BIOTECHNOLOGY AND GENETIC ENGINEERING
Introduction:
    Biotechnology is a field of life science that uses living organisms and biological
systems to create modified or new organisms or useful products. A major
component/field of biotechnology is genetic engineering which modifies DNA to
alter the function or other traits of living organisms.
    Biotechnology would not be possible without genetic engineering. In modern
terms, this process manipulates cells’ genetic information using laboratory
techniques in order to change the traits of living organisms.
    Genetic engineering is the foundation of biotechnology, since the
biotechnology industry is, in a general sense, a vast field that involves making use
of other living species for humans’ needs.
GENERAL OBJECTIVE OF THE MODULE:
    The main objective of this module is to offer a broad view of biotechnology and
genetic engineering as one of its major field, integrating historical events,
applications based on sound knowledge of processes and methods used to
manipulate living organisms or the substances and products from these organisms
for medical, agricultural, and industrial purposes.
SPECIFIC OBJECTIVES:
    At the end of the module, the learner should be able to:
   1. demonstrate knowledge of the definitions of biotechnology based on the
      views of different scholars.
   2. demonstrate knowledge of essential facts of the history of biotechnology and
      description of key scientific events in the development of biotechnology.
   3. describe the different branches of biotechnology.
   4. identify the different fields in biotechnology particularly genetic engineering,
      tissue culture and cloning.
   5. determine and evaluate the applications of biotechnology in medicine,
      agriculture, industry and environment focusing on its impacts in the society.
   6. evaluate the drawbacks in biotechnology.
   7. determine some safety considerations in biotechnology.
   8. demonstrate an appreciation of biotechnology especially in achieving food
      security, its promising applications in the field of medicine and its
      applications to solve environmental problems.
Lesson 1: Definitions and Historical Events in Biotechnology
Intended Learning Outcomes:
        At the end of the lesson, the learner should be able to:
    1. demonstrate knowledge on concepts of biotechnology as defined by
       different authors.
    2. develop his own definition of biotechnology.
    3. demonstrate knowledge on the historical events in biotechnology.
    4. demonstrate appreciation on the contributions of people or groups of
       people in the discovery of products and processes for specific use.
LESSON PROPER:
    I.      Definitions of Biotechnology
     The term biotechnology was coined in 1919 by Karl Ereky, a Hungarian engineer.
At that time, the term included all the processes by which products are obtained
from raw materials with the aid of living organisms.
     Nowadays, according to the Convention on Biological Diversity (CBD),
biotechnology is defined as “any technological application that uses biological
systems, living organisms, or derivatives thereof, to make or modify products or
processes for specific use” (CBD, 1992). The living organisms or derivatives thereof
most frequently used include microorganisms, animals and plants (or their isolated
cells) as well as enzymes.
     Biotechnology, as the word suggests, is combination of biology and technology.
Biotechnology is the use of technology to use, modify or upgrade the part or whole
of biological system for industrial and human welfare. Because of this complex
relationship and its major impact on human welfare, it is believed that biotechnology in
future may become a major force for human existence. (Kumar and Gupta, 2012).
     The term biotechnology refers to the technical applications of biological systems
for the production of natural substances (antibiotics, biogas, enzymes, etc.) and
involves manipulation of living organisms for the benefit of man (Soetan, 2008 as
cited in Tonukari, Avwioroko, & Ehwerhemueoha, 2010).
    Biotechnology is a multidisciplinary field encompassing microbiology, chemistry,
biochemistry, genetics, molecular biology, immunology, cell and tissue culture and
physiology, as well as engineering (Tonukari, 2004 as cited in Tonukari, Avwioroko, &
Ehwerhemueoha, 2010).
     Biotechnology, broadly defined, includes any technique that uses living organisms (or
parts of organism) to make or modify products, to improve plants or animals, or to develop
microorganisms for specific uses.
    At its simplest, biotechnology is the commercial and large scale exploitation of living
organisms or their components, e.g., enzymes for the welfare of mankind through molecular
genetics. (Kumar and Gupta, 2012).
    II.     Biotechnology Timeline (Kumar and Gupta (2012):
 Year                                          Historical events in biotechnology
 1750 BC                                       Summerians brew beer
 500                                           The Chinese use moldy curds as an
                                               antibiotic to treat boils
 100                                           Powdered Chrysanthemum is used in China
                                               as an insecticide
 1797                                          Jenner inoculates a child with a viral
                                               vaccine to protect him from smallpox
 1855                                          The Escherichia coli bacterium is discovered
                                               as production tool for biotechnology
 1859                                          F. Miescher discovers Nuclein (now known
                                               as DNA) from pus cells
 1919                                          The word “biotechnology” is first used by a
                                               Hungarian agricultural engineer
 1928                                          Fleming discovers penicillin, the first
                                               antibiotic
 1941                                          The term “genetic engineering” is first used
                                               by a Danish microbiologist
 1977                                          Genetically engineered bacteria are used to
                                               synthesize human growth protein
 1981                                          The first “gene - synthesizing” machines are
                                               developed. The first genetically engineered
                                               plant was reported.
 1982                                          Humulin, Genentech’s human insulin drug
                                               produced by genetically engineered
                                               bacteria for the treatment of diabetes, is the
                                               first biotech drug to approved by the Food
                                               and Drug Administration
 1984                                          The DNA fingerprinting technique was
                                               developed. The first genetically vaccine was
       developed. Chiron clones and sequences
       the entire genome of the HIV virus.
1986   The first biotech- derived interferon drugs
       for the treatment of cancer, Biogen’s Intron
       A and Genentech’s Roferon A, are approved
       by the FDA. The first genetically engineered
       human vaccine, Chiron’s Recombivax HB, is
       approved for the prevention of hepatitis B.
1990   The first federally approved gene therapy
       treatment was performed successfully on a
       4- year old girl suffering from an immune
       disorder.
1993   The FDA declares that genetically
       engineered foods are “not inherently
       dangerous” and do not require special
       regulation.
1994   Calgene’s Flavr Savr tomato, engineered to
       resist rotting, was approved for sale.
1995   The first full gene sequence of a living
       organism other than a virus is completed for
       the bacterium “Haemophilus influenzae”.
1997   Scottish scientist report cloning a sheep
       (Dolly), using DNA from adult sheep cells.
1999   The complete genetic code of the human
       chromosome is first deciphered. The rising
       tide of public opinion in Europe brings
       biotech food into the spotlight.
2000   “Golden Rice”, modified to make vitamin A,
       promises to help third- world countries
       alleviate night blindness.
2003   Dolly, the cloned sheep that made headlines
       in 1997, is euthanized after developing
       progressive lung disease. Dolly was the first
       successful clone of a mammal.
2008   Paolo Macchiarini carries out the world’s
       first tissue- engineered whole organ
       transplant, replacing a Colombian woman’s
       windpipe made with the patient’s own stem
                                                cells.
 2012                                           Development of genetically engineered
                                                stem cells to seek out and kill HIV in mice.
Lesson 2: Branches and Fields in Biotechnology
Introduction:
    Biotechnology has rapidly emerged as an area of activities having marked impact
on all aspects of human welfare ranging from food processing, protecting the
environment, human health to quality of human life throughout the world.
     Based on applications, there are there are six branches of biotechnology, viz.,(a)
bioinformatics, (b) blue biotechnology, (c) green biotechnology, (d) red biotechnology, and (e)
white/grey biotechnology.
     Moreover, there are three famous biotechnological fields, namely: genetic engineering,
tissue culture and cloning.
Intended Learning Outcomes:
     At the end of the lesson, the learner should be able to:
    1. distinguish the different branches of biotechnology.
    2. demonstrate knowledge on the different fields of biotechnology
    3. demonstrate appreciation on the products of genetic engineering which is one of the
        major field of biotechnology.
Lesson Proper:
        I. Branches of Biotechnology
    A. Bioinformatics
    - an interdisciplinary field which addresses biological problems using computational
        techniques, and makes the rapid organization and analysis of biological data
        possible.
    - Referred to as computational biology, and can be defined as, “conceptualizing
        biology in terms of molecules and then applying informatics techniques to
        understand and organize the information associated with these molecules, on a
        large scale”.
    - Plays a key role in various areas, such as functional genomics, structural genomics,
        and proteomics, and forms a key component in the biotechnology and
        pharmaceutical sector.
   B. Blue biotechnology
    - Used to describe the marine and aquatic applications of biotechnology, but its use is
       relatively rare.
   C. Green biotechnology
    - Green biotechnology is the application of biotechnology processes in
      agriculture and food production.
    - Examples: selection and domestication of plants via micropropagation; designing
      transgenic plants to grow under specific environments in the presence (or absence )
      of chemicals; engineering of a plant to express a pesticide, thereby ending the need
      of external application of pesticides, e.g. Bt corn; livestock breeding where
      modern biotechnology is being employed commercially to introduce novel
      performance features in productive livestock (e.g. different wool
      characteristics for sheep, or improved milk characteristics in cattle).
   D. Red biotechnology
    -   Applied to medical processes
    -   Examples: designing of organisms to produce antibiotics, and the engineering of
        genetic cures through genetic manipulation.
    -   Within the field of red biotechnology, which deals with applications in
        human and animal medicine, there are various further distinctions that can
        be made: biopharmaceutical drug development (the development of
        therapeutic human proteins by recombinant methods.
   E. Grey/White Biotechnology
    -   Also known as industrial biotechnology, a biotechnology applied to industrial
        processes
    -   Examples: designing of an organism to produce a useful chemical; using of enzymes
        as industrial catalysts to either produce valuable chemicals or destroy hazardous /
        polluting chemicals.
II. Fields in biotechnology
Famous biotechnological fields are:
1) Genetic engineering
    - Genetic engineering, also called genetic modification, is the direct
       manipulation of an organism's genome using biotechnology.
    -   Genes are the chemical blueprints that determine an organism's traits.
        Moving genes from one organism to another transfers those traits. Through
        genetic engineering, organisms can be given targeted combinations of new
        genes, and therefore new combinations of traits that do not occur in nature
        and, indeed, cannot be developed by natural means.
    -   It will enable the plants and animals breeder to select the particular gene
        required for a desired characteristic and modify only that gene. Life forms
        containing ‘foreign’ DNA are termed transgenic. These methods potentially
        allow totally new functions to be added to the capabilities of organisms that
        results in improved plants and animals for productivity, quality of products,
        disease resistance, etc.
    -   In industrial microbiology it will permit the production in microorganisms of
        a wide range of hitherto unachievable products such as human and animal
        proteins and enzymes such as insulin and chymosin (rennet)
    -   In medicine, better vaccines, hormones and improved therapy of diseases
    -   and in environmental aspects, a wide range of benefits such as pollution
        control can be expected.
Products of Genetic Engineering
     Specific applications of genetic engineering are abundant and increasing rapidly
in number. Genetic engineering is being used in the production of pharmaceuticals,
gene therapy, and the development of transgenic plants and animals.
1) Pharmaceuticals
     Human drugs such as insulin for diabetics, growth hormone for individuals with
pituitary dwarfism, and tissue plasminogen activator for heart attack victims, as well
as animal drugs like the growth hormones, bovine or porcine somatotropin, are
being produced by the fermentation of transgenic bacteria that have received the
appropriate human, cow, or pig gene.
2) Gene Therapy
     The first clinical gene therapy is underway to correct an enzyme deficiency
called ADA in children. Bone marrow cells are removed, defective DNA in bone
marrow cells is supplemented with a copy of normal DNA, and the repaired cells are
then returned to the patient’s body.
3) Transgenic Plants
    Transgenic plants that are more tolerant of herbicides, resistant to insect or viral
pests, or express modified versions of fruit or flowers have been grown and tested in
outdoor test plots since 1987. The genes for these traits have been delivered to the
plants from other unrelated plants, bacteria, or viruses by genetic engineering
techniques.
Adoption of Genetically Modified Crops
   Plants, bacteria, fungi and animals whose genes have been altered by
manipulation are called Genetically Modified Organisms (GMO). GM plants have
been useful in many ways. Genetic modification has:
    a. made crops more tolerant to abiotic stresses (cold, drought, salt, heat).
    b. reduced reliance on chemical pesticides (pest-resistant crops).
    c. helped to reduce post harvest losses.
    d. increased efficiency of mineral usage by plants (this prevents early
       exhaustion of fertility of soil).
    e. enhanced nutritional value of food, e.g., Vitamin ‘A’ enriched rice. In
       addition to these uses, GM has been used to create tailor-made plants to
       supply alternative resources to industries, in the form of starches, fuels and
       pharmaceuticals. Some of the applications of biotechnology in agriculture is
       the production of pest resistant plants, which could decrease the amount of
       pesticide used. Bt toxin is produced by a bacterium called Bacillus
       thuringiensis (Bt for short). Bt toxin gene has been cloned from the bacteria
       and been expressed in plants to provide resistance to insects without the
       need for insecticides; in effect created a bio-pesticide. Examples are Bt
       cotton, Bt corn, rice, tomato, potato and soybean etc.
     Currently 59 countries have granted approvals to use biotech crops for food or
feed, yet only 27 countries grow genetically modified (GM) crops. James (2013)
states that about 175 million hectares of land in the world in 2013 were planted with
GM seed. About 18 million farmers use GM seed, and 50% of them are from
developing countries. The majority of the GM products are utilized for feed and fiber
in the major industrialized countries. Soybeans, maize, and cotton are the major
transgenic crops grown in the world.
4) Transgenic Animals
     Presently, most transgenic animals are designed to assist researchers in the
diagnosis and treatment of human diseases. Several companies have designed and
are testing transgenic mammals that produce important pharmaceuticals in the
animal’s milk. Products such as insulin, growth hormone, and tissue plasminogen
activator that are currently produced by fermentation of transgenic bacteria may
soon be obtained by milking transgenic cows, sheep, or goats.
Figure 1: Genetic engineering process in plants
2) Tissue culture
     Tissue culture, a method of biological research in which fragments of tissue from
an animal or plant are transferred to an artificial environment in which they can
continue to survive and function. The cultured tissue may consist of a single cell, a
population of cells, or a whole or part of an organ. Cells in culture may multiply;
change size, form, or function; exhibit specialized activity (muscle cells, for example,
may contract); or interact with other cells.
                                          Image credit: orbitbiotech.com
Figure 2: Steps in plant tissue culture
3) Cloning
     Cloning describes the processes used to create an exact genetic replica of
another cell, tissue or organism. The copied material, which has the same genetic
makeup as the original, is referred to as a clone. The most famous clone was a
Scottish sheep named Dolly.
    There are three different types of cloning:
    - Gene cloning, which creates copies of genes or segments of DNA
    -   Reproductive cloning, which creates copies of whole animals
    -   Therapeutic cloning, which creates embryonic stem cells. Researchers hope
        to use these cells to grow healthy tissue to replace injured or diseased
        tissues in the human body.
                                   Image credit: khanacademy.org
Figure 3. Gene cloning
                              Image credit: slideplayer.com
Figure 4. Reproductive cloning
Image credit: https://sites.google.com/site/apbiostemcells/home/what-is-therapeutic-cloning
Figure 5. Therapeutic cloning
Enrichment:
    Watch the video: “Cloning animals- Dolly the Sheep” (ctrl+ click to follow the link
https://www.youtube.com/watch?v=Krh7V3Z4Vr4). Give your short reflection on
the video.
Lesson 3: Applications, Drawbacks and Safety Considerations in Biotechnology
Introduction:
     The use of biology to develop technologies and products for the welfare of
human beings is known as Biotechnology. It has various applications in different
fields such agriculture, medicine, industry and environment.
        Agriculture                                                Medicine
                        Applications of Biotechnology
           Industry                                               Environment
                                                                        nt
Figure 6: Applications of Biotechnology
    While biotechnology provides an expansive advantage for humans and
environment, there are also several potential disadvantages to consider viz.,
concerns about ethics, uncertainty, cost, health and environmental concerns and
effect on gene flow.
Intended Learning Outcomes:
    At the end of the lesson, students should be able to:
   1.   determine the several applications of biotechnology
   2.   demonstrate knowledge on the drawbacks of biotechnology
   3.   determine the safety considerations in biotechnology
   4.   demonstrate appreciation on the positive impacts of biotechnology for
        human welfare and the environment.
Lesson Proper:
        I. APPLICATIONS OF BIOTECHNOLOGY
        A. Biotechnology and Agriculture
   1.     Reduced vulnerability of crops to environmental stresses
    -    Crops containing genes that will enable them to withstand biotic and abiotic
         stresses may be developed. One of the latest developments is the
         identification of a plant gene, At-DBF2, from Arabidopsis thaliana, a tiny
         weed. When this gene was inserted into tomato and tobacco cells (Flintoft,
         2009; Licatalosi and Darnell, 2010 as cited in Tonukari, Avwioroko, &
         Ehwerhemueoha, 2010), the cells were able to withstand environmental
         stresses like salt, drought, cold and heat, far more than ordinary cells.
    -    Researchers have also created transgenic rice plants that are resistant to rice
         yellow mottle virus (RYMV).
   2.     Increased nutritional qualities
    -    Proteins in legumes and cereals may be transformed to provide the amino
         acids needed by human beings for a balanced diet (Bruce and Bruce, 1999 as
         cited in Tonukari, Avwioroko, & Ehwerhemueoha, 2010).
   3.   Improved taste, texture or appearance of food
    -    Modern biotechnology can be used to slow down the process of spoilage so
         that fruit can ripen longer on the plant and then be transported to the
         consumer with a still reasonable shelf life (ADB, 2001 as cited in Tonukari,
         Avwioroko, & Ehwerhemueoha, 2010). This alters the taste, texture and
         appearance of the fruit. More importantly, it could expand the market for
         farmers in developing countries due to the reduction in spoilage.
   4. Reduced dependence on fertilizers, pesticides and other agrochemicals
    -   Crops have been genetically engineered to acquire tolerance to broad-
        spectrum herbicide. Herbicides can now be sprayed on transgenic crops
        without inflicting damage on the crops while killing nearby weeds (Gianessi
        et al., 2002 as cited in Tonukari, Avwioroko, & Ehwerhemueoha, 2010).
    -   Similarly, many crops have been genetically modified to express resistance
        to toxins or pesticides used in farm lands (Iwalokun, 2005 as cited in
        Tonukari, Avwioroko, & Ehwerhemueoha, 2010). For example, Bt corn.
        Bacillus thuringiensis (Bt), is a soil bacterium that produces a protein with
        insecticidal qualities. In this form, the Bt toxin occurs as an inactive protoxin,
        which requires digestion by an insect to be effective. There are several Bt
        toxins and each one is specific to certain target insects. Crop plants have
        now been engineered to contain and express the genes for Bt toxin, which
        they produce in its active form. When a susceptible insect ingests the
        transgenic crop cultivar expressing the Bt protein, it stops feeding and soon
        thereafter dies as a result of the Bt toxin binding to its gut wall.
   5. Production of novel substances in crop plants
    -   Biotechnology is being applied for novel uses other than food. For example,
        oilseed can be modified to produce fatty acids for detergents, substitute
        fuels and petrochemicals.
    -   Potatoes, tomatoes, rice, tobacco, lettuce, safflowers, and other plants have
        been genetically-engineered to produce insulin and certain vaccines (Murray
        et al., 2000 as cited in Tonukari, Avwioroko, & Ehwerhemueoha, 2010). And
        since they are edible, they will not need syringes, which are not only an
        additional expense in the traditional vaccine preparations but also a source
        of infections, if contaminated (Pascual, 2007 as cited in Tonukari, Avwioroko,
        & Ehwerhemueoha, 2010).
        B. Biotechnology and Medicine
    In medicine, modern biotechnology finds promising applications in such areas as
drug production, pharmacogenomics, gene therapy, genetic testing, parasitology,
immunology, etc.
   1. Genetic testing
    Genetic testing is now used for carrier screening, or the identification of
unaffected individuals who carry one copy of a gene for a disease that requires two
copies for the disease to manifest: forensic/identity testing, sex determination,
confirmational diagnosis of symptomatic individuals, newborn screening, etc.
(Mulligan, 1993; Somia and Verma, 2000 as cited in Tonukari, Avwioroko, &
Ehwerhemueoha, 2010). The test involves the direct examination of the DNA
molecule itself.
    The tests currently available can detect mutations associated with rare genetic
disorders like cystic fibrosis, sickle cell anemia, and Huntington’s disease. Recently,
tests have been developed to detect mutation for a handful of more complex
conditions such as breast, ovarian, and colon cancers.
   2. Parasitology
    The essential tools to help overcome the difficulties encountered in
development of vaccines for protozoan and helminth parasites of livestock could be
provided by the use of monoclonal antibody and genetic engineering technologies
(Soetan, 2008 as cited in Tonukari, Avwioroko, & Ehwerhemueoha, 2010).
Biotechnology is helping a lot in the control of malaria parasites and other infectious
diseases through the discovery of their pathogenesis. Medical fields like veterinary
parasitology can provide promising avenues for significant breakthroughs in vaccine
production if biotechnology is applied to their researches.
   3. Gene therapy and virology
    Gene therapy simply refers to a technique used in correcting defective genes. It
could also be defined as the transfer of therapeutic genes to target cells. The
technique employs the use of some vehicles called vectors such as adenoviruses,
simplex virus, liposomes, polyethylene glycol (PEG), gene gun, etc.
     Gene therapy may be used for treating, or even curing genetic and acquired
diseases like cancer and AIDS by using normal genes to supplement or replace
defective genes or to bolster a normal function such as immunity (Mulligan, 1993 as
cited in Tonukari, Avwioroko, & Ehwerhemueoha, 2010). As of June 2001, more
than 500 clinical gene-therapy trials involving about 3,500 patients have been
identified worldwide (Cross and Burmester, 2006 as cited in Tonukari, Avwioroko, &
Ehwerhemueoha, 2010).
       C. Production of Biochemicals and Biopharmaceuticals
    Biotechnology has enhanced the production and manipulation of enzymes for
the benefit of mankind in biochemistry and chemistry (Soetan, 2008 as cited in
Tonukari, Avwioroko, & Ehwerhemueoha, 2010). In food and drink industries, a
number of enzymes are utilized. For example, enzymes are used in bread making,
cheese production, meat tenderizing, syrups and sugar production, confectionary,
production of alcoholic drinks, tea, chocolate and coffee production, protein
hydrosylates and condiments, etc.
    Biotechnology is used in the production of recombinant pharmaceuticals.
Production of recombinant insulin has been used in the management of diabetes.
Other examples include synthesis of human growth hormones like somatostatin and
somatotropin to manage growth disorders, production of recombinant factors VIII
and IX to treat haemophilia and Christmas disease respectively, production of
erythropoietin to control anaemia, relaxing to aid child birth, serum and albumin
used as plasma supplement, interferon and interleukins used in the management of
cancers (Soetan and Abatan, 2007 as cited in Tonukari, Avwioroko, &
Ehwerhemueoha, 2010).
       D. Environmental Applications of Biotechnology
    Environmental biotechnology can be defined as a discipline that studies the
application of biotechnology to solve environmental problems. It involves the
processes of portable water production, waste water purification, solid waste
management and soil and sediment clean-up. It also includes newer developments
such as the use of biopesticides, bioremediation of recalcitrant pollutants and
biosensors for environmental monitoring (Soetan, 2008 as cited in Tonukari,
Avwioroko, & Ehwerhemueoha, 2010).
    Environmental sanitation has now been made easy through the use of
biotechnology. Microorganisms are engineered and adapted by this renowned
technology in an effort to find sustainable ways to clean- up contaminated
environments. (ctrl + click to follow the link
https://www.youtube.com/watch?v=8ZXRDovD5MQ)
    The bacteria digest the waste at the site and turn it into harmless byproducts.
After the bacteria consume the waste materials, they die off or return to their
normal population levels in the environment (Keener, Hoban & Balasubramanian)
II. DRAWBACKS OF BIOTECHNOLOGY
    A. Ethics
    Debates over the ethics of biotechnology have been ongoing for decades. The
question mostly lies in the morality of various practices employed in research and
development. Ethics-related concerns include cloning, xenotransplantation, stem cell
research, fetal tissue use, and genetic modification of organisms.
    B. Uncertainty
    The biggest concern over biotechnology is the uncertainty in its long term
effects. The immediate advantages are clear in many circumstances, but they may
directly or indirectly impact the future in unforeseen ways.
    C. Cost
     Balancing benefits of biotechnology with cost, especially in the field of medicine,
can be one tricky aspect. In terms of investment, the value of biotech products is
often miscalculated with failure to include the factors of risk and product
development periods, which can ultimately lower the return on profit. Thus far,
biotech products are often more expensive and less practical than alternatives.
   D. Health Concerns
   - Eating GMO’s
   - Livestock consuming GMO’s
   E. Environmental Concerns
    - Pollution
    - Too much altering of crops is destroying the soul of natural farming
    - Genetically modified species can damage the natural ecosystem.
   F. Gene Flow
    - Genetic contamination
    - Cross breeding
III. SAFETY CONSIDERATIONS IN BIOTECHNOLOGY
1. Pathogenicity
    -   The potential ability of living organisms and viruses (natural and genetically
        engineered) to infect humans, animals and plants and to cause disease.
    -   Toxicity and allergy associated with microbial production.
    -   Other medically relevant effects, e.g. increasing the environmental pool of
        antibiotic-resistant microorganisms.
    -   Problems associated with the disposal of spent microbial biomass and the
        purification of effluents from biotechnological processes.
    -   Safety aspects associated with contamination, infection or mutation of
        process strains.
    -   Safety aspects associated with the industrial use of microorganisms
        containing in vitro recombinant DNA.
Problems of biologically active biotechnology products
    -   Vaccines and antibiotics are obvious examples of biologically active products,
        and care must be taken to prevent their indiscriminate dispersal.
    -   Contaminants in otherwise safe processes may produce toxic molecules that
        could become incorporated into final products leading to food poisoning.
        Allergic reactions to product formulations must also be guarded against.
    -   Overuse of antibiotics in agriculture could lead to carry-over into human
        foods, resulting in possible development of antibiotic resistance in human
        disease organisms. Many countries now restrict the use of antibiotics in
        agriculture.
    When properly practiced, biotechnology is safe and the benefits deriving from
biotechnological innovations will surely lead to major improvements in the health
and well-being of the world’s population. However, biotechnology must always be
subjected to sound regulations for its successful application. The potential risks of
biotechnology are manageable, and regulations have been constructed for that
management.
2. Biowarfare and bioterrorism
     The use of biological weapons (i.e. disease causing microorganisms) in warfare
has a long and disgraceful history, easily predating gunpowder and nuclear warfare
as instruments of mass destruction.
    In the mid fourteenth century the Black Death epidemic, most probably caused
by bubonic plague, swept through Europe, the Near East and North Africa and was
undoubtedly the most devastating health disaster in recorded history. At that time
the Mongols, when attacking besieged cities, hurled plague-infected cadavers into
such cities and the rapid and ensuing epidemic weakened and destroyed the
population. A spectacular and destructive use of biological weapons.
     Bioterrorism has been defined as the intentional or threatened use of viruses,
bacteria, fungi or toxins from living organisms or agents to produce death or disease
in humans, animals and plants (Center of Disease Control and Prevention, Atlanta,
USA). Within the armory of weapons of mass destruction, biological weapons are
considered more destructive than chemical weapons, including nerve gases, since
with a biological attack it is never known when the contaminants have been
removed.
      The bioterrorist might not aim at causing deaths on a large scale but rather
causing economic and political turmoil. This happened recently in Washington, USA
when anthrax spores sent through the postal system to various establishments
caused national alarm and the final cost of clean-up was estimated at US$500 000–1
billion.
    Following on from the 9/11 bioterrorist acts in New York and elsewhere in the
USA, their Government has set in motion extensive programmes to counteract
bioterrorism.
     From an historical consideration vaccines have been the single most cost
effective public health intervention that has shielded populations from so many
deadly diseases, e.g. smallpox. While vaccination has been highly successful against
so many microbially induced diseases there are still many diseases where success is
limited or non-existent. Furthermore, the very high costs and difficulties involved in
vaccinating large populations quickly make it practically impossible to use
vaccinations to protect against bioterrorist attacks.
     Three categories of Potential biological agents (Centre of Disease Control and
                            Prevention, Atlanta, USA)
Category A: agents include the most serious – smallpox, anthrax, plague, botulism,
tularaemia and viral haemorrhagic fevers such as Ebola
Category B: agents have a similar potential for large-scale dissemination but
generally cause less serious illnesses – typhus, brucellosis and food poisoning agents
such as Salmonella and E. coli 0157
Category C: agents include novel infectious diseases, which could emerge in future
threats.
                                     References
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Bradenberg, O. et al., (2011). Introduction to Molecular Biology and Genetic
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