Basic Concepts on Laboratory Biosafety and Biosecurity PDF

PRINCIPLES IN MLS PRACTICE 1 Title of the lesson: Basic Concepts on Laboratory Biosafety and Biosecurity Lecturer/Professor: Ms. Arianne Rose A. Lim Transcriber/s: John Carlo P. de Pedro Basic Concepts on Laboratory Biosafety...

PRINCIPLES IN MLS PRACTICE 1 Title of the lesson: Basic Concepts on Laboratory Biosafety and Biosecurity Lecturer/Professor: Ms. Arianne Rose A. Lim Transcriber/s: John Carlo P. de Pedro Basic Concepts on Laboratory Biosafety and Biosecurity  In 1967, Mortality and morbidity increased due to small OUTLINE pox.  Brief History of Laboratory Biosafety  Serious concerns about biosafety practices  Brief History of Laboratory Biosecurity worldwide were raised, contributing directly to the decision of the World Health Assembly to  Local and International Guidelines on consolidate the remaining virus stocks into two Laboratory Biosafety and Biosecurity locations: the Center for disease Control and  Different Organizations in the Field of Prevention (CDC) in the US and State Biosecurity Research Center of Virology and  Fundamental Concepts of Laboratory Biotechnology Vector (SRCVB VECTOR) in Biosafety and Biosecurity Russia.  Classifications of Microorganisms  In 1974, CDC published the Classification of Etiological According to Risk Groups Agents on the Basis of Hazard  Categories of Laboratory Biosafety  In 1976, the National Institutes of Health (NIH) of the According to Levels United States published the NIH Guidelines for Research Involving Recombinant DNA Molecules. BRIEF HISTORY OF LABORATORY  WHO’s first edition of Laboratory Biosafety Manual BIOSAFETY (1983) and the CDC and NIH’s jointly-published first edition of the Biosafety in Microbiological and Biomedical Laboratories (1984), marked the development of the  Laboratory biosafety and biosecurity traces its history in North America and Western Europe. practice of Laboratory Safety.  Individuals who handle and process microbiological  Biosafety officers adopted the administrative role of specimen are vulnerable to pathogenic microorganisms ensuring the proper equipment and facility controls are in which are possible sources of Laboratory Acquired place based on the specified biosafety level of the Infections (LAI) laboratory.  In 1943, the origins of Biosafety is rooted in the US  Arnold Wedum, director of Industrial Health and Safety Biological Weapons program as ordered by the US at the US Army Biological Research Laboratories was President Franklin Roosevelt and was active during the recognized as one of the pioneers of Biosafety that Cold War. provided the foundation for evaluating the risk of handling infectious microorganism.  Ira L. Baldwin became the first scientific director  In 1966, Wedum and Microbiologist Morton Reitman, of Camp Detrick. analyzed multiple epidemiological studies of laboratory-  In 1969, President Richard Nixon terminated the US based outbreaks.. Biological Weapons program.  Newell A. Johnson designed modifications for biosafety at BRIEF HISTORY OF LABORATORY Camp Detrick. He engaged some of the leading scientists about the nature of their work, and developed specific BIOSECURITY technical solutions such as Class III Safety Cabinets and  In 1996, the US Government enacted the Select Agent Laminar flow hoods to address specific risks. Regulations to monitor the transfer of a select list of  In 1984, American Biological Safety Association biological agents. (ABSA) was formed.  In 2001, after the terrorist attacks and the anthrax  In 1907 and 1908, Arnold Wedum described the use of attacks also known as Amerithrax, the US government Mechanical Pipettors to prevent laboratory-acquired changed its perspective. infections.  The revised Select Agent Regulations required specific  In 1909, a pharmaceutical company in Pennsylvania security measures for any facility in the United States that developed a ventilated cabinet to prevent infection from used or stored one or more agents on the new, longer list mycobacterium tuberculosis. of agents.  In 2012, the Select Agent Regulations sought to address the creation of two tiers of select agents.  Tier 1 Agents are materials that pose the greatest risk of deliberate misuse, and the remaining select agents. 1 of 3  Singapore’s Biological Agents and Toxins Acts is similar the Cartagena Protocol on Biosafety which the in scope with the US Regulations but with more severe Philippines signed on May 24, 2000. penalties for noncompliance.  In 1987, NBF considered as an expansion of the NCBP  In 2005, South Korea’s Act on prevention of Infectious which played an important role in pioneering the Diseases was amended to require institutions that work establishment and development of the current biosafety with listed Highly Dangerous Pathogens to implement system of the country. laboratory biosafety and biosecurity.  Department of Agriculture (DA) also issued  In Japan, the Infectious Disease Control Law was Administrative Order No. 8 to set in place policies on the recently amended under Japan’s Ministry of Health, Labor importation and release of plants and plant products and Welfare. It also established four schedules of select derived from modern biotechnology. agents that are subject to different reporting and handling  The Department of Health (DOH), together with NCBP, requirements for possession, transport, and other activities. formulated guidelines in the assessment of the impacts on health posed by modern Biotechnology and its  In Canada, Canadian Containment Level (CL3) and CL4 applications. facilities that work with risk group 3 or 4 are required to undergo certification.  In 2008,The Danish Parliament passed a law that gives the Minister of Health and Prevention the authority to DIFFERENT ORGANIZATIONS IN THE FIELD OF regulate the possession, manufacture, use, storage, sale, BIOSAFETY purchase or other transfer, distribution, transport and disposal of listed biological agents.  American Biological Safety Association (ABSA)  Promotes biosafety as scientific discipline and LOCAL AND INTERNATIONAL GUIDELINES ON provides guidance to its members on the LABORATORY BIOSAFETY AND BIOSECURITY regulatory regime present in North America  Asia Pacific Biosafety Association (A-PBA)  In February 2008, the Comite Europeen de  Founded in 2005 Normalisation (CEN), a European Committee for  Acts as a professional society for biosafety Stardardization published the CEN Workshop Agreement professionals in the Asia-Pacific Region. Active 15793 (CWA 15793) which focuses on Laboratory Biorisk members of the International Biosafety Working Management. Group are required to directly contribute to the  CWA 15793 can be applied to international stakeholders; development of the best biosafety practices. however, they do not have the force of regulation while  European Biological Safety Association (EBSA) conformity is voluntary.  Founded on June 1996  Developed among experts from 24 different  Aims to provide a forum for discussions and countries including Argentina, Australia, debates on issues of concern and to represent Belgium, Canada, China, Denmark, Germany, those working in the field of Biosafety. Ghana, UK, US among others.  Philippine Biosafety and Biosecurity Association  In 2011, CWA 15793 was updated and intended to (PhBBA) maintain a biorisk management system among diverse  The long term goal of the association is to assist organizations and set out performance-based requirements the DA and DOH in their efforts to create a with the exclusion of guidance for implementing a national national policy and implement plan for laboratory biosafety system. biosafety and biosecurity.  In 2014, the agreement was used until it was officially  Biological Risk Association Philippines (BRAP) expired.  A non-government association that works to  In 1983, WHO published its 3rd Edition of the Laboratory serve the emergent concerns of biological risk Biosafety Manual. management in various professional fields such  In 2003, Cartagena Protocol on Biosafety made effective as in the health, agriculture, and technology which applies to the 168 Member-countries that provides sectors throughout the country. an international regulatory framework to ensure an adequate level of protection in the field of safe transfer FUNDAMENTAL CONCEPTS OF LABORATORY handling and use of living modified organisms (LMO) resulting from modern biotechnology BIOSAFETY AND BIOSECURITY  The National Committee on Biosafety of the Philippines (NCBP) established under E.O 430 series of 1990 was  Biosafety defines as the containment principles, formed on the advocacy efforts of scientists. technologies and practices that are implemented to  On March 17, 2006, the Office of the President prevent unintentional exposure to pathogens and toxins, or promulgated E.O 514 establishing the National Biosafety their accidental release. Framework (NBF) which prescribes the guidelines for its  Biosecurity refers to the protection, control, and implementation, strengthening the National Committee on accountability for valuable biological materials within Biosafety of the Philippines. laboratories, in order to prevent their unauthorized access,  NBF is a combination of policy, legal, administrative, and loss, theft, misuse, diversion or intentional release. technical instruments developed to attain the objective of 2 of 3  By simple definition, Biosafety protects people from aerosol route, for which there no available vaccines or germs while Biosecurity protects germs from people. treatment.  In 1966, Charles Baldwin worked for the Dow Chemical  Marburg and Crimean-Congo Company containment systems products, created the Hemorrhagic Fever biohazard symbol used in labeling biological hazards  Biosafety and Biosecurity share common perspectives in terms of risk assessment and management methodologies, personnel expertise, responsibility and control and program management among others. CLASSIFICATIONS OF MICROORGANISMS ACCORDING TO RISK GROUPS  Risk Group 1 – Includes microorganisms that are unlikely to cause human or animal disease.  Low individual and Community Risk  Risk Group 2 – Includes microorganisms that are unlikely to be a significant risk to laboratory workers and the community, livestock, or the environment. Laboratory exposure may cause infection, however, effective treatment and preventive measures are available while the risk of spread is limited.  Moderate individual risk, and limited to moderate community risk  Risk Group 3 – Include microorganisms that are known to cause serious diseases to humans or animals and may present a significant risk to laboratory workers.  High individual risk, and limited to moderate community risk  Risk Group 4 – Includes microorganisms that are known to produce life-threatening diseases to humans or animals.  High Individual and community risk CATEGORIES OF LABORATORY BIOSAFETY ACCORDING TO LEVELS  Biosafety Level 1 (BSL – 1) – Is suitable for work involving viable microorganisms that are defined and with well-characterized strains known not to cause disease in humans.  Bacillus subtilis, Naegleria gruberi, and Infectious canine hepatitis virus  Biosafety Level 2 (BSL - 2) – Is basically designed for laboratories that deal with indigenous moderate-risk agents present in the community. It observes practices, equipment, and facility design that are applicable to clinical, diagnostic and teaching laboratories consequently observing good microbiological techniques.  Hepatitis B Virus, HIV, Salmonellae, Taxoplasma species  Biosafety Level 3 (BSL – 3) – Puts emphasis on primary and secondary barriers in the protection of the personnel, the community and the environment from infectious aerosol exposure.  Mycorium tuberculosis, St. Louis Encephalitis Virus and Coxiella.  Biosafety Level 4 (BSL – 4) – Is required for work with dangerous and exotic agents that pose high individual risks of life-threatening diseases that may be transmitted via the 3 of 3