3.0 PURPOSE AND NEED 
3.1 Purpose of the Proposed Action 
The purpose of the proposed field test is to determine whether the 
alterations in the genetic material of the experimental tobacco have any 
detrimental effect on growth or characteristics of the tobacco. 
The purpose of NIH approval of this proposed field test is, as set forth in 
the Guidelines, to determine that the test complies with the Guidelines and 
presents no significant risk to health or the environment. 
3.2 Need for the Proposed Action 
Growth of the experimental tobacco has been compared with the parent 
tobacco in the confinement of a greenhouse under controlled conditions. 
Such tests, however, cannot duplicate the rigors of field testing and 
exposure to the variety of stresses present in the natural environment. If 
genetic engineering of plants is to provide material of value to agriculture, 
the engineered plants, like conventionally produced genetic alterations, 
must be tested under field conditions. 
The NIH review and approval of this proposed field test is being conducted 
under the "Voluntary Compliance" section of the NIH Guidelines to provide 
review at the national level of whether the test can be conducted safely 
with no significant risk to health or the environment. 
Environmental Assessment 
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