The Nonproliferation Review

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A NEW APPROACH

Philippe Stroot & Ursula Jenal

To cite this article: Philippe Stroot & Ursula Jenal (2011) A NEW APPROACH, The
Nonproliferation Review, 18:3, 545-555, DOI: 10.1080/10736700.2011.618656

To link to this article: http://dx.doi.org/10.1080/10736700.2011.618656

Published online: 12 Oct 2011.

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 A NEW APPROACH
Contributing to BWC Compliance via
Biosafety, Biosecurity, and Biorisk
Management

Philippe Stroot and Ursula Jenal

This article describes the status of biosafety, biosecurity, and biorisk management worldwide and,
considering the difficulties of enforcing and monitoring compliance with the Biological Weapons
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Convention (BWC), analyzes how institutions’ effective biorisk management can help in
responding to concerns regarding the prevention of the development of bioweapons that would
otherwise be difficult to address. The biorisk management approach aims to ensure responsible,
safe, and secure handling of biological materials. Developed with the support of the life sciences
community, it contributes to the objectives of international organizations to respond to natural or
deliberate biological threats to public health and the environment. Achieving effective biorisk
management across all institutions still requires increased awareness at the highest level, as well
as allocation of appropriate resources and efforts in both biosafety and biosecurity training and
development and transfer of expertise. However, establishing and valuing a culture of ethical and
safe behavior and implementing effective biorisk management appear likely to prevent misuse of
biological materials and significantly improve control of potential dual-use issues in the life
sciences community. For these reasons, the BWC should not only encourage state parties to take a
more active part in ensuring the development of biosafety, biosecurity, and biorisk management,
but also promote relevant non-state actor programs.

KEYWORDS: Biological Weapons Convention; biorisk management; life sciences

The Biological Weapon Convention (BWC) requires state parties to take national measures
to prohibit and prevent the misuse of biological agents and toxins. Meanwhile, biosafety,
biosecurity, and biorisk management programs that are independent of the BWC regime
have contributed to the safety and security of laboratory and industry operations.
Biosafety, biosecurity, and biorisk management aim at protecting the human community
and the environment by promoting and implementing measures for the safe and secure
use of hazardous or potentially hazardous biological materials
In this article, the terms ‘‘biosafety’’ and ‘‘biosecurity’’ are used as defined in the
‘‘Laboratory Biosafety Manual’’ and the ‘‘Laboratory Biosecurity Guidance’’ published by
the World Health Organization (WHO). Biosafety and biosecurity cover the use of biological
materials in research or diagnostic laboratories and production facilities.1 They encompass

Nonproliferation Review, Vol. 18, No. 3, November 2011

ISSN 1073-6700 print/ISSN 1746-1766 online/11/030545-11
– 2011 Monterey Institute of International Studies, James Martin Center for Nonproliferation Studies
http://dx.doi.org/10.1080/10736700.2011.618656
 546 PHILIPPE STROOT AND URSULA JENAL

neither safety issues related to marketed medicinal products, which are mostly covered by
quality assurance programs such as the pharmaceutical industry’s good manufacturing
practices, nor animal and plant health and food safety issues, which the Food and
Agriculture Organization labels as biosecurity.2
The term ‘‘biological safety,’’ or ‘‘biosafety,’’ first appeared in the United States in the
late 1950s, and its use has spread across most parts of the world since then. However, the
application of basic hygiene measures to prevent infections due to unsafe handling of
pathogens in laboratories predates the term. With the development of genetic engineer-
ing, biosafety also came to cover the prevention of harm to the environment from
genetically modified organisms. Biosafety now refers to biological containment measures,
operational procedures, and management practices aimed at preventing unintentional
exposure to hazardous (or potentially hazardous) biological agents and materials in
laboratories and other facilities.
The more recent practice of laboratory biosecurity covers the institutional and
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personal security measures designed to prevent the loss, theft, misuse, diversion, or
intentional release of valuable biological materials, including pathogens and toxins. It
includes the protection of containment facilities from sabotage or other wrongdoing.
Biosecurity, together with biosafety, applies to all laboratory activities involving
hazardous or potentially hazardous biological materials, including those related to bio-
defense programs. From practical and managerial standpoints, biosecurity complements
the wide range of safety measures to protect laboratory workers, the community, and the
environment. As a result, laboratory biosecurity has become increasingly integrated into
biosafety and has evolved into the more recent concept of ‘‘biorisk management,’’ which
covers the whole spectrum of biological risks in or arising from laboratories (see Figure 1).
Biorisk management involves the implementation of technical, behavioral, and manage-
ment measures based on risk assessment. A global and systemic approach to effectively
manage these measures has been developed in the ‘‘Laboratory Biorisk Management
Standard.’’3 This approach not only encompasses the definition and implementation of
biosafety and biosecurity control measures, but also addresses their oversight and review,
as well as the appropriate allocation of responsibilities and resources. It is compatible with
and can be integrated into other safety, quality or environment management systems that
are already implemented in many institutions.
Biosafety, biosecurity, and biorisk management have become a significant part of
global public health, in particular in the context of the implementation of the WHO’s
International Health Regulations, a legally binding international agreement to prevent,
protect against, control, and provide a public health response to the international spread
of disease.4 The regulations require countries and regions to develop core surveillance and
reporting capacities. Enhancement of national and regional laboratory capacity appears
essential in this context, and countries have been requested, among other measures, to
expand the implementation of biosafety and biorisk management programs.5
This article appraises how biosafety, biosecurity, and biorisk management may
support some of the objectives of the BWC in the challenging context of a worldwide
expansion of laboratory capacity and advancements in the life sciences and related
 CONTRIBUTING TO BWC COMPLIANCE VIA BIOSAFETY, BIOSECURITY, AND BIORISK MANAGEMENT 547

FIGURE 1
Spectrum of biological risks and their control.

Natural Emerging threats Deliberate

diseases, (resistance, Laboratory Laboratory Vandalism, misuse,
outbreaks GMOs, etc.) accidents negligence sabotage bioweapons

Public health
Biosafety
Biosecurity

Biorisk management

applications; it also identifies ideas and steps for consideration during the Seventh BWC
Review Conference in December 2011, as well as afterward.
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Worldwide Status of Biosafety and Biosecurity Regulations and Implementation

With the development of the biomedical sector*and of the life sciences and associated
technologies in general*regulations in biosafety, and to some degree in biosecurity, have
been implemented in various parts of the world. However, the regulations and their
implementation are neither homogeneous nor harmonized.
The most developed countries, including Australia, Canada, the European Union
states, Japan, Singapore, Switzerland, and the United States, have developed comprehen-
sive regulations that cover most biosafety aspects, including in many cases the possible
impact of genetically modified organisms on the environment. Although the specific
direction, content, and strength of requirements of these regulations may vary, they all
apply similar concepts, such as risk assessment and containment levels. This can be
illustrated by the situation in Europe, where national regulations*despite their common
foundation on the same EU directives*require specific containment and protection
measures that may be more or less stringent depending on the country.
Ways to implement these regulations and ascertain compliance may also vary
significantly. Taking again the European situation as an example, the regulations of EU
states may involve significantly different authorization or notification procedures that may
or may not be accompanied by an actual inspection regime.
The situation appears even more variable in other parts of the world. Many
developing and emerging states have limited biosafety regulations, if any. In many cases,
biosafety regulations are solely based on the Convention on Biodiversity and its Cartagena
Protocol, which deal with the safe handling, transport, and use of living modified
organisms in relation to possible adverse effects on the environment and do not address
the use of natural pathogens in laboratories or in industry.6 The public health regulations
of some countries cover naturally occurring pathogens, but rarely in the context of their
use in laboratories. In other countries, sector-specific regulations address only narrower
aspects of biosafety, such as the disposal of hospital waste.
 548 PHILIPPE STROOT AND URSULA JENAL

Governmental control over biosafety regulations may be even more irregular. EU

states, for example, apply an authorization regime, at least for the work on genetically
modified organisms, whereas other countries like the United States approach biosafety
issues more from the angle of institutional responsibility and liability. Whether an
inspection procedure accompanies the authorization process also depends on the country
or region. Very few states, including Canada and Singapore, require their high-containment
facilities to be formally certified.
Many BWC state parties have regulations that criminalize activities linked to the
development, production, or use of biological weapons and that include export or import
controls for possible dual-use agents or technologies.7 However, some states regulate the
security of biological agent use in laboratories and in the industry; among these states are
Australia, Denmark, France, the United Kingdom, and the United States. These regulations
generally focus on the surveillance of high-containment facilities and on lists of highly
pathogenic agents with potential for bioweapons use, such as the select agents list in the
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United States.8
Institutions in countries without appropriate regulations use documents such as
the WHO’s ‘‘Laboratory Safety Manual’’ or guidelines from other nations (mainly the
United States and Canada) as references to define their containment measures and manage
biological risks. The international community has come to recognize the lack or
incompleteness of biosafety and biosecurity regulations as a significant problem and has
started to promote the development of comprehensive biosafety and biosecurity
regulations through the implementation of multinational or bilateral programs.
Meanwhile, the huge growth in biomedical activities in the academic, public, and
private sectors (as well as the worldwide establishment of local diagnostic and public
health response capabilities as required by the International Health Regulations) has led to
fast-growing biocontainment capacity in most parts of the world. At the close of 2010, the
total number of laboratories designated as Biosafety Level-4 (BSL-4)*the highest
containment level*exceeded fifty worldwide.9 Many more facilities operate at the
second-highest containment level, BSL-3. We estimate, based on extrapolation from
figures published in the United Kingdom and Belgium, that roughly 2,000 BSL-3 facilities
exist across Europe.10 Given the importance of the biomedical and biotechnology sectors
in North America, the number of BSL-3 laboratories there is likely to be at least the
same. Fewer BSL-3 laboratories operate in other parts of the world, but their number is
rising, including in developing countries. It may be worthwhile to point out that,
despite authorization regimes in some countries, there is no systematic data collec-
tion that could provide information on the exact number of containment facilities
worldwide.
Discrepancies exist in the way that institutions manage biosafety and biosecurity.
Large private corporations generally run comprehensive biorisk management programs
based on high internal standards that they tend to apply in all their facilities, including
overseas, irrespective of the country. The situation differs in the academic and public
sectors, as well as in smaller private companies; some organizations manage biological risk
in an effective manner, while others have only limited measures in place. The situation also
 CONTRIBUTING TO BWC COMPLIANCE VIA BIOSAFETY, BIOSECURITY, AND BIORISK MANAGEMENT 549

varies geographically. Developing countries, in particular, generally lack the appropriate

resources to manage biosafety and biosecurity appropriately; among the main challenges
to effective management of these risks are the lack of awareness at the highest levels of
political and public governance, inadequate material resources and infrastructure, lack of
sufficient technical expertise, and insufficient training.11
Sustainability is a crucial element for both the biorisk management programs and
the facilities, but high-containment facilities built according to Western technical
standards are often impossible to operate and maintain in countries with poor technical,
logistical, and financial resources. The need to increase laboratory capacity throughout the
world thus requires a huge international effort to develop a global biosafety and
biosecurity culture, to train laboratory staff, and to build sustainable and effective
biological containment facilities. International organizations such as the WHO and the
World Organisation for Animal Health have sponsored these efforts, often with financial
assistance from programs such as the US International Biological Threat Reduction
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Program and others run by Canada and the European Union.

It is clear that how biosafety and biosecurity are handled around the world is far
from uniform. Large discrepancies exist across regions and individual nations with respect
to the existence of regulations, their scope and extent, actual biocontainment capacity,
and the management of biological risks. To strengthen laboratory capacity and develop
sustainable biological containment and biorisk management habits around the world,
several initiatives have been launched, including by the WHO (supported technically by
five major collaborating centers in Australia, Canada, Europe, and the United States) and
by the International Federation of Biosafety Associations.12 Their success will certainly
depend on the support they will receive from the various concerned communities and
organizations.

BWC Compliance through Biosafety, Biosecurity, and Biorisk Management

Programs
Major challenges facing the BWC include how to install substantive mechanisms to
monitor and enforce compliance and how to set up and oversee treaty implementation at
the national level. These difficult tasks are somewhat linked to the challenge facing state
parties of how to monitor biological risks at the institutional level via state regulatory and
oversight capacity, an issue that has become even more critical since the overall threat
perception regarding bioweapons misuse has largely shifted from state to terrorist actions.
Furthermore, due to advances in molecular biology techniques and genetic
engineering, as well as novel approaches such as synthetic biology and nanobiotechnol-
ogy, a wide range of biological materials could potentially be used to create biological
weapons. The biological agents involved may differ from those on the lists with select
highly pathogenic microorganisms. Developing such weapons would require qualified
scientists using sophisticated techniques and equipment but not necessarily high-
containment facilities. In addition, as observed from the history of bioterrorism (i.e., the
2001 anthrax attacks and the deliberate contamination of food with Salmonella in The
 550 PHILIPPE STROOT AND URSULA JENAL

Dalles, Oregon, in 1984), the threat may also arise from the use of basic microbiology
techniques.13 Therefore, controlling a finite list of agents and high-containment facilities
addresses only part of the threat spectrum and consequently misses certain dimensions of
preventing misuse of biological agents and techniques. In contrast, the explosion of
biological activities worldwide renders the control of all potentially worrisome activities
and facilities impossible*or at least far from cost-effective.
Concerns about possible misuse of biological agents and techniques remain
generally low or moderate in the scientific community because in the overall picture of
biological threats, nature still is by far the main ‘‘bioterrorist.’’ Additionally, across the
whole spectrum of risks related to laboratory use of biological agents, negligence and
accidents are of far greater concern than hypothetical scenarios of terrorism and crime.
Outside the armament-disarmament-security context, European experts active in the
biological field do not consider bioterrorism or the development of bioweapons among
the main biological threats.14 This perception reflects the reality of the biological threat
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spectrum but also that these experts belong to a community far removed from armament
activities and concerns. Consequently, trying to develop dual-use and biosecurity
awareness in the scientific community could appear peculiar and may prove wholly
ineffective if disconnected from other, more prevalent concerns, such as public health
issues, biosafety, or the need to protect valuable biological materials. Implementing
biosecurity without considering biosafety would be particularly preposterous, unwar-
ranted, and inefficient in countries or institutions that lack the basic means to sustain a
sufficient level of laboratory safety in addressing public health issues.
From this angle, a world of difference seems to exist between the BWC’s legitimate
goal of preventing any possible bioweapons development and the scientific community’s
actual work, which theoretically could lead to the development of such weapons. The vast
majority of life sciences institutions conduct their work in an open, honest, and responsible
manner. Therefore, they could perceive intrusive verification processes or control
mechanisms as unjustified and consider them as unwarranted patronization by the arms
control community. Such perceptions would generate substantial resistance to efforts to
strengthen the BWC in this sector.
Taking these elements into consideration, it may appear that instituting regulations
together with a top-down control approach could achieve some of the more desired
objectives of the BWC; however, in reality, doing so would add little to the treaty’s current
limited ability to ensure compliance. In contrast, the biotechnology sector and the
life sciences community already support responsibility-based institutional biorisk
management programs. Biorisk management covers biosecurity and addresses concerns
about the dual-use potential of many processes and products; it developed out of legal
obligations and voluntary initiatives derived from risk awareness and a sense of social
responsibility. Biorisk management directly involves the people who deal with biological
materials and related techniques as part of their daily activities in the relevant institutions.
This bottom-up approach could be complemented with a monitoring or other control
process run by the national authority in charge of BWC oversight. Adapting the biorisk
management process to the BWC’s goals could therefore serve the disarmament interests
far better then a regulatory and verification process alone, while generating support from
 CONTRIBUTING TO BWC COMPLIANCE VIA BIOSAFETY, BIOSECURITY, AND BIORISK MANAGEMENT 551

the sectors involved in the life sciences. The culture of biorisk management appears to
offer the best protection against accidents and misuse while allowing unimpeded
scientific progress and development.15 Promoting responsible, safe, and secure opera-
tions in institutions where biological work takes place is likely to strengthen the overall
level of biosecurity, encourage institutional reporting, and ease authorities’ oversight
requirements.
Implementing such a bottom-up approach should build on and strengthen ongoing
international initiatives and projects but at the same time give priority to the following
aspects relevant to a BWC perspective.

1) Efforts to increase awareness about dual-use issues in the scientific community

should not be disconnected from other matters like biosafety or the need to
protect valuable biological materials; these topics should be addressed
together with ethics issues related to biological discoveries and biomedical
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advances. Raising awareness about biosafety, biosecurity, and bioethics

should begin early in the training of all future life sciences researchers and
professionals*before they handle biological agents, not when they are about
to work on sensitive materials or access a containment facility.

2) Appropriate training, knowledge building, and information transfer are needed

in parallel with awareness-raising to ensure the development of efficient and
sustainable biorisk management programs worldwide. In this context, devel-
oping countries*where lack of specific knowledge constitutes a known
challenge*merit more attention. For reasons of perception and technology,
training aimed at preventing misuse and, more generally, enhancing biosecur-
ity should always be connected to biosafety training. Given the need to take
into consideration differences in settings and socioeconomic situations while
guaranteeing safe and secure activities, biosafety and biosecurity training
should be based on both recognized competence requirements and a flexible
train-the-trainer approach.

3) Biosafety professionals play a key role in the management of biological risks in

their organizations, as well as in the transfer of knowledge to other institutions
and countries. Their roles and responsibilities may vary according to regulations,
policies, or cultures, but these professionals are essential to the implementation
of biosafety and biosecurity programs. They generally play a prominent role in
biological risk assessment, as well as in the design and implementation of biorisk
management programs and the training for activities involving biological
materials. Biosafety professionals interact with many stakeholders, including
management, scientists, students, and public authorities. They are in a key
position to identify and evaluate the risks of misuse of biological materials,
technologies, or facilities in their institutions; to make their management and
staff aware of such risks; and to develop appropriate measures. It is therefore
critical that biosafety professionals be fully qualified, including in matters that
 552 PHILIPPE STROOT AND URSULA JENAL

relate to bioethics and misuse prevention, and that all parties within the
institution explicitly recognize this competence. Defining competency require-
ments for biosafety professionals was in fact the purpose of a 200911
international workshop run by the European Committee for Standardization
(CEN) with the support of the WHO.16 Attended by biosafety and biosecurity
experts, the workshop resulted in a CEN Workshop Agreement on biosafety
professional competence.17

4) As indicated above, the ‘‘Laboratory Biorisk Management Standard’’ may

contribute significantly to BWC objectives at the institutional level.18 This
consensus document of the international biosafety community uses a manage-
ment system approach to consider biosafety and biosecurity together in all their
aspects, from risk assessment and resource allocation, to the implementation of
risk control measures and their verification within the institution. Its strength and
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wide acceptance within the community derives from the peer-recognized

approach to its formulation, which leaves room open for developing appropriate
context-specific, risk-based technical solutions, which is enabling the establish-
ment of sustainable programs, particularly in settings and countries with limited
resources. Some institutions have voluntarily applied the standard; its further
propagation, together with awareness-raising efforts, will undoubtedly favor safer
and more secure biological activities. Developing a certification scheme for the
standard in particular would encourage generalized use. Certification, however,
could also contribute to national oversight of biological risk management;
certifying organizations, sites, and facilities against the standard would offer a
degree of guarantee that such institutions have addressed dual-use questions and
implemented a control system. It could therefore help authorities set their
verification priorities, as indicated by national inspectors of some EU countries
that participated in a 2010 workshop on implementing the laboratory biorisk
management standard.19 However, moving toward a certification scheme would
require additional efforts to develop an accreditation process for the certifiers. In
the long run, it might also be useful to move the current CEN Workshop
Agreement to the International Organization for Standards, which would then
ease certification against biorisk management systems internationally.20

5) Biosafety organizations, including the American Biological Safety Association,

the European Biosafety Association, the Asia-Pacific Biosafety Association, and
others, comprise another major player in the development and promotion of
biosafety and biosecurity internationally and/or nationally. They offer a
platform for the biosafety professional community, including government
representatives, to share experience and expertise with members and other
stakeholders. Their activities include providing information and training,
participating in methodology or technology developments, performing some
oversight of the status of biorisk management, and collaborating on the
development or improvement of regulations. The main biosafety organizations
 CONTRIBUTING TO BWC COMPLIANCE VIA BIOSAFETY, BIOSECURITY, AND BIORISK MANAGEMENT 553

also provide support to a growing number of local organizations. Many of these

international and local associations have recently regrouped under the
umbrella of the International Federation of Biosafety Associations.21
It is clear that the success of these initiatives and activities to promote biorisk
management also depends on governments and international bodies recognizing the
importance of such efforts. To some extent, national authorities could promote a global
biorisk management approach that includes biosecurity, as a number of countries already
do with biosafety management. The BWC itself could play a more significant role in the
global international effort to improve biorisk management. For example, the Seventh BWC
Review Conference could officially recognize the need for integrated biorisk management
and CEN’s laboratory biorisk management standard as a possible tool to help control dual-
use risk in institutions.
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Conclusion: The BWC’s Potential Role in Supporting Biorisk Management

The initiatives and actions promoting biorisk management, whether they stem from state
parties or non-state organizations, must complement each other in order to achieve the
goals of the BWC. The BWC state parties should therefore consider actions to encourage the
development of complete regulatory frameworks that not only focus on dual-use issues,
but also cover the various dimensions of biological risk management (encompassing
biosafety, biosecurity, and bioethics) in the relevant institutions. They should also recognize
the need for institutions to develop sustainable biological laboratory capacities that use
biorisk management programs to respond to all possible biological threats*natural and
man-made*in full respect of ethical, safety, and security norms. Such recognition will not
only connect the BWC to its stakeholders active in the field, but also join international
organizations with the life sciences community in their efforts to develop a healthier and
safer world.
There are several specific steps that state parties should request stakeholders to
carry out. These steps include:
. raise awareness of dual-use issues in the context of promoting biosafety and
bioethics;
. develop training programs and organize appropriate knowledge transfer in
biosafety and biosecurity;
. establish specific functions and responsibilities with respect to the development
of biorisk management in institutions (biosafety professionals);
. recognize standardization and certification against a biorisk management
standard as a major driving force of international implementation of biorisk
management programs; and
. support biosafety organizations in their role in advocating and assisting with the
local development of biosafety and biosecurity practices.
These steps are likely to gain support from various national stakeholders because
they contribute to national programs for the advancement of science and technology
 554 PHILIPPE STROOT AND URSULA JENAL

development, education, and/or public health. State party reporting on concrete actions in
these areas should be incorporated into existing confidence-building mechanisms; doing
so would enhance the visibility of these actions and thus contribute to a more positive
perception of the confidence-building measures. This, together with improvements in
effective biorisk management in life sciences institutions, is likely to improve compliance
with BWC reporting requirements. Moreover, developing an oversight mechanism for
biorisk management in life sciences institutions (perhaps indirectly via a certification
scheme), together with a good reporting system, is likely in the long term to render less
necessary a strong BWC inspection program focused on the control of dual-use risks in
laboratories and in the industry in general.
Although the suggested actions to foster biosafety, biosecurity, and biorisk
management might not address the entire spectrum of disarmament objectives (especially
those linked to possible state-sponsored military activities), they are highly likely to
significantly contribute to addressing some of the BWC concerns, more specifically, those
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related to dual-use risks in academic, public, and private life sciences sectors.

NOTES
1. World Health Organization (WHO), ‘‘Laboratory Biosafety Manual,’’ 3rd. ed., WHO/CDS/CSR/LYO/
2004.11, 2004, Bwww.who.int/csr/resources/publications/biosafety/Biosafety7.pdf; WHO, ‘‘Biorisk
Management: Laboratory Biosecurity Guidance,’’ WHO/CDS/EPR/2006.6, September 2006, Bwww.who
.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2006_6.pdf.
2. On good manufacturing practices in Europe, see for instance, ‘‘EudraLex Volume 4: Good
Manufacturing Practice (GMP) Guidelines,’’ in ‘‘The Rules Governing Medicinal Products in the EU,’’
Bec.europa.eu/health/documents/eudralex/vol-4/index_en.htm; for practices in the United States,
see Code of Federal Regulations, Title 21, sections 210, 211, revised April 1, 2001, Bwww.accessdata.fda
.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart210&showFR1.
3. European Committee for Standardization (CEN), ‘‘Laboratory Biorisk Management Standard,’’ CEN
Workshop Agreement (CWA) 15793, February 2008, Bftp.cenorm.be/PUBLIC/CWAs/wokrshop31/
CWA15793.pdf. The CEN standard is an international reference document analogous to and
compatible with related management systems, such as OHSAS 18001 for occupational health and
safety, and ISO 14001 for environmental management.
4. WHO, ‘‘International Health Regulations (Second Edition, 2005),’’ 2008, Bwhqlibdoc.who.int/
publications/2008/9789241580410_eng.pdf.
5. Nicoletta Previsani, ‘‘Biosafety and Biosecurity in Laboratories,’’ lecture delivered to the Second Global
Conference of OIE Reference Laboratories and Collaborating Centres, Paris, France, June 2123, 2010,
Bwww.oie.int/doc/ged/D7760.PDF.
6. The Cartagena Protocol on Diversity to the Convention on Biological Diversity, September 11, 2003,
Bbch.cbd.int/protocol/.
7. UN Office at Geneva, BWC National Implementation Database, Bwww.unog.ch/80256EE600585943/%
28httpPages%29/4ADF8E868AAE82B3C1257578005563E1?OpenDocument; Verification Research,
Training and Information Centre (VERTIC), BWC Legislation Database, Bwww.vertic.org/pages/
homepage/databases/bwc-legislation-database/introduction.php.
8. National Select Agents Registry, ‘‘HHS and USDA Select Agents and Toxins,’’ US Department of
Agriculture, Bwww.selectagents.gov/.
9. Philippe Stroot, ‘‘Overview of Dual-Use Control at International and Institutional Levels,’’ lecture
delivered at the Third International Symposium on Biosecurity and Biosafety: Future Trends and
Solutions, Milan, Italy, October 1315, 2010, Bwww.bioemergency.eu/pdf/01Stroot.pdf.
10. UK House of Commons, ‘‘Innovation, Universities, Sciences and Skills*6th Report, Pre-Appointment
Hearing with the Chair-Elect of the Biotechnology and Biological Sciences Research Council, Professor
 CONTRIBUTING TO BWC COMPLIANCE VIA BIOSAFETY, BIOSECURITY, AND BIORISK MANAGEMENT 555

Sir Tom Blundell,’’ 2008; Institut Scientifique de Sante Publique-Wetenschappelijk Instituut Volksge-
sondheid, ‘‘Rapport: Les Installations de Haut Niveau de Confinement en Belgique: Période
19952008’’ [Report: High-Containment Facilities in Belgium: From 19952008], 2009, Bwww
.biosafety.be/CU/PDF/Rapport_ISP_FR_D_2009_2505_40.pdf.
11. Nicoletta Previsani, ‘‘The WHO Global Biosafety and Laboratory Biosecurity Programme,’’ lecture
delivered to the Latin America Laboratory Biosafety and Biosecurity Conference, Rio de Janeiro, Brazil,
May 1315, 2008, Bwww.biosafetyandbiosecurity.org/pdfs/2/Previsani.pdf; International Federa-
tion of Biosafety Associations (IFBA), ‘‘The IFBA Declaration on Advancing Global Biosafety and
Biosecurity,’’ IFBA International Conference, Bangkok, Thailand, February 17, 2011, Bwww
.internationalbiosafety.org/English/pdf/2011/IFBA-Bangkok-Declaration.pdf.
12. See for example WHO, ‘‘Global Biosafety and Laboratory Biosecurity Programme,’’ Bwww.who.int/ihr/
biosafety/collaborating-centres/en/index.html; and IFBA, Bwww.internationalbiosafety.org/english/
index.asp.
13. Jonathan E. Suk, Anna Zmorzynska, Iris Hunger, Walter Biederbick, Julia Sasse, Heinrich Maidhof, and
Jan C. Semenza, ‘‘Dual-Use Research and Technological Diffusion: Reconsidering the Bioterrorism
Threat Spectrum,’’ PLOS Pathogens 7 (2011), Bedoc.rki.de/oa/articles/reEB2cQKhvoh/PDF/293v2z90
FHRRQ.pdf.
14. Emmanuelle Brun, ‘‘Expert Forecast on Emerging Biological Risks Related to Occupational Safety and
Downloaded by [Laurentian University] at 09:48 31 May 2016

Health,’’ European Agency for Safety and Health at Work, European Risk Observatory Report EN 3,
2007, Bosha.europa.eu/en/publications/reports/7606488.
15. WHO, ‘‘Responsible Life Sciences Research for Global Health Security: A Guidance Document,’’ WHO/
HSE/GAR/BDP/2010.2, 2010, Bwhqlibdoc.who.int/hq/2010/WHO_HSE_GAR_BDP_2010.2_eng.pdf.
16. CEN, ‘‘Biosafety Professional Competence (BSP),’’ CEN Workshop 53, Frankfurt, Germany, December 17,
2009, Bwww.cen.eu/cen/Sectors/TechnicalCommitteesWorkshops/Workshops/Pages/WS53-BSP.aspx.
17. CEN, ‘‘Biosafety Professional Competence,’’ CWA 16335, September 1, 2011, Bwww.cen.eu/CEN/
sectors/technicalcommitteesworkshops/workshops/Pages/ws53-bsp.aspx.
18. CEN, ‘‘Laboratory Biorisk Management Standard.’’
19. Goedele De Bruyne and Philippe Stroot, ‘‘Management Systems, CWA 15793 and Implementation of
Biorisk Management,’’ Pre-Conference Workshops of the European Biosafety Association, Ljubljana,
Slovenia, June 21, 2010.
20. CEN Workshop Agreements are peer-established consensus-based specifications drawn up in an open
workshop according to specific procedures; their application is voluntary and not limited to CEN
member states. ISO Standards are standards developed by the International Organization for
Standardization though specific and more demanding processes involving multiple stakeholders; their
application is in principle also voluntary, but they have a wider recognition.
21. IFBA, ‘‘Biosafety and Biosecurity: Building Sustainable Capacity,’’ Second Annual Biosafety Conference,
to be held in Johannesburg, South Africa, June 2829, 2012, Bwww.internationalbiosafety.org/
english/index.asp.