Biosafety and Biosecurity in Laboratories PDF

BASIC CONCEPTS ON LABORATORY BIOSAFETY AND BIOSECURITY Prepared by: Next Slide Janelle Faye D. Salvarino, RMT INTENDED LEARNING OUTCOMES discuss the history and the related policies and guidelines governing laboratory biosafety and biosecurity. differentiate the fundamental...

BASIC CONCEPTS ON LABORATORY BIOSAFETY AND BIOSECURITY Prepared by: Next Slide Janelle Faye D. Salvarino, RMT INTENDED LEARNING OUTCOMES discuss the history and the related policies and guidelines governing laboratory biosafety and biosecurity. differentiate the fundamental concepts between laboratory biosafety and biosecurity. explain the different local and international organizations of biosafety. classify microorganisms according to their risk group. categorize laboratories according to their biosafety level. BIOSAFETY vs. BIOSECURITY BIOSAFETY “PROTECT PEOPLE AGAINST BAD BUG” Containment principles, technologies, and practices implemented to prevent unintentional exposure to pathogens and toxins, or their unintentional release WHO Laboratory Safety Manual BIOSECURITY “PROTECT BAD BUG AGAINST BAD PEOPLE” Protection, control and accountability for valuable biological materials within laboratories, in order to prevent their unauthorized access, loss, theft, misuse, diversion or intentional release. BRIEF HISTORY OF LABORATORY BIOSAFETY FRANKLIN ROOSEVELT In 1943, US Pres. Franklin Roosevelt ordered the US BIOLOGICAL WEAPONS PROGRAM and was active during the COLD WAR. But this program was terminated by US PRES. Richard Nixon in 1969. RICHARD NIXON BRIEF HISTORY OF LABORATORY BIOSAFETY 1943 IRA L. BALDWIN became the 1st scientific director of CAMP DETRICK (FORT DETRICK) Tasked with establishing the biological weapons program for defensive purposes to enable US to respond if attacked by such weapons. After World War II, Camp Detrick was designated a permanent installation for biological research and development. BRIEF HISTORY OF LABORATORY BIOSAFETY NEWELL A. JOHNSON Tasked with establishing the biological weapons program for defensive purposes to enable US to respond if attacked by such weapons. He developed specific technical solutions such as CLASS III SAFETY CABINETS AND LAMINAR FLOW HOODS AMERICAN BIOLOGICAL SAFETY ASSOCIATION formed in 1984 promote biosafety as a scientific discipline and serve the growing needs of biosafety professionals  BRIEF HISTORY OF LABORATORY BIOSAFETY ARNOLD WEDUM Described the use of mechanical pipettors to prevent laboratory-acquired infections in 1907 and 1908. In 1909, a pharmaceutical company in Pennsylvania developed a ventilated cabinet to prevent infection from Mycobacterium tuberculosis  BRIEF HISTORY OF LABORATORY BIOSAFETY In 1967, WHO aggressively pursed the eradication of the small pox virus. Serious concerns about biosafety practices worldwide were raised. Consolidation of the remaining virus stocks into two locations: CENTER FOR DISEASE CONTROL AND PREVENTION (CDC) in US STATE RESEARCH CENTER OF VIROLOGY AND BIOTECHNOLOGY VECTOR (SRCVB VECTOR) in RUSSIA In 1974, CDC pusblished the CLASSIFICATION OF ETIOLOGICAL AGENTS ON THE BASIS OF HAZARD, that introduced the concept of establishing ascending levels of containment associated with risks in handling groups of infectious microorganisms.  BRIEF HISTORY OF LABORATORY BIOSAFETY In 1976, The NATIONAL INSTITUES OF HEALTH (NIH) of the US published the NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT DNA MOLECULES This explained in detail the microbiological practices, equipment, and facility necessarily corresponding to four ascending levels of physical containment. Laid the foundation for the introduction of a code of biosafety practice. WHO’S 1ST EDITION OF LABORATORY SAFETY MANUAL (1983) and the CDC and NIH’s jointly published 1st edition of the BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES (1984) marked the development of the practice of laboratory biosafety. Established the model of biosafety containment levels with certain agents. BIOSAFETY OFFICERS ensure that the proper equipment and facility controls are in place based on the specified biosafety levels of the laboratory BRIEF HISTORY OF LABORATORY BIOSAFETY ARNOLD WEDUM Director of INDUSTRIAL HEALTH and SAFETY at the US ARMY BIOLOGICAL RESEARCH LABORATORIES in 1944 Considered as one of the pioneers of biosafety MORTON REITMAN In 1966, together with Wedum, analyzed multiple epidemiological studies of laboratory-based outbreaks BRIEF HISTORY OF LABORATORY BIOSECURITY In 1996 US Govt enacted the SELECT AGENT REGULATIONS to monitor the transfer of a select list of biological agents from one facility to another. In 2001, Terrorist attacks and anthrax attacks (AMERITHRAX) occured Anthrax - A serious infectious disease caused by Bacillus anthracis. (Cutaneous / Inhalation / Gastrointestinal anthrax) BRIEF HISTORY OF LABORATORY BIOSECURITY Revision of SELECT AGENT REGULATIONS in 2012 sought to address the creation of two tiers of select agents. Select agents are biological agents and toxins that have been determined to have the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal or plant products.  LOCAL AND INTERNATIONAL GUIDELINES ON LABORATORY BIOSAFETY AND BIOSECURITY In February 2008, the Comite Europeen de Normalisation (CEN) published the CEN Workshop Agreement 15793 which focuses on laboratory biorisk management. This offers a mechanism where stakeholders ccan develop consensus standards and requirements in open process. The CWA 15793 was developed among experts from 24 different countries including, Argentina, Australia, Belgium, Canada, CHina, Denmark, US, UK, etc. Was later on updated in 2011. In 1983, the WHO published the 3rd edition of Laboratory Biosafety Manual to address concerns on biosafety guidance for research and health laboratories, issues on risk assessment and guidance to commission and certify laboratories. It includes Biosafety Levels 1-4, biological safety cabinets, good microbiological practices and how to disinfect and sterilize equipment. In terms of biosecurity, it covers the packaging required by international transport regulations.  LOCAL AND INTERNATIONAL GUIDELINES ON LABORATORY BIOSAFETY AND BIOSECURITY The Cartagena Protocol on Biosafety (CPB) Made effective in 2003 which applies to the 168 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 (LMO) resulting from modern biotechnology. March 17, 2006, the office of the President promulgated E.O 514 establishing NATIONAL BIOSAFETY FRAMEWORK (NBF) which prescribes the guidelines for its implementation, strengthening the National Committee on Biosafety of the Philippines. It is combination of policy, legal, administrative, and technical instruments developed to attain the objective of Cartagena Protocol on Biosafety which the Philippines signed on May 24, 2000.  LOCAL AND INTERNATIONAL GUIDELINES ON LABORATORY BIOSAFETY AND BIOSECURITY The new NATIONAL COMMITTEE ON BIOSAFETY OF THE PHILIPPINES (NCBP) Established under E.O. 430 series of 1990 was formed on the advocacy efforts of scientists. The mandate of NCBP focuses on the organizational structure for biosafety. 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. Department of Health (DOH), together with NCBP Formulated guidelines in the assessment of the impacts on health posed by modern biotehcnology and its applications. DIFFERENT ORGANIZATIONS IN THE FIELD OF BIOSAFETY DIFFERENT ORGANIZATIONS IN THE FIELD OF BIOSAFETY American Biological Safety Association A regional professional society founded in 1984. Promotes biosafety as a scientific discipline and provides guidance to its members in NORTH AMERICA. DIFFERENT ORGANIZATIONS IN THE FIELD OF BIOSAFETY ASIA-PACIFIC BIOSAFETY ASSOCIATION Founded in 2005 that acts as professional society for biosafety professionals in the Asia-Pacific region. Members are from SINGAPORE, BRUNEI, CHINA, INDONESIA, MALAYSIA, THAILAND, PHILIPPINES and MYANMAR. DIFFERENT ORGANIZATIONS IN THE FIELD OF BIOSAFETY EUROPEAN BIOLOGICAL SAFETY ASSOCIATION A nonprofit organization founded in June 1996. Focuses on encouraging and communicating among its members information and issues, as well as emerging legislation and standards. DIFFERENT ORGANIZATIONS IN THE FIELD OF BIOSAFETY PHILIPPINE BIOSAFETY AND BIOSECURITY ASSOCIATION Long term goal is to assist the DA and DOH in their efforts to create a national policy and implement plan for laboratory biosafety and biosecurity. DIFFERENT ORGANIZATIONS IN THE FIELD OF BIOSAFETY BIOLOGICAL RISK ASSOCIATION PHILIPPINES A non-government and nonprofit association. It has launched numerous activities in cooperation and collaboration with other associations, on a national and international scale. “Assess, Mitigate, Monitor” FUNDAMENTAL CONCEPTS OF LABORATORY BIOSAFETY AND BIOSECURITY In 1996, Charles Baldwin, an environmental health engineer working for Dow Chemical Company containment systems products, created the biohazard symbol used in labeling biological materials carrying significant health risks. RISK ASSESSMENT A systematic process of gathering information and evaluating the likelihood and consequences of exposure to or release workplace hazard/s and determining the appropriate risk control measures to reduce the risk to and acceptable risk. RISK A combination of the LIKELIHOOD of an incident and the severity of the HARM (CONSEQUENCE) if that incident were to occur. HAZARD An object or situation that has the potential to cause adverse effects when an organism, system, (sub)population is exposed to it. HEIRARCHY OF CONTROLS RISK ASSESSMENT A systematic process of gathering information and evaluating the likelihood and consequences of exposure to or release workplace hazard/s and determining the appropriate risk control measures to reduce the risk to and acceptable risk. Includes the following: Virulence and pathogenicity Infectious dose Environmental stability Route/s of exposure Communicability Quantity concentration Availability of vaccine or treatment Gene product effects Origin of agent CLASSIFICATIONS OF MICROORGANISMS ACCORDING TO RISK GROUP RISK GROUP 1 RISK GROUP 2 No or low individual and Moderate individual risk and community risk Low community risk RISK GROUP 3 RISK GROUP 4 High individual risk and High individual and Low community risk community risk CLASSIFICATIONS OF MICROORGANISMS ACCORDING TO RISK GROUP RISK GROUP 1 A microorganism that is unlikely to cause human disease or animal disease. RISK GROUP 2 A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposures may cause serious infection, but effective treatment and preventative measures are available and the risk of spread of infection is limited. CLASSIFICATIONS OF MICROORGANISMS ACCORDING TO RISK GROUP RISK GROUP 3 A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another. Effective treatment and preventive measures are available. RISK GROUP 4 A pathogen that usually causes serious human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly. Effective treatment and preventive measures are not usually available. PERSONAL PROTECTIVE EQUIPMENT Correct use of appropriate PPE is an essential component to disrupt the chain of infection and stop disease transmission  PERSONAL PROTECTIVE EQUIPMENT last line of defense and least effective method of control against a hazard and does NOT take the place of engineering or administrative controls DONNING means to put on and use PPE properly to achieve the intended protection and minimize the risk of exposure DOFFING means removing PPE in a way that avoids self-contamination Gloves– protect hands and allow efficient removal of organisms from hands Gowns and Aprons– protect skin and clothing Face masks– protect mucous membranes of mouth and nose Respirators- prevent inhalation of infectious material Goggles – protect eyes Face shields – mucous membranes of face, mouth, nose and eyes  DONNING OF PERSONAL PROTECTIVE EQUIPMENT  DOFFING OF PERSONAL PROTECTIVE EQUIPMENT  DOFFING OF PERSONAL PROTECTIVE EQUIPMENT BIOSAFETY LEVELS They are designated in ASCENDING are used to identify the protective measures ORDER, by degree of protection needed in a laboratory setting to protect provided to the personnel, the workers, the environment, and the public. environment and the community Designations are based on a composite of the design features, construction, BIOSAFETY LEVEL 1 (BSL-1) containment facilities, equipment, practices BIOSAFETY LEVEL 2 (BSL-2) and operational procedures required for BIOSAFETY LEVEL 3 (BSL-3) working with agents from the various risk BIOSAFETY LEVEL 4 (BSL-4) groups. CONTAINMENT - The combination of physical design parameters and operational practices that protect personnel, the immediate work environment and the community from exposure to biological agents. The term "biocontainment" is also used in this context. BIOSAFETY LEVEL 1 (BSL-1) Laboratories under BSL-1 are used to study infectious agents or toxins not known to consistently cause disease in healthy adults. Most appropriate among undergraduate and secondary educational training and teaching laboratories. They follow basic safety procedures (Standard Microbiological Practices) and require no special equipment or design features. Standard engineering controls in BSL-1 laboratories include easily cleaned surfaces that are able to withstand the basic chemicals used in the laboratory. BIOSAFETY LEVEL 2 (BSL-2) BSL-2 laboratories are used to study moderate- risk infectious agents or toxins that pose a risk if accidentally swallowed, or exposed to the skin. (Blood, body fluids, tissues or primary cell lines) BSL-2 labs must also have access to equipment that can decontaminate laboratory waste, including an incinerator, an autoclave, and/or another method, depending on the biological risk assessment. BIOSAFETY LEVEL 3 (BSL-3) applicable to clinical, diagnostic, teaching, research, or production facilities where work is performed with indigenous or exotic agents that may cause serious or potentially lethal disease that may be transmitted through the air and through inhalation exposure. Researchers perform all experiments in biosafety cabinets that use carefully controlled air flow or sealed enclosures to prevent infection. Laboratories are designed to be easily decontaminated. These laboratories must use controlled, or “directional,” air flow to ensure that air flows from non-laboratory areas (such as the hallway) into laboratory areas as an additional safety measure. BIOSAFETY LEVEL 4 (BSL-4) Used for dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections and life-threatening disease that is frequently fatal, for which there are no vaccines or treatments, or a related agent with unknown risk of transmission. The laboratories incorporate all BSL 3 features and occupy safe, isolated zones within a larger building or may be housed in a separate, dedicated building Access to BSL-4 laboratories is carefully controlled and requires significant training. BIOSAFETY LEVEL 4 (BSL-4) CABINET LABORATORY: all work with infectious agents or toxins is done in a Class III Biosafety Cabinet​with very carefully designed procedures to contain any potential contamination. In addition, the laboratory space is designed to also prevent contamination of other spaces. BIOSAFETY LEVEL 4 (BSL-4) SUIT LABORATORY Laboratory personnel are required to wear full-body, air-supplied suits, which are the most sophisticated type of personal protective equipment​. All personnel shower before exiting the laboratory and go through a series of procedures designed to fully decontaminate them before leaving. BIOLOGICAL SAFETY CABINET (BSCs) BSCs, isolators and local exhaust ventilators are enclosed, ventilated working spaces that can be used in laboratories as primary containment devices. THREE CLASSES OF BSC: The most commonly used primary 1. CLASS I BSC containment devices.Three different classes 2. CLASS II BSC of BSC exist 3. CLASS III BSC It protecst the operator, the laboratory environment and/or the work materials from exposure to infectious aerosols and splashes that may be generated when manipulating materials containing biological agents.  CLASS I BSC open-fronted enclosures that draw an inward airflow across the work surface through the front opening. The air passes upwards through a high efficiency particulate air (HEPA) filter before being exhausted. They provide personnel and environmental protection, but do not offer product protection for materials located in the work area.  CLASS II BSC open-fronted enclosures, similar to Class I BSC, in which air enters the cabinet through the front opening to provide operator protection. The inward air bypasses the work area by being pulled through the front grill and underneath the workspace. Provides PRODUCT PROTECTION. TYPES: IIA ○is self-contained ○70% of the air is recirculated into the work area IIB ○exhaust is discharged outside the building ○used when the ff. are involved radioisotopes toxic chemicals carcinogens  CLASS III BSC a closed, sealed, negative-pressure enclosure to which HEPA-filtered air is supplied. The enclosure is sealed to ensure safe gaseous decontamination. Operators access the working area using integrated gloves or gauntlets. Class III BSCs are normally f itted with a pass box (often independently ventilated) or dunk tank to facilitate the movement of potentially contaminated work materials in and out of the cabinet. Provides the highest level of safety to the lab worker SPECIMEN PACKAGING AND TRANSPORT The goal of specimen transport is to maintain the specimen as near to its original state as possible-- with minimal deterioration-- and to prevent risks to the specimen handler.​  CLASSIFICATION OF BIOLOGICAL SPECIMENS CATEGORY A UN 2814 - human UN 2900 - animals An infectious substance which is transported in a form that, when exposure occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals. CATEGORY B UN 3373 considered a dangerous good, yet deemed somewhat less dangerous than Category A. infectious substance which does not meet the criteria for inclusion in Category A. EXEMPT those collected directly from humans or animals, including, but not limited to, excreta, secreta, blood and its components, tissues and tissue fluid swabs, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment, and prevention. CONTAINERS USED FOR TRANSPORT PRIMARY CONTAINER SECONDARY CONTAINER MAILING CONTAINER OR TERTIARY CONTAINER PRIMARY CONTAINER contains the specimen; placed in a test tube, it is screw-capped, and is sealed with a waterproof tape​. Keep the vials in upright position. SECONDARY CONTAINER screw-capped, waterproof, and unbreakable​. s. Plastic pouches, if used, should be heat-sealed or tightly closed by applying rubber bands. There should be enough absorbent material (paper napkins/old newspaper) packed around the vials to absorb all fluid in case of breakage or leakage. TERTIARY/MAILING CONTAINER If a plastic pouch was used as a secondary container, it can now be placed inside a separate plastic container and adhesive tape should be applied around the lid of the container. A Thermocol box or vaccine carrier containing ice/gel packs could be used as the outer container. TRIPLE PACKAGING SYSTEM