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 (GLPs) Bioethics and social issues: Theories of bioethics challenges facing modern biotechnology research and application Standard operating procedures for research involving microbes and recombinant DNA Management of intellectual property: patenting copyrights and trademarks Designing of containment facilities: laboratories Biosafety cabinets intellectual property rights as applied to biotechnology Greenhouses Ethical theories intellectual Property key policy issues in the research setting Ethical principles Protection of traditional knowledge for biotechnology innovation Ethical issues surrounding GMOs and recombinant DNA research national and international and legal and regulatory framework for Intellectual property and relevance to biotechnology National policies for biotechnology products and research Principles of Risk assessment and management Challenges of Biotechnology policy development and implementation Biosafety procedures: Assigning of Biosafety levels Features of the Uganda biotechnology and Biosafety policy and its linkage to other national and global policies The concept of Biosecurity National guidelines for research with GMOs and 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