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First Fruit [Secure eReader]
eBook by Belinda Martineau

eBook Category: Technology/Science/Business
eBook Description: In 1994 a little California biotech startup called Calgene introduced the Flavr Savr tomato, the first genetically engineered whole food ever brought to market, and laid the groundwork for the entire agricultural biotechnology industry. In a fast-paced narrative full of colorful characters, surprising twists and turns, and several eye-opening revelations, Belinda Martineau chronicles the story behind the making of the Flavr Savr, from its conception, through its much-heralded introduction to market, and its ignominious disappearance. As a member of the Calgene team that developed the Flavr Savr and secured its regulatory approval, Martineau underwent a transformation from an enthusiastic believer in biotechnology's promise to a battle-weary skeptic. Her account serves as a cautionary tale for the biotech age, offering a revealing look at how the science of genetic engineering is actually done, how corporate decisions are really made in biotech startups, and how the regulatory system in the U.S. does and doesn't work. Most importantly, First Fruit goes beyond the polarized debate currently surrounding genetically modified foods to illustrate both the benefits and the risks of this new technology.

eBook Publisher: McGraw-Hill Companies, Published: 2002
Fictionwise Release Date: July 2002




Preface

The U.S. Food and Drug Administration (FDA) held a series of meetings in late 1999 that were designed to gain feedback from the public on the agency's policies regarding genetically engineered foods. As a pioneer in the field of biotech foods, part of Calgene, Inc.'s successful effort to gain FDA approval of the Flavr Savr\\a153tomato, the world's first commercially available genetically engineered whole food, I had been closely following the debate brewing over them. Public feedback on the topic was sure to be anything but dull. Curiosity, therefore, led me to Oakland, California, on December 13 for the last of the FDA's three meetings, entitled "Biotechnology in the Year 2000 and Beyond." It was an eye-opener.

I was surprised to discover, for example, that although the Flavr Savr tomato had been off the market and unavailable for a couple of years, it still played a prominent part in the debate, especially on the pro-genetic engineering side. Deputy Commissioner for International and Constituent relations Sharon Smith Holston, mentioned it in her opening remarks. James Maryanski, Biotechnology Coordinator for the FDA's Center for Food Safety and Applied Nutrition, in his general description of the FDA's policy toward these new foods, emphasized the lengthy, full review his agency had conducted on Calgene's tomato. The FDA's Food Advisory Committee, Maryanski explained, not only agreed with the agency's conclusion that the Flavr Savr tomato was safe but also recommended that in light of the lack of safety concerns over Calgene's tomato, subsequent biotech foods need not undergo similarly thorough assessments prior to commercialization.

Maryanski's talk left me feeling anxious and ambivalent. I was proud, on the one hand, that the several years' worth of experiments my colleagues and I had carried out to demonstrate the safety of the Flavr Savr tomato had stood up to the agency's scrutiny so well that they had helped establish the FDA's general process for dealing with all biotech foods. But, on the other hand, I couldn't think of a genetically engineered product more innocuous than the Flavr Savr tomato (which contains minimal foreign material). The fact that Calgene's tomato had paved the way for a process that involved only voluntary consultations between the producers of biotech products and the FDA made me feel, therefore, somewhat uneasy.

The intemperance of the debate added to my unease. As she opened the meeting Deputy Commissioner Holston made what I thought at the time was a rather unusual request of mature adults in a reasonably official setting. She asked everyone to "listen to one another." She knew better than I did. Throughout the FDA's presentations, two expert panel "discussions" on scientific, safety, regulatory, and labeling issues, and nearly 100 2-minute talks by members of the general public, not much meaningful listening seemed to take place between proponents and opponents of biotech foods in Oakland's Federal building that day. The amount of meaningful exchange inside, in fact, appeared roughly equivalent to the amount that occurred between the rival rallies, one fresh from the Seattle WTO protest a couple of weeks earlier, staged outside in the courtyard throughout the day. Nearly nil.

This lack of effective communication on the subject of genetically engineered foods wasn't for lack of desire to exchange information, however, or so it appeared on the surface of the debate. Opponents repeatedly asked for more information, in the form of more safety data and the labeling of biotech food products, while proponents often admitted that a "serious information gap" existed between the two sides. The most consistent message Deputy Commissioner Holston said she had heard throughout the proceedings, in fact, was that "consumers need to be educated."

The problem, I decided as I pondered the situation on my train ride home that evening, was largely in the execution (or lack thereof) of bridging that information gap, especially, it seemed to me, on the part of the pro biotech camp. At the FDA's meeting (and from what I'd seen previously in the popular press) representatives of the ag biotech industry and its supporters in the academic community tended to convey general ideas, as opposed to specific facts, to the public. Proponents rarely referenced safety data published in scientific journals or accessible, through the Freedom of Information Act, in various government documents. And while communicating technical results effectively in public settings is difficult, to say the least, relying on oversimplifications could, I believed, be more troublesome.

And the trouble with the general ideas being conveyed by the ag biotech industry's proponents, as I saw it, was that taken at face value, many of them weren't very convincing. The oft-given description of genetic engineering as an extension of traditional breeding methods, for example, had once been referred to by an acting associate commissioner for the FDA's Legislative Affairs, as the "spin" the Clinton administration had (back in 1993) put on the matter of biotech foods. "Spin," I felt quite certain, was not the kind of information the opponents of agricultural biotechnology wanted from the new industry's supporters. Neither were they reassured to hear that a so-called consensus supporting the idea that biotech crops were safe to grow on tens or hundreds of millions of acres existed among scientists utilizing genetic engineering under the highly contained conditions of their own labs or small field trials. Opponents were being told that there was "no evidence that any of these products is unsafe" when what they were asking for was positive evidence that biotech foods were, in fact, safe to grow and consume.

That's why I decided to write this book. James Maryanski's speech at the FDA's meeting convinced me (and friends of mine who still work in the ag biotech business confirmed) that Calgene's data supporting the safety of the Flavr Savr tomato remain remarkably relevant. Many of the experiments we did at Calgene, for example, continue to serve as the boilerplates for other companies in assessing the safety of their new products. The Flavr Savr tomato's story includes a (if not the) prime example of experimental data used to demonstrate the safety of biotech foods. I hope, therefore, that telling this story will provide opponents with hard facts they can use to objectively evaluate agricultural biotechnology and, thereby, help move the debate over genetically engineered foods beyond the level of slogans and sound bites. Proponents will be reminded that despite being labeled as such, sales of the world's first genetically engineered whole food were brisk. Labels, therefore, need not necessarily serve as warnings on biotech foods.

In this attempt to move beyond slogans and sound bites, however, I have used the following quote from Albert Einstein as a guiding principle. "Most of the fundamental ideas of science are essentially simple and may, as a rule, be expressed in a language comprehensible to everyone." Human beings also play a critical role in my rendition of the birth of the ag biotech industry. I therefore hope readers of First Fruit will find it intellectually nourishing yet easily digestible.

Copyright © 2001 by Belinda Martineau


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