In an upbeat and collegial Science magazine editorial in June (F.D. Raines, Science, 280:1671, 1998), the outgoing director of the federal Office of Management and Budget (OMB), Franklin D. Raines, addressed how the scientific community might better help to maintain the Clinton administration's commitment to R&D. Raines alluded to the "excitement and wonder of science" and called for better measures of the success of research, greater priority-setting for research fields, and ways to strengthen the government-university partnership.
But there is an almost surreal element of "hear no evil, see no evil" in Raines's article. He seems to have forgotten that federal regulation of science, as well as its funding, was under his purview at OMB, which has the responsibility for final sign-off on all federal regulations. During Raines's tenure, regulation of research, especially academic research, has been federal agencies' b[E WITH CARAT]te noire. Treatment of the new biotechnology by the U.S. Department of Agriculture (USDA) and U.S. Environmental Protection Agency (EPA) is a case in point.
First, by way of background, there is a broad and long-standing scientific consensus about the continuum between conventional and new biotechnology, which was capsulized in an authoritative 1989 analysis of new biotechnology by the U.S. National Research Council (and to which I have alluded in these pages previously): "With classical techniques of gene transfer, a variable number of genes can be transferred, the number depending on the mechanism of transfer; but predicting the precise number or the traits that have been transferred is difficult, and we cannot always predict the phenotypic expression that will result. With organisms modified by molecular methods, we are in a better, if not perfect, position to predict phenotypic expression."
A 1992 editorial in the distinguished scientific journal Nature (356:1-2, 1992) made a similar point: "The same physical biological laws govern the response of organisms modified by modern molecular and cellular methods and those produced by classical methods, and [therefore] no conceptual distinction exists between genetic modification of plants and microorganisms by classical methods or by molecular techniques that modify DNA and transfer genes."
However, on Raines's watch federal agencies treated classical methods and modern molecular methods very differently, imposing new regulations and establishing and maintaining gratuitous new bureaucracies to regulate products made with the newest, most precise, and sophisticated techniques.
Item: USDA's 1997 "regulatory reform" of oversight of field trials of gene-spliced organisms was woefully inadequate. The Animal and Plant Health Inspection Service's regulations continue to impose excessive and hugely expensive field-test design and other burdens on gene-spliced organisms. For example, during shipping or cultivating, gene-spliced plants cannot be mixed with plants modified in other ways (which includes virtually all cultivated crop and garden plants), and all living plants must be destroyed at the completion of the field trial.
Item: In 1997, the EPA issued a regulation under the Toxic Substances Control Act that has halted most research into any "new'' organism (strangely defined as one that contains combinations of DNA from unrelated sources) that might be used, for example, to degrade oil spills or clean up toxic wastes. For EPA, "newness" is synonymous with risk. Because gene-splicing techniques can easily be used to create new gene combinations with DNA from disparate sources, these techniques therefore "have the greatest potential to pose risks to people or the environment," according to the EPA. But, as discussed above, a broad scientific consensus holds that the genetic technique employed is irrelevant to risk, as is the origin of a snippet of DNA that may be moved from one organism to another; what matters is its function.
Item: The EPA is expected any day to issue a final regulation that requires review as pesticides of the testing of gene-spliced crop and garden plants that have been modified for enhanced pest or disease resistance. This policy is so potentially damaging and outside scientific norms that in August 1996, 11 major scientific societies representing more than 80,000 biologists and food professionals published a report that excoriated the EPA's proposal. The societies' report warned that the EPA policy would:
- discourage the development of new pest-resistant crops and prolong and increase the use of synthetic chemical pesticides;
- increase the regulatory burden for developers of pest-resistant crops;
- limit the use of biotechnology to larger developers who can pay the inflated regulatory costs; and
- handicap the United States in competition for international markets.
While these proposals, among others, were sailing through his agency and ravaging research in several promising new scientific areas, where was Franklin Raines?
Henry I. Miller is a fellow at Stanford University's Hoover Institution and the author of Policy Controversy in Biotechnology: An Insider's View (Austin, Texas, R.G. Landes Co., 1997).