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

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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.



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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

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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

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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.

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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.

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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

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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.

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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.

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