R. Rabin


these definitions. The agencies adopted the scientific principles underlying
the definitions in ways consistent with their legislation. They will use the
definitions to identify levels of review for microbial products, or as factors
to consider in reviewing product applications or research experiments.
 The agencies will seek to operate their programs in an integrated and
coordinated fashion; together they should cover the full range of plants,
animals, and microorganisms derived by the new genetic engineering
techniques. To the extent possible, responsibility for a product use will lie
with a single agency. Where regulatory oversight or review for a particular
product is to be performed by more than one agency, the policy establishes
a lead agency, and consolidated or coordinated reviews. All of this will be
clear to you in the forthcoming Federal Register Notice.
 Unfinished business by the Biotechnology Science Coordinating
Committee includes defining "release into the environment" and revisiting
the concept of "containment," both physical and biological. When the
committee completes its examination of these topics, once more I am
confident that the agencies will consider this guidance in new rule-making
or modifying regulations affecting genetically engineered organisms. Also,
there remains the question of how to deal with those organisms that
exchange DNA by known physiological processes. The public will have the
chance to comment on the new definitions per se and their applicability to
environmental release, to contained industrial large-scale operations, to
food and food additives, drugs, medical devices, and other possible
products.
 In closing, I briefly return to "Leadership" in biotechnology. Leadership
is needed from more than researchers and those who will develop
products. All will lose or gain by the quality of leadership in the federal
agencies, the congressional committees and their staffs, the trade
associations, in short, all the stakeholders in biotechnology.
 Congress can show leadership in the regulatory arena by giving the
current statutes and authorities a chance to work within the
administration's revised version of the Coordinated Framework for
Regulation. Industry can show leadership by continuing its cooperative
attitude with the agencies and responding substantively to the new Federal
Register Notice. Researchers and government officials can show leadership
by their insistence that modern molecular and cellular biology are as
applicable to plant science and agriculture as they are to health science
and pharmaceuticals production. The relative neglect of academic basic
research in plant science in the totality of federal basic research policy and
financing no longer can be justified. Al Wood emphatically would agree.