POST GRADUATE PROGRAM IN PLANNING AND

ENTREPRENEURSHIP
END SEMESTER PROJECT – 2010
GMP GLP & BIOSAFETY REGULATIONS

TITLE
Benefits of Biosafety practices
FACULTY
Manisha Bano
Rai Business School, New Delhi

Submitted by:-
Girish Wasudev Ghugare
Email id:[email protected]
Type of Project
Individual
TO WHOM SO EVER IT MAY CONCERN 

This is to certify that Girish wasudev Ghugare, students of MBA (Industry Integrated) from
Rai Business School, New Delhi have completed their class project in GMP GLP BIOSAFETY
REGULATIONS titled ,“ Benefits of Biosafety practices”,under my guidance and supervision . I
wish them all the best in their future endeavors. 
 
 

Manisha Bano

Rai Business School

New Delhi

 
 
 
 
 
 
 
 
 
 
 
Acknowledgement

I would like to express my heartfelt gratitude to all the faculties of RBS, New Delhi,
especially my internal supervisor Manisha Bano, without whose guidance this project would
not have been possible.

Sincerely,

Girish wasudev Ghugare

 
 
 
 
 
Executive Summary:
TABLE OF CONTENTS

Topic page no.

1.Introduction:
 Background
 what is biosefty
 Biosafety During Industrial Production 
 Need for biosefty

2. Laboratory biosecurity as a complement to Industrial biosafety:

3. The biorisk management approach:

 Securing valuable biological materials (VBM)

4. Countering Bio risks:

 Accountability for VBM
 Potential misuse of bioscience
 Accountability for VBM
 Legitimate research, codes of conduct and codes of practice

5 . Industrial biosecurity programme :

 Industrial biosecurity risk assessment
 Responsibility for VBM
 Public/Security Health

6.Elements of a laboratory biosecurity plan
 Securing laboratory equipment
 Physical biosecurity
 Personnel management
 Information security
 Management of laboratory biosecurity activities

7.Training
Background:

Disease diagnosis, human or animal sample analysis, epidemiological studies, scientific

research, and pharmaceutical developments: all of these activities are carried out in biological
laboratories in the private or public sectors. Biological materials are handled worldwide in
laboratories for numerous genuine, justifiable and legitimate purposes, where small and large
volumes of live microorganisms are replicated, where cellular components are extracted and
many other manipulations undertaken for purposes ranging from educational, scientific,
medicinal and health-related to mass commercial and/or industrial production. Among them,
an unknown number of the facilities, large and small, work with dangerous pathogens or their
products every day. The general public expects laboratory personnel to act responsibly and
not to expose the community to biorisks, to follow safe working practices (biosafety)
associated with practices that will help keep their work and materials safe and secure
(biosecurity), and to follow an ethical code of conduct (bioethics). Often suspicious of work
taking place in laboratories, the uninformed public may even feel threatened by the presence
of a biological laboratory in their neighborhood. It is the technical and moral duty of
laboratory managers and laboratory workers, with the support of national authorities, to
reassure the general public, to persuade them that the activities being conducted are beneficial
and necessary, and to prove that the biorisks inherent to laboratory work are controlled with
appropriate safeguards to meet their expectations. However, despite advances in technology,
the availability of more and more sophisticated instruments for laboratory use, increasingly
effective techniques and the availability of personal protective equipment, human error
remains one of the most important factors at the origin of accidents. Poor concentration,
denial of responsibilities, inappropriate accountability, incomplete record-keeping,
suboptimal facility infrastructure, refusal to acknowledge ethical considerations, lack of (or
lack of respect for) codes of conduct, etc. may be at the origin of laboratory-acquired
infections, loss of material and inappropriate manipulations, or even possibly
intentional misbehaviour. Pathogens and toxins have been used, even in the recent past, to
threaten and harm people, to disrupt society, economies and the political status quo (5). This
has
happened in spite of applicable international agreements banning the use of biological agents
for malicious use. As those who carry out such acts show disregard for ethical values (6), do
not respect the right of people to a safe and peaceful life, or do not recognize global treaties
and conventions, several regulatory approaches to limit unauthorized access to biological
agents and toxins available in biological laboratories are now being carefully considered and
implemented worldwide.

What is biosafety?

Biosafety is a term used to describe efforts to minimize the potential risks that may stem from
the use of biotechnology or products derived therefrom. With specific reference to genetically
modified organisms (GMOs), biosafety aims at “ensuring that the development and use of
GMOs, and products derived from them, do not negatively affect plant, animal and human
health, agricultural systems, or the environment”. GMOs are living organisms, which unlike
chemicals do not become diluted once introduced into the environment; instead they disperse
to new habitats and multiply. The transgene product (toxin or enzyme) is continually
produced once the GMO is metabolically active, thereby posing a risk to health and the
environment.
Laboratory biosafety describes the containment principles, technologies and practices that are
implemented to prevent the unintentional exposure to pathogens and toxins, or their
accidental release .

Biosafety During Industrial Production –

Many of the processes of manufacture have the potential to generate biohazards. Therefore, it
is not surprising that several noninfectious illnesses are associated with biotechnology
industrial
products/processes.Inhalation appears to be the most significant mode of entry of microbes or
microbial products into the body, while entry by ingestion or skin contact can readily be
prevented by good operating practice. Most reported health problems are associated with
downstream processes, and the risk of allergic reaction is the greatest after the product is
more concentrated. During extraction of intracellular enzymes, the greatest risk is posed by
the processes of handling the large quantities of cell debris. 
An effective monitoring strategy should involve environmental assessment of emissions at all
stages of a manufacturing process, and a critical assessment of the biosafety performance of
process equipments; in addition, it should maintain adequate surveillance of worker health.
The Laboratory biosafety manual (LBM3), published in 2004 in its third edition (2),has
already provided guidance to laboratory workers on how to perform laboratory work safely,
to laboratory managers on how to set up a managerial approach to biosafety and to regulatory
authorities, to help them consider necessary aspects for the development of adequate national
biosafety regulations. A top-down approach associated with bottom-up support for biosafety
regulations has been very successful in advancing the biosafety agenda.
The present document aims to expand the laboratory biosecurity concepts introduced in
LBM3, and to strike a balance between the long-known biosafety procedures and
practices described in LBM3 and the more recently introduced and broader biosecurity
concepts. It further introduces the overarching "biorisk management" approach that has
resulted from careful thinking, comprehensive study of prevailing practices and
recommendations, review of international norms and standards, and relevant ethical
considerations Shortcomings currently observed in a number of settings are discussed,
and practical solutions are proposed.The document is intended for the use of relevant national
regulatory authorities,laboratory directors (laboratory managers) and laboratory workers, all
of whom play key roles in the field of biosciences and in public health in general.

Why is there an increased need for biosafety?

Over the last two decades there have been significant advances in genetics which have
resulted in increased interest and investment in biotechnology. Modern biotechnology
encompasses processes, which allow the manipulation of the genome at the level of the gene,
referred to as recombinant-DNA technology. This has been employed to introduce new traits
into plants such as resistance to herbicides, insects, fungi and viruses. Fruit ripening, starch
content, oil profile and male sterility have also been altered via genetic engineering,
achieving results that would not be possible using traditional breeding techniques, as genes
are invariably moved across species.

The technology’s potential has given rise to major concerns with respect to the
possible adverse environmental, agricultural, human, animal and plant health consequences
due to the introduction of genetically engineered crops. This has led to the development of
regulatory regimes or biosafety systems that are specifically applied to ensure that the
products created by the new techniques are as safe as those of traditional biotechnology.

Laboratory biosecurity as a complement to laboratory biosafety

Laboratory biosafety and biosecurity mitigate different risks, but they share a common
goal: keeping VBM safely and securely inside the areas where they are used and stored.
Laboratory biosafety is the expression used to describe the containment principles,
technologies and practices that are implemented to prevent unintentional exposure to
pathogens and toxins, or their accidental release.
A comprehensive biosafety culture translates into the understanding and routine
application of a set of safe practices, procedures, actions and habits that protect the
people working with biological materials.
Laboratory biosecurity may be addressed through the coordination of administrative,
regulatory and physical security procedures and practices implemented in a working
environment that utilizes good biosafety practices, and where responsibilities and
accountabilities are clearly defined. Biosafety and laboratory biosecurity are
complementary. In fact, the implementation of specific biosafety activities already
covers some biosecurity aspects. The systematic use of appropriate biosafety principles
and practices reduces the risk of accidental exposure and paves the way for reducing
the risks of VBM loss, theft or misuse caused by poor management or poor
accountability and protection. Laboratory biosecurity should be built upon a firm
foundation of good laboratory biosafety.
Through microbiological risk assessments performed as an integral part of an
institution's biosafety programme, information is gathered regarding the type of
organisms available at a given facility, their physical location, the personnel who
require access to them, and the identification of those responsible for them. A
laboratory biosecurity risk assessment should further help establish whether this
biological material is valuable and warrants security provisions for its protection that
may be insufficiently covered through recommended biosafety practices. This approach
underlines the need to recognize and address the ongoing responsibility of countries
and institutions to ensure the expectation for a safe and secure laboratory environment.
A specific laboratory biosecurity programme, managing the identified biorisks, should
be prepared and designed for each facility according to its specific requirements, to the
type of laboratory work conducted, and to local and geographical conditions.
Laboratory biosecurity activities should be representative of the institution’s various
needs and should include input from scientific directors, principal investigators,
biosafety officers, laboratory scientific staff, maintenance staff, administrators,
information technology staff, law-enforcement agencies and security staff, if
appropriate. A sound code of practice should be included for personnel practice.
Laboratory biosecurity measures should be based on a comprehensive programme of
accountability for VBM that includes:
1. regularly updated inventories with storage locations,
2. identification and selection of personnel with access,
3. plans of use of VBM,
4. clearance and approval processes,
5. documentation of internal and external transfers within and between facilities,
and of any
6. inactivation and/or disposal of the material.
Likewise, institutional laboratory biosecurity protocols should include how to handle
breaches or near-breaches in laboratory biosecurity including:
1. incident notification,
2. reporting protocols,
3. investigation reports,
4. recommendations and remedies, and
5. oversight and guidance through the Biosafety Committee.

The protocols should also include how to handle discrepancies in inventory results, and
describe the specific training to be offered, and the training that personnel should be
required to follow. The involvement, roles and responsibilities of public health and
security authorities in the event of a security breach should also be clearly defined.
Documenting procedures to manage behaviour and the interaction of workers with the
facility and its equipment should also be considered.
These issues should be addressed according to a goal-setting approach to make sure the
objective of minimizing biorisks is reached, rather than following a prescriptive
approach to demonstrate compliance to a given set of rules. A goal-setting approach
furthermore enables facilities to be creative, imaginative and innovative, allowing for
responding to unexpected events, and for new findings and considerations to be easily
incorporated into existing management systems. Goal-setting principles-based
approaches enable staff to deal with the unpredicted and unfamiliar in the most prudent
and safe manner until more expert opinion can be obtained.

3. The Bio risk management approach

Based on a documented agent-based biorisk assessment that includes laboratory

biosecurity considerations, laboratories containing VBM should develop systems and
controls to provide the required degree of assurance that biosafety and laboratory
biosecurity risks are appropriately managed, and that the consequences of release of
any VBM from the laboratory are appropriately minimized. Managing these risks
represents:
1. reducing the risk of unintentional exposure to pathogens and toxins or their
accidental release (biosafety), and reducing the risk of unauthorized access,
loss, theft, misuse, diversion or intentional release of VBM to tolerable,
acceptable levels (laboratory biosecurity);
2. providing assurance, internally and externally (facility, local area, government,
global community, etc.), that suitable measures have been adopted and
effectively implemented;
3. Providing a framework for continuous awareness-raising for biosafety,
laboratory biosecurity and ethical code of conduct, and training within the
facility.
The present document does not provide prescriptive guidance on the development of
laboratory biosecurity measures, but describes recommendations and performance
expectations, placing responsibility on national authorities and facility managers to
demonstrate that appropriate and reasoned biorisk minimization procedures have been
established and will be implemented. These recommendations do not call for
compliance with a set of requirements, but rather help to identify and set goals to be
achieved. This approach allows countries and facility managers to define and choose
appropriate systems and controls to ensure that the biorisk management goals that have
been identified are reached. It allows institutions to adapt their laboratory biosecurity
plans to their particular situation.

 Securing valuable biological materials (VBM) :

Laboratory biosecurity is more than just the safeguarding of dangerous pathogens and
toxins from individuals or organizations who would use them for harm. While
protection of dangerous pathogens and toxins is obviously appropriate, the scientific,
medical and pharmaceutical communities should also consider protecting materials
with historical, medical, epidemiological, commercial or scientific value. These
decisions should be taken with due consideration to the fact that scientists serve only as
temporary custodians of valuable scientific assets whose past and current value to
science may be understood, but whose utility for the future can only be estimated.
Some VBM have intrinsic value and they need to be preserved for study by future
generations of scientists. Their transfer and sharing should be encouraged or
maintained as long as appropriate documentation allowing to track them is available.
Thus scientists have a duty to maintain VBM according to current best practice. If a
decision is taken to destroy unwanted or unnecessary materials, protocols must be
followed to ensure their full and complete destruction and documentation. The
protection of VBM includes appropriate storage conditions, documentation of their
storage, use, transfer to more appropriate laboratories, or proof of complete destruction.
The classification of biological materials as VBM should be left to their caretakers
(laboratory managers and scientists) who should know and understand their value and
should be able to address and define the level of protection required. To address these
issues, the caretakers of VBM should consult with partners, e.g. in the research
community and in the security, intelligence or information technology (IT) sectors to
ensure the protection of their valuable assets against identified biorisks. If the facility
holding the collection cannot ensure its protection, the laboratory manager together
with the responsible scientist(s) should make arrangements to safely transfer them to a
more secure site. In this way, policy-makers, scientists, laboratory directors and
security engineers, supported by journal editors and publishers of research results, may
achieve an appropriate balance between the protection of VBM and the preservation of
an environment that promotes legitimate microbiological research.
All microorganisms, natural or laboratory-modified, may be included in the broad
definition of VBM. Although some agents have heightened capacities to cause harm if
intentionally misused, virtually all may have legitimate uses for medical, commercial
and scientific applications. Their value should prompt a responsibility to limit
opportunities for VBM to be inappropriately accessed while at the same time preserve
opportunities for their study and legitimate use, e.g. for the development of improved
vaccines, diagnostics and therapies, work that requires handling, using, transporting,
transferring and sharing of VBM.

Countering biorisks:

 Accountability for VBM

While it is difficult to mitigate the consequences of theft of VBM, i.e. possible misuse,
diversion, etc., especially after they have left a given facility, it is easier to minimize
such consequences by establishing appropriate controls to protect VBM from
unauthorized access or loss. Unauthorized access is the result of inappropriate or
insufficient control measures to guarantee selective access. Losses of VBM often result
from poor laboratory practices and poor administrative controls to protect and account
for these materials. It is important to establish practical realistic steps that can be taken
to safeguard and track VBM. Indeed, a comprehensive documentation and description
of VBM retained in a facility may represent confidential information, as much as
records and documentation of access to restricted areas. However, such documentation
may prove useful for example to help discharge a facility from possible allegations. For
useful reference, it is recommended that such records be collected, maintained and
retained for some time before they are eventually destroyed.
Specific accountability procedures for VBM require the establishment of effective
control procedures to track and document the inventory, use, manipulation,
development, production, transfer and destruction of these materials. The objective of
these procedures is to know which materials exist in a laboratory, where they are
located, and who has responsibility for them at any given point in time. To achieve this,
management should define:
1. which materials (or forms of materials) are subject to material accountability
measures;
2. which records should be kept, by whom, where, in what form and for how long;
3. who has access to the records and how access is documented;
4. how to manage the materials through operating procedures associated with
them (e.g. where they can be stored and used, how they are identified, how
inventory is maintained and regularly reviewed, and how destruction is
confirmed and documented);
5. which accountability procedures will be used (e.g. manual log book, electronic
tables, etc.);
6. which documentation/reports are required;
7. who has responsibility for keeping track of VBM;
8. who should clear and approve the planned experiments and the procedures to be
followed;
9. who should be informed of and review the planned transfer of VBMs to another
laboratory
Accountability does not necessarily imply the identification of exact quantities of
biological materials. Living replicating organisms may vary in quantity and quality
over the course of laboratory activities and time, and knowing the exact quantity of
organisms at any given time is generally not realistic. Moreover, with some biological
materials, any amount may be considered significant and relevant. However, biological
Biorisk management • Laboratory biosecurity guidance • September 2006
- 20 -
materials that are confined to particular containers should be tracked as discrete items.
For example, it is possible to maintain an inventory of frozen stocks and an access log
to many forms of stored materials. These forms of records are useful as a means of
knowing permanently where VBM are located and who has responsibility for them.
Records should be secured and easiliy identified, legible and traceable to the activities
described. Any changes in biosecurity protocols or equipment and operations should be
introduced following clear and documented change-management processes.
Accountability also means ensuring that materials are properly safeguarded. A
person(s) with expert knowledge of the material in use and its storage should be
accountable. Any anomalies seen by the employee should be promptly reported to the
laboratory manager.

 Potential misuse of bioscience

Bioscience research has contributed to the progress of humanity through the
development of new vaccines and drugs, and to an improved understanding of human
health. However, bioscience has the potential to harm if misused, i.e. the biosciences
are inherently dual-use. Although the vast majority of applications of bioscience have
been used for good and peaceful purposes, the potential for harmful misuse may
suggest the need for specific protective measures for laboratory facilities, the VBM
they contain, the work performed, and the staff involved. Biological research is
essential to the development of modern health care, public health, agriculture,
medicine, veterinary medicine, food production and life science. Products of biological
research benefit many economic and social sectors and have the potential for enhancing
the health and welfare of virtually every human being.
However, the potential misuse of the biosciences represents a global threat that requires
a balanced approach to laboratory biosecurity, acknowledging both its risks and
benefits. Such a balanced approach strives to protect the valid role and function of
biological laboratories while safeguarding the VBM they may contain. A possible
approach to minimizing the dual-use of materials and equipment within a facility is to
give a competent biosafety and laboratory biosecurity manager the responsibility for
the scientific programme, in consultation with the principal investigator, for approving
research projects and authorizing experiments, in compliance with national
requirements and bioethical considerations. The role of the institutional biosafety
committee and of the research manager in this context is described below.

 Legitimate research, codes of conduct and codes of practice

The advances of science open doors to infinite possibilities to make use of acquired
knowledge and techniques (9). National authorities and laboratory managers should be
able to provide for a legislative and/or regulatory framework defining legitimate and
ethical research projects and keep an oversight on laboratory activities and personnel.
Systems and controls should be in place to avoid illegitimate or unethical research.
Researchers, laboratory workers and biosafety and laboratory biosecurity managers
should communicate and collaborate, and strive to find the correct ethical balance for
the activities performed. A voluntary code of conduct can be more effective than one
that is imposed provided it is understood and agreed among stakeholders.
The code of conduct should involve evaluation of the purpose of the work,
consideration for its impact the publication of research results, and enumerate
considerations and conditions for or against the publication of results that may have
dual-use implications (21). In 2001, a research team backed by a federal grant in
Australia created a genetically engineered mousepox virus unexpectedly capable of
evading vaccine-induced immunity (12). Although the results of the research are not
criticable, the publication of the research details has generated strong debates
worldwide. Comprehensive bioethical reviews should be carried out and documented
before final decisions are reached on the publication of data, balancing pros and cons of
their dissemination.
As one example, influenza viruses of the subtype H1N1 that had been the cause of the
1918-1919 pandemic were reconstructed in 2005 from tissues of recovered permafrost
preserved victims and used in BSL3 containment laboratories for pathogenicity studies.
Further studies are now planned to combine the genes of the H1N1 pandemic virus
with the highly pathogenic H5N1 to investigate virus transmissibility and hopefully be
better prepared for a new pandemic. The balance between the lessons one can learn
from those studies and the risks of synthesizing potentially new deadly viruses may be
argued, but bioethical considerations, international review and control of this research
should be extensively examined. There is for example no international agreement, other
than specifically for variola virus DNA fragments, that stipulates which sequences may
be handled in a laboratory without notification or without specific authorization, and
there is no international agreement on what kind of biosafety containment level and
laboratory biosecurity practices should apply for specific situations (22). These
decisions should be left with national or international biosafety-biosecurity-bioethics
committees, who should request laboratory managers and laboratory workers to take a
responsible risk management approach, and show proof thereof. Only open debates,
transparency and documented reasoning may help gain the support of the global
community.
Natural risks
Biorisks are not confined only to adverse events related to the accidental or intentional
release of VBM. Risks are also represented by natural disasters, threatening the
containment and laboratory biosecurity of laboratories in regions at geological risk
(earthquakes, hurricanes, floods, tsunamis, etc.). When constructing or maintaining
laboratory facilities in such regions, the possible negative outcomes of release of VBM
during natural adverse events should be considered, and acceptable biorisk
management provisions should be planned.
Transport of materials
The use and storage of VBM should be limited to clearly identified areas. The only
VBM permitted outside a restricted area should be those that are being moved from one
location to another for specific, authorized reasons. Transport security endeavours to
provide a measure of security during the movement of biological materials outside of
the access-controlled areas in which they are kept until they arrive at their destination.
Transport security applies to biological materials within a single institution and
between institutions. Internal material transport security includes reasonable
documentation, accountability and control over VBM moving between secured areas of
a facility as well as internal delivery associated with shipping and receiving processes.
External transport security should ensure appropriate authorization and communication
between facilities before, during and after external transport, which may involve the
commercial transportation system. The recommendations of the United Nations Model
Regulations for the Transport of Dangerous Goods (23), providing countries with a
framework for the development of national and international transport regulations
include provisions addressing the security of dangerous goods, including infectious
substances, during transport by all modes.
Transfer of materials
Many countries request to file import and export permits for biological materials before
the transfer of such specimens is authorized. These procedures allow for registering and
tracking of materials entering or leaving a country, and they are particularly important
in the case of alien or dangerous pathogens.
In some instances, stakeholders may deem their collections of VBMs so valuable to
warrant the secure storage of a duplicate set in a different location. In such cases,
transfer notifications should be established and their access secured.
 Industrial biosecurity programme

A comprehensive laboratory biosecurity programme involves:

1. identification of VBM
2. associated agent-based microbiological risk assessment and laboratory
biosecurity risk assessment
3. bioethical and scientific analysis of research projects before they are authorized
4. allocation of responsibilities and authorities among staff and facility managers
5. communication between parties involved
6. development of and training on emergency plans; and
7. tailored biosecurity training for employees of the facility and for external firstresponders.
All these steps should be the result of a transparent and documented reasoning process
that carefully evaluates the impact of biorisk management breaches, and prepares and
plans for worst-case scenarios. Individual components of this programme are described
below.

 Laboratory biosecurity risk assessment

While the backbone of the practice of biosafety is a microbiological risk assessment,

effective laboratory biosecurity programmes should, in addition, perform appropriate
laboratory biosecurity risk assessments, followed by the development, approval and
endorsement of strategies for their management. Assessment of the suitability of
personnel, training and adherence to VBM protection procedures are tools that may be
used to achieve these goals. It is important that these biorisk assessment efforts be
regularly re-evaluated in an ongoing programme to respond to the requirements of
national and institutional standards.
A competent scientific manager should be responsible for managing the scientific
programme within the facility. The scientific manager should make sure that
appropriate risk assessments for research projects have been performed and cleared,
and all records thereof are securely kept; that work is performed according to plan or
only with authorized deviations from original plans; that management systems,
procedures and records are properly maintained. Assessment timing and scope,
describing situations requiring a risk assessment to be carried out or an existing
assessment to be re-evaluated, should also be clearly defined and adhered to.
In the context of a biosecurity risk assessment, security and intelligence forces play the
fundamental role of complementing the biosafety risk assessments performed by the
laboratory management with local threat assessments. Collaboration between these
different stakeholders and proactive clarification of their roles, responsibilities and
authorities should help in case of emergencies, where first-responders need the
appropriate information, knowledge and skills to provide the most appropriate
interventions.

6.2 Responsibility for VBM

Laboratory biosecurity should mainly be based on:

1. control and accountability for VBM
2. defining their storage location
3. describing and scrutinizing their use; identifying personnel (and visitors) who
should be granted access to them
4. documenting their transfer
5. certifying their inactivation and disposal, and
6. sharing this information with appropriate counterparts within the facility.
Laboratory biosecurity measures should be adapted to the needs of the institutions or
facilities adopting them. Their identification should be the result of a biosecurity risk
assessment that includes input from scientific personnel and laboratory management,
biosafety officers, maintenance staff, IT staff, administrators and law-enforcement
representatives.
Local law enforcement may be the police or other local, regional or national security
force that is trained to manage security issues. Facilities that handle dangerous
pathogens and toxins should ensure that all emergency response personnel, including
local law enforcement, are aware of the safety issues on-site and the procedures to be
followed if an incident occurs.
The facility should establish a clear working relationship with the local lawenforcement
agency to provide a response to security incidents on-site. A clear protocol

Public Security Health

Intentional misuse of a
biological agent
should be drawn up detailing the circumstances under which law-enforcement
personnel may be summoned, the protocol to follow once on-site, and the scope of
authority for all parties involved. Regular on-site training and orientation for the local
law-enforcement agency is also recommended.
At facility level, it is recommended that the ultimate responsibility for VBM should lie
with the laboratory/facility manager or director, who should be responsible for
providing the appropriate conditions to minimize breaches in biosafety and laboratory
biosecurity. The facility manager may delegate this responsibility to the principal
investigator for routine activities. However, the facility manager will respond in case of
biosafety or biosecurity breaches.
At international level, national authorities should be ultimately responsible for breaches
in biosafety and laboratory biosecurity that may be at the origin of public health
emergencies of international concern

6.3 Elements of a laboratory biosecurity plan

Laboratory biosecurity should specifically address the policies and procedures

associated with physical biosecurity, staff security, transportation security, material
control and information security. It should also include emergency response protocols
that address security-related issues, such as specific instructions concerning when
outside responders may be called (fire brigade, emergency medical personnel or
security personnel), including the protocol to follow once on-site and the scope of
authority of all parties involved. It is important for the laboratory security plan to
anticipate the most likely situations that would require exceptional access. Just as
training is essential for good biosafety practices, it is also essential to train for good
biosecurity practices, particularly in emergency situations. Hence regular training of all
personnel on security policies and procedures helps ensure correct implementation.
Laboratory biosecurity describes both a process and an objective that is a key
requirement for public health and welfare. It requires consideration of the reason for
developing regulations, what the objects of the regulations are, how regulations are
written, who develops regulations, and who pays for their development and application.
It includes the generation and sharing of scientific knowledge, and involves bioethical
considerations such as transparency of decision-making, public participation,
confidence and trust, and responsibility and vigilance in protecting society. Effective
laboratory biosecurity is a societal value that underwrites public confidence in
biological science (17).
Securing laboratory equipment
Although laboratory biosecurity mainly focuses on protection of VBM, safeguarding
laboratory equipment from unauthorized access, misuse or removal is an important
aspect of laboratory biosecurity that should also be addressed. In biological
laboratories, this responsibility lies with the facility managers, the principal
investigators and the laboratory staff: all laboratory personnel have a responsibility to
take reasonable precautions against theft or misuse of such equipment. Such
responsibilities should be clearly outlined in the biorisk management protocol of a
facility. On the other hand, security measures for laboratory equipment should be
commensurate with the potential risks and imposed in a manner that does not
unreasonably hamper research or access to these assets.
As for VBM, not all pieces of laboratory equipment have comparable sensitivity or the
same potential for dual-use. Some equipment, e.g. bioreactors, incubators, aerosol
disseminators or aerosol test chambers, are among those that may conceivably be used
for both legitimate and illegitimate purposes. Specific and detailed laboratory
biosecurity measures, procedures and practices may mitigate the risks of their
inappropriate use.
Physical biosecurity
Physical biosecurity, comprised of engineering, structural and security personnel
elements, is intended to select, control and document access to laboratories and to the
materials they contain, and to limit improper removal of VBM and equipment. Access
controls are used to limit access to restricted areas to individuals who have proper
authorization and to keep track of traffic in and out of these areas. Physical biosecurity
measures may become more stringent and more costly as the value of the assets
increases and as the location of the materials to be protected is approached.
Personnel management
Personnel management procedures should define the roles, responsibilities and
authorities of laboratory personnel who need to handle, use, store, transfer and/or
transport VBM, and the manner in which the organization ensures that individuals are
appropriate for the positions they hold. These procedures should clearly describe and
document the training, experience, competency and suitability requirements for
individuals who have access to VBM, ensuring that members of the workforce have
appropriate personal and technical qualifications and skills. Documented procedures
for the recruitment of personnel should be clearly established and followed. The
professional and bioethical eligibility and suitability for working with VBM of all
personnel who have regular authorized access to sensitive materials is also central to
effective laboratory biosecurity risk management.
A mechanism should be developed to ensure that the integrity of the facility will not be
compromised through the absence of key individuals. Such a mechanism should
include succession planning for management, scientific, technical and administrative
personnel to ensure that critical knowledge of safe and secure operation of the facility
does not reside with a single individual, in the event of his/her unavailability or
departure. Documented procedures for dismissal of personnel to be disallowed access
to the facility should be developed. Provisions describing personnel management
should also address procedures and training for visitors, contractors, subcontractors,
suppliers, cleaning and maintenance staff.
Information security
Information security establishes prudent policies for handling sensitive details on
VBM. Examples of sensitive information may include laboratory security plans and
inventories, and storage locations of VBM. Information security should ensure that the
required and appropriate level of confidentiality is preserved by the system that is used
to acquire, store, manipulate and manage information.
It is important to establish practical realistic steps that can be taken to safeguard and
track VBM. A comprehensive documentation and description of VBM represents the
caretaker role of the current laboratory managers to accurately pass on the historical
archive of VBM. Some of the information may be confidential but should be available
for use by future generations. Such documentation may also prove useful to help
discharge a facility from possible allegations.
It is also important to document the existence, location and access to the information
for future interests, as security concerns change over time. The objective of information
security is to limit access to individuals who have a need to access the information.
This may be achieved through marking and secure storage requirements as well as
through processes intended to control the manner in which the information is
communicated and to whom.
Protection of information should be consistent with the level of risk it poses in terms of
potentially compromising a VBM. The higher the level of risk associated with the
VBM the institution holds, the greater protection the information associated with the
security system will require. Overdoing or exaggerating the sensitivity or level of
suspicion can have unintended negative repercussions. This is a difficult process which
may require careful consideration and reflection.
Therefore laboratory management and relevant authorities should develop appropriate
policies that govern the marking and handling of information and how that information
is gathered, maintained, distributed, documented, accessed, shared and stored within
the facility and with appropriate counterparts.

Management of laboratory biosecurity activities

Effective laboratory management is a fundamental requirement for both laboratory

biosafety and laboratory biosecurity. In order for laboratory managers to be committed,
involved and supportive to the safe and secure practice of science, they should bear the
responsibility of articulating the need and rationale for both laboratory biosafety and
laboratory biosecurity activities. Setting out national performance expectations, i.e.
placing responsibility on the facility to demonstrate that appropriate and valid risk
reduction (minimization) procedures have been established, should encourage
employees to invest the time and effort required to account for and safeguard the VBM
they control. Compliance should be reinforced throughout a facility by the regular use
of means to encourage accountability and responsibility (training, scientific meetings,
performance reviews, appraisals, codes of conduct/practice, etc.). The requirement to
establish a clear biorisk management programme places the responsibility on facility
managers to demonstrate that risks are controlled. Only this approach, as opposed to a
strict compliance approach, is likely to ensure the commitment and support of
managers in the long term, as facility managers should ultimately be held responsible
for breaches in biosafety and laboratory biosecurity.
Laboratory biosecurity activities should be established with clear and consistent
policies and guidance. These activities should be integrated into the overall policies and
administrative procedures of the facility. Managers are responsible for ensuring that
biosecurity plans and incident response plans are enforced and revised as needed.
Reevaluation
is a necessary and ongoing process since it is unlikely that the range of
VBM and threats at any given institution will remain static. Biosecurity programme
managers should also conduct biosecurity programme audits (assessments), provide
remedial strategies for identified vulnerabilities and gaps, and ensure that the facility’s
threat and risk assessment is regularly reviewed and updated. Training and
familiarization concerning the objectives and requirements of laboratory biosecurity
activities should be ongoing.

7. Training

Laboratory biosecurity training, complementary to laboratory biosafety training and

commensurate with the roles, responsibilities and authorities of staff, should be
provided to all those working at a facility, including maintenance and cleaning
personnel, and to external first-responders and responsible staff involved in ensuring
the security of the laboratory facility. Such training should help understand the need for
protection of VBM and equipment and the rationale for the laboratory biosecurity
measures adopted, and should include a review of relevant national policies and
institution-specific procedures. Training should provide for protection, assurance and
continuity of operations. Procedures describing the security roles, responsibilities and
authority of personnel in the event of emergencies or security breaches should also be
provided during training, as well as details of security risks judged not significant
enough to warrant protection measures. The biorisk management plan should ensure
that laboratory personnel and external partners (police, fire brigade, medical emergency
personnel) participate actively in laboratory biosecurity drills and exercises, conducted
at regular intervals, to revise emergency procedures and prepare personnel for
emergencies.
Training should also provide guidance on the implementation of codes of conduct and
should help laboratory workers understand and discuss ethical issues. Training should
also include the development of communication skills among partners, the
improvement of productive collaboration, and the endorsement of confidentiality or of
communication of pertinent information to and from employees and other relevant
parties.
Training should not be a one-time event. Training should be offered regularly and
taken recurrently. It should represent an opportunity for employees to refresh their
memories and to learn about new developments and advances in different areas.
Training is also important in providing occasions for discussions and bonding among
staff members, and in strengthening of the team spirit among members of an institution.
wordnetweb.princeton.edu/perl/webwn –

http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2006_6.pdf

http://www.unescobkk.org/fileadmin/user_upload/shs/BiosafetyRegs/THAILAND_Biosafety_Guideli
nes_in_Genetic_Engineering_and_Biotechnology_for_Laboratory_Work.pdf

http://www.bio-economy.net/bioeconomy/member_states/files/executive_summary_ib.pdf

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