The means of utilization and manipulation of biological systems and processes for the advantage of man. The methods of biotechnology are commonly considered as selective alterations of genes as in the case of production of genetically engineered crops. In a broader sense, the activities which does not involve gene modification such as fermentation, chicken breeding,mammalian and plant tissue cultures also fall under the definition of biotechnology.

A set of measures and procedures introduced to prevent exposure of genetically modified organisms, tissues, cells or products made of these organisms with environment. For example, greenhouses, tight sealed containers during transport etc.

A set of measures and procedures applied during experimental field release of GE crops transformed to produce pharmaceuticals and industrials to ensure that no genetic material will be released to the environment. These measure include but not limited to spatial, time and reproductive isolation, monitoring and controlled pollination.

A substance intended for use in the diagnosis. cure. mitigation, treatment, or prevention of disease in man or other animals and articles (other than food) intended to affect the structure or any function of the body of man or other animals.

An event is the insertion of a particular transgene into a specific location on a chromosome ( A single transformation experiment generates many events since the inserted gene is incorporated into different locations in each target cell used for obtaining transformed cells.

Genetically Engineered:
An organism that has been altered by addition of DNA or modification of its own DNA.

Human Biologics:
A 'virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product. . . applicable to the prevention, treatment, or cure of a disease or condition in human of human beings' 42 U.S.C 262(i)

Veterinary Biologics:
A 'virus, serum, toxin or analogous product intended for the use in treatment of domestic animals.' 21 U.S.C 151