Basic Concepts on Laboratory Biosafety and Biosecurity Flashcards
Observing and implementing laboratory safety precautions are of utmost importance in the medical technology practice. Individuals who handle and process microbiological specimen are vulnerable to pathogenic microorganisms which are possible sources of______________(LAI).
laboratory acquired infections
Laboratory biosafety and biosecurity traces its history in 1)_______________ The origins of biosafety is rooted in the 2)__________ which began in 3)______, as ordered by then US President Franklin Roosevelt and was active during the Cold War. It was eventually terminated by 4)____________ in 5) ________. In 1943, 6)___________ 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. After the Second World War, Camp Detrick was designated a permanent installation for biological research and development.
Biosafety was an inherent component of biological weapons development. Later on, 7)_________ designed modifications for biosafety at Camp Derrick. 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 8)_____________ (ABSA) in 1984. The association held annual meetings that soon became the ABSA annual conferences (Salerno et al., 2015).
Other contributors outside the United States included 9) ___________ who described the use of mechanical pipettors to prevent laboratory-acquired infections in 1907 and 1908 (Kruse (1991), cited by Salerno, 2015). Moreover, ventilated cabinets, early progenitors to the nearly ubiquitous engineered control now known as the biological safety cabinet, were also first documented outside of the US biological weapons program. In 1909, a pharmaceutical company in Pennsylvania developed a ventilated cabinet to prevent infection from mycobacterium tuberculosis.
At the height of increasing mortality and morbidity due to 10)________ in 11) _______, WHO aggressively pursued the eradication of the virus (College of Physicians of Philadelphia 2014). It was also during this time that serious concerns about biosafety practices worldwide were raised, contributing directly to the decision of the World Health Assembly to consolidate the remaining virus stocks into two locations: the Center for Disease Control and Prevention (CDC) in the United States and the 12) ____________ (SRCVB VECTOR) in Russia.
In 1974, the CDC published the 13) _____________, that introduced the concept of establishing ascending levels of containment associated with risks in handling groups of infectious microorganisms that present similar characteristics. Two years later, the 14) ________ (NIH) of the United States published the 15) _____________. It explained in detail the microbiological practices, equipment, and facility necessarily corresponding to four ascending levels of physical containment.
1) North America and Western Europe.
2) US biological weapons program
3) 1943
4) US President Richard Nixon
5) 1969
6) Ira L. Baldwin
7) Newell A. Johnson
8) American Biological Safety Association
9) Arnold Wedum
10) smallpox
11) 1967
12) State Research Center of Virology and Biotechnology VECTOR
13) Classification of Etiological Agents on the Basis of Hazard
14) National Institutes of Health
15) NIH Guidelines for Research Involving Recombinant DNA Molecules
These guidelines laid the foundation for the introduction of a code of biosafety practice. This code, along with WHO’s first edition of 1)___________, and the CDC and NIH’s jointly-published 2) ___________marked the development of the practice of laboratory biosafety. These documents established the model of biosafety containment levels with certain agents which increased the biosafety levels for biological agents that pose risks to human health. 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. Although biosafety levels are concentrated in a combination of engineered controls, administrative controls, and practices, the emphasis is clearly on the equipment and facility controls, with little attention given to risk assessment.
This progress in biosafety practice continued until the emergence of a community of 3) _________ who adopted the administrative role of ensuring that the proper equipment and facility controls are in place based on the specified biosafety level of the laboratory.
4) _______, director of Industrial Health and Safety at the US Army Biological Research Laboratories in 1944, was recognized as one of the pioneers of biosafety that provided the foundation for evaluating the risks of handling infectious microorganisms and for recognizing biological hazards and developing practices, equipment, and facility safeguards for their control. In 1966, 5) _________and ________, colleagues at Fort Detrick, analyzed multiple epidemiological studies of laboratory-based outbreaks.
1) Laboratory Biosafety Manual (1983)
2) first edition of the Biosafety in Microbiological and Biomedical Laboratories (1984)
3) “biosafety officers”
4) Arnold Wedum
5) Wedum and microbiologist Morton Reitman
Brief History of Laboratory Biosecurity
In 1) _____, the US government enacted the 2) _______ to monitor the transfer of a select list of biological agents from one facility to another. Slightly after the terrorist attacks and the 3) ________ of 4) _____, also known as 5) ______, 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.
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. This change was intended to make the regulations more risk-based, mandating additional security measures for Tier 1 agents.
Other countries also relatively implemented and prescribed biosecurity regulations for bioscience facilities.
Singapore’s 6) __________is similar in scope with the US regulations but with more severe penalties for noncompliance (Republic of Singapore 2005).
In South Korea, the 7) ____________ 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 8) ___________ was recently amended under Japan’s Ministry of Health, Labor, and Welfare. It also established four schedules of select agents that are subject to different reporting and handling requirements for possession, transport and other activities.
Then in Canada, Canadian containment level (CL) 3 and CLA 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. Around the world, biosecurity implementation has become a purely administrative activity based on a government- developed checklist.
1) 1996
2) Select Agent Regulations
3) anthrax
4) 2001
5) Amerithrax
6) Biological Agents and Toxins Act
7) Act on Prevention of Infectious Diseases
8) Infectious Disease Control Law
Local and International Guidelines on Laboratory Biosafety and Biosecurity
no lontor
In February 2008, the 1) ____________(CEN), a European Committee for Standardization published the 2) ___________ (CWA 15793) which focuses on laboratory biorisk management. The Workshop offers a mechanism where stakeholders can develop consensus standards and requirements in an open process. The CWA 15793 can be applied to international stakeholders, however, they do not have the force of regulation while conformity is voluntary. 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 among diverse organizations and set out performance-based requirements with the exclusion of guidance for implementing a national biosafety system. Since it originated in the European workshop agreement framework, confusion among countries outside Europe arose especially in the United States in terms of its applicability. Nevertheless, the agreement was used until it officially expired in 2014 (Gronvall, 2015).
To address concerns on biosafety guidance for research and health laboratories, issues on risk assessment and guidance to commission and certify laboratories, the WHO in 1983 published its 3) __________. It includes information on the different levels of containment laboratories (Biosafety levels 1-4), different types of biological 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. The manual puts emphasis on the continuous monitoring and improvement directed by a biosafety officer and the biosafety committee. Unfortunately, there is no mechanism to ensure that the WHO biosafety guidance is being adhered to, or that people working in laboratories are sufficiently trained.
The 4) ____________ (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 5) ______________(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 ……………….
1) Comité Européen de Normalisation
2) CEN Workshop Agreement 15793
3) 3rd edition of the Laboratory Biosafety Manual
4) Cartagena Protocol on Biosafety
5) living modified organisms
6)
7)
8)
9)
10)
The new 1)_____________ (NCBP) established under E.O. 430 series of 1990 was formed on the advocacy efforts of scientists. The mandate of NCPB focuses on the organizational structure for biosafety: procedures for evaluation of and field release of regulated materials; and procedures on physico-chemical and biological proposals with biosafety concerns; procedures and guidelines on the introduction, movement, containment. On March 17, 2006, the Office of the President promulgated E.O. 514 establishing the 2) __________ (NBF), which prescribes the guidelines for its implementation, strengthening the National Committee on Biosafety of the Philippines. 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 1987 has played an important role in pioneering the establishment and development of the current biosafety system of the country and was acknowledged as a model system for developing countries.
The 3)_____________ (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. The guidelines aid in evaluating and monitoring processed food derived from or containing GMO. Currently, DOH, in the midst of technological advances, recognizes the need to update the minimum standards and technical requirements for clinical laboratories. It requires clinical laboratories to ensure policy guidelines on laboratory biosafety and biosecurity (DOH Administrative Order No. 2007-0027).
1) National Committee on Biosafety of the Philippines
2) National Biosafety Framework
3) Department of Agriculture
Different Organizations in the Field of Biosafety
- _____________________ (ABSA) a regional professional society for biosafety and biosecurity founded in 1984. It promotes biosafety as a scientific discipline and provides guidance to its members on the regulatory regime present in North America.
American Biological Safety Association
Different Organizations in the Field of Biosafety
- __________________ (A-PBA) a group founded in 2005 that acts as a professional society for biosafety professionals in the Asia-Pacific region. Its members are from Singapore, Brunei, China, Indonesia, Malaysia, Thailand, the Philippines, and Myanmar. Active members of the International Biosafety Working Group are required to directly contribute to the development of the best biosafety practices.
Asia-Pacific Biosafety Association
Different Organizations in the Field of Biosafety
- __________________ (EBSA) a non-profit organization founded in June 1996, that aims to provide a forum for discussions and debates on issues of concern and to represent those working in the field of biosafety. EBSA focuses on encouraging and communicating among its members information and issues on biosafety and biosecurity as well as emerging legislation and standards.
European Biological Safety Association
Different Organizations in the Field of Biosafety
- __________________ (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. Also included are members of the steering committee and technical working groups of the National Laboratory Biosafety and Biosecurity Action Plan Task Force established as per DPO No. 2006-2500 dated September 15, 2006. A long term goal of the association is to assist the DA and DOH in their efforts to create a national policy and implement plan for laboratory biosafety and biosecurity.
Philippine Biosafety and Biosecurity Association
Different Organizations in the Field of Biosafety
- __________________ (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. It has launched numerous activities in cooperation and collaboration with other associations, on a national and international scale in the promotion of biosafety, biosecurity, war and biorisk management as scientific disciplines. bone BRAP goes by the tagline, “assess, mitigate, monitor.”
Biological Risk Association Philippines
Fundamental Concepts of Laboratory Biosafety and Biosecurity
WHO issued a common understanding of biosafety derived from the practical guidance on techniques to be used in laboratories. Biosafety has long been practiced in most nations especially among institutions that handle and process microbiological specimen.
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 refers to “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” (WHO, 2006).
By simple definition, “biosafety protects people from germs” while “biosecurity protects germs from people.”
In 1) ___________, 2) _____________, 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.
Biosafety and biosecurity share common perspectives in terms of risk assessment and management methodologies, personnel expertise and responsibility, control and accountability for research materials including microorganisms and culture stocks, access control elements, material transfer documentation, training, emergency planning, and program management among others.
To sum up, biosafety focuses on laboratory procedures and practices necessary to prevent exposure to and acquisition of infections while the maintenance of secure procedures and practices in handling biological materials and sensitive information falls under biosecurity.
1) 1966
2) Charles Baldwin
Classifications of Microorganisms According to Risk Groups
WHO recommends an agent risk group classification for laboratory use that describes four general risk groups based on principal characteristics and relative hazards posed by infectious toxins or agents. 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 Risk Group 1, Risk Group 2, Risk Group 3, and Risk Group 4:
- Risk group 1 - includes microorganisms that are unlikely to cause human or animal disease. These microorganisms bring about low individual and community risk. 4288
- 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.
- 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 life-threatening diseases to humans or animals. It represents a significant risk to laboratory workers
Categories of Laboratory Biosafety According to Levels
In order to facilitate precautionary measures, CDC categorized laboratories into four biosafety levels-Biosafety Level 1, Biosafety Level 2, Biosafety Level 3, and Biosafety Level 4. Biosafety level designations are based on a composite of the design features, construction, containment facilities, equipment, practices, and operational procedures required for working with agents from the various risk groups. They are designated in ascending order, by degree of protection provided to the personnel, the environment, and the community (BMBL, 5th edition).
