TROUBLE IN THE GARDEN
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.[4] 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 insur- ed? 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.[4] 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.
PREFERRING THE LEAST HARMFUL WAY
March 23, 1999, the Los Angeles Unified School District adopted a path-breaking new policy on pesticides in schools. The City of Los Angeles operates the largest public school system in the country. The policy says, in part:
"It is the policy of the Los Angeles Unified School District (District) to practice Integrated Pest Management (IPM)....
"Pesticides pose risks to human health and the environment, with special risks to children. It is recognized that pesticides cause adverse health effects in humans such as cancer, neurologic disruption, birth defects, genetic alteration, reproductive harm, immune system dysfunction, endocrine disruption, and acute poisoning. Pests will be controlled to protect the health and safety of students and staff, maintain a productive learning environment, and maintain the integrity of school buildings and grounds. Pesticides will not be used to control pests for aesthetic reasons alone. The safety and health of students, staff and the environment will be paramount.
"Further, it is the goal of the District to provide for the safest and lowest risk approach to control pest problems while protecting people, the environment, and property. The District's IPM [Integrated Pest Management] Policy incorporates focusing on long-term prevention and will give non-chemical methods first consideration when selecting appropriate pest control techniques. The District will strive to ultimately eliminate the use of all chemical controls.
"The Precautionary Principle is the long-term objective of the District. The principle recognizes that:
"1. No pesticide product is free from risk or threat to human health, and
"2. Industrial producers should be required to prove that their pesticide products demonstrate an absence of the risks enumerated in paragraph two (2) rather than requiring that the government or the public prove that human health is being harmed.
"This policy recognizes that full implementation of the Precautionary Principle is not possible at this time and may not be for decades. But the District commits itself to full implementation as soon as verifiable scientific data enabling this becomes available."
To us, what seems most important about this policy is that it commits the Los Angeles school district to selecting the least harmful way to manage pests. Where two pest control techniques are available, the least harmful will be selected. This is a simple, but powerful way to make decisions about technologies that can degrade human health and the environment.
Our hat is off to Californians for Pesticide Reform (CPR) -- a coalition of over 130 organizations working to reduce the damage from pesticides in California. For further information about CPR and its other work, contact them at 49 Powell Street, Suite 530, San Francisco, CA 94102; tel. (415) 981-3939; or E-mail: pests@igc.org, or see www.igc.org/cpr.
For example, see their June, 1999, report FIELDS OF POISON, which documents the shocking failure of California health authorities to control the poisoning of farm workers by pesticides. CPR published this study with the Pesticide Action Network North America (PANNA), the United Farm Workers of America, AFL-CIO, and the California Rural Legal Assistance Foundation. The report (in English and Spanish) is available on the web at https://www.panna.org/panna/resources/documents/fieldsAvail.dv.html.
CORRECTION: MAD COW DISEASE
We reported incorrectly last week (REHW #683) that Montana health officials buried in a landfill the carcasses of 80 elk that had been slaughtered because they were suspected of carrying a form of "mad cow disease." In actual fact, before the landfill plan could be carried out, local opposition swelled and in early January, a portable incinerator was brought in from North Dakota and the 80 elk carcasses were incinerated at a cost of $50,000 which was provided by an Emergency Environmental Fund in the governor's budget. The ashes were buried on the farm where the elk had been raised.
The elk had been slaughtered by state officials because they were suspected of harboring chronic wasting disease (CWD), a form of "mad cow disease" that strikes elk and deer. There is no test for CWD in living elk, so Montana officials -- who had found symptoms of the disease in one of the 80 elk last fall -- took action consistent with the precautionary principle. Subsequent tests revealed symptoms of CWD in three of the 80 animals, so the entire herd was, in fact, at risk of spreading the disease to elk in the wild, if any of them escaped from captivity. These were the first confirmed cases of CWD among elk in Montana.[1] CWD has not been found in wild elk in Montana though it is present in wild deer and elk in parts of Colorado and Wyoming.
The Attorney General of Montana, Joe Mazurek, called for a precautionary halt in the licensing of new game farms in Montana, and a ban on importing elk and deer into the state, to protect two of Montana's local industries, cattle ranching and hunting.[2] The State of Massachusetts has reportedly banned elk farming because confinement creates conditions conducive to transmission of CWD, with the potential for spreading the disease into the wild if a confined animal escapes. Again, this is an expression of the precautionary principle in action. So far as we know, no other state has banned elk farming.
The U.S. Food and Drug Administration and Canadian health authorities in August advised blood centers to refuse blood donations from people who had spent six or more cumulative months in England between Jan. 1, 1980 and Dec. 31, 1996, on the assumption that everyone who spent substantial time in England during that period is potentially infected with the human form of mad cow disease and that it can be transmitted through blood.[3] This, too, was a precautionary action because no evidence exists that the human form of mad cow disease has ever been transmitted through a blood transfusion. However, as the JOURNAL OF THE AMERICAN VETERINARY MEDICAL ASSOCIATION reported, "current studies cannot exclude this possibility."
A recent report in SCIENCE magazine argues that the transmission of infectious diseases from wildlife to humans has reached epidemic proportions worldwide during the past two decades, and that the problem is being exacerbated greatly by "globalization" of the economy.
** HIV-1, the virus that gives rise to AIDS, is now believed to have originated in one or more species of chimpanzee.[5,6] Chimpanzee meat is considered a delicacy in parts of Africa to such an extent that the extinction of all wild chimpanzee populations is now a real possibility.[6] Chimps are killed to supply the dinner tables of logging camps where forests are being cut down to provide lumber for export to the wealthy nations of the world. It is not known when the HIV-1 virus made the leap from chimps to humans, but AIDS was first reported in humans in 1983. Worldwide, about 35 million humans have now been infected with the HIV-1 virus.[6]
** An influenza virus that originated in chickens killed at least four humans in Hong Kong in 1997.[7] After this avian flu virus made the leap to humans, it did not propagate efficiently from human to human, but this was just a matter of luck. Pigs and some primates can also carry influenza viruses that can make the leap to humans with deadly effect.
** The emergence of Lyme disease in the northeastern U.S. resulted from changes in the habitat of deer carrying the deer tick, which then transmitted the disease to humans.[4]
** Global warming has extended the range of mosquitoes carrying malaria and dengue fever in South America, Central America and Asia. In the early 1990s, dengue fever (known as "breakbone fever" because it is so painful) made its appearance in Texas along the border with Mexico.[4]
The transmission of infectious diseases from wildlife to humans is being greatly enhanced by international shipments of food and fiber, domesticated animals, and timber. This is one of the huge uncounted costs of "globalizing" our economies. Biological contaminated wastes, such as landfill leachate and runoff, and ballast water from ships, contribute to the problem as well.
The globalized economy is introducing alien species to many parts of the world at an unprecedented rate. The introduction of alien species is putting evolutionary processes on "fast forward." For example, in the past, new insects appeared in the Hawaiian Islands at the rate of one every 50,000 years. In recent decades, new species of insects have appeared in the Islands at the rate of 15 to 20 per year.[8] Stanford biologist Peter Vitousek estimates that the introduction of alien species is now the second-largest cause of species extinction, after habitat loss.[8] Vitousek and some of his colleagues view the shuffling of the world's species as a global change as important as global warming but easier to control because it could be done without disrupting modern lifestyles (or provoking the wrath of the oil giants).
Vitousek argues that humans can take thoughtful action to minimize the damage caused by introduced species. For example, citizens can be warned by governments that a new species of plant or animal has appeared and citizens could then mobilize to locate and remove the invading species. We are not powerless in the face of modern trends, but we must first recognize that concerted action is necessary and possible. We believe thoughtful action might include taking steps to slow the rate at which the world's economies are being "globalized." Selecting leaders who have not embraced the cult of "free trade" would be an important step we could take.
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