31 August 1981 
Thomas £• Malone, Acting Director 
N ational Institutes of Health 
Building 1, Room 124 
Bethesda, Maryland 21013 
Dear Mr. Malonet 
It is with considerable concern that I write regarding the 
decisions of the National Institutes of Health which progressively 
weaken its modest controls for Recombinant DNA experiments. In- 
stead of strengthening provisions for containment and for over- 
sight by the NIH and local biohazards safety committees, the thrust 
has been to exempt increasing numbers and types of experiments. 
For example, in 1980 NIH's Recombinant Advisory Committee (RAC) 
reclassified as category III— 0 most work with E. Coli K-12 and 
Saccharomyces cerevisiae and determined that it could be done 
at the PI level of physical containment, requiring registration 
only with the local biosafety committee, not with NIH. At its 
April 23—24, 1981 meeting, the RAC then exempted all experiments 
in the III-O category from the guidelines with the exception of 
large-scale work and experiments involving CDC class 3 agents. 
Furthermore, RAC reclassified certain experiments with toxin 
genes at the same time, I understand, that one of the consultants 
who proposed this reclassification stressed that the risks from 
experiments with genes coding for toxins are unknown . 
Such actions are most astonishing for scientists to take based, 
it appears, more on faith that nothing will go wrong — the violations 
to date of the guidelines aside — than on proper risk assessments 
studies along a range of present and projected experiments. It should 
be inconceivable for an organization of scientists such as NIH to 
preside over the steady dismantling of the guidelines before it has 
in hand a rich body of risk assessment information to support this 
position . 
. Additionally troublesome, particularly at a time when the comraer- 
ci/lization of RDNA is growing, is the proposal by David Baltimore 
and Alan Campbell, members of the RAC, to move from mandatory guidd- 
lines to a recommended code of standard practice. If these are 
abolished, you are in effect creating a familiar situation wherein 
mandatory controls will follow lethal accidents or injury. This 
approach contradicts the whole idea of controls which is to prevent 
death or injury. 
In contrast, by requiring safe practices in the uses of RDNA 
techniques and effective review and enforcement mechanisms, the NIH 
can show an authentic commitment both to high standards in research 
and the avoidance of harmful experiments. It does not have to repeat 
past mistakes and wait for human suffering to produce health and 
safety controls. The NIH can choose at the outset to put the health 
and safety of the whole society above special interests. 
ICttl . 
