Bio-containment Technologies - Building BSL-3 lab, challenges in developing countries
The design and construction of containment facilities (especially BSL-3 labs) in developing countries presents formidable challenges when the intent is to meet accepted international standards. Special measures based on broadly based risk analyses are required to ensure that these standards are met and more importantly, are sustainable over the longer term. This presentation is based on a recently completed Canada-funded laboratories upgrade project located in Nairobi, Kenya but the lessons learned may apply equally in other similar contexts. (http://hub.africabiosciences.org/)
In most of the developed world there is increasing reliance on sophisticated and relatively expensive technologies to achieve and maintain bio-containment. Concepts such as 'Venturi valves', 'electronical interlocks' and 'proximity card access readers' are all widely understood and commonly applied. However this is not necessarily the case the world over. In fact, aside from South Africa most of the research laboratories in academic and other institutions still operating in sub-Saharan Africa date from 35-40 years ago and are quite basic. They may even be considered sub-standard by accepted world standards.
The challenge then is to design and build safe and efficient bio-containment facilities which are also affordable to operate and maintain, all commensurate with local capacity. It is accepted that this can often be achieved by selectively substituting Special Operating Protocols in place of expensive engineering solutions. On the other hand there are limits to the low-cost, low-tech approach below which containment may be compromised due to increased risk. In these situations, it may be appropriate to import expertise and more costly technologies from abroad to ensure compliance with internationally accepted bio-safety standards. However, this raises other issues which are of equal concern to international development agencies, such as the development of longer term indigenous capacity for on-going operation and maintenance.
Aside from technology-related issues, special attention needs to be focused on the way procurement contracts are structured and managed. Assumptions and expectations based on other parts of the world may not be directly and fully transferable to the operating environments of developing countries. This includes contracts for design professionals, construction contractors and other suppliers of materials and services. For example, we found that there was less incentive for design professionals to complete fully detailed drawings and specifications before construction contract award within an operating environment where extensive use of 'cash allowances' is accepted practice. This makes it more difficult to control project costs and completion schedule and contrasts sharply with the North American practice of 'fixed price' contracts based on reducing ambiguity and minimizing changes to contracts.
Even more than usual, we found that there is a critical need for on-going and a wide range of communication initiatives in bio-containment projects implemented in developing countries. These need to be targeted at increasingly wider circles of project stakeholders - from the immediate project team of consultants and contractors, to the staff and visitors of the host institution, to the local community and local governing authorities, to the funding and certifying agencies. In our experience, training and mentoring have proven to be the most critical and constantly applied elements of all these initiatives.
Due to a variety of reasons, the risks in designing and building BSL-3 labs in developing countries are much greater than in similar projects in the developed world . However, these risks can be mitigated by appropriate implementation strategies responsive to the local context and which are focused on building longer term capacity.
Barbara Johnson, PhD, RBP
Biosafety Biosecurity International
National Academies of Science, Trans-Federal Task Force Recommendations and Executive Order 13486 for Strengthening Biosafety and Biosecurity in the United States.
Over the past months two prominent reports and an Executive Order regarding biosafety and biosecurity in the US have been issued. The Trans-Federal Task Force report proposes options and recommendations to improve biosafety and biocontainment oversight of research and research-related activities at high and maximum containment laboratories in the United States, without hindering the progress of science. The National Academies of Science report proposed an appropriate framework of laboratory security and personnel reliability measures to optimize benefits, minimize risk, and facilitate the productivity of research. The findings of the Executive Order seeks to evaluate the effectiveness of current regulations and laws regarding biosafety, biosecurity and actual practices and make recommendations if to strengthen them where needed.
Together the three reports address a variety of topics to include:
monitoring employees throughout employment and maintaining the security risk assessment process,
making appeals to Security Risk Assessemnt rejection possible,
conducting a risk assessment for transporting SA,
enhancing personnel reliability,
identifying proper ways of inventorying materials, and
developing minimal prescriptive physical security measures and ranking SA according to the risk they pose (higher risk = higher security requirements).
The overall consensus is that these measures and proposed activities should not be more burdensome than those measures already in place. In the case of developing a minimum prescriptive physical security measures care must be taken with developing prescriptive requirements and ensuring they address actual problems and are truly minimal measures that can be implemented be all stakeholders with particular attention to those operating at the lowest level of required security.
Committee on Laboratory Security and Personnel Reliability Assurance Systems for Laboratories Conducting Research on Biological Select Agents and Toxins, National Research Council, National Academies of Science
http://www.nap.edu/catalog.php?record_id=12774
Brad Globe International Centre for Infectious Diseases, Canada
Emerging and Dangerous Pathogens Laboratory Network
The 2007 World Health Report on Global Public Health Security highlighted the “myriad opportunities for the rapid spread of infectious diseases in today’s highly mobile, interdependent and interconnected world”. Over the past decade, a series of successive outbreaks has raised new challenges for coordination of multi-national laboratory response, surge capacity and scientific collaboration. Lessons learned from these events indicate that the resources of individual institutions cannot ensure timely response to numerous geographically distributed events occurring concomitantly. The necessary resources and skills are themselves distributed globally.
Development of a laboratory response network for Emerging and Dangerous Pathogen (EDP) is recognized as critical to support laboratory responses to outbreaks, and enhance readiness for epidemic activity that is geographically distributed or has the potential to become a global threat.
Initiate in March of 2998, the EDPLN is an informal global network of BSL-4 ad selected BSL-3 laboratories for laboratory readiness and response to outbreaks of Emerging and Dangerous Pathogens.
EDPLN is intended to provide:
Rapid communications and sharing of technical advice immediately following an outbreak alert;
Real-time diagnostics, reference laboratory, surge capacity and applied research in support of detection, intra-epidemic surveillance, patient management and control of EDP outbreaks;
Research on new diagnostics, applications for field use, and appropriate transfer of technology to regional networks and countries in threatened regions;
Current knowledge and scientific expertise on laboratory science and tools, for EDPs and disease ecology; and
Opportunities for participation in field responses.
J. Craig Reed, Ph.D., RBP
Inspirion Biosciences
Global Biosafety and Biosecurity Challenges - Options for nations with limited resources
Every nation operates biological laboratories either for the detection of human and animal diseases, biological research and/or biological production. Therefore, every nation confronts challenges associated with the mitigation of biosafety and biosecurity risks. This presentation will explore the range of resources necessary for the implementation of effective biosafety and biosecurity programs as well as the limitations on these resources. Based on the presenter’s experience working with containment laboratory staff and ministers from a wide variety of countries, we will explore how foreign assistance of limited duration can be most efficiently utilized. Emphasis will be placed on the prioritization of biosafety and biosecurity objectives, the development of a plan of action that considers prioritization of available resources, and the critical importance of sustainability and self-sufficiency. The presentation will conclude with a discussion of the role that open markets and free enterprise play in sustainability, specifically for the creation of for-profit business enterprises that not only develop products and provide services for laboratories, but also create jobs for scientists outside the federal payroll.
James “Sandy” Ellis Senior Biocontainment Architect, Merrick Canada ULC
Designing for Biocontainment: form follows function vs. function follows form
Within every design process, the constraints of time, space and budget are always on the minds of the designers, the owner, the end-users, and the contractors. Time and budget come with their own set of unique challenges, but this presentation will focus on the third dimension of design, which is defining the space…or the form and function of a biocontainment facility.
Form refers to the shape, visual appearance, or arrangement of an object. It is the manifestation of creation. Function is how something operates, which can be also describes as its purpose. Designing and constructing a form can be conducted for the sole purpose of aesthetic, a beauty to the eye of the beholder – or design and construction can be for the purpose of a structured representation of the functions, activities or processes for which it is created.
As the title of this presentation suggests, there is an inherent balance (or clash) between function and form. Decisions need to be made in order to find the desired balance and avoid the clashes. This presentation will cover some processes that will help mitigate this delicate scale when designing for a project, and more importantly the process of Programming for Containment. We will discuss the issues that affect both new and renovation projects and some of the pitfalls found through lack of proper programming.
Jennifer Gaudioso
International Biological Threat Reduction Program
Sandia National Laboratories, NM, USA
Biorisk Assessment Processes and Models - Advantages and Limits to Modeling Biorisks Using a Quantitative Process
Training of personnel is a key component of any biorisk management program. While those inside the profession are concerned with processes, the outside world is more concerned with visible effectiveness. The research laboratory is the Achilles heel of biological research, and anything that goes awry at any research facility affects the public’s reaction to research everywhere. This presentation invites participants to review their current training programs and assess that they are meeting both the basic requirements of the institution and what the larger public expects. Jim Welch, the presenter of this program, serves as the executive director of the Elizabeth R Griffin Research Foundation brings his experience of working with US and global audiences and biorisk training programs as an advocate in advancing the need for safe and effective research. He is not a scientist, but brings to scientific audiences the reality that it is often non-scientists who determine the appropriate risk boundaries of scientific research. This presentation will provide the audience with key benchmarks to use in assessing how workers and communities assess the quality of training programs.
Jim Welch
"Water, Batteries and Ice" – An Outsider’s View of Biorisk Training
Training of personnel is a key component of any biorisk management program. While those inside the profession are concerned with processes, the outside world is more concerned with visible effectiveness. The research laboratory is the Achilles heel of biological research, and anything that goes awry at any research facility affects the public’s reaction to research everywhere. This presentation invites participants to review their current training programs and assess that they are meeting both the basic requirements of the institution and what the larger public expects. Jim Welch, the presenter of this program, serves as the executive director of the Elizabeth R Griffin Research Foundation brings his experience of working with US and global audiences and biorisk training programs as an advocate in advancing the need for safe and effective research. He is not a scientist, but brings to scientific audiences the reality that it is often non-scientists who determine the appropriate risk boundaries of scientific research. This presentation will provide the audience with key benchmarks to use in assessing how workers and communities assess the quality of training programs.
Joseph H. Wilson
Effluent Treatment Systems for Containment Facilities; Options and Considerations An Effluent Treatment System (EDS) is one of the most expensive systems to purchase and operate for a bio-containment facility. Very often we have seen misapplication of EDS technologies in the field resulting in great problems for the end user after implementation. Also, we have seen overspecification of technology resulting in significantly greater acquisition, operation, and maintenance costs to the end user than would have been necessary if the end user had been properly informed prior to making their technology choices. Conventional wisdom dictates that specifications for these systems rely on the old “autoclave” specification requirements of 121 degrees C or higher treatment temperature over extended treatment times of 30 minutes to 2 hours. However, effluent can be easily decontaminated using lower temperatures with or without chemical augmentation, or by chemical treatment only, resulting in more reliable systems that are less expensive to acquire and operate.
There are 6 different types of EDS technologies available that will be described, and for each bio-containment scenario there are at least 2 or 3 viable options. The criteria for selection of each of these technologies will be described and discussed in each facility scenario (facility type). Significant reductions in use of resources (steam, water, electricity) and significant gains in long term reliability and maintenance cost reductions can be achieved by understanding the technologies available for each facility scenario. Our goal is to educate architects, engineers, and end users of the options they have to save money and avoid problems resulting from improper technology selection and specification.
Karen B. Byers
Lessons Learned in Laboratory Acquired Infections: Clinical (diagnostic) vs. Research
Case reports of laboratory-acquired infections provide valuable guidance for prevention efforts. Between 1979 and 2004, there were 1, 448 laboratory-acquired infections reported in the scientific literature. The major “lessons” for biosafety programs from these and recent publications will be highlighted in this talk.
Ling Ai Ee Singapore General Hospital, SingHealth,
Ministry of Health
National Guidelines, Regulations and Legislation affecting biosafety practices in Singapore
Biosafety practice in Singapore came to the fore after the anthrax letters incidence in the United States of America, reinforced by local experience with emerging infectious diseases in the Asia Pacific region – Nipah (Malaysia and Singapore) 1997, SARS (2003), Avian influenza and the ongoing H1N1 pandemic. The following guidelines, regulations and legislation lay the foundation for good biosafety practices in Singapore: The Animal and Birds Act, 1965, for prevention of spread of diseases of animals, birds or fish, the Strategic Goods (Control) Act, 2002, which enables on-line cross agency collation of importation approvals for biologicals and toxins (and other strategic goods) and their export, the Biological Agents and Toxins Act, 2005, to prohibit/regulate the possession, use, import, transshipment, transfer and transportation of biological agents, inactivated biological agents and toxins and to provide for safe practices in the handling of such agents and toxins, the Singapore Biosafety Guidelines for research on Genetically Modified Organisms, 2006, to ensure the safe containment, handling and transport of GMOs in research and to provide a common framework for assessment and notification of research on GMOs and a code of Ethical practice in Human Biomedical Research which was formulated in 2009 by the Ministry of Health.
BSL3 Labs: Theory and Practice The used terms “theory and practice” in this presentation contain a multitude of subjective factors on the part of the principal and the general contractor. This presentation will demonstrate how the project owner will get the optimal solution for his BSL3 laboratory and to avoid incorrect decisions considering the sometimes vastly different opinions and concepts between owner, consultants and project planner or general contractor.
The scope of this presentation will cover following chapters: Pre-planning (Pre-project engineering), project planning, project execution, operation, maintenance.
For a successful project planning and project execution there should be an extensive and honest co-operation of both parties = team-work.
Maureen Ellis International Federation of Biosafety Associations (IFBA)
IFBA – An Emerging Global Biosafety Community The International Federation of Biosafety Associations (IFBA) was established in 2001 to advance biosafety on a national and international level through collaboration among biosafety associations, international agencies, non-governmental organizations, private industry and governments. By working in partnership with its member organizations and leveraging resources, the IFBA is able to effectively reach down to the national level in countries throughout the world and deliver sustainable biosafety capacity building programs where they are most needed.
The call for biosafety assistance is broad and far reaching as the risks from emerging infectious diseases continue to grow. In May 2005, The World Health Assembly adopted resolution WHA58.29 Enhancement of Laboratory Biosafety, a plan to mobilize international resources to strengthen global biosafety. While some progress has been made, much work remains to be done and more intensive action is needed in many countries around the world. This is a global problem that requires a global solution.
To this end, the IFBA will convene an international forum to provide greater visibility to this neglected area and act as a much needed catalyst for long-term biosafety capacity building. The IFBA’s conference on “Global Biosafety and Biosecurity: Taking Action”, to be held in February 2011, Bangkok, Thailand, will bring together policy makers, governments, international agencies, donors and stakeholders from all regions to advance biosafety and biosecurity in support of the worldwide fight against emerging infectious diseases. Key IFBA objectives include:
Identify urgent gaps and priorities in under-addressed regions of the world
Explore the elements of cost-effective and sustainable programs
Facilitate a dialogue to leverage resources and collectively enhance local capacity
Advocate strategies for strengthening national policies and programs
Empower nascent biosafety associations and those new to the field
As a global ambassadors for biosafety and by working together, the IFBA serves as the organization that bridges the gap between policy makers, funding organizations and the biosafety community.
Securing Biological Materials and Fostering Responsibility
Many diagnostic and research laboratories around the world do not have appropriate biosecurity measures in place despite working with dangerous pathogens such as avian influenza, anthrax, foot-and-mouth disease virus, brucella. In some instances, these facilities are located in terrorist-prone areas and are in serious states of decay. Vulnerabilities in one region present a global risk. In the face of such threats to global health security, the International Federation of Biosafety Associations (IFBA) is collectively responding by bringing together all regions and stakeholders to mobilize the necessary resources and make measureable progress regarding this under-addressed issue.
Biosecurity for biological materials present unique challenges including:
Many biological laboratories are located in close proximity to public areas (hospitals, universities)
There is often a changing workforce (students, visiting scientists)
Biological materials are located in many areas within the laboratory (fridges, freezers, incubators)
Pathogens can replicate and theft of minute quantities is significant
There are no devices to detect their unauthorized removal from a facility
Securing and accounting for biological materials requires a fundamentally different approach. How best to enhance biosecurity is not simply a matter of physically securing these laboratories and restricting access to their collections of pathogens. Fostering a sense of vigilance and accountability among those working in these laboratories is central to effective biosecurity programs. Leadership that not only values security but encourages teamwork and camaraderie is one of the most effective ways of empowering individuals at the local level to take responsibility for the security of their pathogen collections. Global public health security depends on the capacity of each of us to act responsibly and contribute to the security of all.
Patty Olinger Emory University
Internal Auditing and Inspection Programs: A different Approach
Is your auditing or inspecting program just checking boxes? Get more out of your auditing program! This talk introduces ideas and concepts on how to transform your audit or inspection program into adding value and doing more than just checking a box. It will provide assistance in capturing meaningful measures and metrics, using as a training tool, and as a safety culture evaluation. The session also discusses how integrated audit programs fit into an overall EHS management system.
Peter Chong Acre Engineering, Singapore
Mobile Biosafety Level-4 (BSL 4) Autopsy Facility: Deployment and Movement Exercise – A Case Study
The Mobile Biosafety Level – 4 Autopsy Facility that was developed and built by Acre Engineering in collaboration with the Forensic Medicine Division, Health Sciences Authority of Singapore was successfully tested and commissioned in November 2006. In order for the facility to be considered as fully mobile and readily deployable, a deployment and movement exercise was carried out in February 2009.
The facility in the form of two standard “reefer” 40 foot by 9 and a half foot containers were lifted by a crane onto two flat bed trailers and put on a “Round-the Island” journey before being lifted off the trailers and put back on the ground again. The services connections were set up again and the various critical perimeters (such as room pressure tests, duct pressure tests, HEPA filters leak tests, breathable air system tests, emergency alarms checks..) were tested once more before the Facility was put into operation again.
This paper sets out to discuss the relevant issues of the deployment of the Mobile BSL 4 Autopsy Facility. Important health and safety aspects will be highlighted. It will cover the lessons learned. Relevant tests, observation before and after the exercise will also be touched on.
Authors:
Peter Chong, Bobby Chong, Acre Engineering, Singapore,
Paul Chui, Forensic Medicine Division, Health Sciences Authority, Singapore
Stefan Wagener, Canadian Science Centre for Human and Animal Health, Canada
Dr. Piers Millett Deputy Head, BWC Implementation Support Unit
Biological Weapons Convention
UN Office for Disarmament Affairs
The Biological Weapons Convention: Turning International Obligation into Effective National Action
Current efforts under the BWC attempt to balance the interests of states with the needs of business and the concerns of the general public to build a regime, tailored to the specific needs of both biology and biologists, that manages the risk that biology could be used to cause harm. There is a layered approach to dealing with the threat posed by biological weapons. The presentation looks at: the international legal framework; how treaties are turned into action; the implementation of the obligations; and the work of the community dedicated to ensuring biology continues only to be used to improve our lives. The discussion of the Biological Weapons Convention (BWC) provides details of key provisions and current status (membership, implementation, etc.) of this important international instrument. It also illustrates how the BWC has changed since it was negotiated. A closer look at the regime details how the model used by the BWC differs from the traditional approach and how this treaty is leading the way in redefining disarmament and non-proliferation for the 21st century. By examining state actions, the presentation covers the different types of commitments under the Convention. It uses the issue of biosecurity as a case study to illustrate the types of outputs produced and the nature of the work programmes that produce them. The presentation also looks at the work of the network of organizations, companies and individuals committed to ensuring that biology is used safely, securely and solely for our collective benefit.
Dr. Robert A. Heckert, DVM, PhD, CBSP
Technology in Animal Biosafety – Past, Present and Future
Animals have historically been used in research for many years and have led to discoveries that have advanced human and animal health. In addition, outbreaks of zoonotic disease continue to occur and remind us of the need to study diseases in the animal reservoir. For these reasons and others there is an ongoing need to work with animals in the vivarium. Maintaining animals in a vivarium requires good procedures, safety equipment and facilities, in order to work safely with the animals. In the last few decades, there have been a large number of technological advances in animal diseases diagnostics, animal caging, equipment to prevent aerosol transmission of pathogens, safe sharps engineering devices, and personal protective equipment that have improved biosafety for animal care workers in the vivarium. Based upon a thorough risk assessment these technological advances should be strategically used in the vivarium to decrease the risks of working with animals in containment.
Stuart D. Blacksell
Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Centre for Tropical Medicine, University of Oxford, United Kingdom
Biosecurity & Bioterrorisim Preparedness and Response - NSAR/CDC select agent registration
The National Select Agents Registry (NSAR) Program of the USA Government oversees the activities of possession of biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products. The NSAR currently requires registration of facilities including government agencies, universities, research institutions, and commercial entities that possess, use or transfer biological agents and toxins. The inspection and certification is usually performed by Centers for Disease Control and Prevention (CDC) staff.
Without NSAR/CDC select agent registration applicants for US National Institute of Health (NIH) select agent programs are unable to receive funds. In Asia, it may be important for some facilities and procedures of applicant laboratories to reach the standards of biosecurity and biosafety expected by the Interagency Select Agent Review Group (ISARG). Following a successful CDC site inspection visit and positive review by the ISARG the recommendation by ISARG will be presented to the Director of Division of Extramural Activities (DEA), NIAID for the approval to waive the restriction on funds used for select agent work.
Specifics of the NSAR/CDC select agent registration process include ensuring facilities and procedures of the laboratories to ensure a high level of biosecurity and biosafety, as required by the US Department of Homeland Security such as those specified in the CDC Select Agents Regulations (42 CFR Part 73) that govern the possession, use and transfer of Select Agents that have the potential to pose a severe threat to public health and safety and to meet Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition.
The NSAR/CDC select agent registration poses as significant challenge for many facilities throughout Asia and the Pacific however the ideals of the program provide the fundamentals for a successful biosecurity & bioterrorisim preparedness and response program.
Theodore J. Traum
Engineering for the Biosafety Professional
Proactive biosafety professionals need to be involved and knowledgeable in the operation, maintenance and certification of their containment facilities and building systems. Frequently, the biosafety professional is called upon to participate in the planning, design and validation of a new biocontainment laboratory or renovation of an existing facility. The biosafety professional’s training and experience is usually limited to the sciences and they may lack the knowledge of basic engineering principles.
For the biosafety professional to participate in these activities, he/she needs basic knowledge and understanding, development of skills to ask questions in engineering terms and the confidence to question the answers.
Presented will be engineering perspectives on:
Air change rates
Drawing schematics
Directional airflow and room pressure differentials
HEPA filtration and exhaust discharge
HVAC control issues
Differential pressure monitors
Emergency power systems
The day-to-day operations of a containment facility require a maintenance program which is proactive and provides for preparation of the laboratory for annual validation. Presented are concepts for the development of relationships between the facilities and contract personnel who maintain the laboratory’s systems. The necessity of team building and record keeping will be emphasized along with a methodology for achieving a team approach.
The goals of the presentation are to empower the biosafety professional in leading the following activities:
Planning and Design
Construction
Operations and Maintenance
Laboratory Validation and Certification
This presentation will provide new tools for your management tool belt.
Making a Containment Laboratory Sustainable – Existing and New
The course, “Making a Containment Laboratory Sustainable – Existing and New,” is designed to provide attendees with an insight into the concept of sustainability and its application. A typical laboratory can use as much as five times the energy per square foot as a typical commercial building. Factors responsible for the high energy usage are attributed to operational policies (i.e., scientists often require 24-hour access,) to industry standards (i.e., single-pass air or once-through air). This course will examine laboratory operations and energy requirements from a holistic perspective. The course will identify significant opportunities for improving efficiencies while meeting or exceeding health and safety standards.
The course will define sustainability as it applies to containment laboratories. It will identify various opportunities for making a laboratory sustainable from both operational and technology perspectives. Sustainable laboratory management practices, sustainable laboratory finishes and stainable laboratory engineering design concepts will be discussed. Implementation of these sustainable opportunities will be evaluated for new and existing laboratories. Utilizing engineering economic principles, the attendees will evaluate the financial advantage of sustainable choices by participating in team exercises.
The goal of the course is to introduce innovative strategies for reducing operating and energy costs. The course is interactive and designed to provide attendees with the experience of evaluating sustainability alternatives and determining if the savings purported are, in fact, actual. Attendees should be biosafety professionals and facility personnel who are seeking information on providing for a sustainable containment facility.
Won Keun Seong Div. of Biosafety Evaluation & Control, KCDC, Seoul, Korea
The Biosafety & Biosecurity in Korea
To establish national regime for biosafety compliance, the legislation is very important with programs for raising biosafety awareness. The Republic of Korea has made efforts to enforce national pathogen control and The Act on the Prevention of Infectious Disease was amended in 2005 to create a system for controlling “highly dangerous pathogens” consisting of the thirty-two listed microorganisms. Any new isolation or acquisition of these agents should be reported to the Korea Centers for Disese Control & Prevention (KCDC). KCDC is also responsible for reviewing and coordinating activities with highly dangerous pathogens, establishing biosafety guidelines, education, and training.
In order to effectively coordinate the observance of Biological and Toxin Weapons Convention, The Act on the Prohibition of Biological or Chemical Weapon and the Control of the Production, Export and Import of Special Biological or Chemical Agents was passed in 2006. This law was intended as an unified measures to harmonize the management of related laws and regulations previously in place. Biosafety and biosecurity inspections are performed to review safety measures and processes in any institutions where pathogens are handled or stored. According to the Cartagena Protocol on Biosafety, The Act on the Transboundary Movement etc. of Living Modified Organisms" was finally enacted in 2008. According to the Act, the certification of the BL3 and BL4 and review of the specific experiments requiring national approvals were enforced. Since 2008, 15 BL3 facilities have received the facility certification from KCDC.
Considering the rapid advances in bioscience and the increasing number of individuals who work with pathogens in bioscience laboratories, the more effective management programs will be necessary to promote beneficial applications of bioscience as well as adequate control of dual-use pathogens. Now we are preparing a new legislation to implement the advanced regulatory framework based on the biorisk assessment and management standard.
