2 
On June 2 3, 1976, the Director of the National Institutes of Health, 
Donald S. Fredrickson, M.D., released Guidelines governing the conduct 
of NIH-supported research on recombinant DNA molecules (see Appendix 
D). Promulgation of these Guidelines followed 2 years of intensive 
discussion and debate within the scientific community and NIH itself, 
with public participation, concerning the hazards of such research and 
the best means for dealing with known hazards and averting the hypothetical 
risks. The Guidelines prohibit certain kinds of recombinant DNA experi- 
ments, which include virtually all the known hazards --for example, 
those involving known infectious agents. For those experiments that 
are permitted, the Guidelines specify safety precautions and conditions 
designed to protect the health of laboratory workers, the general public, 
and the environment against hypothetical hazards. 
The issuance of Guidelines establishing conditions and precautions 
with respect to recombinant DNA experiments is viewed by NIH as 
within the category of a Federal action that may significantly affect 
the quality of the human environment. Hence, the NIH Director 
ordered the publication of this statement--first in draft (Federal Register, 
September 9, 1976) and now in final --pursuant to the National Environ- 
mental Policy Act (NEPA). 
Although NEPA assumes that such Federal actions will not be taken 
until the NEPA procedures are completed, the Director of NIH concluded 
that the public interest required immediate issuance of the Guidelines, 
rather than deferral for the months that would be required for completion 
of the NEPA process. This was because experiments utilizing recom- 
binant DNA technology were proceeding in various laboratories throughout 
the country with only general and purely voluntary restrictions. Therefore, 
the escape of potentially hazardous organisms was more likely in the 
absence of NIH action. Further, prompt issuance of the Guidelines 
was believed necessary in order to promote their acceptance by scientists 
in the United States and abroad who do not come under the purview 
of NIH. 
Thus the issuance of the Guidelines is an action designed to protect 
the environment from possible untoward effects of recombinant DNA 
experiments. Undeniably, the conduct of recombinant DNA experiments 
in conformance with the Guidelines results in less risk to the environ- 
ment than the conduct of such experiments without guidelines. Evaluation 
of the protection afforded by the Guidelines depends on the assessment 
of risks related to the experiments, necessitating consideration of 
the experiments as well as the Guidelines. 
