BIOSAFETY AND BIOSECURITY (copy)

LABORATORY BIOSAFETY

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.

From their sources in the laboratory.

Laboratory Biosafety are release from where

LABORATORY BIOSECURITY

The set of measures aimed at the protection, control and accountability for valuable
biological materials and protection of other
valuable items (e.g. equipment) within
laboratories,

loss
theft
misuse
diversion of
and/or unauthorized access intentional unauthorized release.

What are the factors prevented in Laboratory Biosecurity

BIORISK MITIGATION

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).

Valuable Laboratory
Material

VLM

Biological agents

include different
microorganisms & the toxins they may produce.

GUIDELINES

Sees or monitors if laboratory biosafety
and biosecurity, and biorisk mitigation are
being observed.

Feb 2008

the Comite’ Europeen de
Normalisation published the CEN
Workshop Agreement 15792 (CWA
15793)

CEN
Workshop Agreement 15793 (CWA
15793)

focus is on laboratory biorisk
management

CEN
Workshop Agreement 15792 (CWA
15793)

offers mechanism where
stakeholders can develop consensus
standards & requirements in an open
access

True

CWA 15793 can be applied to
international stakeholders but do not have the forceof regulation while conformity is voluntary

2014

When did CWA 15793 expired

No force of regulation (for international stakeholders) Already expired

The CWA’s major drawbacks

LABORATORY BIOSAFETY MANUAL 3RD EDITION (WHO) - 1983

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

packaging

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

DRAWBACK OF LABORATORY BIOSAFETYMANUAL3RDEDITION (WHO) - 1983

No mechanism toensure that guidelines are adhered to or that people working in labs are sufficiently trained

micro lab

it is required to have a biosafety/safety cabinet.

true

Even the safety cabinets have levels of which class should be used in certain types or kinds of laboratory and organism that are being contained.

CARTAGENA PROTOCOL ON BIOSAFETY(CPB) - 2003

To ensure adequate level of protection in safe transfer, handling, & use of living modified organisms resulting from modern biotechnology

Living Modified Organisms

LMO

NATIONAL COMMITTEE ON BIOSAFETY OF THE PHILIPPINES

EO 430 s 1990

NATIONAL COMMITTEE ON BIOSAFETY OF THE PHILIPPINES

NCBP

NCBP

Focuses on the organizational structure for biosafety

NCBP

procedures for evaluation of proposals with biosafety concerns

NCBP

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

NCBP

procedures on
physico-chemical & biological
containment.

True

In NCBP, it is also the release and how you are going to dispose the materials that are being used in the
lab.

NATIONAL BIOSAFETY FRAMEWORK

NBF

NBF

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

NBF

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

False

NBF, is not considered as expansion of NCBP.

AD 8 BY THE DEPARTMENT OF
AGRICULTURE

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

Tama Behavior

Indi ka makabasta-basta pasulod tanom from other contries without permit

DOH with NCBP

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

AD 8 BY THE DEPARTMENT OF
AGRICULTURE

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

DOH A0 2007 - 0027

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

American Biological Safety Association

ABSA

1984

when was ABSA founded

ABSA

Promotes biosafety as scientific discipline& provides guidance to its members on theregulatory regime present in NorthAmerica

Asia-Pacific Biosafety Association

A-PBA

2005

when was A-PBA founded

A-PBA

To directly contribute to the development of the best biosafety practices.

False

A-PBA does not Include the Philippines like DOH and other agencies

European Biological Safety Association

EBSA

1996

EBSA founded

EBSA

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

Philippine Biosafety & Biosecurity Association

PhBBA

PhBBA

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

PhBBA

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

food and water diseases

Example area of concern of PhBBA

PhBBA

Control the spread and entry of animal products from other countries.

Biological Risk Association Philippines

BRAP

BRAP

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

agriculture, veterinary, and more

fields under BRAP

Risk Group 1
Risk Group 2
Risk Group 3
Risk Group 4

CLASSIFICATION OF MICROORGANISMS ACCORDING TO RISK GROUPS (WHO)

Risk Group 1

Includes microorganisms that are unlikely to cause human or animal disease.

Risk Group 1

They bring about low individual & community risk.

Risk Group 2

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

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 3

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.

Cholera

Example of Risk Group 3

Risk Group 4

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.

BSL - 1
BSL - 2
BSL - 3
BSL - 4

CLASSIFICATION OF LAB BIOSAFETY
ACCORDING TO LEVELS (CDC)

Biosafety Level

BSL

BSL - 1

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

B. subtilis, Naegleria gruberi

Examples of BSL - 1

BSL - 2

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

Hepa B, HIV, salmonellae, toxoplasma
species

Examples of BSL-2

True

BSL -2 is appropriate when work is done with human blood &fluids, tissues, or primar yhuman cell lines where there uncertain presence of infectious agents

True

In BSL -2 Handwashing &waste decontamination facilities must be available &access to the lab must be restricted when work is being conducted.

biosafety cabinets

What is used when expecting aerosols or splashes

BSL - 3

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

BSL - 3

All lab activities are performed in a biosafety cabinet.

BSL - 3

There is a need for secondary barrier and Personnel must be supervised by scientists

M. tuberculosis

Example of BSL-3

BSL -4

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

BSL -4

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

class III biosafety cabinet

Lab worker should work using _____ or in a full body, air-supplied positive pressure personnel suit.

BSL - 4

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

Specifications for the design
Requirements for equipment
Management standards

The containment level prescribes in BSL - 4

Specifications for the design

structure of the laboratory such as sealability for fumigation, materials for bench tops and observation windows

Requirements for equipment

such as autoclaves and microbiological safety cabinets

Management standards

such as
disinfection policies and access control

bacteria, viruses, fungi, prions

Examples of Biological Agents

four Hazard Groups

Biological Agents are classified into

The agent is pathogenic to humans
The agent is a hazard to employees
The agent is transmissible to the community
There is effective prophylaxis or treatment available

BIOLOGICAL AGENTS CLASSIFICATION IS BASED ON WHETHER

Hazard Group 1

Unlikely to cause
disease

Hazard Group 2

Can cause human
disease

Hazard Group 2

May be a hazard to
employees

Hazard Group 3 and 4

Can cause severe
human disease

Hazard Group 3 and 4

May be a serious
hazard to employees

Hazard Group 3

May spread to the
community

Hazard Group 2 and 3

Usually effective
prophylaxis or treatment
available

Hazard Group 4

Likely to spread to the
community.