Biosafety and Bioethics of
Biotechnology
ABS-832
Dr Attya Bhatti
Assistant Professor
Head of Department
ASAB-NUST
Course Contents
Principles of Biosafety
Biotechnology: benefits and concerns/risks
Procedures and good laboratory practices Bioethics and social issues: Theories of bioethics
(GLPs) challenges facing modern biotechnology
Standard operating procedures for research research and application
involving microbes and recombinant DNA Management of intellectual property:
Designing of containment facilities: laboratories patenting copyrights and trademarks
Biosafety cabinets intellectual property rights as applied to
Greenhouses biotechnology
Ethical theories intellectual Property key policy issues in the
Ethical principles research setting
Ethical issues surrounding GMOs and Protection of traditional knowledge for
recombinant DNA research biotechnology innovation
National policies for biotechnology products national and international and legal and
and research regulatory framework for Intellectual property
and relevance to biotechnology
Principles of Risk assessment and management
Challenges of Biotechnology policy
Biosafety procedures: Assigning of Biosafety development and implementation
levels
Features of the Uganda biotechnology and
The concept of Biosecurity Biosafety policy and its linkage to other national
National guidelines for research with GMOs and and global policies
microbes
Recommended Books
Bioethics and Biosafety by M. K. Sateesh
Bioethics and Biosafety in Biotechnology by V. Sree Krishna
(Online available)
Toward a More Natural Science: Biology and Human Affairs by Kass, Leon
Cutting-Edge Bioethics by Kilner, John. Eerdmans
Biological Safety: Principles And Practices (Biological Safety: Principles &
Practices) by Diane O., Diane O., Ph.D. Fleming and Ph.D. Fleming
Biotechnology, Biosafety, and Biodiversity: Scientific and Ethical Issues for
Sustainable Development by Sivramiah Shantharam, Jane F. Montgomery
and Satellite Symposium on Biotechnology and Biodiversity
Assignments: Every Student will present Assignment/seminar
Quiz: Class Quizzes will held after 2-3 lectures
Total Credits: 3(3-0)
Class Timing: (11 30 hrs – 1300hrs)
Tuesday
Thursday
Marks Distribution
Ist sessional Exam = 15%
2nd sessional Exam = 15%
Assignments= 5-10%
Quiz= 8%
Class attendance= 1%
Final Exam= 50%
Biosafety
Biosafety is the prevention of large-scale loss of biological
integrity, focusing both on ecology and human health.
The maintenance of safe conditions in biological research to
prevent harm to workers, non-laboratory organisms, or the
environment.
A fundamental objective of any biosafety program is the containment of
potentially harmful biological agents.
The term “containment” is used in describing safe methods, facilities and
equipment for managing infectious materials in the laboratory environment
where they are being handled or maintained.
Technical Definitions
• Biohazard: An agent of biological origin that has the capacity
to produce deleterious effects on humans, i.e.
microorganisms, toxins and allergens derived from those
organisms; and allergens and toxins derived from higher
plants and animals.
• Biosafety: The containment principles, technologies and
practices that are implemented to prevent the unintentional
exposure to pathogens and toxins, or their accidental release.
• Biosecurity: Control of accidental and deliberate release of
biohazardous material
Why we need Biosafety
Some unfortunate examples of disease outbreaks in research labs:
1950‐1976:
•A survey of 5000 labs showed 3921 cases of disease outbreaks
•Most commonly reported were: Hepatitis, tuberculosis, typhoid, brucellosis,
rabbit fever
2003-2014:
•SARS infects researchers in a lab in Singapore
•A US and a russian scientist are infected by Ebola. One survives, one dies.
•Polio virus escapes from two idian labs
•Scientists from Boston University contract rabbit fever (a serious bacterial
disease)
•Anthrax exposure in a Huston lab due to aerosols leaked inside an unshielded
Centrifuge
• Dengue
• Ebola
Support medical and scientific research on microbes and the
human immune response to them.
Apply such research to the discovery and development of
vaccines, drugs, and diagnostic tests designed to protect the
general population
Ensure that the every has sufficient research facilities to
carry out these activities.
Biosafety in Various Disciplines
Biosafety is related to several fields
• ECOLOGY
• AGRICULTURE
• MEDICINE
• CHEMISTRY
• EXOBIOLOGY
Biosafety in Academic Research
Research Universities:
• Promoting safe laboratory
practices,
• Procedures; proper use of
containment equipment and
facilities;
• Provides advice on laboratory
design and risk assesment of
experiments involving infectious
agents, rDNA in-vitro and in-
vivo.
Bottom Line: Risk & Containment
Biohazard Symbol
• In 1966, Charles
Baldwin at National
Cancer Institute at
NIH.
• Symbol to be
memorable but
meaningless” so it
could be learned.
• Blaze orange – most
visible under harsh
conditions
Biosafety Issues
• Laboratory Safety
• Bloodborne pathogens (BBP)
• Recombinant DNA (rDNA)
• Biological waste disposal
• Infectious substance and
diagnostic specimen shipping
Biosafety Issues
• Respiratory Protection
• Bioterrorism and Select agents
• outdoor and indoor air quality
• Occupational safety and health in the use
of research animals
• Biohazards used in animal models
Biohazardous Materials
• Viruses
• Bacteria
• Fungi
• Chlamydiae/Rickettsiae
• Prions
• Recombinant DNA
Types of pathogens
Bacteria
– Size: 0.3 to 2 μm
– Single‐celled organisms
– Various morphologies
– Examples: Salmonella spp., E.
coli, Vibrio spp. (Cholera),
Mycobacterium (Tuberculosis)
Virus
– Size: 18‐200 nm
– Basic structure: capsid (protein) +
nucleic acid
– Obligate parasites
– Enveloped vs. non‐enveloped
– Examples: Hepatitis, polio, HIV
Protozoa
– Size: 5‐10 μm
– Single‐celled eukaryotes
– Numerous morphologies
– Examples: Cryptosporidium spp., Plasmodium
spp. (Malaria), Giardia spp.
Helminths
• – Size: 20‐100 μm
• – Multi‐cellular eukaryotes
• – For transmission mainly concerned with
eggs
Biohazardous Materials
• Transgenic Plants, Animals and Insects
Biohazardous Materials
• Human and Primate Cells, Tissues, and
Body Fluids
• Brain Tissue from Demented Patients
• Viral Vectors
– Replication deficient viruses
Biosafety Concepts
Biosafety In Microbiological
and Biomedical Laboratories
“BMBL” (acronym)
CDC/NIH Publication
Safety “Guidelines”
Regulations of Institution receives
NIH funding
Code of Practice and “Gold”
Standard in Industry
Gold Standard
HHS Publication No. (CDC) 93-8395
