STANFORD UNIVERSITY MEDICAL CENTER

ST'ANFORI), Ci\LIFOKN121 94305

DEPtlRTMENT OF BIOCHEMISTRY
STAhI ORD U\l\ERSITl SCHOOL 01 hfEDlCINE

Area Code 415

497-61Gl

April 22, 1981

Dr. William Gartland, Head
Office of Recombinant DNA
NIGMS, Bldg. 31 4A52
Bethesda, MD 20205

Dear Bill,

   I am writing to you regarding the proposed changes in The Guide-
lines for Recombinant DNA Research put forward by Drs. Baltimore and
Campbell that appeared in the Federal Register of Friday, March 20, 1981
on pages 17994-7 (Vol. 46 /#54). As I understand their recommendation it
is 1) to convert the current NIH Guidelines for Recombinant DNA Research
from mandatory regulations (for virtually all university and institute
scientists) to a non-mandated, but recommended code of standard prac-
tices and 2) to reduce the recommended containment levels for certain
experiments.

   Lest there be any doubt about my views on this let me be quite
direct. I strongly favor their suggestion and have done so for some
time. Indeed, in a letter to Dave Baltimore of July 2, 1980, I said "I
find it increasingly difficult to accept the maintenance of a non-
trivial government bureaucracy to contend with the mythical possibility
that recombinant DNA experimentation is hazardous.  After all we have not
imposed the same requirements on virus research or other 'potential
hazardous' laboratory activities. In those instances, society and the
government have accepted individual and institutional assurances for
safe practices and culpability for negligence or deliberate violations.
RAC has elected a strategy for evolutionary change in The Guidelines,
but in my view, it has not been without paying a substantial price: the
time and energy of ORDA, RAC members, institutional committee members
and the scientists doing the research, as well as the expenditures to
maintain ORDA, ORDA, RAC and the new layers of bureaucracy that have
been spawned in the universities. I do believe it is time to seriously
consider whether the ORDA-RAC format should continue . . . . I would
favor its dissolution and replacement by something like the advisories
put out by CDC in the field of pathogenic microorganisms and tumor virus
research; that is, an effective and a relatively simple classification
and advisory for handling pathogenic or potentially pathogenic organisms
and viruses. Didn't that kind of advice serve us well for tumor viruses
before recombinant DNA"?

Page 2
Dr. William Gartland

   I have no reason to change my views now. The present proposal
seems eminently sensible and prudent. It transforms The Guidelines from
regulations (which they were) to guidelines (which they should be). My
own early concerns that some recombinant DNA experiments might carry
risks have long been dissipated. The data, discussions and experience
of the last six years have convinced me that our earlier concerns are no
longer warranted. I now believe that there is more to fear from the
intrusions of government in the conduct of scientific research than from
recombinant DNA experiments themselves. Consequently, I welcome the
changes put forward by Baltimore and Campbell and hope that RAC will
approve them promptly.

With best wishes,

Sincerely,

<

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Willson Prof sor of Biochemistry

Paul Berg

C.C. Dr. David Baltimore
PB/hk