Basic Concepts on Laboratory Biosafety and Biosecurity (CDU)

laboratory acquired infection

individuals who handle and process microbiological specimen are vulnerable to pathogenic microorganisms which are possible sources of ?

north america, western europe

laboratory biosafety and biosecurity traces its history in N_________ ______ and W_____ _____

Franklin Roosevelt

the origins of biosafety is rooted in the US biological weapons program which began in 1943, as ordered by then US President F_______ ______ and was active during the Cold War

Richard Nixon

he terminated the cold war in 1969

Ira L. Baldwin

in 1943, I__ ______ became the first scientific director of Camp 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

fort detrick

camp detrick was eventually called as ?

camp detrick

after the second world war, ____ ____ was designated a permanent installation for biological research and development.

biosafety

_______ was an inherent component of biological weapons development

Newell A. Johnson

designed modifications for biosafety at Camp Detrick

class III safety cabinets, laminar flow hoods

Newell Johnson engaged some of Camp Detrick's leading scientists about the nature of their work, and developed specific technical solutions such as _____ ____ _______ _____ and ______ ______ ____ to address specific risks.

1984

the ABSA was formed in ?

1955

when was the first unofficial meeting of the ABSA?

American Biological Safety Association

meaning of absa

Arnold Wedum

he described the use of mechanical pipettors to prevent laboratory-acquired infections in 1907 and 1908

ventilated cabinets

early progentors to the nearly ubiquitous engineered control now known as the biological safety cabinet

biological safety cabinet

also first documented outside of US biological weapons program

pennsylvania

a pharmaceutical company in _______ developed a ventilated cabinet to prevent infection from myycobacterium tuberculosis

1909

in (what year),
a pharmaceutical company in pennsylvania developed a ventilated cabinet to prevent infection from myycobacterium tuberculosis

smallpox

mortality and morbidity increased in 1967 due to ______

laboratory acquired infection

individuals who handle and process microbiological specimen are vulnerable to pathogenic microorganisms which are possible sources of ?

Franklin Roosevelt

he origins of biosafety is rooted in the US biological weapons program which began in 1943, as ordered by then US President_______ and was active during the Cold War

1955

when was the first unofficial meeting of the ABSA?

American Biological Safety Association

meaning of absa

center for disease control and prevention, state research center of virology and bacteriology VECTOR

the World Health Assembly consolidated the remaining virus stocks into two locations: the C_________ __ ______ ____ __ ________ in the United States and the S_____ R___ C_____ ___ V____ __ ___ B_______ in Russia.

classification of etiological agents on the basis of hazard

introduced the concept of establishing ascending levels of containment associated with risks in handling groups of infectious microorganisms that present similar characteristics.

NIH guidelines for research involving recombinant dna technology

Two years later (1976), the National Institutes of Health of the United States published the ___

1964-1965

the date when NIH and CDC joined the meetings

NIH guidelines for research involving recombinant dna technology

It explained in detail the microbiological practices, equipment, and facility necessarily corresponding to four ascending levels of physical containment

biosafety practice

NIH's guidelines laid the foundation for the introduction of a code of____

Laboratory Biosafety Manual, Biosafety in Microbiological and Biomedical Laboratories

This code, along with WHO's first edition of L_____ B_____ M____ (1983) and the CDC and NIH's jointly-published first edition of the B______ M____ ___ B______ L________ (1984), marked the development of the practice of laboratory safety.

salmonella

In 1984, members of the Rajneeshee commune in The Dalles, Oregon, purchased a strain of____

Seattle, Washington

where did the Rajneeshee purchased Salmonella strains?

10, 750

The Rajneeshee commune contaminated local salad bars, sickening over _ individuals

bruce edwards ivins

he started the anthrax attacks in 2001

anthrax

bacillus anthracis: ?

botulism

clostridium botulinum: ?

plague

Yersinia pestis: ?

smallpox

variola major: ?

tularaemia

francisella tularensis: ?

viral hemorrhagic fevers

filoviruses and arena viruses: ?

easily disseminated
- cause high mortality
- cause public panic and social disruption
- require special action for public health preparedness

classification of agents of bioterrorism:

Category A: poses a risk to national security because:

moderately easy to disseminate
- cause moderate morbidity
- require enhanced disease surveillance and public health diagnostic capacity

classification of agents of bioterrorism:

Category B:

- could be engineered for mass dissemination in the future
- have potential for high morbidity, mortality and major health impact

classification of agents of bioterrorism:

Category C includes emerging pathogens that:

inhalation, skin, mucous, gastrointestinal

The routes of entry of biological weapons into the human body are mainly

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.

laboratory safety and emergency response guidance for laboratories working with select agents

built upon 1999 guidelines BMBLthe emphasis on biosafety levels are given on the

equipment, facility controls

the emphasis on biosafety levels are given on the ____________ with little attention given to risk assessment

biosafety officers

they 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

health and human services

HHS

Arnold Wedum

he is the director of Industrial Health and Safety at the US Army Biological Research Laboratories in 1944

Arnold Wedum

he 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

Morton Reitman

In 1966, Wedum and microbiologist ________ colleagues at Fort Detrick, analyzed multiple epidemiological studies of laboratory-based outbreaks

select agent regulations

In 1996, the US government enacted the ______ to monitor the transfer of a select list of biological agents from one facility to another

Amerithrax

the terrorist and anthrax attacks of 2001, also known as

2012

what year was the select agent regulation revised wherein it required specific security measures?

select agent and toxin list

past or potential use as biological weapon, countermeasures available, infectivity, contagiousness, etc.

tier 1 agents

are materials that pose the greatest risk of deliberate misuse, and the remaining select agents.

Biological agents and toxins act

Sinagpore's ____________ is similar ins cope with the US regulations but with more severe penalties for noncompliance

Act on Prevention of Infectious Diseases

In South Korea, the _______ 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 agents

Infectious Disease Control Law

In Japan, the _________ was recently amended under Japan's Ministry of Health, Labor, and Welfare.

3, 4

In Canada, Canadian containment level ___ and CL ___ facilities that work with risk group 3 or 4 are required to undergo certification

danish parliament

In 2008, the _____ passed a law that gives the Minister of Health and Prevention the authority to regulate the use of biological agents.

Comite Europeen de Normalisation

In February 2008, the _________ a European Committee for Standardization published the CEN Workshop Agreement 15793 which focuses on laboratory biorisk management

occupational safety and health administration

OSHA

2014

the CEN workshop agreement expired in ?

1983

WHO in (year) published its 3rd edition of the Laboratory Biosafety Manual.

laboratory biosafety manual 3rd edition

it contains the different levels of containment laboratories, different types of biological safety cabinets, good microbiological techniques, and how to disinfect and sterilize equipment

biosecurity

it covers the packaging required by international transport regulations and other types of safety procedures for chemical, electrical, ionizing radiation, and fire hazards

cartagena protocol on biosafety

made effective in 2003 which applies to 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 resulting from modern biotechnology

national committee on biosafety of the Philippines

NCBP meaning

430

The NBCP was established under E.O. ____ series of 1990 from the advocacy efforts of scientists

514

On March 17, 2006, , the Office of the President promulgated E.O. ___, establishiing the national biosafety framework

National biosafety framework

It 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

NCBP

The NBF can be considered as an expansion of the _____, 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

8

The Department of Agriculture also issued Administrative Order No. _ to set in place policies on the importation and release of plants and plant products derived from modern biotechnology

Department of Health

together with NCBP, formulated guidelines in the assessment of the impacts on health posed by modern biotechnology and its applications

american biological safety association

ABSA

american biological safety association

it is a regional professional society for biosafety and biosecurity founded in 1984

american biological safety association

It promotes biosafety as a scientific discipline and provides guidance to its members on the regulatory regime present in North America

asia-pacific biosafety association

A-PBA

asia-pacific biosafety association

it is a group founded in 2005 that acts as a professional society for biosafety professionals in the Asia-Pacific region

singapore, brunei, china, indonesia malaysia thailand philippines myanmar

A-PBA members

European Biological Safety Association

EBSA

5, 22

anthrax attacks - deaths, _ pax infected

European Biological Safety Association

it is 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.

Philippine Biosafety and Biosecurity Association

PhBBA

Philippine Biosafety and Biosecurity Association

it is 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

national laboratory biosafety and biosecurity action plan

PhBBA includes members of steering committee and technical working groups of the ________ Task Force established as per DPO No. 2006-2500 dated September 15, 2006

biological risk association philippines

BRAP

biological risk association philippines

a non-government and non-profit association that works to serve the emergent concerns of biological risk management in various professional fields

biosafety

long been practiced in most nations especially among institutions that handle and process microbiological specimen

biosafety

the WHO laboratory biosafety manual defines __________ as the containment principles, technologies, and practices that are implemented to prevent unintentional exposure to pathogens and toxins, or their accidental release.

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)

containment

it is the combination of physical design parameters and operational practices that protect personnel, the immediate work environment and the community from exposure to biological agents

valuable biological material

these are materials that require protection, of their economic and historical (archival) value, and/or the population from their potential to cause harm

biohazard

these are biological agents which have the potential to cuse adverse effects to personnel and/or humans, animals, and the wider community and environment

biorisk

it is a combination of the likelihood of an exposure to an infectious agent, toxin, or biological hazard that will cause harm, and the consequence, or severity, of that harm if exposure does occur

biorisk management system

it is a process by which laboratories and facilities combine safety and security to control or minimize risks associated with the handling, storage, and disposal of biological agents and toxins

biorisk mitigation

it is a process of controlling or reducing the possibility of accidental exposure or unauthorized access to harmful biological organisms (specifically microbes) with the use of safety equipment, personal protective equipment, and behavioral practices

assessment, mitigation, performance

the AMP model of biorisk management: