SUSTAINING AMERICAN LEADERSHIP IN BIOTECHNOLOGY 231

expression and activity with flanking sequences whose identity and
functions were known in advance. The beauty of these regulatory
sequences-these origins of replication, ribosome binding sites, promoters,
operators and terminators-is that they don't produce a gene product.
They only initiate and modulate nucleic acid synthesis at a specific region.
They are the governors of the business.
 The changing ethos surprised many. We had accepted containment;
deliberate release was now antiethical. Rancor and litigation replaced
accord. Molecular biologists and geneticists, who had dominated
biotechnology, were aggressively challenged by ecologists.
 The arguments centered on the lack of experience and information
about the fate and environmental effects of introduced genetically
engineered organisms. Widely accepted test protocols to provide data on
survival, multiplication, dispersal and effects were not available. The NIH
RAC struggled with the problem. Its environment subcommittee
recommended a series of "Points to Consider" in conducting research that
involved intentional release. But it was clear that the government needed
more than NIH to be the spear carrier for its agencies as the new organisms
had to be moved out of the lab for testing under natural conditions. Also,
NIH could hardly be blamed for reluctance to be in court on issues with
which it had little experience and which were allied much more closely
with other agencies' research and regulatory functions.
 In April 1984, Jay Keyworth, then the President's Science Advisor,
called policy officials of departments and agencies to a meeting in the Old
Executive Office Building. I attended as the representative of the National
Science Foundation. He delivered a plain message: The developing
industry doesn't understand the regulatory labyrinth of biotechnology.
Make your regs and policies understandable. You will continue to meet as a
newly constituted Cabinet Council Working Group on Biotechnology. You
will report to the Cabinet Council on Natural Resources and the
Environment.
 Eight months later on the last day of the year, the Working Group's
labor was published in the Federal Register as the Coordinated
Framework for the Regulation of Biotechnology. It also described the
Biotechnology Science Board, an overarching policy apparatus with
quasi-regulatory power. During the following three-and-a-half month
public comment period it became evident that this first effort to forge a
national policy was flawed.
 On other fronts, things were going poorly in the spring and summer of
1985. Member nations of the Organization for Economic Cooperation and
Development were attempting to agree on safety considerations for