Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 31
4
AVAILABLE RESOURCES, REGULATIONS, AND GUIDELINES
(PLENARY SESSION)
Chair: Serhiy Komisarenko
This session described and evaluated many of the international, regional, and national
resources available to countries looking for guidance on how to build, operate, and improve
containment labs. The first talk provided an overview of the regulatory landscape and an
orientation to the wide variety of guidance available. The second presentation then highlighted
an international network of biocontainment expertise, while the third examined elements
involved in creating a successful regional or national biosafety organization. Finally, a number
of people gave short presentations detailing their countries’ national regulatory frameworks.
During the subsequent discussion, Session Chair Serhiy Komisarenko (Palladin Institute of
Biochemistry, Ukraine) encouraged the group to think about how they could spread their
knowledge to their intended audience.
PLENARY PRESENTATIONS
International Regulatory Frameworks, Standards and Guidelines
Ingegerd Kallings (Swedish Institute for Communicable Disease Control, Sweden)
presented examples of various international standards and guidelines and detailed the
documents’ contribution to biosafety.
Dr. Kallings explained that regulations (and biosafety itself) are an attempt to address
the very real problem of laboratory-associated infections (LAIs), which started soon after
microorganisms were first cultured in labs. While the incidence of LAIs has decreased in recent
years, they still occur and cause fatal infections in lab workers.1 While human failures are
typically blamed for LAIs, Dr. Kallings feels it would be more productive to think of LAIs as
indicators of systemic failure stemming from a lack of training, understanding, and validation
resulting in non-compliance.
Dr. Kallings then discussed some of the international frameworks developed to
contribute to biosafety and biosecurity (Box 4-1). In an attempt to increase the availability of
biosafety information, the International Federation of Biosafety Associations (IFBA) created a
compendium of regulations and guidelines from around the world.2
1
Examples of recent fatal LAIs include cases of herpes B encephalitis in 1997, meningitis in 2000, severe
acute respiratory syndrome in 2003, and Ebola in 2004.
2
International Federation of Biosafety Associations. Available at:
http://www.internationalbiosafety.org/Organizations/fde5681c-ca94-4a20-827a-
0716f524babc/Resources/pdf/Compendium/Compendium_Update_Feb_10_2010.pdf. Accessed
September 10, 2011.
31
OCR for page 32
32 Biosecurity Challenges
Box 4-1
Some Key International Biosafety and Biosecurity Documents and Organizations
The Protocol for the Prohibition of the Use in War of Asphyxiating, Poisonous or Other Gases, and
of Bacteriological Methods of Warfare (Geneva Protocol), which was signed in 1925 and entered into
force in 1928, prohibits the use of chemical and biological weapons.a
The Biological and Toxin Weapons Convention (BWC), which was signed in 1972 and entered into
force in 1975, prohibits States Parties from producing, developing, or retaining biological or toxin
weapons or their means of delivery.b States Parties retain the right to use biological agents and toxins for
peaceful purposes.
United Nations Security Council Resolution 1540, which was adopted in 2004, requires States to
ensure that their domestic resources are not misused to support the proliferation of biological, chemical,
or nuclear weapons.c
The Cartagena Protocol on Biosafety to the Convention on Biological Diversity, which was adopted
in 2000 and entered into force in 2003, governs the transfer of genetically modified organisms (GMOs)
between countries.d
The Global Partnership Program Against the Spread of Weapons and Materials of Mass
Destruction, which Canada as chair of the G8 started in 2002, is an international cooperative threat
reduction program.e The program initially focused on non-proliferation and disarmament activities in the
former Soviet Union but has since expanded to address threats in other locations. Over a ten-year period,
more than $20 billion U.S. have been pledged to the program.
Australia Group’s Export Control Lists specify dual-use biological equipment, toxins, pathogens, and
chemical weapons precursors that participating countries agree to exercise vigilance when exporting.f
The United Nations Educational, Scientific and Cultural Organization (UNESCO) Universal
Declaration on Bioethics and Human Rights, which was adopted in 2005, provides a framework for
guiding ethical decision-making in medicine and the life sciences.g
Organisation for Economic Co-operation and Development (OECD) Best Practice Guidelines on
Biosecurity for Biological Research Centers, which were published in 2007, are guidelines for
securing repositories of biological information and materials.h
The World Health Organization (WHO) has put out widely used biosafetyI and biosecurityj guidelines.
Biosafety in Microbiological and Biomedical Laboratories (BMBL) (United States HHS, 2009) is a
national document that is widely used internationally.
The World Organisation for Animal Health (OIE) publishes standards for testing for terrestrial and
acquatic animal diseases of global importance and standards for vaccine banks. The recommendations
are widely used in international trade for screening animals and animal products.k
The Food and Agriculture Organization of the United Nations (FAO) has produced a number of
publications on biosecurity for food and agriculture.l
The International Plant Protection Convention produces standards that may be incorporated into
national legislation to reduce the spread of plant pests and pathogens.m
The International Criminal Police Organization works to stop criminal and terrorist use of biological
agents and toxins and publishes bioterrorism incident pre-planning and response guides.n
OCR for page 33
33
Available Resources, Regulations, and Guidelines
a
The text of the Geneva Protocols is available at: http://www.un.org/disarmament/WMD/Bio/pdf/Status_Protocol.pdf. Accessed
October 13, 2011.
b
The Biological Weapons Convention. Available at: www.unog.ch/bwc. Accessed August 29, 2011.
c
http://daccess-ods.un.org/TMP/5389472.24617004.html. Accessed September 10, 2011
d
The Cartagena Protocol on Biosafety. Available at: www.cbd.int/biosafety. Accessed August 29, 2011.
e
Global Partnership Program. Available at: http://www.international.gc.ca/gpp-ppm/global_partnership-
partenariat_mondial.aspx?menu_id=1&view=d. Accessed August 29, 2011.
f
The Australia Group. Available at: http://australiagroup.net. Accessed August 29, 2011.
g
Universal Declaration on Bioethics and Human Rights. Available at: http://www.unesco.org/new/en/social-and-human-
sciences/themes/bioethics/bioethics-and-human-rights/. Accessed August 29, 2011.
h
OECD. Available at: http://www.oecd.org. Accessed August 29, 2011.
I
Laboratory Biosafety Manual. Available at: http://www.who.int/csr/resources/publications/biosafety/en/Biosafety7.pdf. Accessed
August 29, 2011.
j
Biorisk Management: Laboratory Biosecurity Guidance. Available at:
http://www.who.int/ihr/biosafety/publications_WHO_CDS_EPR_2006_6/en/index.html. Accessed August 29, 2011.
k
World Organisation for Animal Health. Available at: www.oie.int. Accessed August 29, 2011.
l
Food and Agriculture Organization of the United Nations. Available at: www.fao.org. Accessed August 29, 2011.
m
International Plant Protection Convention. Available at: www.ippc.int. Accessed August 29, 2011.
n
INTERPOL. Available at: www.interpol.int. Accessed August 29, 2011.
She also described internationally binding transport regulations (see Box 4-2), and Dr.
Kallings indicated she generally considers transport regulations to be unnecessarily strict and
lacking the solid foundation that a risk-analysis could provide.
Box 4-2
Transport Regulations and Guidance in International Law
The United Nations Economic Commission for Europe’s Recommendations on the Transport of
Dangerous Goods (U.N. Model Regulations), which were last updated in June 2011, form the
foundation for most international shipping regulations.a
The International Civil Aviation Organization (ICAO) issues internationally binding transport
regulations based on the U.N. Model Regulationsb
The International Air Transport Association (IATA) adds some additional transport requirements.c
The World Health Organization (WHO) compiles and regularly updates a guidance document that
serves as a comparatively-user friendly source on transport requirements.d
a
http://live.unece.org/fileadmin/DAM/trans/danger/publi/unrec/English/Recommend.pdf. Accessed September 10, 2011. U.N. Model
Regulations Available at: http://www.unece.org/trans/danger/publi/unrec/rev16/16fword_e.html. Accessed September 30, 2011.
b
International Civil Aviation Organization. Available at: www.icao.int. Accessed August 29, 2011.
c
International Air Transport Association. Available at: http://www.iata.org/whatwedo/cargo/dangerous_goods/Pages/index.aspx.
Accessed September 10, 2011.
d
Guidance on regulations for the Transport of Infectious Substances 2011-2012. Available at:
http://www.who.int/ihr/publications/who_hse_ihr_20100801/en/index.html. Accessed August 29, 2011.
OCR for page 34
34 Biosecurity Challenges
She then provided information about the multiple International Organization for
Standardization/International Electrotechnical Commission (ISO/IEC) European Committee for
Standardization (CEN) standards related to biosafety and biosecurity, including the CEN
Workshop Agreement (CWA) 15793:2008 Laboratory Biorisk Management Standard.3 A diverse
international group of 76 participants from 26 countries developed CWA 15793 using the CEN
procedures, which facilitated the rapid development of the standard. While CWA 15793 is a
generic document that defines a voluntary standard for a risk-based, performance-oriented
approach to biosafety and management of biological risks, she indicated that its voluntary rules
may be adopted nationally. In the CWA 15793 approach, all components of a laboratory (e.g.,
workers, pathogens, standard operating procedures, equipment, buildings, the community, etc.)
are considered as parts of a unified system. The standard describes a system management
approach centered on the principle of continual improvement for reducing risks below a target
level. While CWA 15793 is compatible with a framework based on pre-defined BSL levels, the
method frees its users to design and implement precautions completely tailored to their
particular situation and goals.4 She also noted that another CEN workshop is currently working
on a new document describing the roles, responsibilities, and competencies necessary to be a
biosafety professional.
Dr. Kallings concluded by observing that in the current system, national regulations take
precedence over international guidelines but many countries still lack a national regulatory
framework. She feels there are currently a sufficient number of regulations to support biosafety
and biosecurity but recommends that gaps be identified and filled and compliance with existing
regulations encouraged before new regulations are added.
IFBA’s Biocontainment Engineering Network
Ken Ugwu (Foreign Affairs and International Trade Canada and IFBA Biocontainment
Engineering Working Group, Canada) described IFBA’s Biocontainment Engineering Network
(BEN) and the main challenges the group is working to address.
Mr. Ugwu introduced IFBA as an international, nonprofit non-governmental organization
(NGO) that has been working in advocacy and operational roles since 2001 to address
biological threats and to advance biosafety and biosecurity worldwide. He explained that IFBA’s
member biosafety professionals, scientists, lab technicians, academics, architects, engineers,
managers, and policymakers form a network of containment expertise. The IFBA BEN then
leverages that expertise to identify practical solutions for containment facilities; advocates to
include those approaches in international guidelines and best practices; mentors individuals
new to the field; builds global capacity; creates consensus on controversial issues; and finds
simple, safe, and workable solutions for low-resource establishments. To achieve those goals,
the IFBA BEN works to find sustainable, practical, and local solutions that create safe and
secure facilities that can be successfully certified and sustained in the long-term.
In Mr. Ugwu’s opinion, the best solutions typically understand and account for cost
pressures, the lack of local technical equipment and replacement parts, unreliable utilities, and
local inexperience in constructing and operating complex BSL-3 facilities. Rather than using a
“one size fits all” approach to BSL-3 facilities, the IFBA BEN advocates tailoring solutions to the
3
CEN 15793:2008 Laboratory Biorisk Management Standard. Available at:
ftp://ftp.cenorm.be/PUBLIC/CWAs/wokrshop31/CWA15793.pdf. Accessed September 10, 2011.
4
The Global Laboratory Initiative (GLI), for example, used the CWA 15793 method to determine minimal,
risk-based recommendations for tuberculosis work without using the traditional BSL nomenclature. See
TB Laboratory Biosafety Guidance. Available at:
http://www.stoptb.org/wg/gli/assets/documents/TB%20Lab%20Biosafety%20Guidance%20factsheet.pdf.
Accessed September 30, 2011.
OCR for page 35
35
Available Resources, Regulations, and Guidelines
situation. As BSL-3 containment space is very expensive to build, operate, and maintain, and
working at the BSL-3 level is less efficient (e.g., protective clothing, entry/exit procedures, and
medical surveillance) than working at lower containment levels, he argued that overdesign and
unnecessary use of BSL-3 labs should be avoided.
To ensure that all needs are met without resorting to overdesign, the IFBA BEN
recommends that a laboratory planning and programming phase precede the design phase of
lab construction. This programming phase should involve architects, engineers, and scientists,
and answer the questions that will drive the design including defining the pathogens and
standard operating procedures to be used, the diagnostic tests to be performed, and the
number of samples to be processed. He suggests the discussion produce a risk assessment
that defines the containment requirements and the facility’s architectural and mechanical
concepts. In particular, IFBA BEN recommends not over-designing BSL-2 and support spaces
and balancing electronic and operational solutions (e.g., considering visual signage instead of
electronic door interlocks). Simple architectural solutions such as epoxy-based paint on
gypsum board for interior BSL-3 walls and simple mechanical solutions such as limiting the
number of Class II, Type B2 BSCs, which are difficult to install and maintain, should also be
considered.
Mr. Ugwu concluded by mentioning that the IFBA BEN is also exploring options for
recognizing qualified certifiers. He explained that while several national authorities including
Singapore and Canada have accredited certifiers, there is no accredited international
certification program for biocontainment facilities. Nor is there a detailed set of criteria for
international certification as the WHO Laboratory Biosafety Manual contains only general
certification guidelines.
Sustaining Regional and National Biosafety Associations: Challenges and
Considerations
Teck-Mean Chua (Asia-Pacific Biosafety Organization [A-PBSA], Malaysia) discussed
the need for biosafety associations (BSAs) and the factors that contribute to the success and
sustainability of professional organizations.
Dr. Chua argued that as we are all exposed to collective risks (e.g., emerging and re-
emerging diseases and bioterrorism) that do not respect national boundaries, we also share a
collective responsibility and should take collective action. He believes that BSAs can help focus
and direct that action at the national, regional, and international levels and observed that in
recent years, many national and regional biosafety organizations have been created as has
IFBA.
He has found no set rule as to whether national or regional BSAs should come first. As
an example, he noted that the A-PBA formed at the regional level in 2005 and then proceeded
to assist members in forming national associations. He feels that starting at the regional level
was logical given that the Asia-Pacific region is a hotbed for emerging and re-emerging disease
outbreaks and that severe acute respiratory syndrome (SARS) and other outbreaks had created
a sense of regionalization among the generally small countries. However, he indicated that it is
also possible for existing national organizations to band together into a regional organization.
Dr. Chua emphasized that new associations should ensure that they have a multi-
disciplinary membership from the beginning. Members should include scientists, administrators,
engineers, architects, and technicians and a variety of agencies including those responsible for
human health, animal health, and domestic security. All desired countries should be
represented, and an association should welcome members from outside its borders.
He also suggested that an association’s organizational structure facilitate collective
leadership and be flexible enough to respond to future challenges. He reminded the group that
BSAs, like all nonprofits with expenses, need realistic business plans and should (1) identify
OCR for page 36
36 Biosecurity Challenges
activities, such as conferences, that will produce income; (2) produce transparent financial
statements that are audited annually; and (3) use membership resources to formulate programs
that serve the collective interests of their members and promote the organization’s mission and
vision.
NATIONAL RESOURCES, REGULATIONS, AND GUIDELINES:
SUMMARIES OF COUNTRY OVERVIEWS
To compare and contrast the approaches different countries use to manage and regulate
high-containment biological labs, some workshop participants developed country overviews that
described a country’s facilities, capabilities, and regulations as well as past accidents, safety
and security issues, and lessons learned. All of the country overviews are included in Appendix
E. Additionally, five of the overview writers presented brief summaries to the group:
• Hüseyin Avni Öktem (Middle East Technical University, Turkey overview),
• Olena Kysil (Taras Shevchenko National University of Kyiv, Ukraine overview),
• Leila dos Santos Macedo (Brazilian Biosafety Association [ANBio], Brazil overview),
• Anwar Nasim (Ministerial Standing Committee on Scientific and Technological
Cooperation, Pakistan overview), and
• Ingegerd Kallings (Swedish Institute for Communicable Disease Control, EU overview).
The countries have chosen a variety of approaches for regulating the biosafety and
biosecurity of their containment labs. Exact numbers of containment labs are typically difficult to
obtain—except for Ukraine where all microbiology labs are required to register with the
government. Only the overview for Sweden indicated the presence of a comprehensive system
for reporting accidents and LAIs; in some cases, no accidents had ever been reported. In many
cases, legislation relevant to containment labs was created to comply with international
agreements such as the BWC, United Nations Security Council Resolution 1540, and the
Cartagena Protocol on Biosafety. Many writers reported comprehensive legislation to regulate
GMOs and recombinant DNA usage. A number of countries have recently developed biosafety
courses for their universities, and many of those courses contain a biosecurity component.
Biosafety training seminars and workshops appear to be becoming more common, and some
countries are starting to translate biosafety documents into their native languages. In general,
high variance exists in the number of laws relevant to and government agencies responsible for
containment labs.
DISCUSSION
Much of the discussion focused on national regulations, which aside from requirements
imposed by donors, are the only rules labs are required to follow. Many speakers stressed that
aside from implementing the International Health Regulations (IHR) and complying with
transport rules, countries have the right to create whatever laws they deem appropriate.
(Discussion of transport regulations is presented in Chapter 6.) While supporting countries’
sovereign rights, many participants still felt that the lack of national regulations or lax
enforcement of those regulations constituted the biggest gaps in the regulatory framework. One
person wondered if a process could be developed to help countries that want to create
regulations, and another warned that reducing the intensity of existing regulations is extremely
difficult. Someone else encouraged countries to adopt risk-based regulations rather than rules
that simply require ticking boxes.
OCR for page 37
37
Available Resources, Regulations, and Guidelines
Perceptions of the impact of biosafety and biosecurity regulations on work varied. One
person indicated that regulations are felt but that they are generally helpful and necessary.
Another pointed to an elevated awareness on the subject increasing international cooperation
and the amount of available equipment. A third commented on a high paperwork burden.
OCR for page 38
