8 
currently available evaluation of the degree of risk associated with 
each particular type of manipulation or host- vector combination. In 
fact, the NIH Recombinant DNA Molecule Program Advisory Com- 
mittee has proposed changes in the Guidelines based, in part, upon 
the conclusions of the F almouth workshop. The revised guidelines are 
expected to officially replace the 1976 guidelines by June 1978. 
The committee considers it important to make the distinction be- 
tween the nature of the safety standards, and whether or not there 
exists a need to impose the safety standards by legislation. In the com- 
mittee’s view, a need now exists to establish by law a regulatory au- 
thority which will permit the imposition of the NIH containment 
standards and experimental guidelines on all recombinant DNA ac- 
tivities which may pose a risk to health or the environment. 
Because of the possibility of rapid advancement in our understand- 
ing of the potential hazards presented by genetically modified orga- 
nisms, a two-year interim control bill is proposed. It is understood that 
Congress wall re-evaluate the need for safety guidelines and the need 
to require them by law in approximately one and a half years after en- 
actment, basing its actions on the recommendations of the study com- 
mission and the performance of the Department of Health, Education, 
and Welfare in implementing this act. It is to be borne in mind, how- 
ever, that legislation is not a direct response to perceived possible haz- 
ards but to the fact that the NTH Guidelines only apply to a fraction 
of the recombinant DNA activities being conducted. The NIH Guide- 
lines are the primary response to potential hazards and, therefore, 
legislation is justified only to the extent that safety guidelines are 
necessary. 
The need for legislation has been endorsed by the Inter-Society 
Council for Biology and Medicine, which includes a large number of 
biological and medical professional societies, the American Associa- 
tion of Universities, and the Director of the National Institute of 
Health. They generally support the provisions of H.R. 11192. 
The following is a summary of the arguments for the need for Fed- 
eral legislation to regulate recombinant DNA activities : 
(1) Safety standards for the protection of health or the en- 
vironment from the hazards of recombinant DNA research and 
technology should extend to all parties engaged in such activities. 
(2) Uniform Federal regulations are needed to prevent widely 
varying state and local regulations. 
(3) Safety standards for large-scale and manufacturing proc- 
esses involving recombinant DNA are not now covered in the NIH 
Guidelines, and should, therefore, by provided by law. 
(4) The health and safety of personnel working with recom- 
binant DNA must be protected by law. 
(5) Uniform Federal regulations will facilitate the United 
States’ role in the development of international safety standards 
for recombinant DNA research and technology. 
COST OP LEGISLATION 
Although the proposed legislation contains no line-item authori- 
zation of appropriations, the Department of Health, Education, and 
Welfare estimates that the following costs will be incurred by tire 
Department in carrying out the functions assigned to it by H.R. 11192. 
[Appendix B — 138] 
