Introduction

Gloved hands holding a tray of biological substances

This course is a brief introduction to the history of biosecurity. It provides the concepts required for
the two other courses in the Principles of Laboratory Biosafety Pathogen Security program.

This e-learning course will take approximately 30 minutes to complete. You can complete this course
in one sitting, or do as many short sessions as you like - leaving and coming back to your last viewed
page as often as needed.
Learning Objectives
At the end of this course, you’ll be able to:

Recognize key events in the history of biosecurity

Define biosecurity

Recognize the importance of biosecurity as it relates to biosafety in facilities

handling pathogens and toxins

A Brief History of Biological Weapons and

Bioterrorism
Pathogens and toxins have a long history of being used as weapons. As
knowledge of microbiology advanced, so did the development and use of
biological weapons.
Roman Empire to the 18th Century
The first known malicious use of biological agents was in the form
of disease. Cadavers and filth were used to elicit fear and cause
harm in selected groups. The Roman Empire used animal carcasses
to contaminate their enemies’ wells. During the Black Plague of the
14th, 15th, and even early 18th centuries, dead bodies and
excrement were used as weapons to initiate widespread disease. For
example, in the 14th century, Tatars used plague against the town of
Caffa. The plague then affected the Tatars and spread to Italy where,
in turn, the healthy population was infected from infested rats and
bodies. In the 15th century, Spanish mixed wine with the blood of
leprosy patients to sell to their French foes in Naples, Italy. Later on,
in the 18th century, during the French and Indian War (Fort
Carillon/Ticonderoga), smallpox-infected blankets were given to
Indigenous Peoples with the intention of starting an outbreak.
19th Century
Louis Pasteur discovered micro-organisms to be the cause of
disease, ushering in the age of medical bacteriology, immunology
and the germ theory of disease. Pasteur's work was complemented
by that of Robert Koch, a German district medical officer who
investigated the anthrax bacillus. Using a home laboratory, Koch
demonstrated that the bacterium Bacillus anthracis alone produces
anthrax in a susceptible animal. This led to the Koch postulates
Biocrimes in the 21st Century
Over the past few decades, there have been a number of documented
criminal acts that involved misused biological material or acts that
presented biosecurity vulnerabilities. Some recent examples are described
below:
1. In 2006, 19 vials containing HIV-positive blood were stolen from a
locked freezer in a Canadian hospital. All of the vials were later
located with no evidence of tampering. The perpetrator of the theft
was never identified or charged.
2. In 2009, a postdoctoral fellow that was studying Ebola virus and HIV
vaccines in a government laboratory was discovered to have 22 vials
containing Ebola DNA in the trunk of his car as he attempted to enter
the United States at the Manitoba-North Dakota border. He was
charged with smuggling into the United States and prosecuted for
violating United States customs statutes.
3. In 2009, a former cardiology fellow in a United States hospital broke
into a laboratory three times after being fired, stealing approximately
$10,000 worth of equipment and sabotaging several experiments. He
was charged with burglary and grand larceny, including
transportation of stolen materials to Russia.
4. In 2009, a postdoctoral fellow at a United States university
meticulously and systematically sabotaged the work of a graduate
student in his laboratory over a 3-month period. The fellow pleaded
guilty to destruction of property.
5. In 2012, a United States hospital technician was accused of infecting
over 40 hospital surgical patients with hepatitis C virus, including one
patient who died of the infection, as a result of sustaining a habit of
drug abuse by stealing syringes with fentanyl and then replacing the
used ones refilled with saline and tainted with his own blood. The
technician was sentenced to imprisonment for fraud and tampering
with commercial products.
6. In 2012, a former Canadian government researcher was intercepted
while on his way to the airport to board a plane to China while
carrying 17 vials of pathogens including strains of Brucella bacteria. In
2014, he pled guilty to a breach-of-trust charge for trying to
commercialize government property and unsafe transportation of a
human pathogen. Charges were also laid against another researcher
who is believed to have fled to China, for whom a Canada-wide
warrant remains in place.
International Milestones in Biosecurity
The following are key codes in the context of biosafety.
Biological and Toxin Weapons Convention
1. The Biological and Toxin Weapons Convention (BTWC) is sometimes referred to as the Biological
Weapons Convention (BWC). It is an international convention banning the development, production,
stockpiling, acquisition and retention of biological weapons.
2. Actual use of biological weapons is prohibited by the 1925 Geneva Protocol to which Biological and
Toxin Weapons Convention makes reference. It is the first arms control convention to ban an entire class
of weapons.
What is a
Biosecurity?
Biosecurity Program?
While the concepts
“Biosafety aims to protect
of biosafety
peopleand
frombiosecurity
dangerousare pathogens,
closely related,
while the
biosecurity between
distinction aims to protect
the two pathogens
is important,
fromparticularly
dangerous when
people.”
considering
R. Salerno
facilities where
& D. infectious
Estes, Sandia,
material
2003 or toxins are handled and stored.
“Biosafety” describes
1. Biosecurity aimsthe containment
to prevent principles,
the deliberate technologies,
theft or diversion and
of biological
agentspractices
operational for malicious
that use.
are implemented to prevent the unintentional
exposure to pathogens or toxins, or their accidental release. In comparison,
“biosecurity” refers to the security measures designed to prevent the loss,
theft, misuse, diversion, or intentional release of infectious material or
toxins. These concepts are not mutually exclusive and are inherently
complementary, as the implementation of good biosafety practices serves
to strengthen biosecurity programs and vice versa.

Loss

Theft

Misuse

Diversion

Intentional release
What is the Purpose of a Biosecurity Program and Why
is it Important?
The purpose of a biosecurity program is to prevent the loss, theft, misuse,
diversion, or intentional release of pathogens, toxins, other regulated
infectious material, and other related facility assets (for example, non-
infectious material, animals, sensitive information).
A biosecurity program is important because it:
1. Reduces the potential for the loss, theft, misuse, diversion, and intentional
release of pathogens and toxins
2. Protects employees and coworkers
3. Protects proprietary materials and information
4. Enhances emergency preparedness and response
Security needs for facilities handling pathogens and toxins are not limited
to those requiring high containment facilities; RiskGroup 2 pathogens and
toxins can also be agents of concern. Any facility that is licensed under the
Human Pathogens and Toxins Act (HPTA) and the Human Pathogens and
Toxins Regulations (HPTR) or is regulated by the Public Health Agency of
Canada or the Canada Food Inspection Agency under the Health of Animals
Act (HAA) and Health of Animals Regulations (HAR) is required to develop
and maintain a biosecurity plan, in accordance with the requirements
established in the Canadian Biosafety Standard (CBS). As such, regulated
facilities need to identify the appropriate controls to implement,
commensurate with the specific risks identified by a biosecurity risk
assessment.
Challenges to Biosecurity
There are a number of challenges to biosecurity.
Nature of the Material
A biosecurity program can be faced with many challenges, some of
which arise from the nature of the material.
1. Because pathogens are self-replicating, even a minute amount
can be replicated into large amounts. Often only small
quantities are needed to cause an infection.
2. It may be difficult to identify how much has been taken since
the agents may not be easily quantified.
3. Also, contained materials are generally not detectable using
“scanning” technologies. Lastly, most agents can also be found
in nature, the environment, and/or clinical specimens.
Laboratory Culture / Environment
Challenges related to the laboratory culture and environment
impact the biosecurity program.
4. The open nature of a university means that laboratories have a
high number of individuals working with, or with access to,
pathogens.
5. Also, many scientists may be unaccustomed to working in a
security-conscious environment.
6. The misperception exists that security means secrecy which
will stifle collaborative efforts, vital in today's global research
and medical environment where laboratories share agents
globally.
Dual-use Potential
Pathogens and toxins can have “dual-use potential” meaning that
they may possess inherent qualities that allow it to be either used
for legitimate scientific applications (for example, commercial,
medical, or research purposes), or intentionally misused as a
biological weapon to cause disease (for example, bioterrorism).
Therefore, common techniques and projects involving these
pathogens or toxins may be employed for nefarious purposes.
For example, the complete sequencing of microorganisms such as
Bacillus anthracis (anthrax) could lead to the identification of
information, such as targets, that may be used in the development
of vaccines and drugs against this pathogen. However, this
improved understanding of anthrax could also be used in a negative
manner to increase the hazards of anthrax or transfer its properties
to other pathogens.
Likewise, sensitive information in facilities handling and storing
pathogens and toxins may need protection from unauthorized
access or theft and to ensure the appropriate level of confidentiality.
Balancing Biosecurity
Biosecurity and
and Biosafety: Biosafety
Similarities
Biosecurity and biosafety
There are similarities are complementary
and differences betweenas biosecurity
biosecurity relies
and on a
biosafety.
sound biosafety
Consider programofand
the definitions thegood biosecurity practices strengthen
two terms.
biosafety.
1. Many of the biosafety program measures such as self-closing doors, physical
separation of lab areas, restricted access, emergency response plans, incidence
reporting, and redundant power supply are also applicable to the biosecurity
program. For example, access control in biosafety practices requires laboratory
access to be limited or restricted to reduce the potential for exposure. The
same requirement is present in biosecurity practices.
Biosecurity and Biosafety: Differences
In some cases, biosecurity practices may conflict with biosafety practices,
requiring personnel and management to devise policies that accommodate
both sets of objectives. For example, signage may present a conflict
between the two programs.
2. Biosafety practice requires that biohazard warning signage be posted on
points of entry to the containment zone (for example, laboratory doors). This
is intended to advise personnel that infectious material is contained within this
area and increase awareness of any special entry requirements or special
provisions required to enter. The biohazard sign normally includes the
biohazard symbol, containment level, entry requirements and contact
information for the investigator which are important pieces of information for
a quick response to an emergency. It may also include the name of the
agent(s). These practices may conflict with security objectives.
3. The conflict between biosafety and biosecurity regarding the release of
information may be mitigated by ensuring the location of the laboratory is
placed away from public areas. Ensuring only persons with a need-to-know
have access to the area, allows the information to be protected by keeping it
“in-house” and away from those individuals who do not have the proper
screening level.
Developing a Biosecurity Program
A biosecurity program is specific for each facility and is based on two main
elements:
1. Conducting a biosecurity risk assessment
2. Developing a biosecurity plan
The biosecurity risk assessment takes into account:
3. Assets involved
4. Threats and vulnerabilities
5. Risk levels and mitigation strategies
6. Risk statements and risk registers
A biosecurity plan is based on the biosecurity risk assessment and includes
the following elements:
7. Physical security
8. Cybersecurity
9. Personnel suitability and reliability
10.Accountability of pathogens, toxins, and other regulated infectious
material
11.Inventory
12.Incident and emergency response
13.Information management
14.Research with dual-use potential
Using a multi-disciplinary approach is important when developing a
biosecurity program. Contributors can include:
15.Scientific directors
16.Principal investigators
17.Biological safety officers
18.Institutional biosafety committee
19.Laboratory and maintenance staff
20.Senior management
21.Human Resources
22.Information technology
23.In-house security staff
24.Local law enforcement agencies.
The next courses take a detailed look at the biosecurity risk assessment and
biosecurity plan development processes.
Summary
Pathogens and toxins have a long history of being used as weapons. As
knowledge of microbiology advanced, so did the development and use of
biological weapons.

With advances in technology and availability, there was an increase in the

use of bioterrorism agents during modern times. This led to biological
warfare programs as well as biosecurity and biosafety practices.

Biological and Toxin Weapons Convention (BTWC), United Nations Security

Council Resolution 1540 (UNSCR 1540), and the Australia Group are three
international milestones in biosecurity.

Biosafety aims to prevent the accidental release of pathogens and toxins

potentially infecting or affecting lab workers, the general population, and
the environment. Biosecurity aims to prevent the deliberate theft or
diversion of biological agents for malicious use (such as bioterrorism,
bioweapons).

A biosecurity program provides the details on the biosecurity measures for

a specific facility.

Challenges to biosecurity include the nature of toxins and pathogens, the

laboratory culture and environment, the dual-use potential of many
pathogens, and the challenges inherent in balancing biosafety and
biosecurity.

Biosafety and biosecurity have a number of similarities as well as

differences.

A biosecurity program must be facility-specific and developed using a

multi-disciplinary approach.

You have completed the first of three modules focusing on biosecurity.