LESSON 6 - BIOSAFETY AND BIOSECURITY

Laboratory Biosafety

The practice of implementing safety measures and protocols to protect individuals who handle and process microbiological specimens from potential pathogenic microorganisms.

Biosafety

The concept of ensuring the safe handling and containment of biological agents to prevent accidental release or exposure.

Laboratory Acquired Infections (LAI)

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

1943

Origin of biosafety is rooted in the US biological weapons program which began in ______, ordered by US President Franklin Roosevelt.

Ira L. Baldwin

He became the first scientific director of Camp Detrick.

President Richard Nixon

In 1969, he erminated the US Biological Weapons program.

Newell A. Johnson

He designed modifications for biosafety at Camp Detrick. He engaged some of the 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.

Safety Cabinets and Laminar flow hoods

Technical solutions that Newell A. Johnson developed to address specific risks.

American Biological Safety Association (ABSA)

An organization formed in 1984 to promote biosafety practices and provide resources for professionals in the field.

Arnold Wedum

In 1907 and 1908, he described the use of Mechanical Pipettors to prevent laboratory-acquired infections.

Mechanical Pipettors

A device described by Arnold Wedum to prevent laboratory-acquired infections.

Ventilated Cabinet

A pharmaceutical company in Pennsylvania developed in 1909 to prevent infection from mycobacterium tuberculosis.

Small pox

This disease increased the mortality and morbidity rate in 1967.

Center for Disease Control and Prevention (CDC)

One of the two locations that the World Health Assembly chosen to consolidate remaining virus stocks, located in the US.

State Research Center of Virology and Biotechnology Vector (SRCVB VECTOR)

One of the two locations that the World Health Assembly chosen to consolidate remaining virus stocks, located in Russia.

Classification of Etiological Agents on the Basis of Hazard

CDC published in 1974 that 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 Molecules

Guidelines published by the National Institutes of Health (NIH) in 1976 to explain in detail the microbiological practices, equipment, and facility necessarily corresponding to four ascending levels of physical containment.

Biosafety in Microbiological and Biomedical Laboratories

WHO’s first edition of Laboratory Biosafety Manual (1983) and the CDC and NIH’s jointly-published first edition in 1984 that marked the development of the practice of Laboratory Safety.

Biosafety officers

Adopted the administrative role of ensuring the proper equipment and facility controls are in place based on the specified biosafety level of the laboratory.

Arnold Wedum

The director of Industrial Health and Safety at the US Army Biological Research Laboratories was recognized as one of the pioneers of Biosafety that provided the foundation for evaluating the risk of handling infectious microorganism.

Morton Reitman

In 1966, Wedum and Microbiologist _____, analyzed multiple epidemiological studies of laboratory-based outbreaks.

Select Agent Regulations

Regulations enacted by the US Government in 1996 to monitor the transfer of a select list of biological agents.

Amerithrax

Also known as anthrax that changed the perspective of the US government in 2001.

2012

What year did the the Select Agent Regulations sought to address

the creation of two tiers of select agents.

Tier 1 Agents

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

Biological Agents and Toxins Act

Legislation in Singapore that is similar in scope with the US Regulations but with more severe penalties for noncompliance (Republic of Singapore 2005).

Act on prevention of Infectious Diseases

Legislation in South Korea that requires institutions working with Highly Dangerous Pathogens to implement laboratory biosafety and biosecurity measures.

Infectious Disease Control Law

Legislation in Japan that establishes different reporting and handling requirements for select agents under the Ministry of Health, Labor, and Welfare.

Canadian Containment Level (CL3) and CL4

Certification required for facilities in Canada working with risk group 3 or 4 microorganisms.

Danish Parliament Law

Law in Denmark that gives the Minister of Health and Prevention authority to regulate the possession, manufacture, use, storage, sale, purchase or other transfer, distribution, transport and disposal of listed biological agents.

CEN Workshop Agreement 15793 (CWA 15793)

European standard focusing on Laboratory Biorisk Management in February 2008.

February 2008

What date did the the Comite Europeen de Normalisation (CEN) publish the CWA 15793?

2011

What year was the CWA 15793 updated 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.

1983

What year did WHO publish its 3rd edition of the Laboratory Biosafety Manual?

3rd edition of the Laboratory Biosafety Manual

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.

Cartagena Protocol on Biosafety (CPB)

International regulatory framework in 2003 ensuring an adequate level of protection in the field safe transfer, handling, and use of living modified organisms (LMOs) resulting from modern biotechnology.

National Committee on Biosafety of the Philippines (NCBP)

Committee established in the Philippines to advocate for biosafety efforts.

E.O 430 series of 1990

NCBP established under ______ was formed on the advocacy efforts of scientists.

March 17, 2006

What date did the office of the President promulgated E.O. 514 establishing the National Biosafety Framework (NBF).

National Biosafety Framework (NBF)

Combination of policy, legal, administrative, and technical instruments in the Philippines to implement the Cartagena Protocol on Biosafety.

May 24, 2000

What date did the Philippines sign for the NBF to attain the objective of the Cartagena Protocol on Biosafety.

Administrative Order No. 8

The Department of Agriculture (DA) issued policies on the importation and release of plants and plant products derived from modern biotechnology in the Philippines.

Department of Health (DOH) guidelines

Guidelines formulated in the Philippines for assessing the impacts on health posed by modern biotechnology and its applications.

DOH Administrative Order No. 2007-0027

It requires clinical laboratories to ensure policy guidelines on laboratory biosafety and biosecurity.

American Biological Safety Association (ABSA)

A regional professional society that promotes biosafety as a scientific discipline and provides guidance to its members on the regulatory regime present in North America.

1984

What year was the ABSA founded?

Asia Pacific Biosafety Association (A-PBA)

Professional society for biosafety professionals in the Asia-Pacific region.

Asia Pacific Biosafety Association (A-PBA)

Active members of the International Biosafety Working Group are required to directly contribute to the development of the best biosafety practices.

2005

What year was the A-PBA founded?

European Biological Safety Association (EBSA)

Association providing a forum for discussions and debates on biosafety issues and representing those working in the field of biosafety.

June 1996

EBSA, a non-profit organization was founded in what date?

Philippine Biosafety and Biosecurity Association (PhBBA)

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.

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.

Biological Risk Association Philippines (BRAP)

Non-government association addressing biological risk management concerns in various professional fields in the Philippines.

“assess, mitigate, monitor”

BRAP’s tagline

Biosafety

Containment principles, technologies, and practices implemented to prevent unintentional exposure to pathogens and toxins or their accidental release.

Biosecurity

Protection, control, and accountability for valuable biological materials within laboratories to prevent unauthorized access, loss, theft, misuse, diversion, or intentional release.

Charles Baldwin

He is an environmental health engineer that created the biohazard symbol in 1966

Risk Group 1

Microorganisms unlikely to cause human or animal disease, with low individual and community risk.

Risk Group 1

Lactobacillus spp., E. coli K12

Risk Group 2

Microorganisms are unlikely to be a significant risk to laboratory workers and the community, livestock, or the environment. This risk group bring about moderate individual risk and limited community risk.

Risk Group 2

Staphylococcus aureus, HBV, E.coli 0157

Risk Group 3

Microorganisms known to cause serious diseases to humans or animals, with high individual risk, and limited to moderate community risk.

Risk Group 3

Mycobacterium tuberculosis, Brucella sp., VEE, Western nile virus

Risk Group 4

Ebola, Marburg, CCHFV

Biosafety Level 1 (BSL-1)

(BSL) Suitable for work involving microorganisms that are defined and known not to cause disease in humans.

Biosafety Level 1 (BSL-1)

(BSL) Bacillus subtilis, Naegleria gruberi, and Infectious canine hepatitis virus

Biosafety Level 1 (BSL-1)

(BSL) Undergraduate and secondary educational and teaching laboratories.

Biosafety Level 1 (BSL-1)

Basic safety practices and safety equipment

Biosafety Level 2 (BSL-2)

(BSL) Hepatitis B Virus, HIV, Salmonellae, Taxoplasma species

Biosafety Level 2 (BSL-2)

(BSL) Work is done with human blood, Body fluids, Tissues, Primary human cell lines

Biosafety Level 2 (BSL-2)

(BSL) Hand washing sinks and waste decontamination facilities

Biosafety Level 3 (BSL-3)

(BSL) Puts emphasis on primary and secondary barriers in the protection of the personnel, the community and the environment from infectious aerosol exposure.

Biosafety Level 3 (BSL-3)

(BSL) Mycorium tuberculosis, St. Louis Encephalitis Virus and Coxiella

Biosafety Level 3 (BSL-3)

(BSL) Work with indigenous or exotic agents

Biosafety Level 3 (BSL-3)

(BSL) Gas tight aerosol generation chamber

Biosafety Level 4 (BSL-4)

(BSL) Dangerous and exotic agents that pose high individual risks of life-threatening diseases that may be transmitted via the aerosol route, for which there no available vaccines or treatment.

Biosafety Level 4 (BSL-4)

(BSL) Marburg or Crimean-Congo Hemorrhagic fever

Biosafety Level 4 (BSL-4)

(BSL) Separate building or isolated zone, Dedicated supply and exhaust, vacuum, and decontamination systems