By Peter Montague
Rachel's Health & Environment Weekly
Feb. 3, 2000
NOTICE: THIS WORK MAY BE PROTECTED BY COPYRIGHT
YOU ARE REQUIRED TO READ THE COPYRIGHT NOTICE AT THIS LINK BEFORE YOU READ THE FOLLOWING WORK, THAT IS AVAILABLE SOLELY FOR PRIVATE STUDY, SCHOLARSHIP OR RESEARCH PURSUANT TO 17 U.S.C. SECTION 107 AND 108. IN THE EVENT THAT THE LIBRARY DETERMINES THAT UNLAWFUL COPYING OF THIS WORK HAS OCCURRED, THE LIBRARY HAS THE RIGHT TO BLOCK THE I.P. ADDRESS AT WHICH THE UNLAWFUL COPYING APPEARED TO HAVE OCCURRED. THANK YOU FOR RESPECTING THE RIGHTS OF COPYRIGHT OWNERS.
Wall Street investors lost confidence in agricultural biotechnology during 1999.[1,2,3] Agricultural biotechnology is by no means dead, but investors drove down stock prices of ag biotech companies during 1999 in a stunning reversal for the industry. The WALL STREET JOURNAL said Jan. 7, 2000, "With the controversy over genetically modified foods spreading across the globe and taking a toll on the stocks of companies with agricultural-biotechnology businesses, it's hard to see those companies as a good investment, even in the long term."
Hardest hit was Monsanto, the St. Louis chemical giant that had spent 5 years and billions of dollars morphing itself into a "life sciences" company, betting its future on biotechnology in pharmaceutical drugs and agricultural crops. As the WALL STREET JOURNAL wrote December 21, 1999, "Billions of dollars later, that concept of a unified 'life sciences' company -- using technology to improve both medicines and foods -- has become an affliction itself for Monsanto. The crop-biotechnology half of the program has grown so controversial that Monsanto has agreed to a deal that is likely not only to push biotech to the back burner, but also to cost Monsanto its independence. And investors are reacting harshly."
Monsanto agreed late in 1999 to merge with Pharmacia & Upjohn, Inc. and the combined company will be run not from St. Louis but from Pharmacia headquarters in Peapack, New Jersey. Monsanto's ag biotech business will be spun off into a separate company and as much as 19.9% of it will be sold.
Two other leaders in ag biotech, the Swiss pharmaceutical giant Novartis AG, and the Anglo-Swiss drug firm AstroZeneca PLC, announced during 1999 that they will combine their ag biotech divisions into one and sell it off, "effectively washing their hands of crop biotechnology," the WALL STREET JOURNAL said.
Thus by the end of 1999, ag biotech companies found themselves in trouble, worldwide, for the first time. Here is a short list of reasons why:
** A lawsuit against the U.S. Food and Drug Administration (FDA) forced the release of government documents showing that FDA scientists had expressed grave doubts about the safety of genetically modified foods even as the agency was publicly declaring such foods "substantially equivalent" to traditional crops. It seems clear from these documents that the scientific integrity of the U.S. regulatory system has been compromised for political purposes, to provide a "fast track" for the rapid, large-scale introduction of genetically modified foods.
** The insurance industry has consistently refused to write policies covering liability for harm caused by genetically modified organisms. Steven Suppan, research director at the Institute for Agriculture and Trade Policy (IATP) in Minneapolis, said last June, "It is worth asking what kind of regulatory system approves for commercialization a technology whose risks are so undetermined that the products developed from the technology have not been insured? An intuitive response is that the U.S. rejection of liability suggests that U.S. agribusiness and the U.S. government have less confidence than is proclaimed publicly in the safety of the products approved and in the integrity of the product review process," Dr. Suppan said.
** A growing body of literature has begun to show that genetically modified crops are creating new kinds of environmental problems for farmers, and that genetically modified crops are exacerbating already-severe economic problems on American farms.
** Europeans and others overseas have continued to insist that the safety of genetically modified foods has not been sufficiently documented and that import of such foods must be prohibited, or they must be labeled. The doubts expressed by FDA scientists, and the growing list of economic and environmental problems are likely to stiffen European resistance to genetically-modified seeds, crops, and foods.
** It became apparent in 1999 that the public rationale for promoting genetically modified foods -- that such foods would "feed the world" -- was based on wishful thinking, not economics. It is now clear that U.S. genetically modified crops are too expensive to "feed the world."
** The rationale for refusing to label genetically modified foods came unraveled in 1999 as biotechnology companies began to announce new crops with special traits (rice with increased vitamin A, for example). For years, biotech companies, the U.S. Department of Agriculture (USDA), U.S. Environmental Protection Agency (EPA), and FDA have argued that labeling genetically modified foods was impossible because it would require food companies to segregate genetically modified crops from conventional crops and it simply couldn't be done. All the crops were mixed together in the grain elevator, so labeling would be impossible, they said.
This silly and disingenuous argument evaporated in 1999. As soon as biotech firms announced specialty foods created by genetic engineering, the labeling problem miraculously disappeared. Labeling is suddenly easy -- indeed, required -- because consumer's can't be expected to pay premium prices for specialty foods if those foods aren't clearly identifiable on the grocery shelf.
Polls have shown that more than 80% of American consumers want genetically modified foods labeled as such. Now that labeling is acknowledged as feasible, will the biotech industry, USDA, EPA, and FDA bend to the public will and start labeling ALL genetically modified foods? Not on your life. Government and industry argue with one voice that labeling is not necessary because genetically modified foods are "substantially equivalent" to the conventional foods they have replaced. They even say labeling would be "misleading" because it would imply that there are differences between biotech foods and conventional foods.
Federal regulations governing biotech foods are founded on the premise that there are no "material differences" between genetically modified crops and conventional crops. This argument, it turns out, was thoroughly discredited by FDA scientists before the regulations were issued.
The FDA spent 1989-1992 developing regulations governing genetically modified foods for humans and feed for animals. This was back when President Bush and Vice-President Quayle were advocating "regulatory relief" for industry.
FDA's rules -- which were announced by Mr. Quayle in 1992 -- allow a biotech company like Monsanto or DuPont to decide for itself whether its food products are "generally recognized as safe" (GRAS). If a company decides that its new genetically modified corn or soybean or potato or wheat is "generally recognized as safe" then no safety testing is required before the products are introduced into the food supply. FDA said these rules -- like all their rules -- are based on "sound science."
However, during 1999 a lawsuit filed by the Alliance for Bio-Integrity in Fairfield, Iowa, forced the FDA to release some 44,000 pages of internal documents for the first time. Among them was a series of memos from FDA scientists commenting on the FDA's proposed "substantially equivalent" policy for biotech foods.
A key issue is whether "pleiotropic effects" will occur when new genes are inserted into plants to give the plants desirable new traits. Pleiotropy means that more than one change occurs in a plant as a result of the new gene. For example, a gene that allows a plant to grow better under drought conditions might also make the entire plant grow smaller. The smaller size would be an unexpected "pleiotropic" effect.
FDA regulations assume that pleiotropic effects will not occur when new genes are inserted into conventional foods such as corn or potatoes or wheat or soybeans. Therefore, FDA says, genetically modified crops are "substantially equivalent" to conventional crops.
Internal memos make it abundantly clear that FDA's scientific staff believes pleiotropic effects will occur when new genes are inserted into food crops. [In the following quotations, words inside square brackets have been added for clarity but words inside normal parentheses were in the original memos.--P.M.]
Commenting on the FDA's proposed biotech regulations in early 1992, Louis Pribyl, an FDA microbiologist, wrote March 6, 1992, "It reads very pro-industry, especially in the area of unintended effects.... This is industry's pet idea, namely that there are no unintended effects that will raise the FDA's level of concern. But time and time again, there is no data to backup their contention, while the scientific literature does contain many examples of naturally occurring pleiotropic effects. When the introduction of genes into [a] plant's genome randomly occurs, as is the case with the current [genetic modification] technology (but not traditional breeding), it seems apparent that many pleiotropic effects will occur," Dr. Pribyl wrote. "Many of these effects might not be seen by the breeder [meaning Monsanto or DuPont or other biotech firm] because of the more or less similar growing conditions in the limited trials that are performed. Until more of these experimental plants have a wider environmental distribution, it would be premature for FDA to summarily dismiss pleiotropy as is done here," Dr. Pribyl wrote.
On the same subject, a memo from the Division of Contaminants Chemistry within FDA's Division of Food Chemistry and Technology said November 1, 1991, "Pleiotropic effects occur in genetically engineered plants... at frequencies up to 30%. Most of these effects can be managed by the subsequent breeding and selection procedures. Nevertheless, some undesirable effects such as increased levels of known naturally occurring toxicants, appearance of new, not previously identified toxicants, increased capability of concentrating toxic substances from the environment (e.g., pesticides or heavy metals), and undesirable alterations in the levels of nutrients may escape breeders' attention unless genetically engineered plants are evaluated specifically for these changes. Such evaluations should be performed on a case-by-case basis, i.e., every transformant should be evaluated before it enters the marketplace."
Instead of heeding the concerns of its scientific staff, FDA issued biotech food rules that assume no pleiotropic effects will occur, therefore no safety testing is required. All biotech foods are assumed to be safe. The stage was thus set for confidence in biotech foods to plummet as soon as word leaked out that the scientific underpinnings of the regulatory system had been compromised.
To be continued next week.
 I am indebted to Steven Suppan, research director at the Institute for Agriculture and Trade Policy (IATP) in Minneapolis, who provided me with several brief, thoughtful summaries of the state of agricultural biotechnology. Contact: firstname.lastname@example.org. Telephone (612) 870-3413.
 Christina Cheddar, "Tales of the Tape: Seed Co. May Yet Reap What They Sow," WALL STREET JOURNAL January 7, 2000, pg. unknown.
 Scott Kilman and Thomas M. Burton, "Biotech Backlash is Battering Plan Shapiro Thought Was Enlightened," WALL STREET JOURNAL December 21, 1999, pg.A1.
 The FDA documents are available at http://www.bio-integrity.org/list.html. And see Marian Burros, "Documents Show Officials Disagreed on Altered Foods," NEW YORK TIMES December 1, 1999, pg. A15.
 Steven Suppan, unpublished paper, "National Summit on the Hazards of Genetically Engineered Foods, June 17, 1999, Capitol Hilton Hotel, Washington, D.C. 2 pgs.
 Some of this literature is summarized in Charles M. Benbrook, "World Food System Challenges and Opportunities: GMOs, Biodiversity, and Lessons From America's Heartland," unpublished paper presented January 27, 1999, at University of Illinois. Available in PDF format at http://www.pmac.net/- IWFS.pdf .
Descriptor terms: biotechnology; monsanto; dupont; novartis; pharmacia; astrozeneca; agriculture; hunger; fda; regula