Basic Concepts on Laboratory Biosafety and Biosecurity PDF

Basic Concepts on Laboratory Biosafety  and Biosecurity Jobhel Christy U. Abad, RMT  Brief History of laboratory Biosafety ▪ The origins of biosafety is rooted in the US biological weapons program which began in 1943, as ordered by then US Presi...

Basic Concepts on Laboratory Biosafety  and Biosecurity Jobhel Christy U. Abad, RMT  Brief History of laboratory Biosafety ▪ The origins of biosafety is rooted in the US biological weapons program which began in 1943, as ordered by then US President Franklin Roosevelt and was active during the Cold War. ▪ It was eventually terminated by US President Richard Nixon in 1969. In 1943, Ira L. Baldwin became the first scientific director of Camp Detrick (which eventually became Fort Detrick), and was tasked with establishing the biological weapons program for defensive purposes to enable the United States to respond if attacked by such weapons.  Brief History of laboratory Biosafety ▪ After the Second World War, Camp Detrick was designated a permanent installation for biological research and development. ▪ Later on, Newell A. Johnson designed modifications for biosafety at Camp Detrick. He engaged some of Camp Detrick's leading scientists about the nature of their work, and developed specific technical solutions such as ( Class III safety cabinets and laminar flow hoods to address specific risks. ▪ Consequent meetings eventually led to the formation of the, American Biological Safety Association (ABSA) in 1984  Brief History of laboratory Biosafety ▪ Outside the United States included Arnold Wedum who described the use of mechanical pipettors to prevent laboratory- acquired infections in 1907 and 1908. ▪ Moreover, ventilated cabinets, early progenitors to the nearly ubiquitous engineered control now known as the biological safety cabinet ▪ In 1909, a pharmaceutical company in Pennsylvania developed a ventilated cabinet to prevent infection from Mycobacterium tuberculosis.  Brief History of laboratory Biosafety ▪ Increasing mortality and morbidity due to smallpox in 1967,WHO aggressively pursued the eradication of the virus. ▪ World Health Assembly decided to consolidate the remaining virus stocks into two locations: Center for Disease Control and Prevention (CDC) in the United states and the State Research Center of Virology and Biotechnology VECTOR (SRVCB VECTOR) in Russia  Brief History of laboratory Biosafety ▪ In 1974, the CDC published Classification of Etiological Agents on the Basis of Hazard ▪ In 1976, two years later the National Institutes of Health (NIH of the United States published the NIH Guidelines, for Research Involving Recombinant DNA Molecules. It explained in detail the microbiological practices, equipment, and facility necessarily corresponding to four ascending levels of physical containment. ▪ These guidelines laid the foundation for the introduction of a code of biosafety practice. This code, along with WHO'S first edition of Laboratory Biosafety Manual (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 practice of Laboratory biosafety  Brief History of laboratory Biosafety ▪ Biosafety levels are the technical means of mitigating the risk of accidental infection from or release of agents in the laboratory setting as well as the community and environment it is situated in. ▪ In 1966 Wedum and microbiologist Morton Reitman, colleagues at Fort Detrick, analyzed multiple epidemiological studies of laboratory-based outbreaks.  Brief History of Laboratory Biosecurity ▪ In 1996, the US government enacted the Select Agent Regulations to monitor the transfer of a select list of biological agents from facility to another. ▪ After the terrorist attacks and the anthrax attacks of 2001, also known as Amerithrax, the US government changed its perspective. The revised Select Agent Regulations then required specific security measures for any facility in the United States that used or stored one or more agents on the new, longer list of agents.  Brief History of Laboratory Biosecurity ▪ The revision of the Select Agent Regulations in 2012 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. Other countries also relatively implemented and prescribed biosecurity regulations: ▪ Singapore’s Biological Agents and Toxins Act is similar with the US Regulations but with more severe penalties for noncompliance.  Brief History of Laboratory Biosecurity ▪ In South Korea, the Act on Prevention of Infectious Diseases in 2005 was amended to require institutions that work with listed “highly dangerous pathogens" to implement laboratory biosafety and biosecurity requirements to prevent the loss, theft, diversion, release, or, misuse of these agents. ▪ In Japan, the Infectious Disease Control Law was recently amended. It also established four schedules of select agents that are subject to different reporting and handling requirements for possession, transport, and other activities.  Brief History of Laboratory Biosecurity ▪ In Canada, Canadian containment level (CL) 3 and CL 4 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 regulate the possession, manufacture, use, storage, sale, purchase or other transfer, distribution, transport and disposal of listed biological agents.  Local and International Guidelines on Laboratory Biosafety and Biosecurity ▪ In February 2008 the Comité Européen de Normalisation (CEN), a European Committee for Standardization published the CEN Workshop Agreement 15793 (CWA 15793) which focuses on laboratory biorisk management. ▪ The CWA 15793 was developed among experts from 24 different countries including Argentina, Australia, Belgium, Canada, China, Denmark, Germany, Ghana, UK, US, among others. It was updated in 2011 and intended to maintain a biorisk management system, the agreement was used until it officially expired in 2014.  Local and International Guidelines on Laboratory Biosafety and Biosecurity ▪ WHO in 1983 published its 3rd edition of the Laboratory Biosafety Manual. It includes information on to the different levels of containment laboratories (Biosafety levels1-4), different types of safety cabinets, good microbiological techniques, and how to disinfect and sterilize equipment. ▪ In terms of biosecurity, it covers the packaging required by international transport regulations and other types of safety procedures for chemical, electrical, ionizing radiation, and fire hazards.  Local and International Guidelines on Laboratory Biosafety and Biosecurity ▪ Cartagena Protocol on Biosafety (CPB), made effective in 2003 which applies to the168 member-countries provides an international regulatory framework to ensure "an adequate level of protection in the field of safe transfer, handling, and use of living modified organisms (LMOs) resulting from modern biotechnology.” ▪ The regulations primarily tackle the safe transfer, handling, and use of LMOs that may have adverse effects on the conservation of biological diversity except those that are used for pharmaceutical purposes.  Local and International Guidelines on Laboratory Biosafety and Biosecurity ▪ The new National Committee on Biosafety of the Philippines NCBP) established under E.0. 430 series of 1990 was formed on the advocacy efforts of scientists. of scientists. The mandate focuses on the organizational structure for biosafety. ▪ On March 17, 2006, the Office of the President promulgated E.O. 514 establishing the National Biosafety Framework (NBF), which prescribes the guidelines for its implementation, strengthening the National Committee on Biosafety of the Philippines.  Local and International Guidelines on Laboratory Biosafety and Biosecurity ▪ The NBF is a combination of policy, legal, administrative, and technical instruments developed to attain the objective of the Cartagena Protocol on Biosafety which the Philippines signed on May 24, 2000. ▪ The NBF can be considered as an expansion of the NCBP, which since 1987has played an important role in pioneering the establishment and development of the current biosafety system of the country.  Local and International Guidelines on Laboratory Biosafety and Biosecurity ▪ The Department of Agriculture (DA) also issued Administrative Order No. 8 to set in place policies on the importation and release of plants and plant products derived from modern biotechnology. ▪ The Department of Health (DOH), together with NCBP, formulated guidelines in the assessment of the impacts on health posed by modern biotechnology and its applications.  Different Organizations in the Field of Biosafety 1. American Biological Safety Association (ABSA) a regional professional society for biosafety and biosecurity founded in 1984. It promotes biosafety as a scientific to discipline and provides guidance to its members on the regulatory regime present in North America. 2. Asia- Pacific Biosafety Association (A-PBA) a group founded in 2005 that acts as professional society for biosafety professionals in the Asia-Pacific region. Its members are from Singapore, Brunei, China, Indonesia, Malaysia, Thailand, the Philippines, and Myanmar.  Different Organizations in the Field of Biosafety 3. European Biological Safety Association (EBSA) a non-profit organization founded in June 1996, EBSA focuses on encouraging and communicating among its members information and issues on biosafety and biosecurity as well as emerging legislation and standards. 4. Philippine Biosafety and Biosecurity Association (PhBBA) created by a multi-disciplinary team with members coming from the health and education sectors as well as individuals from the executive, legislative, and judicial branches of the government.  Different Organizations in the Field of Biosafety 5. Biological Risk Association Philippines (BRAP) a non- government and non-profit association that works to serve the emergent concerns of biological risk management in various professional fields such as in the health. Agriculture, and technology sectors throughout the country.  Biohazard warning sign for laboratory doors  Fundamental Concepts of Laboratory Biosafety and Biosecurity ▪ The WHO Laboratory Biosafety Manual (LBM) defines BIOSAFETY as "the containment principles, technologies, and practices that are implemented to prevent unintentional exposure to pathogens and toxins, or their accidental release.“ ▪ On the other hand BIOSECURITY "the protection, control, and accountability for valuable biological materials within laboratories, in order to prevent their unauthorized access, loss, theft, misuse, diversion, or intentional release“  Fundamental Concepts of Laboratory Biosafety and Biosecurity ▪ In 1966, Charles Baldwin, an environmental health engineer working for the Dow Chemical Company containment systems products, created the biohazard symbol used in labeling biological materials carrying significant health risks.  Classifications of Microorganisms According to Risk Groups ▪ Risk group classification for humans and animals is based on the agent's pathogenicity, mode of transmission, host range, and the availability of preventative measures and effective treatment. Through the classification, infective microorganisms are classified as: 1. Risk group 1 - includes microorganisms that are unlikely to cause human or animal disease. These microorganisms bring about low individual and community risk.  Classifications of Microorganisms According to Risk Groups ▪ 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. This risk group bring about moderate individual risk and limited community risk.  Classifications of Microorganisms According to Risk Groups ▪ Risk group 3 - includes microorganisms that are known to cause serious diseases to humans or animals and may present a significant risk to laboratory workers. It could present a limited to moderate risk if these microorganisms spread in the community or the environment, but there are usually effective preventive measures or treatment available. They bring about high individual risk, and limited to moderate community risk. ▪ Risk group 4- includes microorganisms that are known to produce to produce life-threatening diseases to humans or animals. It represents a significant risk to laboratory workers  Categories laboratory Biosafety According to Levels ▪ Biosafety Level 1 (BSI-1) is suitable for work involving viable microorganisms that are defined and with well-characterized strains known not to cause disease in humans. Examples of microorganisms being handled in this level are Bacillus subtilis, Naegleria gruberi, infectious canine hepatitis virus, and exempt organism sunder the NIH Guidelines. This level is the most appropriate among undergraduate and secondary educational training and teaching laboratories that require basic laboratory safety practices, safety equipment, and facility design that requires basic level of containment.  Categories laboratory Biosafety According to Levels ▪ Biosafety Level 2 (BSL-2) is basically designed for laboratories that deal with2indigenous 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. Examples of microorganisms that could be handled under this level are Hepatitis B virus, HIV, salmonellae, and Toxoplasma species. BSL-2 is appropriate when work is done with human blood, body fluids, tissues, or primary human cell lines where there is uncertain presence of infectious agents. Hand washing sinks and waste decontamination facilities must be available and access to the laboratory must be restricted when work is being conducted. All procedures where infectious aerosols or splashes may be created are conducted in biosafety cabinets or other physical containment equipment.  Categories laboratory Biosafety According to Levels ▪ Biosafety Level (BSL-3) puts emphasis on primary and the environment from infectious aerosol exposure. Work with indigenous or exotic agents with a potential for respiratory transmission, and that may cause serious and potentially lethal infection are being conducted here. Examples of microorganisms handled here are Mycobacterium tuberculosis, St. louis Encephalitis virus and Coxiella.  Categories laboratory Biosafety According to Levels ▪ Biosafety Level 4 (BSI-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 aerosol route, for which there are no available vaccines or treatment. Specific practices, safety equipment, and appropriate facility design and construction are required for instance when manipulating viruses such as the Marburg Or the Crimean- Congo hemorrhagic fever and any other agents known to pose a high risk of exposure and infection to laboratory personnel, community, and environment.    Biorisk Management Jobhel Christy U. Abad, RMT  Objectives At the end of the lesson, the students should be able to: ▪ Explain the importance of biorisk management; ▪ Discuss the AMP model; and ▪ Identify risk assessment, mitigation, and performance evaluation procedures.   Biorisk Management and the AMP Model ▪ Biorisk is the risk associated to biological toxins or infectious agents. The source of risk may be: ▪ Unintentional access ▪ Accidental release ▪ Loss, Theft, Misuses, Diversion ▪ Intentional unauthorized release of biohazards  Biorisk Management ▪ It is the integration of biosafety and biosecurity to manage risk when working with biological toxins and infectious agents. ▪ The system or process to control safety and security risks associated with the handling or storage and disposal of biological agents and toxins in laboratories and facilities.  AMP Model: 3 Primary Components ▪ These components are collectively known as the AMP Model. ▪ AMP Model requires control measures that are based on robust risk management, and continuous evaluation of the effectiveness and suitability of the control measure. ▪ They are collectively known as RISK RESPONSE.  AMP Model: 3 Primary Components ▪ The AMP (assessment, mitigation, and performance) model for biorisk management requires that control measures (mitigation) be based on a substantive risk assessment assessment) and that the effectiveness and suitability of the control measures be evaluated (performance).  AMP Model: 3 Primary Components ▪ Assessment (A) a process of evaluating the biorisk(s) arising from a biohazard(s), considering the adequacy of any existing controls, and deciding whether the biorisks is acceptable  AMP Model: 3 Primary Components ▪ Mitigation(M) controlling or reducing the possibility of accidental exposure or unauthorized access to harmful biological organisms (specific microbes) with the use of safety equipment, personal protective equipment, and behavioral practices. ▪ Performance(P) the effectiveness and suitability of the control measures be evaluated.  KEY COMPONENTS OFBIORISK MANAGEMENT RISK ASSESSMENT ▪ The initial step in implementing a biorisk management. It includes following that are present in the laboratory: 1. Identification of hazards 2. Characterization of the risks  KEY COMPONENTS OFBIORISK MANAGEMENT ▪ HAZARD refers to anything in the environment that has the potential to cause harm. ▪ RISK is generally defined as the possibility that something bad or unpleasant (injury or loss) will happen. For a risk to occur, there must be situation for the hazard to cause harm. ▪ Example: A sharp needle is a hazard, but if no one is using it, the needle will not pose any risk.  RISK ASSESSMENT ▪ It is the process used to identify the hazardous characteristics of an infectious organism, the activities that could lead to exposure, the chances of contracting a disease after an exposure and the consequences of an infection. ▪ In performing risk assessment, a structured and repeatable process is followed.  STEPS IN RISK ASSESSMENT: ▪ Define the situation ▪ Define the risk ▪ Characterize the risks ▪ Determine if the risks are acceptable or not  DEFINE THE SITUATION ▪ The risk assessment team must identity the hazards and risks of the biological agents to be handled. ▪ At risk hosts (humans or animals inside and outside the lab) must be identified. ▪ The work activities and laboratory environment including location, procedures, and equipment should also be defined.  DEFINE THE RISKS ▪ It must include a review of how individuals inside and outside the laboratory may be exposed to hazards ▪ It could either be through droplets, inhalation, ingestion, or inoculation in case a biological agent has been identified as the hazard.  CHARACTERIZE THE RISKS ▪ To characterize the overall biosafety risks, the risk assessment team needs to compare the likelihood and the consequences of infection - either qualitatively or quantitatively.  DETERMINE IF THE RISKS ARE ACCEPTABLE OR NOT ▪ This process of evaluation thebiorisks arising from a biohazard takes into account the adequacy of any existing controls and deciding whether the biorisks is acceptable.  MITIGATION PROCEDURES ▪ Biorisk mitigation measures are reactions and control measures that are put into place to reduce or eliminate the risks associated with biological agent sand toxins. ▪ There are five major areas of control or measures that can be employed in mitigating the risks: Elimination, Substitution, Engineering Controls, Administrative Controls and PPE.  Hierarchy of Controls   Hierarchy of Controls ▪ Controlling exposures to hazards in the workplace is vital to protecting workers. The hierarchy of controls away of determining which actions will best control exposures. ▪ The hierarchy of control is a system for controlling risks in the workplace. The hierarchy of control is a step by step approach to eliminating or reducing risks and it ranks risk controls from the highest level of protection and reliability through to the lowest and least reliable protection.  ELIMINATION ▪ Elimination physically removes the hazard at the source. This could include changing the work process to stop using a toxic chemical, heavy object, or sharp tool. It is the preferred solution to protect workers because no exposure can occur. ▪ It is the most difficult and most effective control measure, involves the total decision not to work with the specific biological agent or even not doing the intended work.  SUBSTITUTION ▪ Replacement of the procedures or biological agent with a similar entity to reduce the risks. ▪ Example: Bacillus anthracis => B. thuringiensis   ENGINEERING CONTROLS ▪ Includes physical changes in work stations, equipment, production facilities, or any other relevant aspect of the work environment that can reduce or prevent exposure to hazards. Examples: ▪ Installation of biosafety cabinets, safety equipment such as centrifuge with cover, autoclave and machines with indicators ▪ Facility design enabling proper airflow, Ventilation system to ensure directional airflow, Air treatment systems to decontaminate or remove agents from exhaust air ▪ Controlled access zones, airlocks as laboratory entrances, or separate building or modules to isolate the laboratory  PERSONAL PROTECTIVE EQUIPMENT (PPE) ▪ Devices worn by workers to protect them against chemicals, toxins, and pathogenic hazards in the laboratory. ▪ Examples: Gloves, gowns, respirators  PERFORMANCE EVALUATION ▪ It’s a systematic process intended to achieve organizational objectives & goals. The model ensures that the implemented mitigation measures are indeed reducing or eliminating risks ▪ Also helps to highlight biorisk strategies that are not working effectively and measures ineffective or unnecessary can be eliminated or replaced  PERFORMANCE EVALUATION  PERFORMANCE MANAGEMENT ▪ Reevaluation of the overall mitigation strategy 