EPIDEMIOLOGY and DISEASE • incubatory carrier – transmits Inanimate (non-living) reservoir

TRANSMISSION the pathogen during the

incubation period • e.g. air, soil, food, milk, water, and
Week13 fomites
• convalescent carrier – transmit
Factors that Contribute to the Spread of pathogen during convalescence • Fomites – contaminated materials
Disease or recovery period • e.g. clothing, bedding,
1. Virulence of pathogen • active carriers – completely urinals/bedpans, eating
2. Susceptibility of the population recovered from disease but and drinking utensils
3. Lack of immunization continue to harbor the • Air – contaminated by dust, smoke, and
4. Inadequate sanitation procedures pathogen indefinitely respiratory secretions of humans
5. Mode of transmission of the pathogen
• passive carriers – carry the expelled into the air by breathing,
Reservoirs of Infections blowing, sneezing, and coughing
pathogen without ever having
• any site where the pathogen can the disease MODE OF TRANSMISSION
multiply or merely survive until it is Animal reservoir • Contact transmission
transferred to the host
zoonoses- infectious diseases that humans • Vehicle transmission
– Human reservoir acquire from animal sources
• Vector transmission
– Animal reservoir Routes:
Contact Transmission
– Inanimate reservoir • Direct contact – with infected animal or
with domestic pet waste - spread of an agent of disease by direct,
Human Reservoir
indirect or droplet transmission
• principal living reservoir of disease • Inhalation – from contaminated hides,
fur, feathers • Direct Contact Transmission
because many human pathogens are
specie-specific • Ingestion – contaminated food and • person to person transmission
water; consumption of infected animal of an agent by
• direct transmission - with signs
and symptoms of disease and products
• physical contact (source to
transmit the disease • Injection of the pathogen – insect susceptible host)
• carrier – harbors the pathogen vector
• Indirect Contact Transmission
but have no signs and
symptoms
 • from source to a non-living Control of Epidemic Disease Types of infection as to cause
object to a susceptible host
• Report cases of communicable • Autogenous infection
• Droplet Transmission diseases to proper agencies
- Is caused by a microorganism from the
• Microbe spread in droplet • Public education microbiota of the individual.
nuclei that travels only a short
distance (<1 meter) i.e. • Identification and elimination of • Iatrogenic infection
coughing, sneezing. reservoirs of infection
- Is an infection that occurs as the result
• Isolated disease person of medical treatment or medical
• Laughing or talking
procedures.
• Participate in immunization
Vehicle Transmission
program • Opportunistic infection
transmission of disease agent by a medium (i.e.
water, food, air, etc.) • Help to treat sick person - Is an infection in immunocompromised
hosts that do not cause disease in
Pathogenesis of infection
• Waterborne Transmission individuals with a normal immune
Pathogenesis system
• water contamination i.e.
cholera, Shigella • Pathos – Disease - It may due to overuse of antibiotics,
immunosuppressive drugs and
• Foodborne Transmission • Genesis – Means origin chemotherapeutic agents.
• raw of poorly preserved or • It is the source or cause of an illness or • Nosocomial infection
prepared food abnormal condition
- Is a type of infection acquired at a
• Airborne Transmission A. INFECTION health care facility
• spread of agents of infection by - It involves the growth and - Each nosocomial infection adds 5-10
droplet nuclei in dust that travel multiplication of microorganism that days to the affected patients hospital
> 1 meter from the reservoir to result in damage to the host. stay
host
- It is the invasion of the body by - Hand washing is still the cornerstone of
Vector Transmission pathogenic microorganisms that modern infection control programs
animals that carry pathogens from one reproduce and multiply, causing disease
by local cellular injury, secretion of a Common Nosocomial infection
host to another
toxin, or antigen-antibody reaction in - Urinary tract infection – 33%
the host.
 - Lung infection – 15% 3. Systemic (Generalized Infection) Extent of infection

- Surgical site infection – 15% - Microbes are spread throughout the 1. Primary infection
body by blood or lymph
- Blood stream infection – 13% - Is an initial infection causing the illness
A. Bacteremia
Predisposing Factors to Nosocomial Infection Example: common cold
- Is the presence of bacteria in the blood
- Wide variety of microbes in hospital (1-10 bacteria/ml of blood) 2. Secondary infection
environment
- The organisms invade the bloodstream - It is caused by opportunistic pathogen
- Weakened or immunocompromised without active multiplication after primary infection has weakened
patients host immune system.
- The highest concentration of bacteria in
- Chain of transmission ( direct or the blood. example: pneumonia or bronchitis may
indirect) from health workers to patient develop after the common cold
from patient to patient fomites- B. Septicemia
3. Latent infection( silent phase)
catheters, needles, dressings, beds,
wheelchairs airborne transmission - Active multiplication of bacteria in the
blood (active multiplication of the - Is clinically silent inside the body
vector-borne transmission without any noticeable illness in the
invasive organism)
Types of infections according to distribution in host before suddenly causing severe
C. Pyemia and acute infection
the host:

1. Local Infection - It is a condition wherein pus-producing Example: over 90% of polio infection are
organisms repeatedly invade the asymptomatic
- It means signs and symptoms are bloodstream and localized at different
confined to one area parts of the body 4. Mixed infection

Example: infected wound, boils, abscess, acne D. Toxemia - It is caused by two or more organisms.

2. Focal infection - Is the presence of toxins in the blood Example: wound infection

- It starts as a local infection and spread - When bacteria are localized in one area 5. Acute infection
to other parts of the body. but produced a toxin, which spreads - Is a type of infection that develops and
and absorbed by the body cells. progress slowly
example: tooth infection, tonsilitis,
appendicitis, wound infection caused by C. example: whooping cough
tetani
6. Chronic infection - It results when the infection produces 3. Epidemic disease – many people
notable changes in human physiology acquire the disease in a particular
- Is an infection which develops slowly that are often associated with damages location or population
with milder but longer-lasting to one or more of the body’s organ
symptoms system. 4. Pandemic disease – an epidemic that
spans the world (world wide epidemics)
example: tuberculosis Classification of infectious diseases:
Effects of infectious disease
Routes of infection 1. Communicable disease
1. Signs
1. Direct transmission
- It is spread from one host to another,
directly or indirectly - These are objective changes that can be
a. Congenital contact – S. agalactiae, N.
measured
gonorrheae, T. pallidum Example: tuberculosis, herpes, flu, AIDS,
chicken pox, mumps example: fever, redness, swelling, paralysis
b. Sexual contact – N. gonorrheae, T.
pallidum, C. trachomatis 2. Contagious disease 2. Symptoms

c. Hand to hand transmission – rhinovirus - It is spread easily from one person to - These are subjective feelings not
another obvious to a person (pain, malaise)
d. Infectious respiratory secretions or
droplets – S. pyogenes, N. meningitidis Example: chicken pox and measles 3. Syndrome

2. Indirect transmission 3. Non-communicable disease - Is a group of signs and symptoms that

are associated with a disease.
a. Fomites – spoon, fork, glass, mug - It is not spread from host to another
example: AIDS
b. Water – salmonella, shigella, vibrio - It is caused by microbes that live
outside the body or by opportunistic Phases of infectious diseases:
c. Arthropod vectors – borrelia,
francisella, yersinia pathogens that live inside the body 1. Incubation period

Disease example: tetanus and botulism - Is the time between the exposure to a
Classification of Disease as to Occurrence: pathogenic organism and the onset of
- Is a specific illness or disorder symptoms.
characterized by a recognizable set of 1. Sporadic disease- it occurs occasionally
signs and symptoms attributed to 2. Prodromal period
hereditary, infection, diet or 2. Endemic disease – constantly present in
environment a particular location or population - Is the appearance of the signs and
symptoms
3. Clinical/illness period Pathogenicity - pertains to the ability of a
pathogenic agent to produce a disease in a
- Is the peak of characteristic signs and susceptible individual 3. Commensalism
symptoms of an infection or a disease
Two (2) General classes of pathogenic - Is a relationship where the organism
4. Decline period microorganisms: benefits, but there is no beneficial or
harmful effect to the host
- Is the period wherein the signs and 1. True pathogens
symptoms begin to subside as the host 4. Parasitism
condition improves - They are able to invade the tissues of
- is a relationship where the organism benefits
healthy individuals through some
- The condition of host deteriorates inherent ability (power) of their own at the expense of the host
possibly leading to death
2. Opportunistic pathogens Virulence
5. Convalescent period/ period of recovery
- These are organisms that normally do - Is the power of the microorganisms to
- Is the full recovery of the surviving host not cause disease in their natural produce disease

Predisposing factors habitat in a healthy person – they may - Is the degree of pathogenicity
cause disease if the host is weakened
1. Gender - It is measured by the number of
- These are organisms that only cause microorganism necessary to cause
2. Genetic factors infections when one or more of the infection in the host
host’s defense mechanisms are
3. Climate and weather Virulent
disrupted, damaged, changed or
4. Nutrition malfunctioning.
-it pertains to a very pathogenic microorganism
5. Fatigue/stress Host-Microbe Relationship or rapidly progressive condition

6. Environment 1. Symbiosis - Those organisms that can establish

infection with a relatively low infective
7. Lifestyle - is the association of two organism living dose are considered more virulent than
together those that require high numbers for
8. Age
2. Mutualism infection
9. Occupation
- Is a symbiotic relationship where both
Pathogens - Are microorganisms that cause the host and organism benefit from one
infection and/or illness another
Factors influencing microbial virulence 2. Cleansing mechanism 5. Phagocytosis

1. Toxic factors - The nasal hairs keep out airborne - Is the process by which certain cells
particles that may contain engulf and dispose off microorganisms
- Toxins are poisonous substance microorganisms and cell debris.
produced by pathogenic
microorganisms - Cough-sneeze reflex contributes to the Phagocytes (polymorphonuclear leukocytes and
removal of potentially infective agents. macrophages)
- Toxigenicity is the ability to produce
toxic substances. - The cells lining the trachea contain cilia - these are cells that ingest and destroy
bacteria and other foreign particles
example: diphtheria toxin, tetanospasmin, 3. Antimicrobial substances
botulism toxin, enterotoxin - these cells ingest bacteria by a process
Example: lysozyme and bile salts known as endocytosis
2. Enzymatic factors
-lysozymes destroy bacterial cell walls; bile salts 6. Inflammation
- These are produced by bacteria disrupt bacterial membranes.
- It plays an important role as a
example: hyaluronidase, coagulase, leucocidin 4. indigenous/normal microbial flora reinforcement mechanism against
3. Cellular structure - These are microorganisms that are microbial survival and proliferation in
commonly found on or in body sites of tissues and organs
- capsule resists phagocytosis healthy persons.
Signs: swelling, redness, heat, pain and loss of
Host resistant factors a. resident flora- inhabit and multiply; colonize function

1. Physical barriers an area for months or years 7. Immune response

- The skin serves as the physical and b. transient flora- inhabit but do not multiply; - it provides the human host with the ability to
chemical barrier to microorganism colonize an area temporarily; they are mount a specific protective response to the
eliminated by either the host inherent immune presence of a microorganism
- The acellular, outermost layer of the defense or by competition with resident flora
skin and tightly packed cellular layers - immune system has a ‘’memory’’ so that if a
underneath provide an impenetrable Note: organism is encountered second time.
physical barrier to all microorganisms Microorganisms usually do not multiply in the
unless damaged esophagus and stomach, but are present in
ingested food and as transient flora.
2 arms of specific immunity 4. Production of toxins 2. Transmission by food and water

A. Humoral (antibody-mediated) a. Exotoxins- these are the most lethal - Infection occur via the faecal-oral route
immunity substances known; specific and more limited;
present in gram-positive bacteria - Gastric enzymes and juices in the
- It is based on the action of soluble stomach act to prevent survival of most
proteins called antibodies that occur in b. endotoxins- it is released when bacteria die organisms
the body fluid and on the plasma and their cell walls undergo lysis, thus liberating
membrane of B lymphocytes the endotoxin, it also liberates fever in the 3. Close contact
hypothalamus - It refers to passage of organism by salivary,
B. Cellular (cell-mediated) immunity
5. Invasion skin, and genital contact
- is based on the action of specific kinds of T-
lymphocytes that directly attack cells infected - The process of penetrating and growing 4. Cuts and bites
with viruses or parasites in tissues - Bites are infection by the normal flora
Infectious noso factors - With some organisms, invasion involves of the mouth
only a few layers of cell, with others it 5. Arthropods
1. Adherence involves deep tissues
- In order for a microorganism to cause -the infectious agents multiply in the arthropod
6. Dissemination which then feeds off a human host and transmit
disease, It must penetrate the mucous
the microorganism
layer and attach to the epithelium - The spread of organisms to distant sites

2. Proliferation Routes of transmission 6. Zoonosis

- It depends on the contact with animals

- In order to establish itself and cause 1. Airborne transmission
disease, a pathogen must be able to or animal by-product
replicate following attachment to host - Respiratory spread of infectious disease
is common - Diseases may be passed by arthropod vector,
cells contact with secretions, and contact with
- Secretions are aerolized by coughing, animal carcasses and products
3. Tissue damage
sneezing and talking
Terminologies
- A disease or an infection is noticeable
only if tissue damage occurs - Infectious diseases such as tubercolusis,
brucellosis, tularemia, legionellosis and 1. Active antiinfectiontion
plague may be acquired through - Is the protection of susceptible humans
inhalation of infectious particles or and domestic animals from
droplet
 communicable diseases by the 7. Complement-fixing antibodies - Capable of transmitting the infection or
administration of vaccines disease
- These are antibodies attached to the
- For this type of immunizations, vaccine surface of pathogens and destroy a. casual/acute/transient carrier- it harbours
may be prepared from killed antibodies by lysis the microorganism temporarily for a few days
microorganisms, living, weakened or weeks.
(attenuated), inactivated bacterial 8. Antigenic shift
toxins. Etc. b. chronic carrier- it remains infected for a
- Is a major genetically determined change in relatively long time, sometimes throughout life
2. Passive immunization the antigenic character of a pathogen which
may result to not being recognized by immune c. convalescence carrier- is an individual who
- It is administered to individuals exposed system has recovered from infection but continues to
to certain pathogens that cause harbours large number of the pathogen
diseases 9. Antigenic drift
d. active carrier- is an individual who has an
- Is a minor antigenic change as a result
3. Natural (innate) immunity overt clinical case of the disease
of mutation in pathogen strains, and
- Is a nonspecific response which activates facilitates the pathogen avoids host 2. Endemic
chemotaxis, the process by which phagocytes immune
are directed to the site of proliferation and - When an organism or disease is
engulf invading organism 10. Anamnestic response constantly present in a population

4. Acquired active immunity - Is the ability of the B lymphocytes to - It is indigenous to a geographic area or
recall pathogens during primary population
- Is the specific response of the host to an exposure, thus second exposure elicits
invading organism higher antibody response 3. Sporadic

5. Opsonizing antibodies BASIC TERMINOLOGIES IN EPIDEMIOLOGY - Occurs occasionally

- These are antibodies attached to the • Is the study of occurrence, distribution 4. Epidemic
surface of microorganisms and render and causes of disease and injury - When a disease affects significantly
pathogens susceptible to phagocytosis large number of people at the same
1. Carrier
6. Neutralizing antibodies time in a geographic area
-is a person or animal who harbours and
- These are antibodies attached to spreads a microorganism that causes disease - Influenza is a classic example of an
surface of microorganisms and block but who does not become ill epidemic
surface receptors
5. Pandemic 11. Contact isolation patients from exposure to infectious agents;
protective isolation
- Is an epidemic over a large area – a type of isolation to prevent
affecting tens of millions of people transmission of diseases spread by close or 21. Strict isolation- a type of isolation to
direct contact. prevent transmission of highly contagious or
6. Incidence rate virulent infections
12. Fomites
-is the number of times a new event occurs in a 22. Prevalence – number of people in a
given period of time – inanimate objects that may be population who develop a disease regardless of
contaminated with infectious organisms and when it appeared (both old and new cases)
7. Incubation period
may serve as a means of their transmission.
- Is the time between exposure to a 23. Malfunction of an organ- e.g.
13. Infection hyperthyroidism
pathogen and the onset of symptoms
– a pathological condition caused by 24. Vitamin deficiency - e.g. scurvy
- It is difficult to determine because growth of microorganisms in the host
individuals often have difficulty
BASIC CONCEPTS ON
pinpointing the date or time of 14. Isolation
exposure LABORATORY BIOSAFETY AND
– the practice of limiting the movement BIOSECURITY
8. Morbidity rate and social contact of a patient who is potentially
infectious or who must be protected from Week 14
- Is the rate at which an illness occurs; a
exposure to infectious agents.
measure of the infectiousness of an INTENDED LEARNING OUTCOMES
organism. 16. Non-pathogenic- not normally causing
disease in a healthy individual • Discuss the history and related policies
- Is the number of cases of a disease in a and guidelines governing laboratory
specified population during a defined 17. Nosocomial infection- infection acquired in biosafety and biosecurity
time interval a hospital or health care facility • Differentiate the fundamental concepts
between laboratory biosafety and
9. Mortality rate 18. Pathogen- an organism or agent capable of
biosecurity
causing disease in a host
- Is the number of deaths due to a • Explain the different local and
disease in a population 19. Respiratory isolation- a type of isolation to international organizations of biosafety
prevent transmission of organisms spread • Classify microorganisms according to
10. Reservoir through the air over short distances their risk groups and
- Is the source of an infection, may be a person, • Categorize laboratories according to
20. Reverse/Protective isolation- a type of their biosafety level
animal or something in the environment. isolation designed to protect highly susceptible
RATIONALE FOR THE LABORATORY BIOSAFETY • American Biological Safety Association • Certification for Risk Group3 and 4
AND BIOSECURITY (1984) was established. handling (Canada)
• Wedum and Morton Reitmann – • 2008 – Danish Government regulated
• To minimize or prevent risk of
analyzed multiple epidemiological the possession, manufacture, use, and
Laboratory Acquired Infection (LAI)
studies of lab-safety outbreaks storage, sale, and other transfer of
• 1967 – Increasing mortality and listed biologic agents
1. BIOSAFETY PROTECTS PEOPLE FROM
morbidity due to smallpox. - World
GERMS
Health Assembly contained the stock
2. BIOSECURITY PROTECTS GERMS FROM
virus culture in Center for Disease GUIDELINES ON LABORATORY BIOSAFETY AND
PEOPLE
Control and Prevention (CDC - USA) and BIOSECURITY
State Research Center of Virology and
Biotechnology (SRCVB VECTOR – Russia) Comite Europeen de Normalisation (CEN)
BRIEF HISTORY OF BIOSAFETY • 1970 – CDC published Classification of Workshop Agreement (CWA 15793:2008)
Etiologic Agents on the Basis of Hazard
• Arnold Wedum (1907) – use of o focus on LABORATORY BIORISK
• 1972 – NIH – USA published NIH
mechanical pipettors to prevent LAIs MANAGEMENT
Guidelines for Research Involving
• Ventilated cabinets (1900) – o First internationally recognized
Recombinant DNA Molecules
progenitors of Biosafety Cabinet (BSC) standard to specifically address hazards
• 1984 - NIH-CDC Biosafety in
• Ira Baldwin (1943) – ordered by US on biologic agents at all containment
Microbiological and Biomedical
Pres. Roosevelt to establish a biologic levels
Laboratories
weapon program for defensive purpose o Intended to maintain a biorisk
in Camp Detrick (Cold War Era) BRIEF HISTORY OF BIOSECURITY management system among diverse
• Arnold Wedum (1944) – Pioneer of organizations and set out performance-
biosafety practices – evaluating the • 1996 – US gov’t enacted SELECT AGENT based requirements with exclusion of
risks of infection, and recognizing REGULATION (SAR) - monitors transport guidance for implementing national
biological hazards. And developing of selected biologic agents biosafety system.
practices, equipment, and safeguard • 2001 – ANTHRAX ATTACK ON USA o Expired in 2014
controls. (Amerithrax)
• 2012 – Revised SAR : specific security Laboratory Biosafety Manual 3rd ed.: WHO,
• Post World War II – Camp Detrick was
measures for facilities that used and 1983
developed to cater Biological Research
and Dev’t, thus the dev’t of Biosafety stored one or more agents o focus on biosafety guidance for
Practices • 2005 – Biological Agent and Toxins Act research and health laboratories, risk
• Newell Johnson – development of (Singapore) assessment and guidance to
specific technical solutions: Class III • Infectious Disease Control Law (Japan) commission and certify laboratories
BSC’s and Laminar Flow Hood
 o Provides information on Laboratory LMOs have no negative effect in AO 8 by Dept. of Agriculture
BIOSAFETY: biodiversity.
✓ Levels of Containment (Biosafety Levels – sets in place policies on importation and
1-4) National Committee on Biosafety of the release of plants and plant-derived products
✓ Different type of Biosafety Cabinets Philippines (NCBP), 1990 from modern biotechnology.
✓ Good microbiological techniques o Established under E.O. 430 s 1990 DOH and NCBP
✓ Proper disinfection and sterilization through advocacy efforts of scientists
o Focused on the Organizational Structure – formulated guidelines in the assessment of
o Provides information on Laboratory for Biosafety: the impacts on health posed by modern
BIOSECURITY: ✓ Procedures for evaluation of proposals biotechnology and its applications.
✓ Packaging requirement for the with biosafety concerns DIFFERENT ORGANIZATIONS IN THE FIELD OF
transport of classified biologic agents ✓ Procedures and guidelines on the BIOSAFETY
✓ Safety procedures for chemical, introduction, movement, and field
electrical, ionizing radiation, and fire release of regulated materials 1. AMERICAN BIOLOGICAL SAFETY
hazards ✓ Procedures on physicochemical and ASSOCIATION (ABSA)
• Also emphasizes on CONTINUOUS biological containment
monitoring and improvement directed • A regional professional society for
by a BIOSAFETY OFFICER and BIOSAFETY National Biosafety Framework (NBF) biosafety and biosecurity (1984). It
COMMITTEE. promotes the biosafety as a scientific
o E.O. 514, March 17, 2006: to strengthen discipline and provides guidance to its
Cartagena Protocol on Biosafety (CPB), 2013 the NCBP members on the regulatory regime
o Combination of policy, legal, present in North America
• Provides and international regulatory administrative, and technical
framework to ensure “An adequate instruments developed to attain the 2. ASIA-PACIFIC BIOSAFETY ASSOCIATION (A-
level of protection in the field of SAFE objectives of Cartagena Protocol on PBA)
TRANSFER, HANDLING, and USE of Biosafety (Signed by Philippines May 24,
LIVING MODIFIED ORGANISMS (LMO’s) • A group founded in 2005 that acts as a
2000).
resulting from modern biotechnology.” professional society for biosafety
o May be considered as an expansion of
✓ Ensure safe transfer, handling, and use professionals in the Asia-Pacific region.
NCBP: Pioneer in biosafety system in
of LMOs that may have effects on PH, and was acknowledge as a MODEL Members:
biological diversity EXCEPT those that BIOSAFETY SYSTEM for developing
are used in PHARMACEUTICAL countries. ✓ Singapore
PURPOSE. ✓ Brunei
• Also provides a framework for RISK Others… ✓ China
ASSESSMENT of LMO, and ensures that ✓ Indonesia
 ✓ Malaysia • Long term goal: Assist DA and DOH in BIOSECURITY
✓ Thailand their effort to create a national policy to
✓ Philippines implement plan for laboratory biosafety • The protection, control, and
✓ Myanmar and biosecurity. accountability for valuable biological
materials within laboratories, in order
3. EUROPEAN BIOLOGICAL SAFETY 5. BIOLOGICAL RISK ASSOCIATION OF THE to prevent their UNAUTHORIZED access,
ASSOCIATION PHILIPPINES loss, theft, misuse, diversion, or
INTENTIONAL release.
• A non-government and non-profit • “To protect the GERMS from PEOPLE”
association that works to serve the
• a non-profit organization found June emergent concerns of biological risk THE BIOHAZARD SYMBOL
1996, that aims to provide a forum for management in various professional
discussions and debates on issues of fields such as in the health, agriculture, • Designed by CHARLES BALDWIN in 1966
concern and to represent those working and technology sector throughout the • The symbol is used in labelling materials
in the field of biosafety. EBSA focuses country. which could possible pose a health risk
on encouraging and communicating • Launched activities in cooperation and • Represent the TRIAD in the CHAIN of
among its members information and collaboration with other associations, INFECTION (Agent, Host, Environment)
issues on biosafety and biosecurity as on a national and international scale in
well as emerging legislation and +Biosafety and biosecurity share a common
the promotion of biosecurity, biosafety, perspectives in terms of:
standards. and bio risk management as scientific
4. PHILIPPINE BIOSAFETY AND BIOSECURITY disciplines. BRAP goes by the tagline ✓ Risk assessment and management
ASSOCIATION (PhBBA) assess, mitigate, monitor.” methodologies
✓ Personnel expertise and responsibility
• Created by a multidisciplinary team WHAT IS BIOSAFETY? BIOSECURITY? ✓ Control and accountability for research
with members coming from the health materials including microorganisms and
FUNDAMENTAL CONCENPTS OF LABORATORY
and education sectors as well as BIOSAFETY AND BIOSECURITY culture stocks
individuals from the executive, ✓ Access control elements
legislative, and judicial branches of the BIOSAFETY ✓ Material transfer documentation
government. Also included are ✓ Training, emergency planning, and
• The containment principles,
members of the steering committee program management among others.
and technical working groups of the technologies, and practices that are
National Laboratory Biosafety and implemented to prevent
UNINTENTIONAL exposure to
Biosecurity Action Plan Task Force
established as per DPO No. 2006-2500 pathogens and toxins, or their
dated Sept. 15, 2006. accidental release.
• “To protect the PEOPLE from GERMS”
 CLASSIFICATION OF MICROORGANISMS BY ▪ RISK GROUP 3 Examples
RISK GROUPS • Includes microorganisms that are
known to cause serious diseases to o Ebola, Hendra, Nipah viruses, Marburg
▪ RISK GROUP 1 humans and animals virus, Lassa virus
• Includes microorganisms that are • May present a significant risk to lab
unlikely to cause human or animal CATEGORIES OF LABORATORY BIOSAFETY
workers. ACCORDING TO LEVELS
disease. • Limited to moderate risk if these
• LOW individual and community risk. BIOSAFET LEVEL 1 (BSL – 1)
microorganisms spread in the
Examples community or the environment, but
• Suitable for work involving viable
there are usually effective
o Escherichia coli K- 12, Saccharomyces microorganisms that are defined and
preventive measures or treatment
cerevisiae (yeast), Lactobacillus spp., with well-characterized strains known
available
not to cause disease in human.
Bacillus subtilis • HIGH individual risk, and LIMITED
Examples of microorganisms being
TO MODERATE community risk
▪ RISK GROUP 2 handled in this level are Bacillus subtilis,
• Includes microorganisms that are Examples Naegleria gruberi, infectious canine
unlikely to be a significant risk to hepatitis virus, and exempt the
o Yersinia pestis (black plague), HIV organisms under the NIH.
laboratory workers and the (culture), SARS virus, Bacillus anthracis,
community, livestock, or the • This level is the most appropriate
hantavirus, yellow fever among undergraduate and secondary
environment.
• Laboratory exposure may cause educational training, and teaching
infection, but effective treatment, laboratories that require basic
and preventive measures are ▪ RISK GROUP 4 laboratory safety practices, safety
available • Includes microorganisms that are equipment, and facility design that
• Risk of spread is limited known to produce life-threatening requires basic level of containment.
diseases to humans and animals. It
• MODERATE individual and BIOSAFET LEVEL 2 (BSL – 2)
community risk presents a significant risk for
laboratory workers • Designed for laboratories that deal with
Examples • Readily transmissible from one indigenous moderate-risk agents
individual to another present in the community It observes
o Pathogenic E. coli, Campylobacter spp, • Effective treatment and preventive
Plasmodium spp, prions, HIV (infected practices, equipment, and facility design
measures are not usually available that are applicable to clinical,
blood only), Streptococcus, Herpes • HIGH individual and community risk
virus, most mammalian cell lines diagnostic, and teaching laboratories
consequently observing good
microbiological technique – hand
 washing sink, waste decontamination BIOSAFET LEVEL 4 (BSL – 4)
facilities.
• Examples of organisms that could be • Required for work with dangerous and
handled under this level are Hepatitis B, exotic agents that pose high individual
HIV, Salmonellae, and Toxoplasma spp. risk and life-threatening diseases for
• BLS 2 is appropriate for body fluid aerosol route agents (with no available
samples and even with primary human vaccine/treatment)
• Specific practices, safety equipment,
cell lines.
• Access to the lab when work in on going and appropriate facility design and
must be restricted. Aerosolized samples construction are required for instances
shall be handled in a Biosafety cabinet when manipulating viruses.
• Class III biosafety cabinet, or a full-body,
or like.
air-supplied positive pressure personnel
BIOSAFET LEVEL 3 (BSL – 3) suit is required.
• Usually a separate building, or
• Emphasis on primary and secondary completely isolated zone w/ specialized
barriers in the protection of the
ventilation requirement and waste
personnel, community, and management system.
environment from infectious aerosols. • The lab personnel must be specifically
• Handling of indigenous and exotic trained in handling extremely hazardous
agents with a potential for respiratory agents.
transmission (serious or lethal). All lab • Examples include, Marburg, Ebola,
activities are done in a biosafety
Crimean-Congo hemorrhagic fever
cabinet. Secondary barriers for this level viruses.
is required, including controlled access,
and ventilation requirements while
special engineering features are being
considered.
• Personnel must be supervised by a
competent scientist in handling the
agent.
• Examples of microorganisms handled:
MTB, St. Louis encephalitis virus,
Coxiella.
Summary of Recommended Biosafety Levels
for Infectious Agents

BSL Agents Practices Primary Barriers & Safety Facilities (Secondary

Equipment Barriers)
Not known to consistently Standard Microbiological None required Open bench and sink
1 cause disease in healthy Practices required
adults

Agents associated with BSL-1 practices plus: Limited Primary barriers: Class I or II BSL-1 plus: Autoclave
human disease. Routes of access; Biohazard warning BSCs or other physical available
transmission include sign; “Sharps” precautions; containment devices used for
2 percutaneous injury, Biosafety manual defining all manipulations of agents
ingestion, mucous any needed waste that cause splashes or
membrane exposure decontamination or medical aerosols of infectious
surveillance policies materials. PPE: Laboratory
coats, gloves, face protection
as needed

Indigenous or exotic agents BSL-2 practice plus: Primary barriers: Class I or II BSL-2 plus: Physical
with potential for aerosol Controlled access; BSCs or other physical separation from access
transmission. Disease may Decontamination of all containment devices used for corridors; Self-closing,
have serious or lethal waste; Decontamination of all open manipulations of double-door access; Exhaust
3 consequences laboratory clothing before agents; PPE: Protective air not recirculated; Negative
laundering; Baseline serum laboratory clothing; gloves; airflow into laboratory
respiratory protection as
needed

Dangerous/exotic agents BSL-3 practices plus: Clothing Primary barriers: All BSL-3 plus: Separate building
which pose high risk of life- change before entering; procedures conducted in or isolated zone; Dedicated
threatening disease; Aerosol- Shower on exit; All material Class III BSCs or Class I or II supply and exhaust, vacuum,
transmitted laboratory decontaminated on exit from BSCs in combination with and decontamination
4 infections have occurred; or facility full-body, air-supplied, systems
related agents with unknown positive ressure personnel
risk of transmission suit
 BIORISK MANAGEMENT PROTECTING PEOPLE FROM
DANGEROUS PATHOGENS
BIOSAFETY + BIOSECURITY = BIORISK
Laboratory biosecurity:
institutional and personal
security measures designed
to prevent the loss, theft,
misuse, diversion, or
intentional release of
pathogens and toxins

PROTECTING PATHOGENS FROM

DANGEROUS PEOPLE

Laboratory Bio risk Management

• Bio risk Management Program (System)
• System or process to control safety and
aims to reduce the BIORISK.
security risks associated with the
WHY BIORISK MANAGEMENT? handling or storage and disposal of KEY COMPONENTS OF BRM
biological agents and toxins in
▪ To prevent Laboratory Acquired 1) RISK ASSESSMENT
laboratories and facilities
Infections (LAI)
▪ To prevent secondary infection among BIORISK MANAGEMENT PROGRAM (BRM) 2) MITIGATION PROCEDURE
the general population
• 3) PERFORMANCE EVALUATION
▪ To prevent environmental and animal A framework comprised of
contamination organizational structure, policies, BIORISK MANAGEMENT
practices, and biosafety guidance,
The risk associated with biological materials in instituted and supported by the Risk Assessment
the laboratory has a safety and a management that provides the
security component procedures and accountability for • Risk identification
preventing occupationally-acquired • Hazard/Threat Identification
Laboratory biosafety: containment principles, • Consequence Evaluation
infections or release of harmful
technologies, and practices • Define situation
organisms to the environment.
implemented to prevent unintentional • Define Risk
• BIOSAFETY + BIOSECURITY = BIORISK
exposure to pathogens and toxins, or • Characterize risk
their unintentional release
 • Determine acceptability or risk STEPS IN RISK ASSESSMENT Personnel

Mitigation Procedures • Define the situation – identify the • Skill level and vulnerability of at-risk
hazard and risks of biological agents to personnel?
• Elimination be handled. Then, identify the
• Substitution susceptible entity (human, Personnel protective equipment
• Engineering Control environment, or animals).
• Administrative control • Appropriate combination of personal
• Define the risks – must include a review protective clothing and safety
• Personal protective equipment of how individuals inside and outside equipment?
Performance Evaluation the laboratory may be exposed to the
hazard (usu. MOT) Place
• Control • Characterize the risk – compare the
• Assurance • Appropriate facility and equipment for
likelihood and consequence of biorisk
• Improvement work to be done?
(infection), either qualitatively or
quantitatively.
BRM: RISK ASSESSMENT
• Determine if risks are acceptable or not
• Initial step in implementing BRM that – take into acct the adequacy of existing
includes identification of hazards and controls, and decide whether or not to
characterization of risks that are accept the biorisk. – if accepted, come
possible present in the laboratory up with a MITIGATION PLAN.
• HAZARD – anything in the environment
RISK ASSESSMENT QUESTIONS
that has the potential to cause harm
(the BAD THAT WILL happen) Pathogen
• RISK – generally defined as the
possibility that something bad or • Risk group? ROT/MOT?
unpleasant will happen (LIKELINESS to • Agent stability and ID50?
happen) • Concentration?
• Availability of effective prophylaxis or
therapy? Antibiotic resistance?
• PSDS/MSDS (Public Health Agency of
Canada Association or ABSA)

Procedures

• Type of laboratory procedures?

 5. Personal Protective Equipment

BRM: MITIGATION PROCEDURE

• Actions and control measures that are

put into place to reduce or eliminate
the risks associated with biological
agents and toxins.

5 MAJOR AREAS OR CONTROL/MEASURES

1. Elimination – most difficult and most

effective control measure. Provides the
highest degree of risk reduction.
2. Substitution – replacement of the
procedure/biological agent with a
similar entity to reduce biorisk.
3. Engineering control – physical changes
in work stations, equipment, production
facilities, or any other relevant aspect of
the work environment.
4. Administrative control – policies,
standards, and guidelines used to
control biorisk.
BRM: PERFORMANCE EVALUATION

• A systematic process intended to

achieve organizational objective and • The result of a robust risk assessment
goals. must be properly recorded,
• To ensure the mitigation procedures are documented, and communicated to all
indeed reducing/eliminating the risks stakeholders of the organization. Only
• Also identifies ineffective/unnecessary though this final process that findings
biorisk mitigation strategies could be decided upon, given
appropriate action, to be able to
provide and establish a clear
manifestation of implementing the
fundamental concept of biosafety and
biosecurity in the laboratory.