PF2 - BIOSECURITY AND BIOSAFET

BIOLOGICAL AGENTS

Any microbiological entity, cellular or non-cellular, naturally occurring or engineered, capable of replication or of transferring genetic material that may be able to provoke infection, allergy, toxicity or other adverse effects in humans, animals, or plants
E.g. bacteria, fungi, viruses, viroids, endo-, and ectoparasites

BIOLOGICAL MATERIAL

Any material comprised of, containing, or that may contain biological agents and/or their harmful products, such as toxins and allergens

BIOHAZARD

specific type of biological material that poses a threat to human or environmental health

BIOSAFETY

Containment principles, technologies and practices that are implemented to prevent unintentional exposure to biological agents or their inadvertent release

BIOSAFETY

Accidental/Unintentional release of biological agents
Protecting people from bad bugs.

BIOSECURITY

Principles, technologies and practices that are implemented for the protection, control and accountability of biological materials and/or the equipment, skills and data related to their handling to prevent their unauthorized access, loss, theft, misuse, diversion or release.

BIOSECURITY

Intentional/Deliberate/Unauthorized release of biological agents
Protecting bugs from bad people.

RISK = HAZARD + SITUATION

• Culture of Mycobacterium tuberculosis + Vortexing = Inhalation of MTB → Laboratory Acquired Infection (LAI)

• HIV positive blood + Accidental puncture during recapping of syringe needle = Parenteral transmission → LAI

BIORISK

consequence + likelihood

BIORISK

biosafety risks + biosecurity risks

laboratory biosafety

protect users

protect those outside tools

protect the environment

PRINCIPLES OF LAB BIOSAFETY - practice and procedure

a. Good microbiological practice and procedure

b. Personnel competence and training

c. Specimen receipt and storage

d. Decontamination and waste management

e. Emergency/incident response

f. Transfer and transportation of Infectious Substances, Biological Specimens

PRINCIPLES OF LAB BIOSAFETY - safety equipment

a. Personal protective equipment

b. lab equipment

PRINCIPLES OF LAB BIOSAFETY - Facility design and construction

a. Facility design

PRINCIPLES OF LAB BIOSAFETY - Increasing levels of protection

a. Good microbiological practice and procedure

b. Personnel competence and training

c. Facility design

d. Specimen receipt and storage

e. Decontamination and waste management

f. Personal protective equipment

g. Laboratory equipment

h. Emergency/incident response

i. Transfer and transportation of Infectious Substances, Biological Specimens

PRACTICES AND PROCEDURES

Most important concept/strict adherence

Aware of potential hazard

Trained and proficient in techniques

Supervisors responsible for:

○ Appropriate laboratory facilities

○ Personnel and training

safety equipments - PRIMARY CONTAINMENT BARRIER

Minimize exposure to hazard
Prevent contact or contain aerosol

safety equipments - PRIMARY CONTAINMENT BARRIER

1. Personal protective equipment (PPE): Gloves, gowns, respiratory, face shield, booties

2. Biological safety cabinets

3. Covered or ventilated animal cage systems

facility design and construction - SECONDARY CONTAINMENT BARRIER / ENGINEERING CONTROLS

Contributes to worker protection
Protects outside the laboratory (Environment and neighborhood)

facility design and construction - SECONDARY CONTAINMENT BARRIER / ENGINEERING CONTROLS

• Building and lab design

• Ventilation

• Autoclaves

• Cage wash facilities

BIOSAFETY LEVEL 1

Handles or process microbes that are not known to consistently cause disease in healthy adults and present minimal potential hazard to laboratory personnel and the environment

BIOSAFETY LEVEL 1

Required: Controlled access. Handwashing sink, Sharp hazards warning policy, PPE, Laboratory bench
Optional: Autoclave

Includes features like: lockable doors, dedicated paper/computer workstations, pest-controlled windows, PPE storage space, non-absorbent and resistant to scratches, moisture and impact, benchtops do not have open seams, backsplashes are installed tight to a wall and sealed, floors are slip-resistant, eyewash station or equipment is needed, cleanable lab furniture, reliable illumnation, electrical stability

BIOSAFETY LEVEL 2

Handles or process microbes that are considered to be moderately hazardous to laboratory personnel and the environment

BIOSAFETY LEVEL 2

Required: Controlled access. Handwashing sink, Sharp hazards warning policy, Physical containment device, PPE, Laboratory bench, Autoclave

Additional features include: sealed non-opening windows, biohazard signage, controlled access system, ante-rooms for BSL2+, 100% exhausted directly outdoors, HEPA-filtered exhaust air, and "hands-free" sinks for BSL 2+

BIOSAFETY LEVEL 3

Microbes being handled can be either indigenous or exotic, and they can cause serious or potentially lethal disease through respiratory transmission

BIOSAFETY LEVEL 3

Required: Self-closing double door access, Controlled access. Sharp hazards warning policy, Handwashing sink, Sealed penetrations, Physical containment device, Laboratory bench, Autoclave

Optional: Personal shower out, Powered air purifying respirator, Exhaust HEPA filter, Effluent decontamination system

BIOSAFETY LEVEL 4

Required for work with dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections and life-threatening disease that is frequently fatal, for which there are no vaccines or treatments, or a related agent with unknown risk of BSL1 transmission

BIOSAFETY LEVEL 4

Required: Self-closing double door access, Controlled access. Sharp hazards warning policy, Handwashing sink, Sealed penetrations, Physical containment device, Positive containment device, Laboratory bench, Autoclave, Personal shower out, Powered air purifying respirator, Exhaust HEPA filter, Effluent decontamination system

BIOSAFETY LEVEL 4

includes chemical decontamination shower, positive-pressure suits are worn, mechanical or electronic interlocks, supply air to be provided through HEPA filtration, 2 stages of HEPA filtration, backup breathing air supply system, supported by UPS

BIOSAFETY LEVEL 3

isolated area, non-opening, sealed, and unbreakable windows with alarm, double-door access and interlocking, walk-through body shower, airtight doors, pressure differential monitoring, visual or audible alarms. interlocks supply and exhaust air systems, exhaust air to pass through one stage of HEPA filtration, deep seal traps

CONTROL MEASURES

1. elimination (strongest)

2. substitution

3. engineering controls

4. administrative controls

5. practices

6. PPE (weakest)

CONTROL MEASURES - elimination

physically remove the hazard

CONTROL MEASURES - substitution

replace the hazard

CONTROL MEASURES - engineering controls

isolate people from the hazard

CONTROL MEASURES - administrative controls

change the way people work

CONTROL MEASURES - practices

standard and special lab biosafety and bisecurity

CONTROL MEASURES - PPE

protect the worker with personal protective equipment

elimination

work with a non-pathogenic/less pathogenic organism that behaves similarly to the organism in question

engineer controls

biosafety cabinets; airflow systems; workspace layout

administrative controls

SOPs; lab rules and regulations; training requirements

practices and procedures

good waste management procedures; keeping BSC un-cluttered; following SOPs

PPE

lab coat; gloves; facemask

biorisk management system performance

the way in which a biorisk management system actually functions to manage or minimize biorisk

PILLARS OF LAB BIOSECURITY - INVENTORY CONTROL

Assurance that there is an awareness of what exists in the laboratory, where it is, and who is responsible for it

Ensure the complete and timely knowledge of:

• What materials exist

• Where the materials are

• Who is accountable for them
  
  

PILLARS OF LAB BIOSECURITY - INVENTORY CONTROL

The biological agent inventory should be up-to-date, complete, accurate and updated regularly to ensure that there is appropriate control and accountability

PILLARS OF LAB BIOSECURITY - INFORMATION CONTROL

Assurance that the sensitive and valuable information stored in a laboratory is protected from theft or diversion

● Biosecurity-related sensitive information

○ Security of dangerous pathogens and toxins

■ Risk assessments

■ Security system design ○ Access authorizations

PILLARS OF LAB BIOSECURITY - INFORMATION CONTROL

Network Security

○ Firewalls

○ User authentication

○ Virus protection

○ Layered network access

○ Desktop security

○ Licensed and updated software (no trojans, backdoors)

○ Restricted software (commercial cloud, torrent)

○ Remote and wireless access controls (Encryption and Authentication)

PILLARS OF LAB BIOSECURITY - PHYSICAL SECURITY CONTROL

the assurance of safety from physical intrusion

Steps include: Deter, Detect, Delay, Respond, Recover

PILLARS OF LAB BIOSECURITY - INFORMATION CONTROL

Communication Security

○ Mail, email, or fax security is required (spear phishing)

○ Limited discussions in open areas

○ Information should only be reproduced when needed and each copy must be controlled as the original

PILLARS OF LAB BIOSECURITY - PERSONNEL CONTROL

The assurance that the people that are given access to sensitive biological materials are trained, capable, reliable and have integrity

PILLARS OF LAB BIOSECURITY - PERSONNEL CONTROL

Insider versus Outsider Threat

○ An insider is a person who has authorized access to a facility, its units (such as laboratories), and its assets.

○ An outsider is a person who does not have authorized access

PILLARS OF LAB BIOSECURITY - TRANSPORT CONTROL

Assurance that the same rigorous processes that protect biological materials in the laboratory follow those materials when they are transported outside laboratory areas

PILLARS OF LAB BIOSECURITY - TRANSPORT CONTROL

Aims to reduce the risk of illicit acquisition of high-risk biological agents.

Relies on chain of custody principles and end-user agreements

PILLARS OF LAB BIOSECURITY - TRANSPORT CONTROL

High risk agents are routinely shipped worldwide for diagnostic and research activities

TRIPLE PACKAGING

EMERGENCY AND INCIDENT RESPONSE

After an incident or calamity, adequate measures must be taken to limit the damage and to restore operations as soon as possible

In response plans, the measures that need to be taken are described for each type of calamity - planning and preparation for potential incidents

Protocol should be written and followed

Drills and exercises can also be used

EMERGING BIOLOGICAL RISKS

Monitoring and assessing the scientific, ethical, and social implications of certain biotechnologies

EMERGING BIOLOGICAL RISKS

Genetically modified microorganisms

Synthetic biology

Gain-of-function research

Stem cell research

Gene editing and gene drives

DUAL-USE RESEARCH OF CONCERN

Legitimate research that yields information or technologies that could be misused for malevolent purposes

DUAL-USE RESEARCH OF CONCERN

Most life sciences research conceivably could be considered DUR in that it has some potential to generate information that could be eventually misused