Ensuring Safety in the Laboratory.

1. LABORATORY BIOSAFETY LEVELS AND
TRANSFER OF BIOLOGICAL SAMPLES
PREPARED BY: FRANCIS DADZIE MINTAH
(MPHIL. BIOTECHNOLOGY)
(kofimintahfm@yahoo.com)
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2. OBJECTIVES
i. To identify and explain the various
laboratory biosafety levels and
discuss the biosafety and bioethical
issues concerning each level.
ii. To discuss the biosafety and
bioethical concerns related to the
transfer of biological samples.
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3. PRESENTATION OUTLINE
1. Introduction
2. Laboratory biosafety levels
3. Transfer of biological samples
4. Conclusion
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4. INTRODUCTION
• Biosafety practices deals with the
application of safety principles in any
environment where hazardous biological
material or agents or microorganisms are
handled, to minimize the potential
harmful effects to human’s health and
environment.
• Biosafety principles has moved from its
application on only microbiological and
biomedical research to a more sophisticated
one which involves rDNA technique.
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5. • Effects of handling of hazardous biological samples is a serious biosafety
and bioethical issues to address.
• In implementing biosafety principles, guidelines are created. For example the
Cartagena Protocol on Biosafety, Ghana Biosafety Act (2011), CDC, CFR
guidelines etc.
• The main concern is to present contamination free environment.
• Biosafety regulatory mechanisms on modern biotechnology should not
be seen as a barrier to biotechnology research and developments but a
means to ensure safe application.
INTRODUCTION CONT’D
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LABORATORY BIOSAFETY LEVELS
• Laboratory biosafety is described as containment principles, technologies,
practices implemented to prevent unintentional exposure to pathogens and
toxins, or their accidental release in order to protect the patient, laboratory
worker and environment (WHO, 2007).
• They are to safeguard the human health and environment.
• Laboratories are categorized into four (4) biosafety levels based on their
hazards.

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TYPES OF BIOSAFETY LEVELS
Biosafety Level 1
(BSL – 1)
Biosafety Level 2
(BSL – 2)
Biosafety Level 3
(BSL – 3)
Biosafety Level 4
(BSL – 4)
NB: Each level has its own mandated
protective practices and prescribed barriers to
protect against microorganisms.

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BIOSAFETY LEVEL 1 (BSL-1) LABORATORIES
• They are suitable for work involving agents of
no known or of minimal potential hazard to
laboratory personnel and the environment.
• However, working with organisms like Bacillus
subtilis, Naegleria gruberi, infectious canine
hepatitis virus, and non-pathogenic E. coli
species may be known to cause disease in
immunocompromised individuals.
• Fairly ubiquitous and usually located in high
schools, community colleges, and municipal
drinking water treatment facilities.

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SAFETY PRACTICES ASSOCIATED WITH BSL-1 LABORATORIES
• Frequent hand washing especially after removing gloves and before leaving the
laboratory.
• Fixing a negative pressure door which can be kept closed when working.
• Limiting access to the lab space when working.
• No smoking, eating, drinking, or storage of food in the laboratory.
• Decontamination of work surfaces after every use and after any spills,
decontamination of laboratory wastes, use of mechanical pipettes only (no mouth
pipetting).
• Use of personal protective equipment (such as lab coats, latex gloves, goggles etc).

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BIOSAFETY LEVEL 2 (BSL-2) LABORATORIES
• They are suitable for work involving
agents of moderate potential risk to
personnel and the environment.
• Found in local health departments,
universities, state laboratories, private
laboratories (e.g., hospitals or health care
systems), and industrial laboratories (e.g.,
clinical diagnostic companies).

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BIOSAFETY LEVEL 2 (BSL-2) LABORATORIES CONT’D
• Used in studying agents associated with human disease. Hence, the presence
of an infectious agent may be unknown.
• Agents do not cause lethal infections and are not transmissible via the airborne
route. Examples are: measles virus, many Salmonella species, pathogenic
Toxoplasma species, Clostridium botulinum, hepatitis B virus etc.
• Primary barriers in BSL-2 labs are approved containment devices which helps
in minimizing contamination and Secondary barriers include all BSL-1
barriers, plus an autoclave (sterilization machine) for lab glassware.

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SAFETY PRACTICES ASSOCCIATED WITH BSL-2 LABORATORIES
It include all standard practices for BSL-1 labs plus the following:
• Special policies and procedures to restrict access to the lab when work is being
conducted.
• Biohazard warning signs posted outside the lab.
• Surveillance of laboratory personnel with appropriate immunizations offered.
• A biosafety manual that includes definitions of any needed waste decontamination
or medical surveillance policies specific to the activities and agents in that lab.
• Supervisory staff who have experience in working with infectious agents and
specific training for laboratory personnel in handling these agents.

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BIOSAFETY LEVEL 3 (BSL-3) LABORATORIES
• They are used when working with
indigenous or exotic agents that have the
potential for respiratory (aerosol)
transmission and may cause serious and
potentially lethal infection.
• They may be located in research institutes
such as the National Institutes of Health
[NIH] and the Centers for Disease Control
and Prevention [CDC]) etc.

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BIOSAFETY LEVEL 3 (BSL-3) LABORATORIES CONT’D
• Agents studied in a BSL-3 lab include Mycobacterium tuberculosis
(tuberculosis), St. Louis encephalitis virus, Francisella tularensis
(tularemia), and Coxiella burnetii.
• The primary hazard is risk of infection from needle sticks, ingestion, or
exposure to infectious aerosols.
• Primary and secondary protective barriers in the BSL-3 lab emphasize
protecting lab personnel, as well as personnel in nearby lab areas, the
community, and the environment from exposure to potentially infectious
aerosols.

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SAFETY PRACTICES ASSOCIATED WITH BSL-3 LABORATORIES
It includes all BSL-2 practices, plus:
• Strictly controlled access to the lab and decontaminating all waste.
• Specific training for lab personnel in handling potentially lethal agents.
• Changing contaminated protective lab clothing and decontaminating all lab
clothing before laundering.
• Institutional policies regarding specimen (serum) collection and storage from
lab workers to establish exposure to infectious agents.
• Corridors must be separated from direct access to the laboratory and air
handling systems must be designed to ensure negative air flow.

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BIOSAFETY LEVEL 4 (BSL-4) LABORATORIES
• They are required for work with
dangerous and exotic agents which pose
a high individual risk of life-threatening
disease.
• Primary hazard: risk of respiratory
exposure to infectious aerosols, mucous
membrane exposure to infectious
droplets, and accidental needle sticks with
needles or other sharp objects
contaminated with infectious material.

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BIOSAFETY LEVEL 4 (BSL-4) LABORATORIES CONT’D
• Agents include all viruses including Marburg virus, Ebola virus, and viruses
that cause Congo-Crimean hemorrhagic fever and Lassa fever etc.
• Primary barriers include conducting procedures in the biosafety cabinets used
at the other biosafety levels in combination with a full-body, air-supplied,
positive pressure personnel suit.
• Secondary barriers in BSL-4 facilities include all the physical barriers at BSL-3
labs together with an isolated zone or a separate building, dedicated supply and
exhaust, vacuum, and decontamination systems; and a recommended absence
of windows.

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SAFETY PRACTICES ASSOCIATED WITH BSL-4 LABORATORIES
It includes all BSL-3 practices, plus:
• Strictly controlled access to the laboratory and decontaminating all
materials exiting the facility.
• Changing clothing before entering and exiting the lab (showering upon
exiting the lab is recommended).
• All laboratory personnel must receive specialized training in handling
extremely dangerous infectious agents and in containment equipment and
functions.

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TRANSFER OF BIOLOGICAL SAMPLES
• It refers to the process of exchanging
biological samples materials between
facilities.
• Regulations on the transportation of
biological agents are aimed at
protecting the worker and environment.

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REGULATIONS CONCERNING THE TRANSFER OF
BIOLOGICAL SAMPLES
• Several countries uses “The Cartagena Protocol on Biosafety” as a
regulatory mechanism for trans-boundary movement of biological samples
or GMOs.
• Article 2(2) of the Cartagena Protocol on Biosafety ascertain that Parties
shall ensure that the development, handling, transport, use, transfer and
release of any living modified organisms are undertaken in a manner that
prevents or reduces the risks to biological diversity, taking also into
account risks to human health. Making the transfer of biological samples
between countries or facilities a highly regulated one.

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• In Ghana, the Ghana Biosafety Authority which was instituted by the Ghana
Biosafety Act, 2011 ensures that any person who wants to transfer
biologicals samples within facilities present documentation of the personnel,
facilities, and justification of need for the biological agent in the transfer and
subsequent approval of the transfer process by the authority.
• Knowledge of the agent/material, response to a spill if dropped and
packaging of the agent/material been transported should be a prerequisite for
the transporter.
REGULATIONS CONCERNING THE TRANSFER OF
BIOLOGICAL SAMPLES CONT’D

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TRANSFER OF BIOLOGICAL SAMPLES CONT’D
In transferring biological samples within or between facilities, complete protection is
achieved through:
(a)Rigorous packaging.
(b)Appropriate labeling (biohazard symbols) of the package.
(c)Documentation of the hazardous contents of the package.
(d)Effective training of workers.

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MATERIAL TRANSFER AGREEMENT (MTA)
• It is a contract between the owner of a material and the intended recipient
governing the transfer and subsequent use of the material.
• It is very useful in transferring biological materials like bacteria, plasmids,
nucleotides, cell lines, cultures, proteins, transgenic animals etc. within
institutions.
• Sharing of materials between university scientists is generally less
problematic than transfers between industry and academia, primarily
because the cultures and motivations of each institution involved in the
exchange are similar (Bennett et. al., 2007).

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CONCLUSION
• Biosafety practices and procedures should be observed in all
laboratories to ensure safe health of its laboratory workers and prevent
transmission of contamination to the environment.
• State and Institutional regulatory principles (like the Cartagena
Protocol on Biosafety, Ghana Biosafety Act etc.) governing the
transfer of biological samples within institutions or countries should
be not be compromised.
• Prevention is key.

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REFERENCES
• Bennett AB, WD Streitz and RA Gacel. 2007. In Intellectual Property Management in Health and Agricultural
Innovation: A Handbook of Best Practices (eds. A Krattiger, RT Mahoney, L Nelsen, et al.). MIHR: Oxford, U.K., and
PIPRA: Davis, U.S.A.
• Cartagena protocol on biosafety to the convention on biological diversity (2000).
• Elger B. S. & Caplan A. L. (2006) ‘Consent and anonymization in research involving biobanks. Differing terms and
norms present serious barriers to an international framework’ 7 EMBO Reports 661 at 661–662.
• Ghana Biosafety Act (2011)
• Nienaber A. (2011). Consent to and authorisation of the export and use of human biological specimens for future research
– perspectives from three African countries.
• Transportation and Transfer of BioAgents Revised July 2014. Biological Safety Manual.
• Occupational Safety and Health Administration (OSHA) Biosafety levels Fact sheet.
• World Health Organisation (WHO) (May, 2007). Transport, Biosafety and Disinfection. Laboratory Training for Field
Epidemiologist.

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THANK YOU