Tab A - Page 60 
Appendix A 
Background Concerning the NIH Guidelines for Research Involving 
Recombinant DMA Molecules 
The NIH Guidelines for Research Involving Recombinant ONA Molecules 
(Guidelines) were first issued on June 23, 1976, and were published In the 
Federal Register on July 7, 1976. The Guidelines were the product of a process 
of scientific and public discussions Initiated In 1973 by scientists with 
concerns about the, safety of the new recombinant DNA techniques. As stated in 
the "Decision of the Director, National Institutes of Health To Release 
Guidelines for Research on Recombinant DNA Molecules": 
"The object of these guidelines is to ensure that experimental DNA 
recombination will have no 111 effects on those engaged in the work, on 
the general public, or on the environment .... It should be noted that 
the development of the guidelines was In large part tantamount to 
conducting an environmental Impact assessment. For example, the 
objectives of recombinant DNA research and alternate approaches to reach 
those objectives, have been considered. The potential hazards and risks 
have been analyzed. Alternative approaches have been thoroughly 
considered to maximize safety and minimize potential risk. And an 
elaborate review structure has been created to achieve these safety 
objectives." 
NIH published a Draft Environmental Impact Statement on the Guidelines In 
the Federal Register for public comment on September 9, 1976. After analysis 
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