ENDTERM PART 2 Flashcards by Tipayyy Perlaaa

The set of containment principles, technologies and practices that
are implemented to prevent the
unintentional exposure to
biological agents and toxins, or
their accidental release

Laboratory Biosafety

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The set of measures aimed at the
protection, control and
accountability for valuable
biological materials

Laboratory Biosecurity

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protection of other valuable
items within laboratories, in
order to prevent their loss, theft, misuse, diversion of, and/or
unauthorized access or
intentional unauthorized release

Laboratory Biosecurity

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Actions and control measures
that are put into place to reduce
or eliminate the risks associated
with biological agents and toxins
and other Valuable Laboratory
Material (VLM)

Biorisk Mitigation

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Focus is on Laboratory Biorisk
Management

CWA 15793

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Offers mechanism where
stakeholders can develop
consensus standards and
requirements in an open access

CWA 15793

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Can be applied to international
stakeholders but do not have the
force of regulation while
conformity is voluntary

CWA 15793

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Ensure adequate level of
protection in safe transfer, handling, & use of LMOs resulting
from modern biotechnology

Cartagena Protocol on Biosafety (CPB)
- 2003

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Procedures on physico-chemical &
biological containment

National Committee on Biosafety of
the Phil (NCBP

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Procedures for evaluation of
proposals with biosafety
concerns

National Committee on Biosafety of
the Phil (NCBP

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Procedures & guidelines on
the introduction, movement
& field release of regulated
materials

National Committee on Biosafety of
the Phil (NCBP

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National Committee on Biosafety of
the Phil (NCBP)

EO 430s 1990

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Prescribes the guidelines for
implementation, strengthening the National Committee on Biosafety of
the Phi

National Biosafety Framework (NBF)

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A combination of policy,
legal, administrative, &
technical instruments
developed to attain the
objective of the Cartagena
Protocol on Biosafety

National Biosafety Framework (NBF)

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Considered as expansion of
NCBP

National Biosafety Framework (NBF)

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National Biosafety Framework (NBF)

EO 514s 2006

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

AD 8 by Dept of Agriculture

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To set policies on the importation
& release of plants & plant products derived from modern
biotechnology

AD 8 by Dept of Agriculture

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The guidelines aid in evaluating &
monitoring processed food
derived from or containing GMO

AD 8 by Dept of Agriculture

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Requires laboratories to ensure
guidelines on policy on
laboratory biosafety &
biosecurity

DOH AO 2007 - 0027

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Promotes biosafety as scientific
discipline & provides guidance to
its members on the regulatory
regime present in North America

American Biological Safety
Association (ABSA) - 1984

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To directly contribute to the
development of the best
biosafety practices

Asia-Pacific Biosafety Association
(A-PBA) - 2005

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Aims to provide a forum for
discussions & debates on issues
of concern & to represent those
working in the field of biosafety

European Biological Safety
Association (EBSA) - 1996

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Created by the health &
education sectors & executive,
legislative, & judicial branches of
the govt

Phil Biosafety & Biosecurity
Association (PhBBA)

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Assisted DA & DOH to create a national policy & implement plan for laboratory biosafety & biosecurity

Phil Biosafety & Biosecurity Association (PhBBA)

Works to serve the emergent concerns of biological risk management in various professional fields

Biological Risk Association Phil (BRAP)

Includes microorganisms that are unlikely to cause human or animal disease

Risk Group 1

They bring about low individual & community risk

Risk Group 1

Includes microorganisms that are unlikely to be significant risk to laboratory workers & the community, livestock or the environment

Risk Group 2

Lab exposure may cause infection, however, effective treatment & preventive measures are available while the risk of spread is limited

Risk Group 2

Brings moderate individual risk & limited community risk

Risk Group 2

Includes microorganisms that are known to cause serious diseases to humans or animals and may present a significant risk to laboratory workers

Risk Group 3

There are effective preventive measures or treatment

Risk Group 3

Bring high individual risk & limited to moderate community risk

Risk Group 3

Includes microorganisms that are known to produce life threatening diseases to humans or animals

Risk Group 4

Represents a significant risk to laboratory workers & be may be readily transmissible from one individual to another while effective treatment & preventive measures are not usually available

Risk Group 4

Bring high individual & community risk

Risk Group 4

Suitable for work involving viable microorganisms that are defined and with well-characterized strains known not to cause disease in human

Biosafety Level 1 (BSL -1)

Ex. B. Subtilis, Naegleria gruberi

Biosafety Level 1 (BSL -1)

Designed for labs that deal with indigenous moderate-risk agents present in the community

Biosafety Level 2 (BSL - 2

Ex. Hepa B, HIV, Salmonellae, Toxoplasma species

Biosafety Level 2 (BSL - 2

Appropriate when work is done with human blood & fluids, tissues, or primary human cell lines where there uncertain presence of infectious agents

Biosafety Level 2 (BSL - 2

Hand washing and waste decontamination facilities must be available & access to the lab must be restricted when work is being conducted

Biosafety Level 2 (BSL - 2

When expecting aerosols or splashes, use biosafety cabinet

Biosafety Level 2 (BSL - 2

Required for work with dangerous & exotic agents that pose high individual risks of life threatening diseases that maybe transmitted via aerosol route, for which there are no available vaccines or treatment

Biosafety Level 4 (BSL - 4)

There must be special safety equipment & practices when working with organisms like Marburg or the Crimean-Congo hemorrhagic fever

Biosafety Level 4 (BSL - 4)

Lab worker should work using class III biosafety cabinet or in a full body, air-supplied positive pressure personnel suit

Biosafety Level 4 (BSL - 4)

This lab is a separate building or completely isolated with specialized ventilation requirements & waste management systems

Biosafety Level 4 (BSL - 4)

Specifications for the design and structure of the laboratory such as sealability for fumigation, materials for bench tops and observation window

Containment level describes

Requirements for equipment such as autoclaves and microbiological safety cabinet

Containment level describes

Management standards such as disinfection policies and access control

Containment level describes

It refers to preventive measures to minimize or prevent acquisition of infections from a healthcare setting

 Infection control

Can be classified into contact precaution, airborne precaution, droplets

 Infection control

Respiratory infection involves the wearing respiratory protective gear, masks

Airborne and droplet precautions

Eye protection like safety glasses or goggles

Airborne and droplet precautions

Use of a 0.5% chlorine solution to reduce the number of pathogenic organisms on the device

Decontamination

Use of soap & water to remove all visible dust, soil, blood, or other body fluids

cleaning

Use of disinfectant to destroy pathogenic organisms (may not eliminate resistant organisms)

Low-level disinfection

Use of disinfectant to destroy pathogens (eliminates most organisms)

Intermediate-level disinfection

se of chemical disinfectants, boiling, steaming

High-level disinfection

Use of high pressure steam, dry oven, chemical sterilant, radiation

Sterilization

Use of multi-step procedure: meticulous cleaning, high-level disinfection, proper drying

Reprocessing

Unlikely to cause disease

Hazard group 1

 Can cause human disease  May be a hazard to employees  Unlikely to spread to the community  Usually effective prophylaxis or treatment available

Hazard group 2

 Can cause severe human disease  May be a serious hazard to employees  May spread to the community  Usually effective prophylaxis or treatment available

Hazard group 3

 Causes severe human disease  Serious hazard to employees  Likely to spread to the community  Usually no effective prophylaxis or treatment available

Hazard group 4

puts emphasis on primary & secondary barriers in the protection of personnel, community, & environment from infectious aerosol exposure.

Biosafety Level 3 (BSL-3)

Ex M. tuberculosis ; all lab activities are performed in a biosafety cabinet; there is a need for secondary barrier; personnel must be supervised by scientists

Biosafety Level 3 (BSL-3)

the Comite’ Europeen de Normalisation published the CEN Workshop Agreement 15793 (CWA 15793

Feb 2008

published to include information on the different levels of containment laboratories, different types of biological safety cabinets, good microbiological techniques, & how to disinfect & sterilize equipment.

Laboratory Biosafety Manual 3rd edition (WHO)- 1983

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

Laboratory Biosafety Manual 3rd edition (WHO)- 1983