Seminar Notes: Biosafety and Security (BY SIR RANDALL JOEY S.

ANGOB)

Objectives:
1. To re-Orient the participants on the importance of biosafety and bio
security in clinical setting. A biosecurity comes with a good biosafety practice, it is interlinked to each
2. To present the framework in developing a biosafety program in clinical other.
laboratory
3. To provide an update on biosafety-related requirements of the BIOSAFETY and BIOSECURITY: Similarities and Differences
Department of Health through Administrative Order 2021-0037

BIOSAFETY
- Protecting people from bad bugs

Definition
WHO LBM 4th edition
 Containment principles, technologies and practices that are implemented to
prevent unintentional exposure to biological or other inadvertent release.

ISO 35001: 2019 “Biorisk Management for Laboratories and Other Related
Organizations”
 Practices and controls that reduce the risk of unintentional exposure or
release of biological agents

BIOSECURITY Pillars of Laboratory Biosecurity

 Protecting bad bugs from bad people  inventory control
 inventory updated and documented
Definition  information control
WHO LBM 4th edition  informatics plays a crucial part in the lab
 Principles, technologies and practices that are implemented for the  personnel control
protection, control and accountability of biological materials and/or the  physical security control
equipment, skills and data related to their handling.  transport control
 Biosecurity aims to prevent their unauthorized access, loss, theft, misuse,
diversion or release.
Response Plan
 dual use research of concern
ISO 35001: 2019 “Biorisk Management for Laboratories and Other Related  emerging biotechnology
Organizations”
 emergency or incident
 Practices and controls that reduce the risk of loss, theft, misuse, diversion
of, or unintentional unauthorized release of biological agent.
Definition
RISK LIKELIHOOD (Pre- CONSEQUENCE
incident) (Post-incident)
a combination of the the probability of an the outcome of an
likelihood of an incident incident (that is exposure incident (exposure to
and the severity of the to and/or a release of and/or a release of
harm (consequences) if biological agent) biological agent) of an unplanned event that results in an event or occurrence with potential of
that incident were occurring in the course of varying severity of harm, injury, harm, or damage causing injury, harm, infection,
occurred laboratory work occurring in the course of intoxication, disease, or damage.
laboratory operation. incidents can involve infectious
materials, infected animals, or toxins,
Consequences may including a spill exposure, release of
include laboratory infectious materials or toxins, animal
acquired infections, other escape, personal injury, or illness,
illnesses or physical missing infectious materials or toxins,
injury, environmental unauthorized entry into the containment
contamination, or zone, power failure, fire, explosion,
asymptomatic carriage of flood, or the crisis situations (e.g.,
biological agents. earthquakes, hurricane).

Definition Incidents include accidents and near

INITIAL RISK RISK CONTROL RESIDUAL RISK misses
MEASURES
risk associated with use of combination of risk that remains after Definition
laboratory infection tools, which includes carefully selected risk BIOLOGICAL BIOLOGICAL TOXIN
activities or procedures communication, control measures have AGENT MATERIALS
that are conducted in the assessment, training, and been applied. If residual any microbiological any materials substance produced by
absence of risk control physical and operational risk is not acceptable, it entity, cellular or compromised of, plants, animals, protists,
measures controls, to reduce the may be necessary to noncellular, naturally containing or that contain fungi, bacteria, or viruses
risk of incident or event apply additional risk occurring or engineered, biological agents and/or whether small or
to an acceptable risk control measures or to capable of replication or their harmful products moderate and produces
stop the laboratory of transferring genetic such as toxins and an adverse effect on
The risk assessment activity. material that they may be allergens humans, animals, or
cycle will determine the to provoke infection, plants.
strategy that should be allergy toxicity or other
used to control the risks adverse effects in
and the specific type of humans, animals, or
risk control measures plants
required to achieve this
Definition
Definition LABORATORY INFECTIOUS DOSE INFECTIOUS
HARM HAZARD BIOHAZARD ACQUIRED SUBSTANCES
adverse effect on the source or situation with potential source of harm INFECTIONS
health of people, animals, the potential for causing caused by biological any infection acquired or the amount of biological the term applies to any
or plants, on the harm materials. reasonably assumed as a agent required to cause material, solid or liquid
environment or on result of exposure to a an infection in the host, which contains biological
property biological agent in the measured in number of agents capable of causing
course of laboratory- organisms infection in either
Definition related activities. humans, animals, or
Accident Incident Often defined as the both.
A person-to-person ID50, the dose that will footwear, safety glasses,
transmission following cause infection and 50% infectious substances can safety goggles, masks
the incident may result in of those exposed include patient and respirators
linked secondary cases. specimens, biological
cultures, medical or Definition
Laboratory-associated clinical wastes and/or Decontamination Disinfectants Disinfection
infections are also known biological products such reduction of viable agents capable of Reduction of viable
as laboratory acquired as vaccines biological agents or other eliminating viable biological agents or other
infections hazardous materials on a biological agents on hazardous materials on a
surface or objects to a surfaces or in liquid surface or object(s) to a
predefined level by waste. pre-defined level by
Definition chemical and or physical chemical and/or physical
Good Microbiological Practice and Standard Operating Procedure (SOP) means These will have varying means.
Procedure (GMPP) effectiveness depending
A basic laboratory code of practice A set of well-documented and validated on the properties of
applicable to types of laboratory stepwise instructions outlining how to chemical, it's
activities with biological agents, perform laboratory practices and concentration, shelf life
including general behaviors and procedures in a safe, timely and reliable and contact time with the
aseptic techniques that should always manner, in line with institutional policies, agents.
be observed in the laboratory best practice and applicable national or
international regulations.
This code serves to protect laboratory
personnel and the community from
infection, prevent contamination of Definition
the environment and provide Decontamination Disinfectants Disinfection
protection for the work material in reduction of viable agents capable of Reduction of viable
use biological agents or other eliminating viable biological agents or other
hazardous materials on a biological agents on hazardous materials on a
surface or objects to a surfaces or in liquid surface or object(s) to a
Definition predefined level by waste. pre-defined level by
PERSONAL BIOLOGICAL AEROSOL chemical and or physical chemical and/or physical
PROTECTIVE SAFETY CABINET means These will have varying means.
EQUIPMENT (PPE) (BSC) effectiveness depending
equipment and or an enclosed, ventilated liquid or solid particles LEVELS OF on the properties of
clothing worn by the working space suspended in air and of a DECONTAMINATION: chemical, it's
personnel to provide a designated to provide size that may allow concentration, shelf life
barrier against biological protection to the inhalation into the 1. Sterilization and contact time with the
agents, thereby operator, the laboratory respiratory tract (usually agents.
 Elimination or
minimizing the environment and/or the less than 10 micrometers
destruction of all
likelihood of exposure. work materials for in diameter)
viable biological
activities where there is
agents and spores
PPE includes, but not aerosol hazard
2. Disinfection
limited to, laboratory  elimination of
coats, gowns, full-body viable biological
suits, gloves, protective agents
3. Cleaning expressed by the direct and control and policies in the
 reduction of combination of organization with regard management system used
viable biological consequences of the to biorisk to establish biorisk
agents event and the associated management policies,
likelihood of occurrence objectives, and processes
where biological material to achieve those
is a source of harm objectives

In Ph: Biorisk Association of the Philippines

International: International Federation of Biosafety Associations

VICENTE SOTTO:
Step by Step Process in taking the exams:

Definition
Biorisk Biorisk management Biorisk Management
System
the effect of uncertainty coordinated activities to management system or
 Senio Senio
r r
Man Mana
agem geme
ent nt
 U
l
t
i
m
a
t
e
l
Levels of Organization y
ISO 35001 WHO Lab Biosafety Manual r
Top Management e
s
Role: p
o
 Ensure that their
n
responsibilities and
s
authorities for relevant roles
i
are assigned and
b
communicated within the
l
organization, including to
e
those who manage, perform,
f
and verify work associated
o
with the control of biological
r
materials.
t
Assign responsibility and authority
h
for:
e
 Ensure that BRM system
s
conforms to the requirements
a
of standards
f
 Report on performance of e
BRM system to top t
management y
o
 Remember that the top f
management shall take the a
ultimate responsibility for the l
organization of BRM l
 they shall not delegate its p
ultimate responsibility but may e
give authority r
 sonnel, contractors, and support the biosafety
visitors to the organization programme
 responsible for protecting the  Providing oversight of the
health and safety of the public biosafety program through
from the risk associated with participation in review
the work being performed with processes in the committees
the organization  The provision of appropriate
 composition of the senior and adequate workers, facilities
management will depend on and other resources deemed
the size and complexity of the necessary for the safe and
organization. secure operation of the facility
1. smaller organization-  Allocating sufficient funds
may include the director or and resources to support
head of the institute or the biosafety
laboratory  defining the rules and
2. larger organization- may responsibilities for biosafety
be composed of a team of all personnel
that is far removed from  Report the top management on
daily laboratory activities the performance of the biorisk
and so may rely more management system and any
heavily on advice from a need for improvement
safety officer  ensure promotion of the biorisk
 Must ensure that appropriate management system
risks assessment is performed  The organization's
and that appropriate resources commitment to buy safety
are available to control the through a policy and possibly
identified risks a code of practice
 Designated with operational  Institute review comma audit
responsibility for overseeing and reporting measures to
the BRM system and ensuring provide assurance that the
the implementation of the requirements of this document
operational function of the (ISO 35001) are being
BRM system implemented and maintained
 Being aware of the overall effectively
institutional risks related to  Making decisions on
hazardous biological agents compliance with applicable
and ensuring completion of the legislative or regulatory
relevant risks assessment by requirements based on the
appropriate individuals organization's internal
 Defining the components and recommendations
procedures (such as emergency Biorisk Management Committee = Biosafety Committee
or incident response,
communication plan, and
 Shall be established in support
occupational health and safety
of the BRM system
plan) that incorporate feedback
 when possible the committee
from frontline personnel to
 shall consist of members who matters
are independent of activities  be chaired by someone
being reviewed for biorisk appointed by a senior and/or
issues top management
 establish a mechanism by  meet at the defined and
which committee members appropriate frequency and
shall refuse themselves from when otherwise required.
participation in committee Biorisk Management Advisor = Biosafety Officer
decision making or procedures
(e.g., vote) on issues where real  Shall be designated to provide  Support the development,
or perceived conflict of interest advice, guidance, and implementation, maintenance,
exist. assurance to BRM issues and continuous improvement of
 have documented terms of  report directly to the senior the organization’s biosafety
reference management and have program
 contribute to the development delegated the authority to  Should have necessary expertise
of institutional biosafety prohibit work in the event that to advise all personnel and
policies and code of practice it is considered necessary to do management on biosafety issues
 Include a representative gross- so and concerns (can be full-time,
section expertise, appropriate  independent of those part-time employee or contractor)
to the nature and scale of the responsible for implementing  Advises and contributes to
activities undertaken the program of work biosafety, biosecurity, and
 ensure issues addressed are  verify in conjunction with technical consultations
formally recorded including other workers, that biorisk  Appraises senior management
the assignment, tracking and have been addressed and/or the biosafety committee of
completion of all actions  Contribute to the development safety related issues within the
 the committee acts as an and/ or delivery of BRM organization
independent review group for training activities  Ensures risks assessment and
issues related to biosafety  advise and assist organization authorization of work are in place
and reports to senior management in ensuring that  Develops and/or delivers safety-
management required authorizations for related training activities
 review new research projects work are in place  Performs periodic laboratory
involving infectious agents, inspections, audits, and
animals, recombinant DNA, assessment
and genetically modified  Reports, investigates and follow-
materials up on incidents or accidents
 Identify, assess and mitigate  Develops and maintains the
potential dual-use risks in biosafety manual and SOP related
research process to biosafety and biosecurity
(proposal/design stage),
 Promotes and monitor
during the research conduct
compliance with legislative or
or all communication stages
regulatory requirements
 Review accidents and
 Communicate with personnel at
incidents
all levels of organization
 perform risk assessments
Scientific Management Laboratory Personnel
 act as an impartial mediator
 An individual/s with  Adhere to institutional policies
in disputes over biosafety
 responsibility for all or part of  complete required training
the science-related program at  follow standard operating 
the facility shall also be procedures and other operational be
designated with specific BRM working practices
responsibility  report to the biosafety officer any 
 plan and coordinate work contravention of these procedures en
activities and ensuring and practices, any areas for
adequate (di nako ma read ang improvement, or any incidents 
sumpay) levels, time, space, with regards to hazardous W
and equipment are available biological materials
 ensure (where necessary in 
consultation with the BRM C
advisory (di nako ma read ang
sumpay) hazard identification 
and risk assessments have been En
performed reviewed by all
affected workers subjected to 
approvals required by the BRM pr
system and that the required
control measures are in place. 
Support Personnel all

 not directly involved in the

laboratory work (e.g., security
and maintenance personnel,
administrators, suppliers)
 how to access to the laboratory
space or biological agents (e.g.,
shipping and receiving personnel)
 Should support the BRM
program
 Complete training by
understanding and identifying
potential hazards
 Communicate identified hazard
to the biosafety officer
 Apply work practices that prevent
exposure to themselves or others
 follow security measures in place
to limit laboratory access

Laboratory Director/ Manager

 Responsible for implementing
processes with the facility or Biosafety Control Measures
Core Requirements  combination of risk control  biological safety cabinets and other primary containment devices
measures that are both the  personal protective equipment
foundation for, and an integral  laboratory design and maintenance
part of, laboratory biosafety  decontamination and waste management
 These measures reflect  outbreak preparedness and resilience
international standards and best
practice in biosafety that are Biosafety programme management cycle
necessary to work safely with  Step 1: Planning  Biosafety policy
biological agents, even where the  Biosafety officer
associated risks are minimal
 Biosafety committee
Heightened Control Measures  a set of risk control measures as
 Step 2: Assessment  Biosafety risk assessment
described in the WHO
o is a systematic framework that
Laboratory Biosafety manual that
determines the likelihood (pre-
may need to be applied in a
incident) and consequences
laboratory facility because the
(post) of inadvertent exposure
outcome of a risk assessment
or unintended release by
indicates that the biological
evaluating the inherent
agents being handled and/or the
characteristics of biological
activities to be performed with
agents and the activities being
them are associated with the risk
performed.
that cannot be brought to an
o It is intended to select and
acceptable risk with the core
requirements only i apply appropriate risk control
Maximum Containment Measures measures, including physical
 a set of highly detailed and
containment design, safety
stringent risk control measures
equipment and operational
described in the 4th edition of the
practices, to reduce risks to an
WHO Laboratory Biosafety
acceptable risk.
manual that are considered
necessary during laboratory work
where a risk assessment indicates STEPS:
that the activities to be performed 1. Gather Information
pose a very high risks to (Hazard Identification)
laboratory personnel, the wider
community and/or the - what biological agents
environment, and therefore an will be handled and what
extremely high level of are their pathological
protection must be provided. characteristics?
 These are especially needed for - what type of lab work
certain types of works with and/or procedures will be
biological agents that may have conducted
catastrophic consequences even - what type(s) of
exposure release were to occur equipment will be used?
- what type of lab facility
Seven (7) monographs of WHO LBM 4th edition, 2020 is available
 Biosafety programme management - what human factor/s
 Risk assessment exist (for ex, what is the
 level of competency of risk control measures?
personnel) - are proposed control
- what other factors might strategies effective,
affect lab operations (ex. sustainable and
Legal, cultural, achievable in the local
socioeconomic, context?
perception)
4. Select and implement
2. Evaluate the risks risk control measures

- how could an exposure - are there any national or

and/or release occur? international regulations
- what is the likelihood of regulating the prescribed
exposure and/or release? risk control measures?
- what info gathered - what risk control
influences the likelihood measures are locally
the most? available and sustainable?
- what are the - are available risk control
consequences of exposure measures adequately
and/or release? efficient or should
- which info influences multiple risk control
the consequences the measures be used in the
most? combination to enhance
- what is the overall initial efficacy?
risk of the activities? - do selected risk control
- what is an acceptable measures align with the
risk? risk control strategy?
- which risks are - what is the level of
unacceptable? residual risk after risk
- can acceptable risks be control measures have
controlled, or should the been applied and how is it
work not proceed at all? now acceptable?
- are additional resources
3. Develop a risk control required and available for
strategy implementation of the risk
control measures?
- what resources are - are the selected risk
available for risk control control measures
measures? compliant with national or
- what risk control international regulation
strategies are most - has approval to conduct
applicable for the the work been granted?
resources available? - has approval to conduct
- are resources efficient to the work been granted?
obtain and maintain those - have the risk control
strategies been
 communicated to relevant  Step 4: Review and  Incident reporting and
personnel? Improvement investigation
- have necessary items  Inventory control
been included in the  Internal and external audits and
budget and purchased? inspections
- are operational and
maintenance procedures
in place?
- have personnel been
appropriately trained?

5. Review risks and risk

control measures Why is there an emerging need for Biosafety and Biosecurity Program in the
Laboratory?
- have there been any  Due to what is written in the AO 2021-0037
changes in activities,
biological agents, ANNEX A: Licensing Standards for Clinical Laboratory
personnel, equipment, or
facilities? I.E Physical Plant
- is there any new There shall be policy guidelines on laboratory biosafety and bio security
knowledge available of which includes the risk assessment that will serve as a basis of biosafety level
biological agents and/or required for this specific clinical laboratory.
the process being used?
- are there any lessons II.B Registered Medical Technologists
learnt from incident There shall be designated Biosafety and Biosecurity Officer-in-charge
reports and investigations primarily of the risk assessment of the DOH-licensed CL
that may indicate
improvements to be V. Information Management /Administrative Policies and Procedures
made? There shall be a risk assessment for every section in the CL
- has a periodic review
cycle been established? VIII.E Environmental Management
There shall be policy for biosafety and biosecurity
 Biosecurity risk assessment
 Step 3: Implementation  Biosafety plan
ANNEX B1: ASSESSMENT TOOL
 Biosecurity plan, lab access, and
physical security
II. HUMAN RESOURCE MANAGEMENT
 Occupational health programmes C. Biosafety and Biosecurity Officer (maybe designated by the HOL)
 Personnel management and REQUIREMENTS: RMT, Certificate of Training in Biosafety and
training Biosecurity
 Safe work practices and SOPs (RITM and/or UP-NTCBB)
 Facility design and safety
equipment III. PHYSICAL PLANT, FACILITIES AND WORK ENVIRONMENT
 Waste management
 Emergency response 14. There are policy guidelines on laboratory biosafety and biosecurity
 Records and documentation Document review: Local risk assessment reviewed at least ANNUALLY
 Written protocols on laboratory biosafety and  Laboratory activities associated with aerosolization (for example,
biosecurity sonication, and i homogenization, centrifugation)
Observe: Good laboratory Practice that includes use of PPEs and other  Laboratory activities associated with sharp materials
precautionary measures  low competency of personnel carrying out the work
ANNEX D1: PLANNING AND DESIGN  highly environmentally stable biological agent
 Inadequate or poor availability of electrical power, dilapidated laboratory
II. Specific Technical Requirements facilities and building systems, malfunctioning equipment, damage from
frequent severe weather and access of insects and rodents to the laboratory
8. Biosafety Cabinets and isolation hoods shall be located so that fluctuation in air the
supply and exhaust or the operations of equipment do not alter the performance
standard of the cabinet/hood.
FACTORS ASSOCIATED WITH GREATER CONSEQUENCES IF
INCIDENT WERE TO OCCUR
ANNEX E: REMOTE COLLECTION
 Low infectious dose
12.3. Technical or operational procedures for remote collection including specimen  highly communicability
handling and transportation
 high severity and mortality
 limited availability of effective prophylaxis or therapeutic interventions
 large susceptible population including laboratory personnel at increased
ACTIVTIES OR EVENTS THAT AFFECT THE RISKS AND WILL risk
THEREFORE TRIGGER A RISK ASSESSMENT INCLUDE:  lack of endemicity such as exotic disease

 Changes to biological agents, or new information available on current

biological agents FACTORS ASSOCIATED WITH BOTH A HIGH LIKELIHOOD OF AND
GREATER CONSEQUENCES FROM A POTENTIAL INCIDENT
 Changes to personnel
 Changes to procedures and practices
 High concentration or volume of the biological agents
 Changes to lab equipment
 Airborne route of transmission
 Changes in international, national, or regional regulations or guidelines
 Changes in national or regional disease status (endemicity of disease or
eradication) TYPES OF CONTROL
 Introduction of new technology
 Lab relocation or renovation
 An incident, accident, lab-acquired infection, or any event where a potential
harm is identified
 Identification and/or implementation of corrective and/ or preventive action
 User feedback
 Periodic review

“ˆWhen lab activities, personnel, processes and technology change, so does the risk.”

FACTORS ASSOCIATED WITH HIGH LIKELIHOOD OF INCIDENTS

OCCURRING