PMLS - Lesson 6

Basic Concepts on Laboratory Biosafety and Biosecurity

1943

The origin of biosafety in the US biological weapons program

Ira L. Baldwin (1943)

First scientific director of Camp Detrick

Fort Detrick

Camp Detrick became _________

Arnold Wedum (1907 & 1908)

Describe the use of mechanical pipettors

Laboratory Acquired Infections

LAI

1909

A pharmaceutical company in Pennsylvania developed a ventilated cabinet to prevent infection from Mycobacterium tuberculosis

1967

Eradication of virus due to increasing mortality rate of small pox

1974

CDC published Classification of Etiological Agents on the Bases of Hazards

Center of Disease Control and Prevention

CDC

National Institute of Health

NIH

1976

NIH published guidelines for Research Involving Recombinant DNA molecules (Introduction of a code of biosafety practices)

1983

Laboratory Biosafety Manual by WHO

1984

Biosafety in Microbiological and Biomedical Laboratories

1996

US government enacted the Select Agent Regulation

Select Agent Regulation

Monitor the transfer of a select list of biological agents from one facility to another

Biological Agents and Toxins Act

Singapore

The Act on Prevention of Infectious Disease

South Korea

Infectious Disease Control Law

Japan

Containment of Level 3 and Level 4 Facilities

Canada

American Biological Safety Association

ABSA

ABSA (1984)

• regional professional society for biosafety and biosecurity

• promotes biosafety as a scientific discipline

• provides guidance to its members on the regulatory regime present in NORTH AMERICA

Asia Pacific Biosafety Association

(A-PBA)

A-PBA (2005)

• Includes Singapore, Brunei, China, Indonesia, Malaysia, Thailand, Philippines, and Myanmar

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

European Biological Safety Association

EBSA

EBSA (June 1996)

• Non-profit organization

• provide a forum for discussion and debates on issues of concern in the field of biosafety

Philippine Biosafety and Biosecurity Association

PHBBA

PHBBA

assist the DA and DOH in their efforts to create a National Policy

Biological Risk Association Philippines

BRAP

BRAP

• non-government and non-profit association

• serve the emergent concerns of biological risk management in various professional fields such as health, agriculture, and technology sectors throughout the country

Occupational Safety and Health Association

OSHA

OSHA’s mission

“Assure safety and healthy working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education, and assistance”

Biosafety

• Prevent unintentional exposure to pathogens and toxins or their accidental release

• protects people from germs

Biosecurity

• protection, control, and accountability for valuable biological materials

• protects germs from people

Charles Baldwin (1996)

created the biohazard symbol used in labelling biological materials carrying significant health risks

RG 1

• No or low individual and community risk

• Unlikely to cause human or animal disease

RG 2

• Moderate individual risk, low community risk

• Can cause disease but unlikely to be a serious hazard

• Treatment and preventive measures are available while the risk spread is limited

RG 3

• High individual risk, low community risk

• Usually causes serious human or animal disease but does not ordinarily spread

RG 4

• High individual and community risk

• Usually causes serious human or animal disease and can be readily transmitted

• Effective treatment and preventive measures are not usually available

North America and Western Europe

Laboratory biosafety and biosecurity traces its history in ______________________________

US President Franklin Roosevelt

Who ordered the biological weapons and was active during the Cold War

US President Richard Nixon (1969)

Who terminated the biological weapons?

Newell A. Johnson

• designed modifications for biosafety at Camp Detrick

• developed specific technical solutions such as Class III safety cabinets and laminar flow hoods

Russia

What country is the State Research Center of Virology and Biotechnology VECTOR (SRCVB VECTOR)

Biosafety Officers

adopted the administrative role of ensuring that the proper equipment and facility controls are in place

Wedum and microbiologist Morton Reitman (1966)

analyzed multiple epidemiological studies of laboratory-based outbreaks

Amerithrax

terrorist attacks and the anthrax attacks of 2001

Singapore’s Biological Agents and Toxins Act (2005)

similar in scope with the US regulations but with more severe penalties for noncompliance

South Korea’s Act on Prevention of Infectious Disease (2005)

require institutions that work with listed “highly dangerous pathogens” to implement laboratory biosafety and biosecurity requirements

Japan’s Infectious Disease Control Law

• recently amended under Japan’s Ministry Health, Labor, and Welfare

• established four schedules of select agents

Danish Parliament (2008)

passed a law that gives the Minister of Health and Prevention the authority to regulate the possession and disposal of listed biological agents

Comite Europeen de Normalisation (CEN)

European Committee for Standardization published the (CWA 15793)

CEN Workshop Agreement 15793 (CWA 15793)

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

• can be applied to international stakeholders

• do not have the force of regulation while conformity is voluntary

Cartegana Protocol on Biosafety (CPB) 2008

• applies to the 168 members-countries provides an international regulatory framework

• “an adequate level of protection in the field of safe transfer, handling and use of living modified organisms organisms (LMOs) resulting from modern biotechnology”

• tackle the safe, transfer, handling, and use of LMOs

Cartegana Protocol on Biosafety

What is CPB?

National Committee on Biosafety of the Philippines

What is NCBP?

Organizational structure for Biosafety

• Procedures for evaluation of proposals with biosafety concerns

• procedures and guidelines on the introduction, movement, and field of release of regulated materials

• procedures on physico-chemical and biological containment

May 24, 2000

When did the Philippines signed the Cartegana Protocol on Biosafety?

Department of Agriculture (DA)

• 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)

Formulated guidelines in the assessment of the impacts on health

DOH Administrative Order No. 2007-0027

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

Biosafety Level 1 (BSL-1)

• suitable for work involving viable microorganisms that are defined and with characterized strains known not to cause disease in humans

• Ex. Bacillus subtilis 7& Naegleria gruberi

• most appropriate among undergraduate and secondary educational training and teaching laboratories

Biosafety Level 2 (BSL-2)

• designed for laboratories that deal with indigenous moderate-risk agents present in the community

• Ex. Hepatitis B virus & HIV

• appropriate when work is done with human blood, body fluids, tissues, or primary human cell line

Biosafety Level 3 (BSL-3)

• puts emphasis on primary and secondary barriers to the protection of the personnel, the community, and the environment from infectious aerosol exposure

• Ex. Mycobacterium tuberculosis

Biosafety Level 4 (BSL-4)

• required for work with dangerous and exotic agents that pose high individual risks of life-threatening diseases

• generally a separate building or completely isolated zone with specialized ventilation requirements and waist management systems

• controlled by the laboratory supervisor in accordance with institutional policies

Biological Safety Cabinet

BSC

• Personal

• Environmental

• Product Protection

What does BSC provides?

Freestanding Class II, Type A2

BSC used in the video

HEPA Filters

for exhaust and supply air

BSC’s air filtration system

keep potentially contaminated air from seeping back onto the worker

Exhausted

30% of filtered air

Filtered

70%

10 centimetes

work at least ___________ inside of the BSC

Do not block

_______ front near and rear grills

clean to dirty

set up workspace in a direction from __________

can disrupt the air flow

too many objects in the BSC ___________

one meter

minimize foot traffic within _____ of The BSC

away from door and room air supply vents

placement of the BSC __________________ helps maintain airflow

Commonwealth Scientific and Industrial Research Organization

• CSIRO

• Biosafety Laboratory 4

Australian Animal Health Laboratory

AAHL

AAHL

• helping to protect Australia from the threat of exotic and emerging animal diseases

• one of the world’s finest animal science research laboratories

• most sophisticated laboratory in the world for safe handling and containment of infectious microorganisms

Geelong, Victoria in 1985

most technically complex of its time

direct movements

use slow, ____________

AAHL Collaborative Biosecurity Research Facility

ACBRF

ACBRF

• biosecurity research facility

• most advance facility

• provides scientific staff with an opportunity to work with small laboratory animals including insects

• allows up to 12 scientists to work at any one time

• has five independent workstations and features

• under 24-hour closed-circuit tv surveillance

Biosecurity Collaboration Platform

new communication system

filtered

Air

heat treated

sewage

incinerated

solid waste

complete a 7 minute chemical wash

all staff leaving the laboratory

7 days

staff must not have contact with livestock animals for _____

Yellow

• Instability

• 4-may detonate

• 3-shock and heat may detonate

• 2-violent chemical change

• 1-unstable if heated

• 0-stable

Red

• fire hazard

• 4-below 73°F

• 3-below 100°F

• 2-below 200°F

• 1-above 200°F

• 0-will not burn

Blue

• health hazard

• 4-deadly

• 3-extreme danger

• 2-hazardous

• 1-slightly hazardous

• 0-normal material

White

• specific hazard

• OX-oxidizer

• ACID-acid

• ALK-alkali

• COR-corrosive

• W-use no water

OSHA

• large regulatory agency of the United States Department of Labor that originally had federal visitorial powers to inspect and examine workplaces

• charged with enforcing a variety of whistleblower statutes and regulations

BSL-4

• Microbes are dangerous and exotic, posing a high risk of aerosol-transmitted infections, which are frequently fatal without treatment or vaccines

• Ebola and Marbug Viruses

BSL-3

• Microbes are dangerous and exotic can cause serious or potentially lethal diseases through respiratory transmission

• Mycobacterium tuberculosis

BSL-2

• Microbes are typically indigenous and are associated with the diseases of varying severity

• They pose moderate risk to workers and the environment

• Staphylococcus aureus

BSL-1

• Microbes are not known to cause disease in healthy hosts and pose animal risk to workers and the environment