The President
The White House
Washington, D.C.

Dear Mr. President:

   For several years, the biomedical research community has
been engaged' in an extremely important debate over the safety
of certain types of genetic research.  The research involves
combining genetic mater.ial from different organisms.   The
technology that permits this type of genetic experimentation,
called recombinant DNA research, is revolutionary, and holds the
Promise of enormous benefits in our understanding of disease
processes, and'could lead us to ways of controlling or' treating
complex diseases such as cancer and hereditary defects.   It could
conceivably lead to improved.ways of producing such important
hormones as insulin, clotting factors, and enzymes important
to treatment of many diseases.  The technology also has conceivable
applications in agriculture and industry.  Clearly, .it is a,
research area of enormous promise*

  Howeve'i ,  re'combinant DNA research also entails unknown but
potentially enormous risks due to .the possibility that micro-
organisms with transplanted genes might prove hazardous to human
and other forms of life-- and might escape from the 1aborator;J.
Indeed, scientists engaged in such research declared a voluntary
moratorium on recombinant DNA research in 1974 when they foresaw
the possibility, for example, of creating in the laboratory self-
propagating infectious bacteria that contain genes from cancer-
causing viruses.  The moratorium was lifted in 1975, but maintained,
again by the researchers themselves, for the specific types of
experiment which might produce cancer-causing bacteria, raise  the
resistance of antibiotics of known bacteria, or have other
dangerous results.

  AOn June 23rd of this year,  the National Institutes of Health
issued comprehensive guidelines for recombinant DNA research
which s.pecify more stringent safety and containment measures
than are currently required or practiced in many areas.  They
specifically prohibit the most potentially dangerous types of
experiments.  In addition, the guidelines prohibit the release
into the air or water or environment of any of the genetic
materials created by the research.


The President
Page Two

   We appreciate the.great care &TH has taken, inthe
formulation of these strict guidelines, in obtaining the
best scientific advice as well as advice from experts in
.law and ethics.  Opportunity was also given for the public
to comment on the guidelines.  The environmental impact
assessment of the guidelines'currently being prepared by
.NIH will offer further opportunities for such comment.

   The guidelines will be widely discussed and debated
with regard to their ultimate adequacy in safeguarding the
public, and they will no doubt further evolve and develop
during this debate and as our understanding of recombinant
DNA advances.  Based on the process by which MIH produced
the present guidelines, we are confident they are a respon-
.sible and major step forward and reflect a sense of social
.responsibility on the part of the research community and
the NIH.

    However, we are gravely concerned that these relatively
stringent guidelines may not be implemented in all sectors
of'the domestic and international research communities and
that.the public will therefore be subjected to undue risks.
The National Institutes of Health has the authority to require
,adherence to the. guidelines as a condition of their grants
and contracts for .research, but they cannot enforce the guide-
lines with respect to other Federal agencies, with respect to
research in the private sector in this country, and with respect
.to research done in other nations.

  `Invparticular, it is clear that recombinant DNA research
has great .potential in the private sect,or, such as pharma--
ceutical manufacture, the oil industry and agricultural products.
It is also clear that some elements of the guidelines, such
as limitations on the size of experiments? public disclosure,
-and non-release of materials into the envrronment, may be
contrary to the interest and practice of research in private
industry, and may therefore be ignored.  In addition, since
private sector research will lead to industrial application,
guidelines must be extended beyond research into application
and production stages.  If the NTM guidelines are necessary
to protect the public in Federally funded research., it is
clear they are necessary for pr.ivately funded research and
application as well.


The President
Page Three
                              
    Given the high potential risks of this research, it seems
imperative that every possible measure be explored for assuring
that the NIM guidelines are adhered to in all sectors of the
research community. ""awe urge you to implement these guidelines
immediately wherever possible by executive directive and/or
rulemaking, and to explore every possible mechanism to assure
compliance with the guidelines in all sectors of the research
community, including the private sector and the international com-
munity. If legislation is required to these ends, we urge'you to
-expedite proposals to Congress 4

.

This is an unprecedented issue in the area of bfomedical
t  f+ has been likened in importance to the discovery of

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interest of permitting this beneficial research to continue with
the'blessing of a reassured public, we must act expeditiously on

Chairman
Subcommittee on