Biosafety is of paramount importance for all microbial products. For example, thousands of people die if alcoholic beverages consist of methanol mixed with ethanol. Fortunately, no such product has been produced by biotech industry that may contain adulterated product. Hence, the biotech products can be said to be safe.

Only a small number of potentially dangerous microorganisms have been used in industry in manufacturing of vaccines or diagnostic reagents e.g. Bordetella putusis (whooping cough) and Mycobacterium tuberculosis (tuberculosis) and foot and mouth disease virus. Safety considerations in biotechnology are given by Smith (1996) (Box 6.2).

However, there is fear and risk in the society associated with genetically engineered microorganisms (GEMs). If the GEMs escape from the laboratory into the environment, they can cause dangerous effect. The GEMS released in environment may disturb the natural balance of microorganisms by the way of introducing foreign DNA into the microbial community.

Thus the metabolic route may get changed. In India, Department of Biotechnology (DBT) has set up (in collaboration with other Departments) a framework for the evaluation and eventual clearance of GEMs.

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The European Federation of Biotechnology (EFB) has classified microorganisms on the basis of potential hazards into the five classes as below:

Class I. Microorganisms that do not cause disease and offer no threat to the environment.

Class II. Microorganisms that may cause disease in human and laboratory workers.

Class III. Microbes causing very severe threat to laboratory workers and small risk to large population.

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Class IV. Microorganisms causing severe illness in humans and pose a serious hazards to laboratory workers and to people at large.

Class V. Microorganisms that offer a more serious threat to environment than to people resulting in heavy economic loss.

Several GRAS (generally regarded as safe) organisms present in the environment have been genetically modified by introducing beneficial genes. They are released to improve the quality of soil and environment as well.

In India the Environment Protection Act (EPA) 1986 provides a framework for the protection and improvement of environment. The rules and regulations for manufacture, use, import, export and storage of hazardous microorganisms, GEMs, were notified in 1989 under the EPA 1986.

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Before granting approval for release of GEMs in the environment the materials is evaluated by the expert committees such as International Biosafety Committee, Review Committee on Genetic Manipulation, and Genetic Engineering Approval Committee.