Dano b

Bacterial Physiology Unit,
Harvard Medical School,
Boston, MA 02115

May 22, 1987.

Mr. L. Val Giddings,
Office of Technology Assessment,
Washington, DC 20510-8025,

Dear Dr. Giddings, bat k

Thank you for sending me a copy of your, Special Report on Genetically
Engineered Organisms in the Environment.

In recently preparing a report on The New Biology, under contract to the OTA
for a publication on Science, Technology, and the Constitution, I had occasion
to go through a number of OTA reports on various aspects of biology and
medicine, and I was impressed by their balance and their high quality. I was
therefore deeply disappointed find the draft on Genetically Engineered
Organisms excessively alarmist in tone and not at all well balanced. TI have
not read the document in detail, but the summary supports the unfortunate
view, widely disseminated in the press, that all organisms prepared by
molecular genetic manipulation must be treated as potentially dangerous,
rather than recognizing that large classes of engineered bacteria, involving
no pathogenic component, present.no greater danger than the bacterial variants
that have been prepared by classical genetic techniques and released in the
past. Thus, on p. 1-4:

"Microbes are small and easy to handle in the laboratory, and they
reproduce rapidly. But these same traits make microorganisms risky to
release into the environment. Because they are invisible, they are
difficult or impossible to track with current techniques... Furthermore,
they are ubiquitous and play key roles in many fundamental ecological
Processes. Releasing them into the environment could therefore trigger a
host of unpredictable -~ and undesirable effects."
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I consider this statement quite illogical, for the ubiquity, density, and high
rate of genetic variation in the microbial world in nature supports the
Opposite conclusion: that our introductions will not be detectable, except
locally and transiently, against the background of all this noise. At a
recent meeting of the NIH RAC Frances Sharples presented the same objection
More succinctly, in opposing a redefinition of recombinant: "The trouble with

microbes is you can't even see them." When I have quoted this statement to
scientists who work with microbes I am met with incredulity or laughter. And
in the RAC -~- including administrators, lawyers, bioethicists, and physicians

as well as microbiologists, Dr. Sharples was outvoted on this issue 16 to 2.

Under these circumstances, there would be no point in my commenting in detail
unless you are prepared to undertake a radical revision. While this would

obviously be difficult for your organization, it ig pertinent to look at the
history of a shorter report on the same subject that is being prepared by the
National Academy of Sciences. The early versions of the report were somewhat
alarmist (though less than your draft), and internally inconsistent in trying

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tc recoicile the view of the ecologist on the committee with the views of
other members; hence there were serious objections from members of the Council
and other members of the Academy who were consulted. Patient work by the
chairman of the committee (a plant pathologist deeply knowledgeable in the,
field) eventually persuaded the ecologist to accept a heavily revised version,
which I find quite satisfactory.

It is my understanding that the mission of the OTA is not to seek a political
consensus on controversial scientific issues but to provide Congress with the
best scientific information and judgment it can obtain. On the issue of
genetically engineered organisms there is a most unusual controversy between
two scientific communities: ecologists (at least those who have made public
statements) and members of scientific disciplines that deal with microbes.
Good advice to Congress really cannot combine these two points of view; and in
choosing between them, the quotation above provides clear evidence of the
innocent and frightened attitude of many ecologists toward the microbial
world. I would also call attention to the history of parallel earlier fears
of unpredictable harm from laboratory research with recombinants, and to

some firmly established and relevant scientific principles, summarized in my
article in Science, Mar. 16, 1987; and I would suggest that the position
supported by ecologists defeats their purpose of protecting against hazards to
the environment, since it will delay the replacement of known toxic chemicals
by harmless biological pesticides.

Because of the heavy representation of ecologists among your contractors, the
extraordinary lack of names that I can recognize as microbiologists or
molecular biologists, and the difference between your review process and that
of the NAS, I can see that it may be impossible for you to undertake the kind
of revision that the NAS did. But unless the report is either buried or
radically revised the OTA will find itself out of step with many of the most
responsible elements in the scientific community, including the NAS, the NIH
RAC, a statement being prepared by the Public Affairs Advisory Committee of
the Amer. Soc. Biol. Chemists, and the recent editorial by Daniel Koshland on
the subject in Science. You may also find yourselves providing fuel to some
of the fringe activists who have so lowered the quality of much of the
discussion of these problems. It would be sad to see the excellent record of
OTA blemished by such a report.

Sincerely,
Soo

Bernard D. Davis,

Adele Lehman Professor of
Bacterial Physiology.
Emeritus.

c/B. Healy

PS. Thinking that I ought to look a bit further into the document before
sending off this letter, I opened it at random and encountered the following.

"Active research cooperation -~ both financial and political -- among
microbiologists, geneticists, ecologists, and evolutionary biologists should
be encouraged.... Unless attention is focused on such efforts, this area of

biotechnology [i.e. risk assessment and risk management] will be without an

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adequate scientific foundation and remain dominated by unsubstantiated
speculation." This statement is much like a letter to Science by one of your
contractors, Norse, which I criticized severely in my later article in that
journal; for while the ecologists promise a definitive experimental basis for
assessing risk they offer no convincing operational program; hence well
established scientific principles (? "unsubstantiated speculation") still
offer our best basis for making broad judgments as to which classes of
organisms might be dangerous and which it would be wasteful to hold up for
detailed investigation.

While I have been inclined to assume that most ecologists have been primarily
motivated by sincere concern for the environment, the naked pressure in this
document for increased financial support -- as though the present extensive
support of molecular biology originated instead of following its breakthroughs
—- encourages a more cynical view, which I have frequently encountered among
my colleagues. I fear that in the long run the tactics of the ecologists will
decrease their support from the rest of the biological community, as well as
harming biotechnology; and I would urge the OTA to consider whether it may not
be lending itself, in this document, to cooptation by a group lobbying for
funds.