On the Eighth Day

Policy Controversy in Biotechnology:
An Insider’s View

by Henry I. Miller, M.D.
(Forthcoming in Academic Press, 1997) 217 pp.

Reviewed by J. Howard Beales III


Ever since human beings domesticated the first plants and animals, they have relentlessly manipulated the genetic composition of useful organisms, producing new and more productive varieties. For example, many common vegetables, from broccoli and Brussels sprouts to cauliflower and cabbage, are the result of manipulating mustard plant genes. As scientific understanding of genetics and cell biology advanced, the ability to introduce traits from distantly related and even unrelated organisms gave rise to the Green Revolution.

Today biologists can manipulate an organism’s genetic code at the molecular level, inserting desirable genes from virtually any source and deleting genes that code for obnoxious characteristics. What was once the comfortable, familiar, and safe science of plant husbandry has become the sexy, exciting, and sometimes frightening science of biotechnology.

Henry Miller’s rather angry book is a collection of seventeen essays, loosely organized into five chapters that detail the current policy controversies surrounding the regulation of biotechnology. Although occasionally repetitive, the prose is highly readable and not at all technical. Miller himself was heavily involved in the development of federal biotechnology regulation during the 1980s and is a harsh critic of deviations from the generally sensible decisions that resulted.

The essays in the first chapter examine the "process versus product" controversy at the heart of disputes over biotechnology regulation. Does the use of recombinant DNA techniques automatically create a need for regulation? Or, should the characteristics of particular products, no matter what techniques are used to produce them, determine whether and how they are regulated? Miller argues strongly for product-based regulation. That was the Food and Drug Administration’s initial approach: evaluate drugs produced with biotechnology by the same standards as other drugs. Unfortunately, the Environmental Protection Agency and the U.S. Department of Agriculture have favored the process view of regulation, which subjects nearly all products of recombinant DNA techniques to special regulatory scrutiny.

There is no need to do so. One of the most valuable portions of the book is the essay "Myths about Biotechnology" in which Miller shows that modern biotechnology is not a distinct technology, nor is it new. Humans have used microorganisms for millennia. They have modified living microbes to produce valuable products such as live-virus vaccines. "Conventional" techniques have moved genes between plants in different genera to produce more productive crops. What is new is the ability to target and move single genes, rather than producing random samples of genes in search of a desirable combination. That ability, however, increases predictability of the likely outcome and, therefore, reduces risk.

Modern biotechnology is unlikely to produce dangerous organisms. The characteristics of serious pests and pathogens are produced by complex genetic combinations and, thus, are unlikely to be reproduced by the precise, controlled transfer of a small number of genes. For the same reason, the risks from genetically modified organisms are not at all analogous to the well known problems that can result when exotic organisms are introduced in a new habitat. The evolutionary advantages that allowed rabbits, for example, to dominate Australia involve much more than a single gene. On these issues, Miller contends, there is broad scientific consensus. The National Academy of Sciences has concluded that recombinant DNA techniques are safe and there is no evidence of unique hazards from those techniques or the transfer of genes between unrelated organisms.

In the second chapter, "The Conflict Between Politics and Science," Miller savagely attacks the Clinton administration’s biotechnology policy. Vice President Al Gore is the "general leading the regulatory agencies’ little known attack on science and technology," aided by a "staff of administrators and advisors who are shockingly callow and shallow." Miller’s attack reaches its crescendo in the chapter’s third essay, "Powerful Idiocy: Lysenko, Gore, and U.S. Biotechnology Policy." Throughout the chapter, Miller simply and effectively quotes what officials have written, pointing out the absurdities of their views. Miller quotes Gore at length:

The most lasting impact of biotechnology on the food supply may come not from something going wrong, but from all going right. My biggest fear is not that by accident we will set loose some genetically defective Andromeda strain. Given our past record in dealing with agriculture, we’re far more likely to accidentally drown ourselves in a sea of excess grain.

Miller concludes:

Biotechnology has been severely Gored by this administration. Like the policies of Lysenko [Joseph Stalin’s enforcer of politically correct Marxist genetics], U.S. regulatory policies of the past three years...are based not on scientific consensus . . . but on ideology that debases both scientific knowledge and common sense.

Miller’s attack is fair and, unfortunately, accurate.

Miller’s anger remains apparent in his third chapter, which details the lack of any science-based justification for the current biotechnology policies of the regulatory agencies. Miller sees the policies of the EPA and the USDA, which seek to require case-by-case approval of virtually all field trials of organisms resulting from biotechnology, as fundamentally inconsistent with environmental protection. Biotechnology, he contends, has the potential to enhance plant resistance to insects and disease, thereby reducing the need for more dangerous agricultural chemicals. The FDA fares only slightly better. Miller regards its fundamental approach of product-based regulation as sound, but he notes that the Clinton administration has attempted to impose unwarranted registration requirements on biotechnology foods.

Throughout Policy Controversy in Biotechnology, Miller shows how agencies tend to choose policies that preserve and expand their bureaucratic empires. In the fourth chapter, he documents the spread of those flawed policies to the United Nations and the consequent threat to overwhelm the potential benefits of biotechnology for developing countries with regulatory restraints. In the final chapter, Miller seeks to explain why government is the problem and what can be done.

Miller offers several useful insights for students of regulatory policy. He notes that a persistent rationale for biotechnology regulation has been the need to reassure the public. Instead, however, the media and the public have taken stringent regulation as evidence of great and unique risk. After all, if the technology is safe, why is it so strictly regulated? In addition, the regulatory process itself heightens the visibility of innocuous experiments and provides ample opportunity to fan public fears about a new Frankenstein. Thus, well-intentioned efforts to calm public fears instead have provided ammunition for the modern Luddites who believe that new is a synonym for evil. Another useful insight is Miller’s contention that the costs of the regulatory regime disproportionately burden academic researchers. In an era of tight research budgets, the time restraints and financial burdens of complying with regulatory requirements are likely to encourage academic researchers to look elsewhere for better research opportunities.

The book unfortunately offers few reliable solutions. Miller is correct that we should not create regulatory distinctions between similar products based on the production techniques employed. For products like drugs, which are already overregulated, that approach poses little risk of undue regulatory expansion; Miller is on firm ground in arguing for reform of the FDA’s drug approval process. For agricultural uses, however, product-based regulation could easily become a wedge to extend regulation to products of conventional breeding techniques that are largely unregulated.

The bureaucratic risk-aversion that prompts regulation of nonexistent risks hardly encourages optimism that the lines between regulated and unregulated products will be drawn as sound science dictates.

J. Howard Beales III is an associate professor of strategic management and public policy at George Washington University.

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