three quarters (46/59) institutions (11/59) and academic
of global BSL4 labs are located in institutions (10/59). Only three percent
urban centres, exacerbating impacts (2/59) of labs are private institutions.
of any accidental releases.
The research focus of 48 labs is human
health, while seven focus primarily
on animal health and four focus on
both human and animal health.
3M A P P I N G M A X I M U M B I O LO G I C A L C O N TA I N M E N T L A B S G LO B A L LY
Key message 3:
More small labs than large labs
BSL4 labs range in size from 28 m2 to 4084 m2.
Of the 44 labs where BSL4 lab size data is available,
half (22/44) are under 200 m2. One quarter (11/44)
of the labs are in the 200-1000 m2 range, and
a quarter (11/44) of the labs are above 1000 m2.
11 labs are
over 1000 m2 11 labs are
200–1000 m2 22 labs are
under 200 m2
4M A P P I N G M A X I M U M B I O LO G I C A L C O N TA I N M E N T L A B S G LO B A L LY
Key message 4: percent (9/22) as having ‘low’ levels of these countries have a score of 90
of biosecurity preparedness. In percent or greater from the 1540
Sound biosafety and comparison, on average for the Committee on the strength of their
biosecurity practices 195 countries surveyed by NTI,
around 60 percent have ‘low’
national legislation to prohibit the
hostile use of biology. 67 percent
exist but are not levels of biosafety preparedness
and around 80 percent have ‘low’
of these countries have a score of
90 percent or greater from the 1540
widely adopted levels of biosecurity preparedness. Committee on national legislation
regulating access to biological
All countries with BSL4 labs that
materials that could be misused.
have obligations under international
Only one-quarter of countries with BSL4
agreements to self-declare national Over 70 percent (17/23) of countries
labs score well on best practice indicators
biosafety and biosecurity legislation with BSL4 labs have national biosafety
for biosafety and biosecurity. Moreover,
and to self-report their labs, do so. associations or are members of regional
few have dual-use policies, and none have
They all (22/22) report their labs or international biosafety associations.
yet signed up to a new international
under the confidence-building 40 percent (9/23) of the countries are
biorisk management standard.
information-sharing process of the members of the International Experts
The Global Health Security Index, Biological Weapons Convention— Groups of Biosafety and Biosecurity
developed by the Nuclear Threat the international treaty that bans Regulators, a forum for national
Initiative (NTI), characterizes 27 the development and possession of regulatory authorities to share their
percent (6/22—excluding Taiwan) biological weapons. To further increase knowledge, experience, and best
of countries with BSL4 labs as having their transparency, nine of the countries practices on biosafety and biosecurity.
‘high’ levels of biosafety preparedness, make these reports publicly accessible,
No labs have yet signed up to the
50 percent (11/22) as having ‘medium’ and 55 percent (28/51) of the BSL4
voluntary standard-setting biorisk
levels of biosafety preparedness, and labs in operation provide links to their
management system ISO 35001
23 percent (5/22) as having ‘low’ levels publications on their institutional
(Biorisk management for laboratories
of biosafety preparedness. The Global websites. All countries (22/22) required
and other related organisations),
Health Security Index characterizes to self-report national biosecurity
introduced in 2019 to establish
23 percent (5/22) of countries with legislation under United Nations
principles, essential components, and
BSL4 labs as having ‘high’ levels of Security Council Resolution 1540,
management processes to mitigate
biosecurity preparedness, 36 percent designed to prevent the proliferation
biosafety and biosecurity risks.
(8/22) as having ‘medium’ levels of of weapons of mass destruction to
biosecurity preparedness, and 41 non-state actors, do so. 86 percent
Only one-quarter of countries with maximum Sample size:
containment facilities score highly on indicators 22 countries.
of biosafety and biosecurity preparedness.
6 countries have ‘high’
levels of biosafety
5 countries have ‘high’
levels of biosecurity
preparedness
11 countries have ‘medium’
levels of biosafety’
8 countries have ‘medium’
levels of biosecurity
preparedness
5 countries have ‘low’
levels of biosafety
9 countries have ‘low’
levels of biosecurity
preparedness
5M A P P I N G M A X I M U M B I O LO G I C A L C O N TA I N M E N T L A B S G LO B A L LY
Key message 5:
Risk assessments for
dual-use are lacking
Only three out of the 23 countries have
national policies on dual-use biological
research and development activities with
significant potential to be repurposed by
state or non-state actors to cause harm.
3 23
countries
out
of
have dual-use
policies
6M A P P I N G M A X I M U M B I O LO G I C A L C O N TA I N M E N T L A B S G LO B A L LY
Study methodology
and challenges
The study followed a five-step The study defined BSL4 labs as There were several
process for collecting and confirming meeting the criteria for maximum challenges to the study:
information on BSL4 labs: containment as specified in the
• There is no single definition of what
WHO Laboratory Biosafety Manual.
Step 1 constitutes a ‘maximum containment’
In general, this relates to labs designed
Collate a list of BSL4 labs from lab. Physical containment measures,
to work with Risk Group 4 pathogens
previous studies and reports. as well as biosafety and biosecurity
that usually cause “serious human or
practices, vary across countries.
animal disease and that can be readily
Step 2 • Characterizing the size of a BSL4 lab
transmitted from one individual
Analyse institutional websites will vary depending on whether lab
to another, directly or indirectly.
for information such as lab space is tightly defined as the space
Effective treatment and preventive
construction date, publications, where work is actually conducted or
measures are not usually available.”
and ongoing research. whether it is more broadly defined
The scope of the study was to include supporting infrastructure
Step 3 restricted to labs working on such as chemical showers, animal
Undertake literature and pathogens that can affect humans, cubicles, utility rooms, etc.
internet searches on reported including zoonotic disease. Labs • Some biosafety and biosecurity
BSL4 labs for additional data. that only work on pathogens causing concepts and terms do not have
disease in animals were excluded. well-defined meanings in some
Step 4 Mobile BSL4 labs were also excluded. languages, or translate well
Contact labs directly to verify between different languages.
and complete the information.
• There was a limited response (13/59)
from labs to information requests.
Step 5
Contact an international group of
experts to review the dataset.
Key recommendations
BSL4 labs must continually work All countries must ensure comprehensive International and
to cultivate a culture of biosafety, risk assessments are conducted for national structures
biosecurity and responsible research dual-use activities with significant must be put in place
with high-risk pathogens at all levels, potential to be repurposed to cause to systematically
from students to principal investigators harm. This is particularly important register and
to laboratory directors. for countries where high-risk pathogen oversee maximum
work is carried out. Internationally- containment facilities.
BSL4 labs must adhere to national recognised guidelines governing high-risk
laws and regulations on biorisk dual-use work must also be developed.
management, implement and share
best practices, participate in peer Countries possessing BSL4
reviews, and adopt international facilities must provide complete,
standards such as ISO 35001 Biorisk regular, and transparent reporting
management for laboratories and under the annual confidence-
other related organisations. building measures of the Biological
Weapons Convention, and under
UN Security Council Resolution 1540.
7Study leads Dr Filippa Lentzos Dr Gregory D. Koblentz is a Senior Lecturer in Science is an Associate Professor & International Security in the and Director of the Biodefense Department of War Studies, and Graduate Program at George Co-Director of the Centre for Mason University’s Schar Science & Security Studies, at School of Policy and Government King’s College London in the in the United States. United Kingdom. Designed by psLondon. Approved by brand@kcl.ac.uk. © May 2021
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