SUSTAINING AMERICAN LEADERSHIP IN BIOTECHNOLOGY 233

Coordination Act of 1986. Since OSTP is directly and strongly affected,
and will have to testify tomorrow, I can only indicate that the
Administration does not support it. By the end of May, technology
everywhere seemed to be on the defensive.
 I return to the suggested topic: how to sustain American leadership in
biotechnology. In this brief historical tour, we have touched on events that
were shaped by those who aspired to leadership and those who attained it,
however briefly. In our democracy, consensus is achieved often with
difficulty; lately, in biotechnology, it seems to have avoided us because no
sustaining leadership is visible. The scientific community has disagreement
within its ranks, the Congress appears bent on new regulatory legislation,
the industry is impatient with government, and government agencies are
accused of managing their affairs not well at all.
 I maintain that new legislation now is premature. The apparatus that
Jay Keyworth established in 1984 and 1985 is healthy and functioning.
The Biotechnology Working Group has delivered its report and
recommendations to the Cabinet's Domestic Policy Council. The Council
approved these on May 20, as a precursor for the President's review. None
of this would have happened if OSTP's Biotechnology Science
Coordinating Committee had not labored zealously under enormous
pressure. Between the Biotechnology Working Group which is dedicated
to policy considerations, and the OSTP's Biotechnology Science
Coordinating Committee which is dedicated to scientific considerations,
the Executive Office of the President has overseen the development of the
new coordinated framework.
 The BSCC was established to coordinate interagency review of scientific
issues related to the assessment and approval of biotechnology research
proposals, biotechnology product applications, and post-marketing
surveillance. It serves as a coordinating forum to address scientific
problems, share information, and develop consensus. It has promoted
consistency in the development of federal agencies' review procedures and
assessments. It will facilitate continuing cooperation on emerging
scientific issues. Given these elements of its charter, the BSCC determined
that its highest priorities were: to establish consistency among the agencies
in the use of current scientific knowledge and to have agencies use
comparable and rigorous scientific reviews.
 Considerable time was spent in seeking adoption by the agencies of the
same or very similar definitions of those genetically engineered organisms
subject to regulatory review. Members eventually agreed on the definition
of an intergeneric, or new, organism, and on the definition of a pathogen.
As a result, they also agreed on what could be excluded from review under