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VII. 
ENVIRONMENTAL IMPACT OF THE GUIDELINES 
A. Impact of Issuance of NIH Guidelines 
The primary impact of issuance of the Guidelines is to provide a 
mechanism for the protection of the laboratory worker, the general 
public, and the environment from the possible hazards that might result 
from recombinant DNA molecule research. Such research is defined 
as that which involves molecules consisting of segments of deoxyribo- 
nucleic acid (the material that determines the hereditary characteristics 
of all known cells) which have been joined together in cell -free systems 
and which have the capacity to infect and replicate in some host cell. 
The Guidelines establish carefully controlled conditions for the conduct 
of experiments involving recombinant DNA. 
Any unusual hazards of this research remain hypothetical at present; 
the speculations on risks that underlie the Guidelines may prove to be 
wrong, and it may be that no potential for hazard exists. Nevertheless, 
the Guidelines take cognizance of the possibility of dangers to the 
laboratory worker, other persons, animals, plants, and the environment 
posed by the emerging research technology involving recombinant DNA 
molecules. They call for a number of measures aimed at reducing or 
eliminating human and environmental exposure to materials containing 
recombinant DNA molecules, in case they should prove hazardous. 
The NIH recognizes that the production of unexpected results is 
inherent in the very nature of scientific research. The danger of 
exposure to certain of the conceivable hazards as a result of 
NIH-sponsored research on recombinant DNA is eliminated by the 
prohibition of certain experiments. The danger of exposure to other 
conceivable but hypotheical hazards is reduced by the containment 
requirements. A totally risk-free situation, however, was not the aim 
of the Guidelines, nor will it be provided by adherence to them. In 
the view of NIH, the level of risk that will result from adherence 
to the Guidelines is extremely small. But views to the contrary have 
been expressed. There have been arguments to the effect that the level 
of acceptable risk assumed in the Guidelines is too high, and arguments 
that it is too low. As a matter of policy, the Guidelines will be subject 
to constant reassessment in the light of new knowledge and the changing 
views of scientists and the public. A variety of channels are available 
for expression of views and action, including the institutional biohazards 
committees, the NIH Recombinant Advisory Committee, and the NIH 
Director's Advisory Committee. There has been extensive opportunity 
for public debate and participation at the State and local governmental 
levels. 
