precise contours of the Guidelines would benefit from thorough 
discussion by the RAC. 
BACKGROUND 
The Guidelines were developed in 1976 to provide standards 
of safety in research with recombinant DNA techniques. The 
purpose of the Guidelines was to protect researchers and the 
public from potential hazards to human health and the environment 
posed by genetically novel organisms. 1 
The central concern of the NIH was the genetic novelty of 
the organisms created by recombinant DNA techniques. As the NIH 
stated in its 1977 Environmental Impact Statement on the 
Guidelines (2), "[cjoncern over the potential for hazard in 
organisms containing recombined DNA develops from the central 
idea that such recombinants will be unique types of organisms, 
not normally arising in nature, and that their properties will 
therefore be unknown and unpredictable." 
As there was only one technique capable of providing 
transgenic organisms in 1976, the Guidelines are written to cover 
only that technique. Current Guidelines (3) apply only to 
recombinant DNA molecules, which they define "...as either (i) 
molecules which are constructed outside living cells by joining 
natural or synthetic DNA segments to DNA molecules that can 
replicate in a living cell, or (ii) DNA molecules that result 
from the replication of those described in (i) above." This 
definition captured most genetically novel organisms for review 
because the recombinant DNA technique depends on joining the 
foreign DNA to be transferred to vector DNA outside of living 
cells. 
THE NEW TRANSGENIC TECHNIQUES 
Since that time, scientists have developed other gene 
transfer techniques (e.g., electroporation, microprojectile 
1. The 1976 "Decision of the Director, NIH, to Release Guidelines 
for Research on Recombinant DNA Molecules" (1, p. 27904) declared 
that "[t]he object of these guidelines is to ensure that 
experimental DNA recombination will have no ill effects on those 
engaged in the work, on the general public, or on the 
environment" . 
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Recombinant DNA Research, Volume 13 
