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May 6, 2004


Miller and Conko Unleashed - Biotech's Antagonists; I Love Humanity - It's People I Can't Stand


Today in AgBioView Special from www.agbioworld.org - May 7, 2004:

* Biotech's Antagonists
* "I Love Humanity; It's People I Can't Stand"


Biotech's Antagonists

- Henry I. Miller and Gregory Conko, TechCentral Station, May 4, 2004†


(Editor's note: This is the first article of a two-part series.) (Part Two appears below)

Controversies continue to engulf the "new biotechnology" -- also known as gene-splicing or genetic modification (GM) -- applied to agriculture and food production. Perhaps pseudo-controversies would be a more apt term, given that every new supposed problem has turned out to be nonexistent or inconsequential, and biotech's benefits are proven: They include less use of chemical pesticides, higher crop yields and more environment-friendly farming practices. Yet each new scare story is given life by the half-truths and misrepresentations of biotech's vocal, well-organized opponents, who are heavy on lobbying and lawyering but light on science and scholarship.

Biotech's most doctrinaire antagonists don't disguise their hostility. Technophobe Jeremy Rifkin claims that it threatens "a form of annihilation every bit as deadly as nuclear holocaust." Greenpeace demands biotech products' "complete elimination [from] the food supply and the environment." And sacked UK environment minister Michael Meacher, speaking on behalf of Greenpeace, has admitted that there could never be sufficient testing to convince him of the safety of biotech foods: "The real problem is whether 10, 20, 30 years down the track, serious and worrying things [will] happen that none of us ever predicted."

Meacher also reaches into the activists' bag of tricks to smear biotechnology with the post hoc, ergo propter hoc fallacy ("one thing happens after another; therefore, the former caused the latter"). He writes, "coinciding with the introduction of [gene-spliced foods] in the US, food-derived illnesses are believed by the official US Centers for Disease Control to have doubled over the past seven years. And there are many reports of a rise in allergies -- indeed a 50 per cent increase in soya allergies has been reported in the UK since imports of GM soya began." He could just as plausibly have ascribed these maladies to the assumption of power by Democratic and Labour governments in the U.S. and U.K., respectively, or to some other equally spurious coincidence of events.

Other groups pose as open-minded skeptics, rather than antagonists, but beneath the rhetoric their arguments and actions lead us to much the same
place: The goal of all the radical activists is to create a groundswell of anxiety toward biotech, and to elicit unnecessary, hugely burdensome government regulation that will make product testing and commercialization practically untenable. Nevertheless, their publications and announcements receive extensive media and government attention, largely because the lavishly funded organizations -- including the Pew Initiative on Food and Biotechnology, the Center for Science in the Public Interest, Environmental Defense, Union of Concerned Scientists, and Resources for the Future -- aggressively tout themselves as occupying the disinterested middle ground in the biotechnology debates. But their PR machines saying that doesn't make it so.

These and other similar organizations feign "moderation" by vaguely acknowledging biotech's potential, and by raising scientific-sounding concerns, but genuine moderation means more than the absence of absurdist rhetoric. Just as the value of real estate depends on "location, location and location," the value of dialogue on biotech's risks and rewards requires "context, context and context."

Balance requires that discussions of biotechnology's risks and benefits be placed within the context of the risks and benefits of older, "conventional" techniques of genetic modification. But activists' relentlessly yet subtly alarmist reports and forums invariably emphasize the things that might go wrong, while studiously avoiding the essential context. They conveniently ignore vast amounts of data, including literally millennia of experience with pre-gene-splicing genetic modification, and they continue to deny the well-established scientific consensus that no unique risks attend the use of gene-splicing techniques. And they carefully nourish the myth that "genetic modification" -- by which they mean only gene-splicing -- is a distinct category that is somehow fundamentally different from other, earlier methods of genetic improvement.

In fact, every hypothetical risk of gene-spliced organisms also exists with conventional breeding methods, and risks are most often greater with the older, less precise techniques. Although standard assessment methods for new plant varieties most often are able to identify potentially harmful outcomes, occasionally the imprecise, trial-and-error techniques of conventional breeding methods lead to problems. Two conventionally bred varieties each of squash and potato and one of celery were found to contain dangerous levels of endogenous toxins and had to be barred from commercialization. Such mishaps are far less likely when genetic changes are wrought with the more precise and predictable gene-splicing techniques, and none has been observed in spite of widespread use of gene-spliced crops and foods for more than a decade. Nevertheless, groups like Pew, CSPI, UCS and RFF continually fret over the alleged "uncertainty" about the new biotechnology's safety. Never is there any hint that similar -- and often greater -- uncertainties characterize the more conventional breeding techniques. Nor is there any discussion of the safety testing that plant breeders, farmers and others conduct as a matter of course.

Why these omissions? Precisely because the activists intend to frighten the public and intimidate regulators into tightening already burdensome regulation.

CSPI, for example, frets about the "transfer of the engineered gene to other species, the emergence of pesticide-resistant pests, and the adverse effects on small farmers or developing nations." One of its reports laments that when it comes to gene-spliced organisms, "Toxicants and anti-nutrients that may affect food safety and nutrition are not always evaluated," and it calls for wholesale changes in the way biotech foods are regulated (read: more regulation). An April 2004 report from the Pew Initiative on Food and Biotechnology took an innovative tack to implying that government regulation is inadequate. It conceded that although the current "first generation" of gene-spliced agricultural products may be overseen appropriately by existing current oversight procedures, in the coming "second generation" of products, "[m]any of these genetic modifications will be substantially more complex than the single-gene, single-trait modifications of the first generation of [gene-spliced] crops. The new products are expected to enter into the regulatory review process in the next two to ten years and could pose novel issues for the regulatory agencies."

The constant refrain: more uncertainty, more concerns, the need for more regulation. A 2002 report from the Pew Initiative agonizes about the potential of foods from future generations of gene-spliced organisms to cause allergic reactions, because scientists understand "little about the fundamental mechanism by which people develop allergies," and "[t]he ability of [gene-splicing] to move genes from one organism into another creates the possibility of introducing allergenic proteins into foods that would not ordinarily contain them." The Union of Concerned Scientists recently commissioned testing that supposedly found gene-spliced material in "conventional" seed preparations, and -- in the press but not in any scientific journal -- they were quick to condemn this "contamination." The Center for Science in the Public Interest has raised various other questions about gene-spliced plants, including the "transfer of the engineered gene to other species, the emergence of pesticide-resistant pests, and the adverse effects on small farmers or developing nations."

When considered in a vacuum -- as though farmers, plant breeders and others had never before sought and wrought genetic improvement of food plants -- these seem like legitimate concerns. However, all types of plant breeding -- including traditional techniques as well as the newer molecular methods -- routinely introduce new DNA, proteins and other substances into the food supply. Since the 1930's plant breeders have performed "wide cross" hybridizations in which large numbers of "alien" genes are moved from one species or one genus to another to create plant varieties that cannot and do not exist in nature. Common commercial varieties derived from wide crosses include tomato, potato, pumpkin, black currant, oat, rice, wheat and corn, among others.

Using pre-recombinant DNA technology such as wide-cross hybridization and mutation-induced breeding, breeders and food producers lack knowledge of the exact genetic changes that produced the useful traits. More important, they have no idea what other changes have occurred concomitantly in the plant -- including those that could alter the ability to cause allergic reactions. Only recombinant DNA techniques allow breeders to identify and fully describe the changes that have been made in the progeny. This increased precision and predictability make foods from recombinant organisms safer than conventional ones -- but paradoxically they are far more intensively regulated. Neither government regulators nor the minions at the radical NGOs have shown the slightest concern about the real risks of plant breeding. Instead, they bleat endlessly about the hypothetical risks of recombinant DNA technology -- which never materialize.

The NGOs' selective memory, in effect, repudiates biology and the history of agriculture. Gene flow is ubiquitous. All crop plants have relatives somewhere on the planet, and some gene flow commonly occurs if the two populations are grown close together. Growing hundreds of crops, virtually all of which (save only wild berries and mushrooms) have been genetically improved, the practitioners of "conventional" agriculture in North America have meticulously developed strategies for preventing pollen cross-contamination in the field -- when and if it is necessary for commercial reasons. The history of canola -- the general term for the genetically improved rapeseed developed by Canadian plant breeders a half-century ago -- offers a good example. The original rapeseed oil, used as both a lubricant and as an edible oil, was harmful when ingested because of high levels of a chemical called erucic acid. Conventional plant breeding led to the development of genetic varieties of rapeseed with low concentrations of erucic acid, and this "canola" oil has now become the most commonly consumed oil in Canada. High-erucic acid rapeseed oil is still used as a lubricant and plasticizer, however, so the high- and low-erucic acid varieties of rapeseed plants must be carefully segregated in the field and thereafter during processing. This is accomplished routinely and without difficulty by Canadian farmers and processors.

But the activists choose to ignore such relevant history and context. Contrary to their remonstrations that they are non-partisan and agnostic about biotechnology, their workshops, conferences and publications show a pervasive, risk-averse, anti-innovation, pro-regulation bias. The new biotech is already subject to illogical, unscientific, excessive, regulation, but the activists demand more.

Another tactic favored by activists and calculated to confuse the public discourse is to establish a kind of moral equivalence between those who hold ideological, anti-biotechnology views and those who are committed to sound science as the basis for public policy.†

For example, the Pew Initiative created a clever device intended both to conceal its own bias and real agenda and to lend legitimacy to radical
views: a "stakeholder forum" comprised of representatives of the food and biotechnology industry, farmer organizations, food retailers, and anti-biotechnology activists. The forum was portrayed as a "balanced" dialogue between biotech's supporters and opponents that included views across the entire spectrum. However, the reality is quite different: a kind of Potemkin Village town meeting. The views represented ranged from the center to the far, far left, with the latter heavily represented. (And in order to mollify their critics, even the middle-dwelling big agribusiness and biotech companies capitulated to the reality of greater, discriminatory regulation of gene-spliced organisms and products derived from them.) The anti-biotech faction included such tenacious, mendacious opponents of agricultural biotechnology as Environmental Defense's Rebecca Goldburg, the Union of Concerned Scientists' Margaret Mellon, and U.S. Public Interest Research Group's Richard Caplan. The 19-person committee contained just three academic scientists -- one of whom also has long been a biotechnology critic.

Pew's notion of "balance" was to mix intractable, anti-technology radicals with academics and industry representatives who have largely moderate, mainstream views. It was transparently obvious in which direction the "consensus" was intended to go. It is also revealing that every member of Pew's stakeholder forum had to agree at the outset that the current, biased, excessive regulatory apparatus is still in some way insufficiently stringent.

In spite of the litmus test and the stacking of the committee, the stakeholder negotiations broke down when the most extreme anti-biotech ideologues overplayed their hand. They made demands that went beyond even the excessive restrictions that the food and biotechnology industry representatives were willing to concede. Although the industry representatives were prepared to endorse a wholly unwarranted new requirement for a formal pre-market notification process for all new gene-spliced food crop varieties, the more radical faction insisted that FDA must reject its current scientific, official approach and require a formal pre-market authorization of all gene-spliced food crops, regardless of the level of risk individual crops posed.

This agenda was pushed especially hard by one member of the stakeholder forum, Greg Jaffe of the Center for Science in the Public Interest. Although his group poses as unbiased and moderate, it too has a hidden agenda. Jaffe is credited with drafting legislation introduced in Congress by Senator Richard Durbin (D-IL) to establish a mandatory approval process for gene-spliced foods. CSPI then orchestrated a campaign to garner support for the Durbin bill, all the while pretending to be nothing more than an uninvested bystander that favored the legislation on its merits.

CSPI also trotted out North Carolina State University entomologist Fred Gould to support the Durbin legislation. Gould, a respected laboratory scientist but longtime supporter of discriminatory, unscientific biotech regulation, had supervised the publication earlier in 2002 of an internally inconsistent and problematic National Research Council committee report about the scientific basis for biotech regulation at USDA. On the one hand, it endorsed the long-held scientific consensus that gene-splicing is a refinement of previous techniques and "presents no new categories of risk compared to conventional methods of crop improvement," but on the other, concluded that regulatory requirements should be higher than "strictly justifiable based on scientific measures of health and environmental risk," to maintain the "legitimacy" of regulatory agency authority. (An interesting concept: that an unscientific, discriminatory, and hugely expensive approach to oversight somehow maintains the legitimacy of regulatory agency authority.)

It should come as no surprise that the NRC report's reviewers included a veritable Who's Who of former and current regulators (who had worked on the regulations in question and, therefore, had a palpable conflict of
interest) and anti-biotechnology activists; or that many of the same persons (and institutions) who signed the CSPI petition supporting Senator Durbin's bill were to be found on the Pew stakeholder's forum, or that they participated in Pew conferences, workshops and reports. Want to produce an anti-biotechnology treatise? Just round up the usual suspects!

The activists' agenda is to keep the pseudo-controversy roiling and to elicit ever more strict and burdensome regulations, so that biotech products become more expensive to develop, less competitive and, therefore, less likely to appear and survive in the marketplace. In the absence of any evidence of unique or incremental risks of the new biotech
-- and always ignoring the essential context of the new and old biotech -- the radical NGOs invoke as a rationale for discriminatory oversight the canard that the public demands more regulation. In the second and final article of this series, we will discuss public attitudes toward biotechnology, their misrepresentation and manipulation.

Henry I. Miller, a fellow at the Hoover Institution, headed the FDA's Office of Biotechnology from 1989-1993. Gregory Conko is Director of Food Safety Policy at the Competitive Enterprise Institute. Their book, "The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution" will be published later this year.


"I Love Humanity; It's People I Can't Stand"

- Henry I. Miller and Gregory Conko , TechCentral Station, May 5, 2004


Part 1 of this series discussed the misconceptions and misrepresentations that are promulgated by anti-biotechnology NGOs. Their significant distortions and omissions of facts are not limited to statements about the nature or risk of the technology itself. The activists also attempt in invidious ways to create a presumption of genuine controversy (where none
exists) over the safety and usefulness of gene-splicing techniques.

For example, the Pew Initiative's 2003 report, "Public Sentiment About Genetically Modified Food," is a typically disingenuous pastiche of truisms, half-truths and sleight-of-hand. Their survey finds that "Americans' knowledge about [biotech] foods remains low," with 54 per cent saying they have heard nothing or not much about them. Then, without enlightening the subjects or offering them any sort of proper context, the survey goes on to pose leading questions about safety and regulation. Not surprisingly, 89 percent agreed with the statement, "Companies should be required to submit safety data to the FDA for review, and no genetically modified food product should be allowed on the market until the FDA determines that it is safe."

This polling technique is rather like the example of Idaho junior high school student Nathan Zohner, who found that 86 percent of survey respondents thought the substance dihydrogen monoxide should be banned when told that prolonged exposure to its solid form causes severe tissue damage, exposure to its gaseous form causes severe burns, and it has been found in excised tumors of terminal cancer patients. Only one in 50 of young Nathan's survey respondents correctly identified dihydrogen monoxide as water, or H2O. As any pollster (as well as common sense) will tell you, it's not hard to design survey questions to elicit a desired response, and Pew has incorporated that trick into their repertoire.

What the almost nine-in-ten respondents in Pew's survey undoubtedly do not recognize is that: 1) with the exception of wild berries, mushrooms and game, and fish and shellfish, virtually all the organisms -- plants, animals, microorganisms -- in our food supply have been modified by one genetic technique or another; 2) because the techniques of the new biotech are more precise and predictable than their predecessors, biotech foods are likely to be even more safe than other foods; 3) food producers are already legally responsible for assuring the safety of their products, and the FDA does not normally perform safety determinations, but primarily conducts surveillance of marketed foods and takes action if any are found to be adulterated or mislabeled, and; (4) unwarranted, excessive regulation, including unnecessary labeling requirements, discourages innovation, imposes costs that are passed along to the consumer and are a disproportionate burden on the poor. The Pew survey purposefully exploits consumers' (understandable) lack of familiarity with the nuances of both the new biotech and the way that food is currently regulated.

With critics raising at every opportunity the possibility of one hypothetical risk or another of gene-splicing -- and a compliant, sensation-seeking media printing every word -- it's no wonder that many of those who have heard about biotechnology find it confusing and a little scary. But more generally, hoodwinking the public on scientific and technological subjects is not difficult. A study by the National Science Foundation found that fewer than one in four know what a "molecule" is, and only about half understand that the earth circles the sun once a year.

Another example of the public's muddled view of biotechnology is reflected in the results of a survey of 1200 Americans, released in October by the Food Policy Institute at Rutgers University. It found that, in an eleven-item true/false quiz that was part of the survey, more than half of the subjects received a failing grade (defined as less than 70 percent correct answers). Only 57 percent recognized the falsity of the statement "ordinary tomatoes do not contain genes, while genetically modified tomatoes do." Perhaps most shocking of all, only two thirds knew that eating genetically modified fruit would not alter their own genes! One wonders whether the one-third who got this question wrong think that if they eat rabbit stew, they'll begin to hop . . .

Such results are not surprising. A reckoning of the costs and benefits that could accrue to an individual confronted by such complex issues explains why few citizens undertake to understand the subtleties of most government policies, let alone those that involve scientific phenomena. There is vastly more to public policy issues -- tax policy, foreign affairs, farm subsidies, health care delivery and so on -- than any one person can grasp. For most citizens the benefit of learning about issues and policies that do not directly affect them is small and the cost is large, so they establish priorities and pursue knowledge that is of the greatest immediate advantage, and they end up not knowing much about public policy. Economists have dubbed these poorly informed citizens "rationally ignorant"; incapable of coming to grips with the nuances of complex policy issues, they simply choose to focus their limited time and resources on other pursuits. NGOs have learned to exploit the public's rational ignorance.

Many NGOs have a dual raison d'Ítre: to pitch fears, not facts, to an unsuspecting public, and to convince regulators to impose unnecessary, discriminatory regulation on the new biotechnology. They have enjoyed modest success. Over-regulation has inflated the costs of research and development, made commercialization -- and even the ability to perform field testing -- uncertain, and put biotech off-limits to some philanthropists.

Consider the example of Harvest Plus, an alliance of organizations devoted to producing and disseminating staple foods rich in micronutrients such as iron, zinc and vitamin A. According to its director, the group has decided that, although they will "investigate . . . the potential for biotechnology to raise the level of nutrients in target crops above what can be accomplished with conventional breeding . . . there is no plan for Harvest Plus to disseminate [gene-spliced] crops, because of the high and difficult-to-predict costs of meeting regulatory requirements in countries where laws are already in place, and because many countries as yet do not have regulatory structures."

Although efforts should be made to reassure the public about the safety of gene-spliced crops and foods, excessive regulation is not the way. The imposition of unwarranted regulation in order to quell public apprehension is not a wise use of government power, nor is it likely to succeed. As the president of Consumer Alert, a national consumer organization, testified to a panel convened by the National Institutes of Health (NIH), "For obvious reasons, the consumer views the technologies that are most regulated to be the least safe ones. Heavy involvement by government, no matter how well intended, inevitably sends the wrong signals. Rather than ensuring confidence, it raises suspicion and doubt" (emphasis in original).

It is apparent that biotech's opponents will never be satisfied. At every opportunity, they will raise spurious questions and make disingenuous assertions, attempting both to prolong "controversy" and to maintain existing unscientific regulatory regimes.

Biologist Donald Kennedy, editor of Science and former FDA Commissioner and Stanford University president, has analyzed various aspects of governmental oversight of America's scientific enterprise. Bringing to it the experience of a scientist and regulator, Kennedy observes that bad public policy usually results when we respond politically to some popular movement, such as radical environmentalism, only to discover that we have mistaken its real motivation. "'We did what they wanted, but after we did it they turned out to want something else' is among the oldest of political complaints. It has all kinds of bad consequences. Not only is the wrong policy put in place, but those who have tried to be responsive experience alienation and disillusionment when they discover that they have not provided any satisfaction."

Kennedy chides policy makers: "Frequently decision-makers give up the difficult task of finding out where the weight of scientific opinion lies, and instead attach equal value to each side in an effort to approximate fairness. In this way extraordinary opinions . . . are promoted to a form of respectability that approaches equal status." Kennedy is too kind. Often the policy makers do know where the weight of scientific opinion lies but use the blandishments and demands of activists as cover for their own over-regulatory tendencies.

Reluctant to let the world know their real agendas, biotech's antagonists seldom tip their hand, but once in a while we get a revealing glimpse. The Pew Charitable Trusts, the parent of the Pew Initiative on Food and Biotechnology, has announced that it is changing its legal and tax status from the more restrictive "foundation" to a "public charity," in order to be able to undertake more overt and aggressive lobbying and advocacy -- that is to say, what it was doing previously in a more understated way.

There are more substantive, less legalistic examples. In 2000, a university research team based in Switzerland and Germany announced an extraordinary scientific tour de force that resulted in a marked enhancement of beta-carotene, or provitamin A, in rice grains. The creation of this "golden rice" (so called because of its yellow color) was widely hailed as an example of how gene-splicing can benefit society, especially the inhabitants of less developed countries. Vitamin A supplementation of the diet prevents blindness and can be life saving to the millions of children who are deficient in the vitamin.

Astonishingly, activists lost no time in attacking even this beneficent innovation. Golden rice's developers were criticized for working with companies to distribute seed to the indigent. Then, torturing the data as they are wont to do, Greenpeace declared that golden rice was a fraud because an adult "would have to eat around 9kg [19.8 pounds] of cooked rice daily to satisfy his/her daily need of vitamin A." Greenpeace's Benedikt Haerlin threatened direct action against test plants in the field. Greenpeace's radical media allies, including the Guardian, rushed to support them, and Michael Pollan of the New York Times dubbed golden rice "the great yellow hype."

All of this is the most vile sort of distortion and misrepresentation. Even small amounts of vitamin supplementation can have huge effects. Golden rice and other products like it can be a life-enhancing, life-saving adjunct to those with vitamin A deficiency -- but only if its producers can ever overcome NGO opposition and regulatory hurdles, and get it to the farmers who need it.

Still, such blatant and rabid militancy might make those who "merely" demand stifling regulation appear temperate by comparison. But correspondence published in the journal Science in 2003 opened a window into the motivations of the so-called "moderate" wing of the anti-biotech lobby. Steven H. Strauss, a Professor of Forest Science at Oregon State University, proposed in an article in that journal a very modest streamlining of the regulation of negligible-risk genetic constructions of gene-spliced plants. The reform that he suggested would remedy, in a small way, the irreconcilable paradox in the current federal oversight of plant
biotechnology: that the use of the most precise and predictable techniques is far more stringently regulated than techniques that are less precise and predictable. In other words, Strauss was lobbying for regulatory proportionality, a recognition of the basic principle that the degree of oversight should be commensurate with the degree of risk.

Jerry Cayford, of Resources for the Future, responded with a letter published in Science: "Steven H. Strauss makes a plea for less onerous field trial regulations for less radical genetic modifications . . . thereby helping smaller companies and public-sector investigators to be able to afford to try out crop variants. Unfortunately, his pleas ignore the politics of the genetically modified (GM) food debate . . . Strauss' proposal, reasonable as it may be, asks critics to surrender a major bargaining chip -- strict regulation of field trials -- but offers them nothing in return."

In other words, although it would favor consumers, researchers, and the public interest, sensible regulatory policy is not a goal in itself but is merely a bargaining chip to be held or given up in a negotiation among radical groups, business interests, academic researchers and government regulators!

Strauss' response to Cayford deplored this "hostage-taking" attitude, because "the costs to people and environment of effectively losing genetic engineering from most agricultural sectors as a result of excess regulation are too great for so simple-minded a political approach." He added that there are few practices more "'democratizing' than protecting and promoting the ideas and work of society's innovators when applied to improve food quality, dependability, and affordability."

The coup de grace in Strauss' response serves as a worthy epilogue to the unworthy efforts and venal motivation of biotech's antagonists, whether they are blatantly belligerent or subtly shifty: "[W]ith the high level of regulation and stigma successfully implanted in places such as Europe, policies and attitudes may take a generation or more to change course. The opportunity costs in dollars, and costs to human health and environment, will be incalculable."

No one should mistake the anti-biotech NGOs' misdemeanors for naive exuberance or excessive zeal in a good cause. Their motives are self-serving and their tactics vicious, an ongoing example of the sentiments expressed by Linus van Pelt, a character in the Peanuts comic strip, "I love humanity; it's people I can't stand." People should fight back. And those who understand these issues need to do a better job of educating the large segment of the public that is uninformed -- not only about the science, but also about the chicanery and mendacity of biotech's foes.

Henry I. Miller, a fellow at the Hoover Institution, headed the FDA's Office of Biotechnology from 1989-1993. Gregory Conko is Director of Food Safety Policy at the Competitive Enterprise Institute. Their book, "The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution" will be published later this year.