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November 15, 2004


AgStrategies For Reforming Regulatory Abuses


Today in AgBioView Special from www.agbioworld.org : November 15, 2004

Six Strategies For Reforming Regulatory Abuses

- Excerpted with permission from "The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution" by Henry I. Miller and Gregory Conko

Praeger Publishers, Hardcover ISBN: 0-275-97879-6; 296 pages $39.95 http://www.greenwood.com/books/BookDetail.asp?dept_id=1&sku=C7879

Habituation, the gradual adaptation to a specific stimulus or to environmental conditions, is a biological phenomenon that may also be said to apply to political influences. Irrational and burdensome public policies can become so much a part of the landscape that their victims consumers, businesses, and institutions no longer experience a sense of outrage or push for reform. In other words, the worst becomes the norm. We see habituation in the passivity of academic and industrial scientists toward the regulatory abuses of the new biotechnology.

Rather than working to make oversight more scientific and consistent, many researchers have capitulated and tried to "work around" regulatory strictures. As a result of this strategy, much research and development has come to naught. Projects have been unable to advance to field testing, and failed companies have been sold at bargain-basement prices or have closed their doors. There are far fewer agricultural biotechnology companies today than there were only a decade and a half ago.

Earlier in this chapter, we suggested ways that government regulation could be improved by structural and management changes, including specific recommendations. But government left to its devices won't adopt these changes. One USDA regulator boasted that only the enlightened regulation by her agency has prevented damage to American agriculture from gene-spliced organisms.

This banality reminds us of the story about the fellow who blows a whistle continuously while walking down Fifth Avenue in New York City. A friend asks him what he's doing, and he responds that it's to keep away the wild lions and tigers. The friend remonstrates that there aren't any wild lions and tigers within six thousand miles, and the fellow says happily, "You see, it's working!"

For two decades, ever-deteriorating government policies have weighed down the progress and promise of the new biotechnology applied to agriculture and food production. But who and what can lift such a weight? Can it be accomplished at a stroke, or must it proceed according to Max Planck's observation that an important scientific innovation rarely makes its way by gradually winning over its opponents, but rather that its opponents gradually die out and the succeeding generation is familiarized with the ideas from the beginning? We fear that the latter is more likely, although it is past time that those outside government began to hold policy makers accountable and to demand change.

Perhaps reflecting the triumph of hope over experience, below we suggest six strategies for "progress"which we would define as the evolution of public policy toward more scientific, risk-based approaches to regulation of the new biotechnology.

1. Scientists Must Actively Protest Unscientific Policies and Regulations

Individual scientists must do more of what physicist and writer Freeman Dyson, the late paleontologist Stephen Jay Gould, and the late microbiologist Bernard Davis have done in their articles and books contribute concisely and wisely to the dialogue on public policy issues. Scientists are especially well qualified to expose unscientific arguments and should do so in every possible way and forum, including writing scientific and popular articles, agreeing to be interviewed by journalists, and serving on advisory panels at government agencies.

Scientists with mainstream views have a particular obligation to expose and debunk the misrepresentations of their few rogue colleagues, whose declarations that the sky is falling receive disproportionate attention. We are reminded of Keith Schneider, the New York Times' environmental reporter who, when asked why he habitually included in his articles extreme and ridiculous speculations from non mainstream scientists, responded, "They're the only ones who will talk to me on the record!"

Although an overwhelming majority of scientists opposes process- or technique-based approaches to the regulation of gene-splicing and its products, few scientists actively protest them. Even as industry trade associations, companies, and government officials conspire to implement and maintain unscientific and excessive regulation, the expected chorus of indignation from individual agricultural biotechnology researchers and farmers fails to materialize.

Dr. Elizabeth Whelan, president of the American Councisl on Science and Health, has offered several possible explanations. She believes that most scientists are more comfortable in their labs than on Nightline or the pages of the New York Times, fear being labeled "paid liars for industry," and are so super-specialized that they are ill equipped to comment on issues of policy.16 She could have added that, as we described in chapter 5, scientists' treatment at the hands of regulators they have agreed to advise can be manipulative and unpleasant.

Many farmers and farm organizations have played an active role in explaining and promoting the many benefits of agricultural biotechnology, but when it comes to specific regulations, farm organizations are much like other industry associations: Depending on their narrow self-interest, they are inclined to sit on the sidelines or even to embrace public policy that keeps the new biotechnology from intruding into and possibly complicating their lives. Paradoxically, they seem at times to regard the promise of a superior, powerful, safe new technology more as a problem than a solution.

Scientists too may be motivated by a desire to try to reduce the uncertainty in their work environment and to placate federal governmental grant makers. But scientists are not your average interest group. They alone possess the skills necessary to debunk activists' propaganda authoritatively, and the very nature of science that is, a systematic search for the truth, wherever it lies should make scientists less likely to pursue narrow, short-term interests at the expense of honesty.

Perhaps it is surprising, then, that instead of demanding rationality in public policy, most scientists have settled for "transparency" and predictability the predictability of delay, frustration, legal liability, public backlash, and loss of markets. Others have been seduced by the myth that just a little excess regulation, even if unwarranted, will assuage public anxiety, neutralize activists' alarmist messages, and bring about the technology's golden age. Although defenders of excessive regulation have made those claims for decades, the public and activists remain unappeased, biotechnology research and development continue to be shackled, and the policy miasma has only deepened.

Exceptions to this naiveté include a few professional societies and a handful of individual scientists who have called for rational regulation in editorials and communications with government agencies. These include the blunt and excellent reports from eleven scientific societies17 and from the Council on Agricultural Science and Technology18 that excoriated the EPA's process-based regulatory approach (chapter 3), and an analysis of food biotechnology by the Institute of Food Technologists.18.5 But the threshold for definitive action is high, the organizations tire long before the activists and regulatory agencies do, and these efforts have had only limited impact.

Encouraging scientists to test the public policy waters is not, however, without its risks. No matter how brilliant a scientist may be in his specialty, acuity on public policy issues requires a broader perspective and different fund of knowledge. An example is the Science editorial by eminent yeast geneticist Gerry Fink in which he recounted how in the late 1970s, National Science Foundation administrator Herman Lewis found a way to circumvent the NIH recombinant DNA guidelines' prohibition on doing certasin gene-splicing experiments in yeast, thereby permitting Fink and his coworkers to perform experiments, literally years before they would otherwise have been able. Their experiments accelerated research leading to the ultimate development of a vastly-improved, second-generation hepatitis B vaccine.

But in his editorial, Fink neglected a critical point that other U.S. researchers who lacked a governmental Good Samaritan were stymied for years by regressive, unnecessarily restrictive federal regulatory policies and, in the end, consumers and patients were denied beneficial options. Because Lewis was such a notable exception to the rule, the real story was about how bad science makes bad policy, and about the real-world impacts of those policies. But Fink lacked a perspective on the wider dimensions of the NIH rules.

2. Scientific Institutions Must Stimulate Public Discourse

The second strategy pertains to science in its institutional forms - professional associations, faculties, academies, and journal editorial boards. These organizations should far more aggressively explore and elucidate the controversies about public policy and elevate the level of discourse on them. They should do much more to point out the flaws in current and proposed policies, and they should be as demanding about rigor on public policy issues as they are about the conduct of research. Scientific societies can create awareness of the importance of regulatory policy by building high-profile public policy symposia into all national and international conferences.

Journals can editorialize appropriately and, to return to the example of the Fink editorial, the editors at Science could have steered it to the more didactic and broader theme. However, the corrupt process of policy analysis at the National Research Council (chapter 3), and editorial failures at major journals interestingly, all in the direction of the overestimation of the risks of the new biotechnology illustrate the shortcomings of important scientific institutions and suggest that we may be asking too much.

Reporters and their editors wield tremendous power and can do a great deal to illuminate policy issues related to science. Too often, however, they botch these stories, in the interest of "balance" conferring a kind of moral equivalence on all points of view even after the dialogue has progressed to a point where some have already been discredited. In the post-Darwinian policy-making world, advocates of "creation biology" deserve less credibility on issues of evolutionary biology than, for example, the works of the late Harvard paleontologist Stephen Jay Gould.

Claims of the invention of perpetual-motion machines, in violation of the laws of thermodynamics, should be discounted. Likewise, endless repetition of the myth that recombinant DNA technology poses some inherent risk, when decades of experimental evidence and commercial use of gene-spliced products have produced no evidence of it, cannot be justified.

All viewpoints are not created equal, but a review of the news coverage by one journalism researcher found that between 1997 and 2000, the New York Times and the London Times used fewer and fewer university-based scientists as sources and that they were more than twice as likely to quote representatives from such activist groups as Greenpeace, Environmental Defense, and the Union of Concerned Scientists, whose views range from foolishness to fraud, from mawkishness to mendacity.19.5

Journalists need to learn that where there's the smoke of activists' alarmist propaganda, there isn't necessarily the fire of genuine controversy, yet we hear endless prattling about presenting "both sides of the issue." There aren't always two sides, however. If the subject were advances in blood banking, would the media seek out activists opposed to blood transfusions?

Journalists seem to delight in predictably extreme and witless quotes from anti-biotechnology activists. As in the creation biology, perpetual-motion machine, and blood transfusion examples above, the media must focus on the legitimate portion of the spectrum of opinion, if they wish to inform the public about what is truly known and unknown, the nature of the risks of using and not using the technology or product, and the importance of public policy in their lives.

The public should be exposed to genuine controversy, to be sure but not to the manufactured, gratuitous pseudo-controversies that are fomented by activists, and that are bread and butter to the media. We do not believe that the public interest is served by a discussion of whether genetically engineered pigs will fly and, in so doing, disrupt air-traffic control, or whether the corona virus that causes SARS (severe acute respiratory syndrome) originated in a field planted with gene-spliced crops.

Aggravating matters further is the common reportorial practice of using business leaders as the sole source of supposedly pro-biotechnology opinions. We discussed earlier in this chapter and in chapter 3 the often myopic and sometimes-bizarre views held by individual company executives, firms, and trade associations that reflect nothing more than self-interested spin. On the other hand, there are many astute, responsible executives and scientists in the corporate sector, but reporters and consumers of news often discount their views because of perceived conflicts of interest.

4. The Biotechnology Industry Must Advocate Scientific Regulatory Policies

Companies and trade associations should eschew short-term advantage and actively oppose unscientific, discriminatory regulations that set dangerous precedents. The U.S. biotechnology industry's support for policies like the USDA's Plant Pest Act regulations, the EPA's technique-based proposals, and the FDA's proposed case-by-case review of all new-biotechnology-derived foods guarantees that they will have a long road to hoe. It ensures recurrences of public-relations disasters like the furors over the alleged killing of Monarch butterflies, purported transfer of genes from gene-spliced crops into native corn species in Mexico, and supposed "contamination" of food by StarLink corn, biopharmed crops, and the like.

Industry's advocacy of fundamentally flawed, unscientific regulatory policies is tantamount to a farmer eating his seed corn. In the long run, commercial interests will benefit most from the predictability and logic of science-based policies and from a robust academic research enterprise. Productivity is squandered by public policy that forces researchers to spend their time and resources doing mountains of unnecessary paperwork instead of experiments, that is anti-competitive, that lays waste to free markets, and that creates potential civil and criminal liability for inconsequential violations.

5. All Stakeholders Should Promote Science-Based Public Policy

The biotechnology industry has spent vast sums to improve its image, but this campaign has been more concerned with public relations than public health; more cheerleader than leader. As discussed above and in chapter 3, the industry has not been a staunch advocate of enlightened public policy.

However, there are others not directly involved in research and development who are important stakeholders in the ultimate applications of science and technology venture capitalists, philanthropists, and consumer and patient groups, for example and who can contribute to needed regulatory reform. They should increase their informational activities and advocacy, by commissioning experts and lobbyists and by joining forces with organizations such as think-tanks that have similar goals..

6. Rethink the Government's Monopoly over Regulation

The devastation wreaked on the public interest by government regulators would not have been possible were it not for the federal regulatory monopoly over the new biotechnology (and the absence of effective oversight by the Congress). However, there is nothing sacrosanct about a government monopoly over regulation, which has made such a morass of the new biotechnology applied to agriculture and food production.

As we have discussed throughout this volume, recombinant DNA technology is subjected to far more stringent oversight than the various manifestations of its less precise and predictable precursor, conventional biotechnology. Most often, the latter are subject only to the strictures of good agricultural practices, but unless organisms exhibit a high degree of risk (for example, by being classified as plant pests or noxious weeds) they are not subject to case-by-case government reviews as they move from research, through development, to commercialization. Rather, society has devised a variety of alternative institutional arrangements that effectively regulate and monitor the testing and marketing of a wide variety of products and services.

Nongovernmental mechanisms exist not only for conventional agriculture (including quality control for seeds) but also for hospital certification, organ transplantation, and tens of thousands of categories of consumer products. As we described in chapter 5, even when government is involved, it is often in the form of policing of the marketplace, rather than pre-testing or pre-marketing review.

It is past time for the biotechnology regulatory pendulum to swing away from unnecessary and discriminatory government reviews, toward other


As we have argued throughout this book, the costs of the present public policy toward the new biotechnology far outweigh its benefits. We have identified several examples where the balance is overwhelmingly negative. The failures of government, industry, and the media, the excessive regulation, pseudo-controversies, and endless repetition of The Big Lie by activists collectively constitute one of the most costly and tragic hoaxes of the last century.

None of this was necessary. We would have been far better off if, instead of implementing regulation specific to the new biotechnology, governments had approached the products of gene-splicing in the same way as they regulate similar products -- new plant varieties, food, pesticides and so on made with older, less precise and predictable techniques. Regulators could simply have applied to the products of the new biotechnology preexisting public policy, which is (more or less) risk-based and which emphasizes surveillance and policing, rather than endless, redundant case-by-case reviews of proposals to test or market products.

Whatever the level of affluence we enjoy in our personal lives, government policy toward the new biotechnology has impoverished our public lives. Government regulators, activists, and many in industry have failed the simple test proposed by Mahatma Gandhi to determine the validity of strategies designed to meet the most basic human needs: "Recall the face of the poorest and the weakest man whom you have seen, and ask yourself if the steps you contemplate are going to be of any use to him. Will he gain anything by it? Will it restore to him control over his own life and destiny?"

The adoption of some of the remedies described here will help to amend, even in this small realm and in a limited way, the validity of historian Barbara Tuchman's sad observation that "mankind, it seems, makes a poorer performance of government than of almost any other human activity." And it will help governments, and the rest of us, to pass Gandhi's test.