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Full Version: Risk Assessment Of Biotechnological Activities And Its Corresponding Products
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Since time unknown, man has been involved in exploiting the nature around him for the benefit of his own. With the advent of biotechnology the tendency has increased and attained the thresh hold level. The level of interference by man is to a great extent arising thoughts of concern within the human population themselves. The genetically modified organisms and their products may disturb the equilibrium of ecosystem and can even pose as a threat to the stability of the planet even.
It was in the early 1970s that the discussions regarding ethical and non ethical issues concerning recombinant DNA technology was initiated. The concern is about non stability of such experiments conducted and their effects upon nature. A committee called as National Institute of Health, USA was formed which look into the issues which needs attention. The committee has put up certain guidelines for the experiments which have to be strictly adhered to by any experiment conducted in any of the nations. The objectives laid down mainly include practices which consist of conducting experiments on any living organism and the techniques applied for the same.
Risk assessment:
Risk assessment of the experiment involves determining the amount of uncertainty and the possible consequences involved in the same. The prime objectives included are determining the kind and level of experiments to be conducted on the living beings. The identification and evaluation of potential threats by the planned introduction of living organisms is done by risk assessment. This assessment is done by two steps:
(i) Initial assessment: These involve determining the risk involved based on the organism which is used for the experiments. Depending on the effect of organisms they are classified in to different Risk Groups (RG) -1, 2, 3, and 4.
RG 1- involves organisms which are not associated with any disease occurring in humans.
RG2- involves organisms which are involved in causing non lethal ailments in humans and for which treatment is easily and effectively available.
RG3- includes organisms which are linked with serious diseased condition in humans and the cure may be available.
RG4- consists of organisms which can cause highly dangerous health issues for which prevention and treatment is not developed.
(ii) Comprehensive assessment: This involves factors such as features of organism included like pathogenicity, virulence etc. and the type of manipulation involved.
Following risk assessment, the experiments are grouped under different categories which require clearance from different organisations like, Institutional Bio Safety Committee (IBC), Recombinant DNA Advisory Committee (RAC), Office of Biotechnology Activities, and many more. After risk assessment, the concerned group of persons involved will be directed to get approval from these committees. The risk assessment takes into consideration the following factors:
(i) The physical and biological nature of both donor and recipient organisms.
(ii) The properties of vector involved
(iii) The characteristics of DNA insert involved
(iv) Different techniques involved like detection, isolation, transfer and expression.
(v) Differences in the native and genetically modified organisms (GMO), the use of such organisms for several benefits and impact of such organisms in the environment and the impact of experiments on the organisms.

Potential threats involved in biotechnology:
The transgenic organism produced may affect other organisms negatively such as development of transgenic weeds or parasites. Often, the transfer is intended to be expressed by organisms lacking some property or by organisms which can provide products of economical importance. The chance of transfer of the transgene into a similar organism resulting in production of a hazardous organism or conditions may also arise wherein the transgene can also be overly expressed disturbing the well being of other organisms. Developments of insects or pathogens which are resistant to such transfers are also possible. The existence of the GMO s may affect the environment in which it thrives upsetting the equilibrium as they do not actually belong to the environment. Finally the product produced can also cause health hazards among organisms and especially humans.
Following the assessment of organisms involved in biotechnology, the products obtained from such organisms is also assessed to confirm that they do not pose any kind of threat to the humans when consumed. The assessment is based on the product that is modified, safety of the introduced transgene and the corresponding products formed .It essentially takes into consideration the genetics of organism involved, the technical procedures followed and composition of product formed.
Risk management associated in handling of microbial pathogens as well as other lab animals is very critical and important. Today in biotechnology industries and pharmaceutical field, large number of microbial pathogens (Bio-Hazard) is being used and handled. Therefore there is a need to understand the importance of bio-hazards and to acquire its complete knowledge, its precautions, and what immediate actions are required in case of its contact during working or during research studies.
Biohazards are biological substances that may pose threat to life or living organisms especially humans. This may include but not limited to waste generated during medical operations, medical research work, or may be living microorganism or their waste. Even after the killing of such pathogens, there is a chance of reaction or immunological triggers in human bodies which is due to so called pyrogens. Pyrogens increases the body temperature and may lead to diseases or disorders.

The sign of bio hazard is U+2623 & symbol (☣). Proper training is required with evaluation of training for new members or students handling bio-hazards. Proper facility is also required with ventilations, classified rooms, safety hoods, personal preventive equipments etc. This helps us to safeguard ourselves from such bio hazards.
Whenever any unexpected contacts with bio hazards occurs, one has to immediately take medical help or treatment as recommended by doctors. Many a times these pathogens in lab or research area are attenuated that is they are half killed and does not cause diseases. On these bases, they are given the hazard level numbers which further depends upon the severity of it.
In this world with the addition of the technology growths pollution also increasing day by day, because of that living beings are facing many problems. That reflects on the humans health, some dangerous diseases like cancer, skin ulcers etc are occurs with this one.