BASIC CONCEPTS OF LABORATORY BIOSAFETY AND BIOSECURITY

Biosafety

• "the containment principles, technologies, and practices that are implemented to prevent unintentional exposure to pathogens and toxins, or their accidental release."

Biosafety

• focuses on laboratory procedures and practices necessary to prevent exposure to and acquisition of infections.

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".

Biosecurity

maintenance of secure procedures and practices in handling biological materials and sensitive information

people, germs

Biosafety protects _______ from ________.

germs, people

Biosecurity protects ________ from _______.

Bacillus anthracis

• Biggest bacteria and is used to make grenades

Charles Baldwin (1966)

• 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.

North America and Western Europe

• history of laboratory biosafety and biosecurity began.

US biological weapons program

• where the origins of biosafety were rooted which began in 1943.

Franklin Roosevelt

• the US president who ordered to officially begin the US Weapon Program in 1943 that was active in the Cold War.

Richard Nixon

• US president who terminated US Biological Weapon Program in 1969

Ira L. Baldwin (1943)

• First scientific director of Camp Detrick(Fort Detrick)

Camp Detrick

• After World War 2, it was designated a permanent installation for biological research and development

Newell A. Johnson

• He designed modifications for biosafety at Camp Detrick later on.

Newell A. Johnson

• He engaged some of Camp Detrick's leading scientists about the nature of their work and developed specific technical solutions (Class Ill safety cabinets & laminar flow hoods to address specific risks.)

1984

• Formation of the American Biological Safety Association (ABSA)

American Biological Safety Association
Asia-Pacific Biosafety Association
European Biological Safety Association
Philippine Biosafety and Biosecurity Association
Biological Risk Association Philippines

DIFFERENT ORGANIZATIONS IN THE FIELD OF BIOSAFETY

Arnold Wedum

• described the use of mechanical pipettors to prevent laboratory acquired infections in 1907 and 1908.

mouth

the use of pipette in early period is through _______

Ventilated Cabinets

• early progenitors of biosafety cabinet

Ventilated Cabinets

• first documented outside of the US biological weapons program.

1909

• a ventilated cabinet to prevent infection from M. tuberculosis was developed by a pharmaceutical company in Pennsylvania.

Mycobacterium tuberculosis

• a ventilated cabinet was developed by a pharmaceutical company in Pennsylvania to prevent infection from ?

1967

increased morbidity and mortality due to smallpox

1967

WHO aggressively pursued the eradication of the virus

CDC in Unites States

State Research Center of Virology and Biotechnology VECTOR in Russia

2 LOCATIONS OF THE REMAINING VIRUS STOCKS:

1974

• CDC published Classification of Etiological Agents on the Basis of Hazard

Centers for Disease Control and Prevention

CDC stands for?

1976

• NIH of the US published the NIH Guidelines for Research Involving Recombinant DNA Molecules

National Institutes of Health

NIH stands for?

NIH Guidelines for Research Involving Recombinant DNA Molecules

• These guidelines laid the foundation for the introduction of a code of biosafety practice.

LABORATORY BIOSAFETY MANUAL(1983)-WHO

BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES(1984) - NIH

• These guidelines marked the development of the practice of laboratory:

Biosafety Officers

• ensures that the proper equipment and facility controls are in place based on the specified biosafety level of the laboratory.

Arnold Wedum

Director of Industrial Health and Safety at the US Army Biological Research Laboratories in 1944

Arnold Wedum

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.

1966

Wedum and microbiologist Morton Reitman, colleagues at Fort Detrick, analyzed multiple epidemiological studies of laboratory-based outbreaks

Morton Reitman

• Wedum and microbiologist ______, colleagues at Fort Detrick, analyzed multiple epidemiological studies of laboratory-based outbreaks

1966

• US government enacted the Select Agent Regulations

2001

• Terrorist attack and anthrax attacks (Amerithrax) happened.

Select Agent Regulations (revised)

• 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.

2012

• revision of the Select Agent Regulations

Tier 1 agents

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

BIOLOGICAL AGENTS AND TOXINS ACT

Singapore

BIOLOGICAL AGENTS AND TOXINS ACT

• More severe penalties for non-compliance

Act on Prevention of Infectious Diseases in 2005

South Korea

Act on Prevention of Infectious Diseases in 2005

• Require institutions working with "highly dangerous pathogens" to implement lab biosafety and biosecurity.

highly dangerous pathogens

Act on Prevention of Infectious Diseases in 2005 require institutions working with "______________" to implement lab biosafety and biosecurity.

INFECTIOUS DISEASE CONTROL LAW

Japan

Canada

• Canadian containment level (CL) 3 and CL4 facilities required to undergo certification.

CL3

CL4

• Canadian containment level _______ and ________ facilities required to undergo certification.

Danish Parliament

• In 2008, 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.

Minister of Health and Prevention

• In 2008, Danish parliament passed a law that gives the ______________ the authority to regulate the possession, manufacture, use, storage, sale, purchase or other transfer, distribution, transport, and disposal of listed biological agents.

2008

• In _______, 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.

Minister of Health and Prevention

• The one who haves the authority to regulate the biological agents in the Danish parliament.

CEN WORKSHOP AGREEMENT 15793

CWA 15793 also called as

CEN Workshop Agreement 15793 (CWA 15793)

• Published by the Comité Européen de Normalisation in February 2008

Comité Européen de Normalisation

CWA 15793 published by the ____________ in February 2008

February 2008

CWA 15793 published by the Comité Européen de Normalisation in _________

CEN Workshop Agreement 15793

focuses on laboratory biorisk management

CEN Workshop Agreement 15793

• Offers a mechanism where stakeholders can develop consensus standards and requirements in an open process.

CEN Workshop Agreement 15793

• 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.

2011

CEN Workshop Agreement 15793 was updated in ________ 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.

CEN Workshop Agreement 15793

The agreement was used until it officially expired in 2014.

2014

When did the CEN Workshop Agreement 15793 officially expire?

3rd edition of the Laboratory Biosafety Manual

• Published by WHO in 1983 to address concerns on biosafety guidance for research and health laboratories, issues on risk assessment and guidance to commission and certify laboratories.

1983

3rd edition of the biosafety laboratory manual was published by WHO in ______ to address concerns on biosafety guidance for research and health laboratories, issues on risk assessment and guidance to commission and certify laboratories.

Cartagena Protocol on Biosafety

CPB stands for?

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 (LMOs) resulting from modern biotechnology".

3rd edition of the Laboratory Biosafety Manual

• 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.

3rd edition of the Laboratory Biosafety Manual

• Puts emphasis on the continuous monitoring and improvement directed by a biosafety officer and the biosafety committee.

2003

Cartagena Protocol on Biosafety was made effective in ________, 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 (LMOs) resulting from modern biotechnology".

168

Cartagena Protocol on Biosafety was made effective in 2003, which applies to the _____ 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".

Cartagena Protocol on Biosafety

• The legislation provides a framework for assessing the risk of LMOs and is focused on ensuring that LMOs do not negatively affect biodiversity.

NATIONAL COMMITTEE ON BIOSAFETY OF THE PHILIPPINES (NCBP)

• Established under E.O. 430 series of 1990 was formed on the advocacy efforts of scientists.

Executive Order No. 430 Series of 1990

National Committee on Biosafety of the Philippines (NCBP) was established under what order?

NATIONAL COMMITTEE ON BIOSAFETY OF THE PHILIPPINES

NCBP stands for?

National Committee on Biosafety of the Philippines

• The mandate focuses on the organizational structure for biosafety: procedures for evaluation of proposals with biosafety concerns; procedures and guidelines on the introduction, movement, and field release of regulated materials; and procedures on physico-chemical and biological containment.

NATIONAL BIOSAFETY FRAMEWORK

• Established on March 17, 2006, after the promulgation of E.O. 514 by the Office of the President

National Biosafety Framework

NBF stands for?

NATIONAL BIOSAFETY FRAMEWORK

• Prescribes the guidelines for its implementation, strengthening the National Committee on Biosafety of the Philippines

March 17, 2006

National Biosafety Framework was established on __________, after the promulgation of E.O. 514 by the Office of the President

Executive Order No. 514

National Biosafety Framework was established on March 17, 2006, after the promulgation of _______ by the Office of the President

Administrative Order No. 8

• Issued by the Department of Agriculture to set in place policies on the importation and release of plants and plant products derived from modern biotechnology.

Department of Agriculture

Who issued the AO 8?

Administrative Order No. 8

• DOH, together with NCBP, formulated guidelines in the assessment of the impact on health posed by modern biotechnology and its applications.

Department of Health

National Committee on Biosafety of the Philippines

who formulated the guidelines in the assessment of the impact on health posed by modern biotechnology and its applications?

American Biological Safety Association

ABSA stands for?

Asia-Pacific Biosafety Association

A-PBA stands for?

European Biological Safety Association

EBSA stands for?

Philippine Biosafety and Biosecurity Association

PhBBA stands for?

European Biological Safety Association

EBSA stands for?

Asia-Pacific Biosafety Association

A-PBA stands for?

Philippine Biosafety and Biosecurity Association

PhBBA stands for?

Biological Risk Association Philippines

BRAP stands for?

American Biological Safety Association

A regional professional society for biosafety and biosecurity founded in 1984.

1984

ABSA was founded in the year?

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 group founded in 2005

Asia-Pacific Biosafety Association

Acts as a professional society for biosafety professionals in the Asia-Pacific region