Attachment II - Page 4 
EXPIANATICN AND JUSTIFICATION 
The action has tvio major effects; 
(A) It revokes the nandatory nature of the Guidelines by elimin- 
ating those sections specifying regulatory procedures and their underlying 
organizational nachinery. These Guidelines would then reseiible the CDC 
Guidelines in setting standards and providing guidance rather than in reg- 
ulating the performance of experiments. This purpose is acccrplished by 
itoTB 1, 2 , 4, and 5 of the proposal. 
Item 5 (elimination of most of Section VI) is included because, 
with the elimination of Section IV, conpliance with the Guidelines will 
effectively beccme voluntary for cdl individuals, regardless of NIH support. 
Special provision for voluntary compliance by individuals and institutions 
not supported by NIH then becomes superfluous. 
(B) It reduces the prescribed level of physical containment for 
most experiments to Pi. This purpose is accomplished by iten 3. 
These two changes are justified from the following considerations; 
(A) Elimination of Regulatory Procedures . Opinions differ as to the wisdom 
of the actions and arguments which led to the adoption of the NIH Guidelines* 
in 1976. However, there is fairly general agre«nent on two points; (i) The 
establishment of Guidelines has had some beneficial effects. In particular, 
it has raised the general level of awareness among investigators and insti- 
tutions of the importance of considering possible hazards that might arise 
during microbiological research, (ii) Since 1976, neither experimental 
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