Or. William J. Garcland 
National Institutes of Health 
February 1, 1982 
Page 3 
1) Containment Guidelines - The heart of the RAC proposal, the simplified 
provisions of Section III, would be followed. The experiments for 
which there are admonitions, set out in III (a) and III (b) of the RAC 
proposal and which are presently prohibited, would instead be permitted 
only if approved on a case by case basis by NIH as indicated in item 4 
below. 
2) Prohibitions - Again following the RAC proposal, absolute prohibitions 
would be eliminated as inflexible and unnecessary. Formerly prohibited 
experiments would be possible under different sets of controls as in- 
dicated below. 
3) Purpose ; Roles and Responsibilities - Following the Gottesman proposal, 
the thrust of the original guidelines would remain unchanged, keeping 
them more than a voluntary code of good practice. Some significant 
procedural requirements would be retained. Formal Institutional guid- 
ance, particularly via the IBC's, would continue to play a key role in 
technology development. 
4) NIH Prior Approvals - As in the Gottesman proposal, certain highly 
sensitive experiments would require RAC review and NIH approval before 
being initiated. The two categories set out in Section III of the RAC 
proposal (i.e., experiments involving deliberate transfer of a drug 
resistance trait to microorganisms not known to acquire it naturally; 
and deliberate formation of recombinant DNAs containing genes for the 
biosynthesis of toxins lethal for vertebrates at an LD^q of less than 
100 nanograms per kilogram body weight) would be the sole classes of 
experiments requiring this ultimate precaution at the present time. 
5) IBC Prior Approvals - As in the Gottesman proposal, large scale pro- 
duction would require IBC approval before initiation. However, the 
present 10 liter threshold for triggering this requirement is too 
cumbersome for current scale-up experiments, particularly industrial 
applications, as well as for many experiments that can now be performed 
with bench-top equipment. This threshold should be raised substantially. 
6) IBC Monitoring and Record Keeping - As in the Gottesman proposal, ex- 
periments would generally be reported to the IBC as they are initiated. 
IBC's would thus continue their monitoring and record keeping functions, 
although approvals would not be necessary. Experiments neither exempt 
from the guidelines nor subject to approvals previously noted would be 
subject to this requirement. For example, experiments involving re- 
lease of DNA organisms into the environment would fall into this category. 
While thorough monitoring of such activities remains prudent, further 
restrictions, except for those sensitive experiments previously noted, 
now seem unwarranted. 
(7551 
