PERFORMING BIOLOGICAL RISK ASSESMENT- Principle and methodology
Dr Se Thoe Su Yun. Deputy Director, Biosafety Branch, Singapore Ministry of Heath. Ms Chook Mee Lan.  Assistant Director, Facilities Services & Safety.  Temasek Life Sciences Laboratory, Singapore. 
 This workshop introduces the principles of performing risk assessment in a biological environment. The methodology used is Activity Base risk assessment which includes hazard identification, evaluation, risk control and performance assessment. There will be class exercise with practical examples. Participants would be able to perform risk assessment in a systematic manner from technical measure, action to documentation by end of the workshop. There will also be a lecture touching on extension of Biorisk assessment to CBRN Preparedness

PERFORMING BIOLOGICAL RISK ASSESMENT- Principle and methodology
Ms Chook Mee Lan.  Assistant Director, Facilities Services & Safety.  Temasek Life Sciences Laboratory, Singapore. 

This workshop introduces the principles of performing risk assessment in a biological environment. The methodology used is Activity Base risk assessment which includes hazard identification, evaluation, risk control and performance assessment. There will be class exercise with practical examples. Participants would be able to perform risk assessment in a systematic manner from technical measure, action to documentation by end of the workshop. There will also be a lecture touching on extension of Biorisk assessment to CBRN Preparedness

Biocontainment Design and Engineering for Biosecurity

Dr. Tony Della-Porta
Managing Director
Biosecurity and Biocontainment International Consultants (Bio2ic), Sydney, Australia

Most biocontainment facilities are biosafety level 2 (BSL-2) facilities in which most human, animal and plant pathogens are handled.  These pathogens present a low personal and environmental risk.  They still represent a risk of infection to the general public who should not be permitted to access BSL-2 laboratories.  The biosecurity and biocontainment requirements will be briefly described.  Higher risk agents are handled in BSL-3 and BSL-4 laboratories and the cost and engineering requirements are significantly higher for these laboratories than for BSL-2 laboratories  BSL-3 facilities are required for Risk Group 3 pathogens which pose a significant risk to personnel and to the environment.  BSL-4 facilities are for Risk Group 4 agents that pose an extreme risk for the staff and the environment.  The requirements for BSL-3 and BSL-4 facilities will be described, together in modern trends for design and construction of BSL-2 to BSL-4 facilities.

Dr.Teck-Mean Chua
Biosafety Consultant
Temasek Life Sciences Laboratory, Singapore

This workshop will cover the details of BSL-1, BSL-2, BSL-3 and BSL-4 laboratories and physical security measures for these laboratories.  The old style BSL-2 laboratories that form the backbone for medical and veterinary diagnostic work have undergone a significant change over the last few decades moving away from small individual purpose specific laboratories to larger multifunctional laboratories which have increasing flexibility built into them to allow for modern changers in work such as provided increasingly by robotics. The process of consultation, risk assessment and work flow analysis to produce laboratories that are suitable for the users is described.  This is associated with a consideration of design principles such as site factors, standards and regulations, a first look at budgeting and construction principles.  Finally we shall cover the types of equipment found in laboratories and the move to robotics.

Biocontainment facilities – Addressing biosecurity and biocontainment issues in design and engineering

Essential Leadership in Bioethics

Dr. Jim Welch
Executive Director
Elizabeth R Griffin Foundation

The sciences of health are about improving the everyday lives of humans, animals and the natural resources that sustain us all. We are about working to prevent, detect and respond to outbreaks that can threaten villages, nations, regions and the world. In that mission, we must often confront situations where risks are uncertain, approaches and methodologies are unique and the potential for misuse by intent or accident can be catastrophic. The requirement that we do that as institutions places us in the category of ‘high reliability organizations.” To maintain high reliability, it is a prerequisite that we commit to an unquestionable path of maintaining public trust in our work. That commitment requires everyone involved to be a leader in the ethics of our work.

Laboratory Biorisk – Monitoring and Evaluation

Mrs T.S.Saraswathy Subramaniam
Malaysia
Laboratory AUDIT
Course Synopsis

Auditing, the systematic evaluation of an organization, is inevitable at recent days. The purpose of an audit is to document whether an organization complies with all necessary requirements specified in the audit standard and applicable legislations. The purpose of safety in workplaces is to eliminate risks, implement adequate control measures to eliminate or reduce occupations safety risks to employees, visitors and other stakeholders. Safety audits will help the organization to get an independent view on various safety initiatives implemented and also provide a record of their due diligence on safety implementation. There are different approaches to a safety audit. This course shares with the participants some of the elements in laboratory audits.

Bioethics, biosafety and biosecurity issues in stem cell research
Mrs T.S.Saraswathy Subramaniam
Malaysia

Stem cells are a class of undifferentiated cells that are able to differentiate into specialized cell types. There are two types of stem cells which have the potential to be used in stem cell-based therapies: multipotent adult stem cells  and pluripotent  stem cells that include embryonic stem cells and induced pluripotent stem cells.

Research using human stem cell preparations holds promise for an increased understanding of the the early stages of genetic diseases, including cancer, and in future applications in cell transplantation therapies for human diseases.  There is now an explosion of R & D research, worldwide using stem cells. This rapidly advancing field has shown many gaps in our knowledge and understanding of stem cell technologies and applications. Many countries have established policies and guidelines that govern research involving stem cells to ensure that such research is conducted in an ethically responsible  manner. Although these policies govern bioethical issues, they are inadequate to address laboratory biosafety.  Current approaches to biohazarad risk assessments and mitigation are more  relevant for microbiological hazards and less appropriate for cell derived materials. Hazard characterisation for stem cells will vary depending on stem cell source, origin, type of cell and activities. Hazard identification and characterization will need to consider tumorigenesis of cells as well as risk of adventitious agents for example, blood borne pathogen risk, Mycoplasma and latent viruses which need biorisk management.

Stem cell banking through long-term storage of different stem cell platforms represents a fundamental source to preserve original features of stem cells for patient-specific clinical applications. Many institutions having biobanks storing stem cells from patients need biosecurity awareness to secure these valuable biological materials.

This presentation will address bioethics, biosafety and biosecurity issues in stem cell research.

Biosecurity Challenges for Biosafety Practitioners
Mr. David Lam
Singapore General Hospital

Development of life sciences has progressed tremendously over the last decade or so. As technology moves forward, they often associate with a “double‐edged sword” effect. When the technology is being applied according to its original intend, we reap its benefits. However, when the application deviates from original intend there is a potential breach in safety envelope. We will take a look at some of the biosecurity challenges that biosafety practitioners may face today

WHO updates – revision of the WHO Laboratory Biosafety Manual

Dr Kazunobu Kojima
Scientist
World Health Organization (WHO)

The WHO Laboratory Biosafety Manual has been serving the global biomedical science community for more than three.  Since the release of the present third edition in 2004, there has been remarkable development in life sciences as well as in biosafety, leading to expectation for the revision to fully update its contents and concepts.

In view of the diverse global readership of this Manual, it is proposed to provide core requirements and some further suggestions for additional safety and security measures based upon local risk assessment.  It is also planned to publish monograph or subject-specific booklets as well as to develop training modules in line with the prime concept of the revised Manual.

The proposed revision concepts – typically outlined as an evidence- and risk-based approach – are truly universal, where one can optimise the combination and extent of safety measures based upon local risk assessment, precisely proportionate to the assessed risks.  While the role of Risk Group (RG; aka Hazard Group) in the particular context of national regulatory framework is noted, our proposition is to dissociate equation of RG of pathogens and biosafety level (BSL) with a thought that the level of risk substantially varies according to elements such as procedures (e.g. propagative or non-propagative), volume/titre etc.  Also each RG consists of pathogens that pose various transmission routes, requiring different control measures.  This novel approach and a particular emphasis on good microbiological practice/procedures would help attain much desired equitable access to diagnostic services without necessitating technically and financially highly challenging containment facilities (e.g. BSL-3) in resource-limited countries without compromising safety.  This is one of the lessons that we’ve learnt from the recent devastating Ebola outbreak.

This presentation is intended to share the key revision concepts and update and to gather thoughts and suggestions as part of a broad consultation process.

OIE’s Biological Threat Reduction Strategy

Dr. Christine Uhlenhaut
Chargée de mission for Biological Threat Reduction
World Organization for Animal Health

The World Organisation for Animal Health (OIE) is the intergovernmental organisation responsible for improving animal health worldwide. In 2015 the OIE published the current Biological Threat Reduction Strategy which is supported by the OIE’s Sixth Strategic Plan (2016-2020) and cuts across all of its six objectives, namely international communication of global animal disease and zoonosis situation; development and implementation of science-based standards and guidelines on prevention, control and eradication of animal diseases, including zoonoses, and safety of international trade of animals and animal products as well as laboratory excellence; ensuring the scientific excellence of information and advice; capacity-building for national Veterinary Services, including their surveillance and response capacities; and strengthening the organisation’s influence on policy design, applied research and governance.

Working Together Makes a Difference – Implementing GHSA and JEE Alliance in Partnership with Biosafety Associations

Mrs. Maureen Ellis
Executive Director
International Federation of Biosafety Associations

Recognizing the need for collective action in building global health security, the International Federation of Biosafety Associations (IFBA) is engaged in ongoing efforts to enhance multisectoral collaboration and foster partnerships between its Member Biosafety Associations and government ministries in the development and implementation of national biosafety and biosecurity action plans. To this end, the IFBA has established membership in both the Global Health Security Agenda (GHSA) Action Package Prevent 3 (APP3) Working Group and the Joint External Evaluation (JEE) Alliance. GHSA planning activities under APP3 recommend that countries develop a strategic plan, informed by a policy framework and including best practices and model national programs, to guide the development and implementation of a national whole-of-government oversight program for pathogen biosafety and biosecurity. The JEE Alliance has been established to give political, financial and technical support to WHO and countries in the coordination and implementation of the country evaluations for compliance to the GHSA and International Health Regulations as well as the ensuing process of capacity building. The main purpose of the Alliance is to serve as a platform for discussion and exchange of views and experiences among partners to facilitate engagement between countries and other relevant organizations and stakeholders involved in health security.

In collaboration with our 39 Member regional and national Biosafety Associations worldwide, the IFBA is engaged in ongoing efforts to implement the GHSA goals under APP3 and the IHR biosafety capacity requirements. Support is provided for developing national biosafety and biosecurity strategies and guidelines, advancing biorisk management practices & procedures, and the certification of competency in biosafety professionals in a variety of technical disciplines related to the safe and secure handling of infectious disease agents. Ensuring that individuals who handle biological materials have demonstrated competencies is an essential component of the overall effort to reduce biosafety and biosecurity risks. 

THE CONTRIBUTION OF THE BIOLOGICAL WEAPONS CONVENTION TO GLOBAL BIOSECURITY

Mr. Daniel Feakes
Chief, BWC Implementation Support Unit
United Nations Office for Disarmament Affairs

The 1972 Biological Weapons Convention (BWC) enshrines the strong international norm against the deliberate use of disease as a weapon into international law. Almost 180 States have joined the Convention and therefore ruled out the option of developing, producing or acquiring biological weapons. No State today publicly admits to the possession of biological weapons, or argues that such weapons are legitimate instruments of national security. The BWC therefore makes a strong normative contribution to global biosecurity. This presentation will describe how the BWC also makes a practical contribution to global biosecurity through its legal provisions dealing with, for example, national implementation, preparedness and response, international cooperation and science and technology, and also through assistance programmes for developing countries aimed at improving their capacity to fully implement the BWC and to promote the peaceful uses of biology. In implementing such activities, the small BWC Implementation Support Unit based in Geneva works with relevant international organizations such as the FAO, Interpol, OIE and WHO, and with initiatives such as the Global Health Security Agenda and the Global Partnership. In reviewing relevant developments in science and technology, the BWC also interacts closely with scientists, academics and industry with regard to technical, legal, ethical and regulatory issues. While primarily a security treaty, the BWC also contributes to achieving the Sustainable Development Goals, particularly those relating to peace and justice and to good health and well-being.

Biorisk Business: Smart Investments

Ms Amal Haq
Program Adviser
U.S. Department of State

A brief talk that will make a case for institutional investment in implementation of a Biorisk Management System

Lessons from 2015 MERS Outbreak in Korea

Prof. Lee, Nam Taek
Deputy Director of BioDefense Research Institute of Korea University
College of Life and Sciences and Biotechnology, Korea University

Nowadays the possibility of bio-incidents is increasing rapidly than ever before, due to frequent emergence of pandemic disease along with intentional bioattacks and accidental release of highly infectious pathogens from laboratories.

The 2015 Middle East Respiratory Syndrome (MERS) outbreak was the largest pandemic which Korean people have ever experienced during the last decade, in terms of economic depression and social panic.

2015 MERS was initially flowed in from Middle East Country by a Korean traveler, and caused 36 death toll out of 186 confirmed cases in three months.

As had been reported before, the characteristics of 2015 MERS-CoV in Korea was nosocomial, which involved not only intra-hospital but also hospital-to-hospital transmission. Based on the epicurve of Richards model, the basic reproduction number was estimated at 11.5 (R₀=11.5). This indicates that infection rate of 2015 MERS was uniquely high compared to any other recent pandemics such as New Flu and SARS. The reasons why 2015 MERS outbreak in Korea has shown such a high infection rate will be mentioned in this conference.

In conclusion, the initial stage of biorisk management of 2015 MERS in Korea was rather unsuccessful due to following reasons: lack of knowledge and experience of the physicians about the characteristics of MERS-CoV., delayed confirmation of the first index case, poor sharing of medical information, poor application quarantine criteria, and limited early use of in vitro diagnosis kit.

However, within a three month from the first confirmation, Korean Government with strong will and control tower could finally subdue the spreading of MERS-CoV through struggling efforts, such as chasing the close-contact with the confirmed case and isolation thereafter, increment of the number of negative pressure room, designation of hospitals specialized for MERS treatment, disseminate masks to the public with large scale, active public health education, and etc.

We Koreans had to pay the fiddler to the last MERS attack. However altogether, we had gained priceless lessons from its attack, with which we can effectively counter another round attacks of pandemics in the future.

Strategy of Laboratory Biosafety Management in Taiwan

Dr. Shu-Hui, Tseng
Director of Infection Control and Biosafety
Centers for Disease Control, R.O.C.(Taiwan)

Since the accident of laboratory acquired infections with SARS-CoV in 2003, Taiwan has acknowledged the importance of laboratory biosafety management. Taiwan CDC referred to other developed countries’ experiences, and by following World Health Assembly resolution 58.29, “Enhancement of Laboratory Biosafety”, and referring to the requirements of “Laboratory Biosafety and Biosecurity” in the International Health Regulations (IHR(2005)), we established regulations of laboratory biosafety management. In 2015, to improve the capability of laboratory self-management, we observed the WHO’s document “Laboratory Biorisk Management Strategic Framework for Action 2012-2016” and guided BSL-3 and above laboratories to implement the Laboratory Biorisk Management Standard CWA 15793, and then gradually promoted it to BSL-2 laboratories. In 2016, we used the WHO’s Joint External Evaluation Tool (JEE Tool) to evaluate our epidemic prevention system (including areas of biosafety and biosecurity) for improving the capability of select agents management.

CURRENT SITUATION AND PLAN ON STRENGTHENING BIOSAFETY AND BIOSECURITY IN VIETNAM

Identifying Critical Points in Biosecurity Management towards Biopreparedness
Prof. Joy Potenciano-Calayo, RMT, MSc., CBO
President, Philippine Biosafety and Biosecurity Association (PhBBA)

Bio-preparedness is the life-saving core of a biorisk management programme. An effective programme assures the clear distinction between biosafety and biosecurity, and providing a complete, robust and continual improvement of the AMP (Assessment-Mitigation-Performance measurement and improvement) for each.

Biosecurity, though practically instituted at various levels, still warrants more scrutiny. Critical control points are needed in order to optimize its implementation. A considerable amount of unpredictability in science and technology, disease trends in human and animal strongly indicate more stringent measures to minimize, if not eliminate biosecurity risks in concerned laboratories and facilities. This talk shall highlight biosecurity awareness, drive and commitment towards biopreparedness as a local experience. 

Capacity building in biorisk management in Southeast Asia –
EU CBRN CoE Project 46
Dr. Philippe STROOT
Xibios – EU CBRN CoE 46

EU CBRN CoE Project 46 aims at the “Enhancement of CBRN capacities of South East Asia in addressing CBRN risk mitigation concerning CBRN first response, biosafety and biosecurity, awareness raising and legal framework”. It involves 8 Southeast Asian countries through the regional CBRN Centre of Excellence located in Manila and their respective National Focal Points. This specific project is a 3-year project that started in September 2015.

Among the 3 components of the project, Component 2 is devoted to biorisk management. It consists of several work packages.  The main one (WP3) is a train the trainer program delivered in two educational pathways. The first pathway aims at training a team of biosafety experts (two per country) in advanced biosafety management (Phase 1), and supporting them to provide a first national training on topics and issues identified by the National Focal Point as important for their country (Phase 2). Phase 1 was ensured through two intensive and highly interactive one-week workshops, held in Vientiane, Laos, and Yangon, Myanmar, respectively, and Phase 2 is starting right after the APBA conference. The second pathway is the training of a number of selected architects and engineers (a maximum of 5 per country) on the design and construction of biocontainment facilities. Two one-week workshops were also conducted in phase 1, one in Manila, the Philippines, the other one in Hanoi, Vietnam. Phase 2 is a short thematic workshop planned for November 2017. Both pathways are driven by strong considerations of sustainability and development of local capacities. A number of experts from SEA were involved as facilitators in both parts of the project, together with European and other experts.

Other parts of Component 2 are devoted to the capacity assessment (WP4) and management of biological waste (WP5). Missions are being conducted in each participating country in order to assess the capacities, vulnerabilities and risks related to diagnostic and research activities in general and to waste management in particular, in view of drafting recommendations and guidelines for national application.

The proposed lecture will focus on the specificities of this project and some of the challenges of such a capacity building program.

National Preparedness – Harnessing Science Over Fear of Biological Threat

Dr. Asadulghani
Head of Biosafety and BSL3 Laboratory & Head (Acting) of Laboratories Operation Management
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Biorisk management is the science of conquering our fears and leading courageous acts in the field of microbiological and biomedical research and diagnosis. Human exposure to biological hazards may cause serious consequence that is the interest to the scientists and the public at large. Scientific knowledge is crucial to the competence and credibility of regulations designed to protect public health from biological hazards. Bangladesh is a country in southern Asia, in the Ganges River delta, on the Bay of Bengal. The country is hit by cyclones every year and coastal areas inundated by a storm surge. Emerging and re-emerging pathogens, such as Bacillus anthracis, Nipah virus, highly pathogenic avian influenza virus H5N1, antimicrobial resistant super bacteria, and MDR/XDR- Mycobacterium tuberculosishave been identified as major public health threats in Bangladesh. Current life science infrastructures in the country need significant improvement to address biological threats and promotion of efficient and sustainable culture of biosafety and biosecurity. A multipronged activity has been initiated to strengthen biosafety and biosecurity status in Bangladesh using the platform of Bangladesh Biosafety and Biosecurity Association supported by CDC and BEP, USA. Resource persons have been trained to provide assistance to labs throughout the country in the area of improving biosafety and biosecurity status. Top level, mid level, and bench workers in all divisions of Bangladesh have been sensitized and trained. For robust dissemination of the knowledge and sciences of Biosafety and Biosecurity, the existing webpage was further developed. Guidelines on handling and disposal of biohazardous materials were drafted. All together this suite of activities will help build a sustainable culture of biosafety and biosecurity that will continue to spread within Bangladesh laboratories. The ultimate goal of this initiative is a sustainable development that meets the needs of the present without compromising the ability of future generations to meet their own needs.

STRENGTHENING CAPACITY BUILDING OF GLOBAL HEALTH SECURITY IN CONSIDERING THREATS OF BIOLOGICAL AGENTS IN INDONESIA

COLONEL DR. YULI SUBIAKTO,APT,MSI
Head Subdirectorate of Health Strenght
Directorate of Health Directorate General of Defense Strenght MoD RI

Introduction

Indonesia is an archipelagic country with a number of islands more than 17,504   with a very strategic position because it is flanked by two continents and two oceans and is in the path of international trade traffic and traffic peoples.   As a tropical country, Indonesia has a wealth of flora and fauna as a natural resource (biodiversity), partly a microorganism that is useful for health, and at the same time a threat to public health.   As scattered biological resources can become disease agents that cause extraordinary events, even causes of outbreaks exploited from the actions of bioterrorism, biological weapons, biocrime and agretororism.

Infectious Diseases of Indonesia

In line with the development of world trade and movement people beginning in the middle ages, some potential contagious infectious diseases that commonly spread in continental Europe, Africa and America and Asian mainland spread to Indonesia such as pes, cholera, dengue hemorrhagic fever, hepatitis, thypus and dysentery. Population dynamics, social culture and environmental changes are also changes in the spread of infectious diseases, including potential outbreaks of infectious diseases. In addition to the increasingly advanced health technology, it is possible to do genetic engineering “Genetic Modified Organism” from disease agents for specific purposes such as bioterrorism, biological weapons, biocrime, agroterorrism to threat human, plant, and animal health.

National Defense

The defense of the state of Indonesia is all the defense of the universe, whose organization is built on awareness of the rights and duties of all citizens and the belief in their own power to maintain the survival of an independent and sovereign nation and state of Indonesia.    Observing the development and pattern of diseases caused by various aspects above, Indonesia must make efforts to prevent, control, combat and combat infectious diseases, both endemic and spread from other countries.    Indonesia as a member country of the United Nations has agreed to implement the provisions of International Health Regulations (IHR) 2005 and is required to have the ability in the prevention, early detection and rapid response to the emerging and re-emerging diseases or events that potentially cause public health emergencies that disturb the world PHEIC.  Global Health Security as a means to strengthen the capacity to prevent, detect and respond to infectious diseases, pandemics and bioterrorism, biological weapons, biocrime and agroterorism through the implementation of International Health Regulation (IHR) 2005 more effectively.   Strengthening capacity building of human resources, infrastructure and facilties, software, code of conduct, biorisk management are needed global health security considering threat of biologigal agent use to realize National Defense strong.

Conclusion

The threat of state defense derived from biological agents is expressed as a real threat because it has the potential to cause an epidemic that could threaten the health of plants, animals and humans, which can cause economic harm, human health and disrupt the security of the country. So that required comprehensive countermeasures ranging from preventive, detection and emergency measures with the step of strengthening capacity building of Global Health Security on human resources, infrastructure and facilty, software, code of conduct, biorisk management.

HUMAN FACTORS AND SYSTEM SAFETY HOW DOES IT TRANSLATE TO REAL LIFE

Dr. Viji Vijayan
Assistant Dean, Safety, Health and Emergency Management
Duke-NUS Medical School

Exactly what is meant by human factors and systems safety, and how does it translate into real life? Humans live and work within a socio-technical system consisting of humans, machines, processes, regulations, organizational structure, environmental conditions, and many other factors. How we interact with the different components of this socio-technical system constitutes human factors and/or ergonomics. In order to be efficient (productive) the human has to interact with the various components in a particular way; in order to assure quality (safety) the human may have to change the way in which he or she interacts with the components. What is the right balance to achieve both efficiency and safety? There are constant goal conflicts in life and we make tradeoffs all the time. This is the “Efficiency–Thoroughness Trade-Off (ETTO) principle, which states there is a trade-off between efficiency or effectiveness on one hand, and thoroughness (such as safety assurance and human reliability) on the other hand”. (https://en.wikipedia.org/wiki/Efficiency%E2%80%93thoroughness_trade-off_principle).

In a biomedical laboratory, what are the goal conflicts and trade-offs, do the workers know that they are making trade-offs, and how do they ensure that they are making the right trade-offs? These are the questions we asked in a study we undertook. Time is the key goal conflict, especially when they are working on time-sensitive experiments or when they are at the end of a month-long experiment. Pressure to publish and to ensure good reproducible results, small sample quantities, and high cost of reagents pose further goal conflicts. The workers are aware of the tradeoffs and mentally calculate the risk at each step of the work. Safety professionals should understand and cater for these real-world situations, to achieve a holistic approach to safety.

ETTOing well is the pathway to glory; ETTOing badly will make you feel sorry

(Eric Hollnagel who described ETTO)

Confronting the Dual Use Dilemma and the International Network on Biotechnology

Dr. Irma R. Makalinao, MD, MA (Peace and Security Studies)
Professor 12 and Graduate Program Director
Department of Pharmacology and Toxicology
University of the Philippines College of Medicine

What is the dual-use dilemma? Dual use refers to materials, technologies and knowledge can that can be used for good and for harmful purposes.  Earlier, the term dual use has been associated with technology transfers between civilian and military applications. In the realm of WMD non-proliferation treaties and related laws integrates the concept of dual use for civilian (peaceful versus non-peaceful) and military purpose (benevolent and malevolent purpose) into a single conceptual framework.  The governance of dual use should consider both national security and human security.  Literature review shows that the new focus has shifted from national security issues related to potential military uses of dual-use technology to people-centered security concerns.  The Fink Report has specifically focused on engaging the life sciences in security through the development of communication channels between the life science community and security officials.  This presentation will provide an overview of the dual-use dilemma from the perspective of the Philippines in relation to the strategic trade management act, the CBRN National Action Plan and international obligations to the BTWC, CWC and the UNSCR 1540.  The dual-use dilemma may require prohibitions in the form of norm, ethical codes and laws.

 A brief discussion on the dual-use concept from lethality analysis perspective versus  intent will be included especially in dealing with dual-use science.

 The International Network on Biotechnology (INB)  is a global network committed to advancing education and raising-awareness about responsible life science. Focusing on emerging developments in the life sciences  and  biotechnology,  the  INB’s  work covers the subject areas of biosafety, biosecurity and bioethics The  INB  is administered  by the  United  Nations  Interregional  Crime  and  Justice Research Institute (UNICRI) and works closely with partner organizations engaged in complimentary missions (WHO, OIE, BWC-ISU, FBI, INTERPOL, and others). INB strives  to  make the  subject  of ‘responsible science’ more accessible and locally relevant.

Biosafety Level 3 Facility: Biosafety Versus Operation cost

Dr. Nguyen Thanh THUY 
Head, Department of Biosafety and Quality Management
National Institute of Hygience and Epidemiology

In the recent years, global epidemics are getting more and more complex. For the diagnosis or research of dangerous infectious pathogens, the bio containment facilities is needed. In 2008, with the support from Japanese International Cooperation Agency (JICA), a BSL3 facility including 4 laboratories were constructed at National Institute of Hygiene and Epidemiology (NIHE). These laboratories have been used for research and diagnosis of Influenza A/H5N1, Influenza A/H1N1, Anthrax, Rabies, Drug Resistant Tuberculosis, MERS CoV…

As the initial design, the BSL3 facility must be operated continuously 24 hours per day in all days of the years, except the maintenance time. The cost of energy consumption (including electricity and oil) is about 150,000 USD per year. This amount is a big challenges for NIHE. Since 2010, an initiative of “Developing energy saving operation mode for BSL3 laboratories” was developed and implemented. After 3 years of testing and evaluation, the solution was approved by the NIHE scientific committee. With energy saving operation mode, when no one working inside the laboratories, only one exhaust fan of biosafety cabinet is operated to maintain negative pressure (-50 Pa) inside laboratories meanwhile all HVAC system is turned off. Besides, issues related to the heat, humidity have been considered and addressed. The results showed that the operation cost of energy saving mode have been reduced by approximately 50% compared to initial mode; operation indicators such as air pressure, temperature, humidity also meet requirements; dust concentration meets requirements for clean room level 7 of ISO 14644-1. The annual risk assessment showed that the energy saving operation mode for BSL3 laboratories is acceptable, no increasing of biorisk at the BSL3 facility. So far, after 5 year of applying the energy saving operation mode for the facility, no biosafety incident or accident occurred.

Standby mode of operation should be considered for all BSL3 facilities. 

The ways forward for Biosafety and Biosecurity Program in Cambodia

Dr. SAU Sokunna
Deputy Director of DHS.MoH
Director of NMMLN
Director of National Biosafety Committee

Biosafety program has been growing in recent years in Cambodia. Biosafety guideline and biosafety curriculum were developed. The biosafety curriculum is focusing on biosafety and biorisk management for laboratory managers and biosafety officers to better control risk associated with biological material. The majority of the national biosafety committee has implemented accurate process for the quality standard which have potential to comply with IHR core capacity biosafety and biosecurity protocols, especially operating procedures related to concepts and skills to develop a sustainable education and awareness system and the training contents related to biosafety /biosecurity/biorisk management.

Biosafety practice and training in Western Africa during the 2014-2016 Ebola epidemic: supports from China CDC

Prof. William J. Liu
Associate Professor
National Institute for Viral Disease Control and Prevention, China CDC

During the 2014-2016 Ebola epidemic, hundreds of Chinese health care workers including physicians for Ebola virus infection treatment, epidemiologists for the public health training, and the Ebola test teams were sent to the West Africa. The Sierra Leone-China Biological Safety Laboratory was newly established in Jui, Freetown, which is the first and state-of-the-art fixed BSL III Lab in West Africa. Since the establishment of the Laboratory on 11th February 2015, the major two tasks of the lab are 1) Ebola virus tests. 2) Human resource training. For the first function, over 14,000 specimens have been tested in the lab during the Ebola epidemic. The service of the lab covered 10 different districts of the country, in comprise of over half of the population of Sierra Leone. In the meantime, the lab collaborated with Ministry of Health and Sanitation, World Health Organization, and  US CDC in the virus persistence study project which provides important reference for the Ebola survivor management. Nearly 5,000 body fluid specimens from Ebola survivors have been tested in the lab. For the second important task, Sierra Leone-China Biological Safety Laboratory plays a pivotal role in the training of the laboratory workforce for the country. Dozens of local laboratory specialists been well trained in the lab on the virus test and biological safety, who have later been the major force for the Ebola diagnosis and surveillance in different organizations of the country. The MOHS of Sierra Leone authorized the designation of the laboratory as the “National Reference Laboratory for Viral Hemorrhagic Fevers” and the “National Training Center for Virus Detection and Biosafety” in the end of June, 2016. China CDC will strengthen the support of the research on and pre-warning of tropical diseases in West Africa. 

NSF Accreditation of Biosafety Cabinet Field Certifiers

Ms. Maren Roush
Program Manager, Biosafety Cabinetry Certification
NSF International

NSF offers two personnel accreditation programs that evaluate the proficiency of individuals who perform field certification of biosafety cabinets (BSCs): an enhanced accreditation program for BSC field certifiers in North America and a basic accreditation program for BSC field certifiers outside of North America. These programs include written (theoretical) and practical (hands-on) examinations, along with continuing education and ethics requirements.

NSF’s enhanced accreditation program is recognized as the premier credential in North America for individuals who certify Class II BSCs in hospitals, laboratories and research facilities. Until 2017, this program was NSF’s only accreditation option for all BSC field certifiers worldwide.

In response to a demonstrated need for improved global field certification infrastructure and at the request of various stakeholder groups, NSF initiated the basic accreditation program in 2017. The basic accreditation program is intended to be more accessible to field certifiers who live and work in targeted areas outside of North America, both in terms of overall cost and availability of testing options in country. The basic accreditation program includes many of the same components as the enhanced program, but is tailored to the international marketplace. It is intended to provide trained field certifiers with credentials to show prospective clients and promote general awareness of the need for routine BSC maintenance. Additional focus is given to international standards other than NSF/ANSI 49 and test methodologies that utilize accessible equipment.

This presentation will provide information about the components of NSF’s basic accreditation program for BSC field certifiers, in addition to a review of the drivers that led to its creation, program goals, and anticipated long-term public health benefits.