On Sat, 8 Jul 2000 00:50:18 -0500 (CDT) Rich Winkel <[EMAIL PROTECTED]> wrote: >http://www.essential.org/monitor/mm2000/mm0001.05.html > > [The Multinational Monitor] > > JANUARY/FEBRUARY 2000 VOLUME 21 NUMBER 1 & 2 > > --------------------------------------------------------------------- > B I O T E C H F U T U R E S > --------------------------------------------------------------------- > > Don't Ask, Don't Know > > The Biotech Regulatory Vacuum > > by Ben Lilliston > >Biotech industry supporters such as Senator Kit Bond, R-Missouri, claim that >most people in the United States have already accepted genetically >engineered crops because of widespread confidence in the government's >ability to regulate the introduction of these new foods. > >"In the United States, we have a system in place that has been developed for >decades to evaluate new products and protect the public," Bond stated at a >news conference during the WTO meeting in Seattle. "The system involves >several agencies; it is rigorous, it is science-based and it has the >confidence of the American people." > >But the very agencies that Bond and others point to as the handlers of the >government's "collective commitment to food safety" are being criticized >from without and within. > >A growing legion of biotech critics are contending that key U.S. food safety >and environmental regulatory agencies have allowed the introduction of >genetically engineered crops into the food supply and the environment >without sufficient precautionary testing. > >Evidence is mounting, they say, that this reckless action is putting people >and ecosystems at risk -- and consumers in the United States in increasing >numbers are joining those in Europe and elsewhere in endorsing this view by >objecting to the sale of genetically engineered foods. > >Opening the Floodgates for GE Food >In 1992, the Food and Drug Administration (FDA) issued a remarkable >"Statement of Policy" that would forever change the food supply. Touted by >then-Vice President Dan Quayle as a deregulatory initiative, the FDA >determined that genetically engineered foods were "substantially similar" to >conventional crops, and thus were not required to be labeled or undergo >special safety testing before they entered the marketplace. > >The 1992 FDA policy opened the floodgates for nearly 50 different >genetically engineered crops and foods to enter the U.S. market. More than >half of all soybeans and a third of the corn crop in the United States are >now grown from genetically engineered seed. Other engineered crops that are >rapidly gaining acreage include canola, cotton, potatoes, tomatoes and sweet >peppers. > >The FDA's policy was a godsend for the biotech industry, which had invested >billions of dollars developing a variety of genetically engineered products >-- all spliced with foreign genes creating crops never before released into >the environment or eaten by humans. If the industry's new products were >required to undergo a battery of tests to prove their safety -- similar to >what is required for a new drug or food additive -- it would set them back >years, perhaps even decades. > >Now, more than seven years later, and despite a growing body of new >scientific evidence of potential environmental and human health risks of >genetically engineered foods, the U.S. regulatory system continues to give >this radical new technology a free ride. All three agencies currently >regulating genetically engineered products -- the FDA (regulating food), >Environmental Protection Agency (EPA, regulating the environment) and >Department of Agriculture (regulating the farm) -- utilize statutes that >were designed to regulate other products. And Congress still hasn't passed a >regulatory statute that deals specifically with the unique threats posed by >genetically engineered crops and foods. > >"This is a mess," says Jean Halloran of Consumers Union. "This fragmented >system is never going to succeed." > >The evidence that biotech foods and crops require more stringent regulatory >oversight is mounting. Earlier this year, the British Medical Association, >akin to the American Medical Association, called for an immediate moratorium >on genetically engineered foods because of potential human health risks >including possible allergenic reactions, and increased exposure to >antibiotic resistance genes (which are spliced into every genetically >engineered food). Renowned gene scientist Arpad Puztai reported in the >prestigious medical journal Lancet in October 1999 that a specific >genetically engineered potato was causing rats to suffer substantial health >effects, including weakened immune systems and changes in the development of >their hearts, livers, kidneys and brains. Another study, published in the >Journal of Medicinal Food last summer, found that a genetically modified >soybean had less nutritional value because of lower levels of the beneficial >phytoestrogen compounds thought to protect against heart disease and cancer. > >Three recent studies indicate that genetically engineered crops react >differently than conventional crops in the environment. In the Spring of >1999, Cornell researchers found that pollen from genetically engineered Bt >corn was toxic to the Monarch butterfly. In November, University of Georgia >researchers reported that Monsanto's genetically engineered Roundup Ready >soybeans were splitting open in heat at a much higher rate than conventional >soybeans because of their unique metabolic structure. And in December, New >York University researchers reported in the journal Nature that roots from >common genetically engineered Bt corn exude the Bt pesticide into the soil, >where it binds with soil particles and remains active for 243 days. > >Health Testing Takes Back Seat >The FDA's 1992 policy statement determined that genetically engineered foods >were in most cases "the same as or substantially similar to substances >commonly found in food" and thus are not required to undergo specific safety >tests prior to entering the market. While food additives are subjected to a >rigorous round of testing, and must meet the standard of "a reasonable >certainty of no harm," the FDA has determined that the genetically >engineered foods currently on the market are not additives. And the FDA has >designated all genetically engineered foods as "Generally Regarded As Safe" >(GRAS) -- making the new foods exempt from mandatory pre-market review. > >After a genetically engineered crop is designated as GRAS, the corporate >owner is "encouraged" to participate in the FDA's "voluntary" consultation >process. James Maryanski, the FDA's biotechnology coordinator, explained at >the FDA's public hearing in December that "the consultations have been >established so that companies have an opportunity to make sure that they are >meeting all of the safety provisions and labeling requirements of the Food >Drug and Cosmetic Act before the product goes to market." Every company that >has placed a genetically engineered food product on the market has >participated in the consultation process. > >"We think that the process, as it's been carried out to date, has done a >highly praiseworthy job of ensuring that the products of foods derived from >crops improved through modern biotechnology are at least as safe as, if not >safer than, those we have hitherto consumed," Val Giddings of the Biotech >Industry Organization stated at public FDA hearings held in Chicago in >December. "We see no evidence based on science, and no evidence based on >experience for any requirement to change this process." > >But the consultation process is not mandatory or uniform -- each company >submits different types of tests -- and only the summary of the data, not >the entire studies, are sent to the FDA. The tests are not peer reviewed or >available for public scrutiny. And the testing is largely done by the >company seeking guidance from the agency. > >Maryanski defended the agency's anti-precautionary policy before a Senate >Committee in October: "FDA's 1992 policy statement and our guidance >documents make clear that premarket clearance is required if there is >scientific uncertainty about the safety of food derived from bioengineered >plants." Yet it is the biotech companies that decide whether there is any >such "scientific uncertainty." > >The FDA's policy is a dramatic shift away from the long-standing requirement >that companies prove their product is safe, says Rebecca Goldburg, of the >Environmental Defense Fund. "In other words, FDA's policy strongly favors >food manufacturers at the expense of consumer protection," Goldburg told the >FDA at public hearings in November. > >Of specific concern is the potential exposure to food allergens. Although >FDA co-sponsored a scientific meeting on food allergies in genetically >engineered foods in 1994, the agency has yet to develop and publish guidance >to industry on how to assess the allergenic potential of new proteins. A >disaster was narrowly avoided in 1996, when University of Nebraska >researchers found that inserting the gene from a Brazil Nut into a soybean >caused a potentially fatal reaction when consumed by people allergic to >Brazil nuts. The Nebraska University test was not required by U.S. >regulatory agencies, and took place after animal tests on the Pioneer Hybrid >engineered soybean did not indicate it was allergenic. > >"Most proteins added to foods via genetic engineering cannot be tested for >allergenicity," Goldburg told the FDA panel. "Instead, industry scientists >simply screen the biochemical characteristics of proteins to see if they are >consistent with the characteristics associated with allergens. It remains to >be seen how effective such screening will be in protecting public health." > >The lack of toxicity testing is another cause for concern. Puztai's rat >study with a strain of genetically engineered potato is one of the few rat >studies conducted on genetically engineered foods. > >"Currently, there is no toxicity testing requirement to ensure engineered >substances are safe," says Halloran of Consumers Union. "We need to see more >studies like Dr. Puztai's, as well as other long-term rat studies." > >An additional characteristic of genetically engineered food is that all >current products include an antibiotic resistant gene. This gene is spliced >into the food to serve as a marker. The product is doused with the >antibiotic -- and those that survive the antibiotic are considered >successfully engineered. The practice of adding antibiotic resistant markers >to genetically engineered foods was instrumental in the British Medical >Association's decision to call for a moratorium on the introduction of new >engineered foods. The British Medical Association's concern, widely shared, >is that the widespread, avoidable use of antibiotics for non-essential >purposes will intensify the problem of antibiotic resistance, already >considered a crisis in the medical community. An estimated $5 billion a year >are spent treating antibiotic-resistant infections in the United States >alone. > >The FDA's oversight is so lax that even pro-biotech groups like the National >Food Processors Association and the Grocery Manufacturers Association urged >the FDA at its Oakland public hearings to make the consultative process with >the FDA mandatory for biotech companies, and that summary data be made >available to the public. > >Groups like the Council for Responsible Genetics, Center for Food Safety, >Union of Concerned Scientists and Consumers Union would like the FDA to >require a battery of health tests and detailed scientific studies, and that >the FDA share all of the data with the public. > >Controversy Within FDA >When the FDA announced its 1992 policy, the agency argued that a clear >scientific consensus supported the policy. But as documents uncovered as a >result of a recent lawsuit filed by the Center for Food Safety and the >Alliance for Bio-Integrity indicate, many of the FDA's own scientists >strongly disagreed with the agency's policy. > >In a memo to FDA Biotechnology Coordinator James Maryanski in 1992, FDA >compliance officer Dr. Linda Kahl argued that genetically engineered crops >and traditional crops were not the same. "The process of genetic engineering >and traditional breeding are different, and according to the technical >experts in the agency, they lead to different risks," Dr. Kahl wrote. > >In a separate memo, Dr. Louis Pribyl, an FDA microbiologist, commented that >a draft of the FDA policy "read very pro-industry, especially in the area of >unintended effects." It is "industry's pet idea that there are no unintended >effects that will raise the FDA's level of concern." But, Prybil wrote, >"there is no data to back up their contention." > >In court filings, the FDA has dismissed the memos as coming from "low-level >FDA employees" and said their comments were not part of the formal record on >which the agency based its decision. A judge is expected to decide upon the >lawsuit against FDA early this year. > >EPA: Ignoring Environmental Risks >The U.S. EPA is in charge of protecting the environment from the adverse >effects of genetically engineered crops. But critics say the agency has >ignored several important environmental statutes and dropped the ball in >evaluating risks. > >The EPA is currently being sued by Greenpeace, the Center for Food Safety >and numerous other environmental groups and organic farmers because of the >way it has regulated crops which contain genes from a naturally occurring >soil bacterium, Bacillus thuringiensis (Bt). Among several charges, the >lawsuit claims that the EPA has ignored the Federal Fungicide, Insecticide >and Rodenticide Act (FIFRA) and the National Environmental Policy Act (NEPA) >by allowing Bt plants on the market. > >According to the lawsuit, the EPA has allowed genetically engineered Bt >plants to enter the market despite recent research indicating that they will >speed up the development of pest resistance to natural Bt sprays (an >important tool for organic farmers); transfer engineered Bt traits to weedy >relatives, creating so-called "Superweeds;" and have adverse impacts on >beneficial insects and other non-target organisms. In addition, the EPA has >ignored a requirement under NEPA to prepare an environmental impact >statement that analyzes the environmental, socio-economic and cumulative >impacts of its program approving genetically engineered Bt plants. > >"EPA has shown a blatant disregard for federal law and their own regulations >by approving Bt crops without fully assessing their environmental safety," >says Joseph Mendelson, legal director of the Center for Food Safety. > >Mendelson points out that both the Cornell University study on Monarch >butterflies and the New York University study describing how engineered Bt >remains toxic in the soil were not required to be done at all, let alone >before the crops entered the marketplace. > >Dr. Charles Benbrook, a former member of the National Academy of Sciences, >believes that the NYU study is as important as the Monarch butterfly study, >which has received a great deal of media attention. "What goes on >underground in a field planted with today's Bt-corn varieties is largely a >mystery. Enhance the toxin levels 100- to 1,000-fold and it becomes a >mystery of some consequence and immediacy," Benbrook says. > >The registrations for the current wave of engineered Bt crops expire in >2001. The real challenge for the EPA will be the next round of genetically >engineered Bt corn -- which is expected to be one, two or three orders of >magnitude more powerful than existing varieties. The new varieties will be >designed to address the corn rootworm complex, a particularly stubborn pest >which has developed a resistance to every single pest tool including crop >rotation, according to Benbrook. "It's going to take a pretty high level of >Bt to control them." > >While the environmental risks of genetically engineered Bt crops are slowly >emerging, even less is know about the human health risks of eating Bt foods. >The EPA has determined that the Bt pesticide in spray form is safe for >consumers to eat. But EPA has not required studies on the long-term and >short-term effects of eating foods with the Bt pesticide spliced into every >cell. > >EPA's Pest Resistance resistance >Although genetically engineered Bt crops have been planted in U.S. fields >since 1995, the EPA has yet to put together a plan to address the potential >effects of pest resistance. > >Both the biotech industry and the EPA recognize that genetically engineered >Bt crops will speed up the development of resistance to Bt by the major >target pests -- the pink bollworm (cotton) and the corn borer (corn). >Margaret Mellon, of the Union of Concerned Scientists, estimates that Bt >crops could lead to pest resistance in as little as two to four years. In >fact, AgrEvo's Bt corn, Starlink, is a second generation Bt crop designed to >be effective if resistance develops. > >To slow the development of resistance, the biotech industry and some farmers >associations are pushing a solution built around refuges -- designating an >area where conventional crops would be grown next to engineered crops. The >conventional crops would allow for the continued survival of insects that >are not resistant to Bt. These insects breed with Bt-resistant insects and >thereby keep the Bt-resistant genes from being passed along to the next >generation. > >But the buffer zone resistance plans are "based in large part on computer >models and not on large-scale field experiments," says EDF's Goldburg. >"Elements of the plans are highly controversial among entomologists and >others who believe they are inadequate to forestall the evolution of >resistant pests." > >According to Benbrook, if pests develop a resistance to the Bt pesticide, it >could be disastrous -- particularly for organic farmers who rely on Bt >sprays as last resort. "That is a loss that could plague farmers for decades >if not centuries," he says. > >Drifting Liability >Earlier this year, British researchers at the John Innes Center in Norwich >found that genetically engineered pollen can travel up to three miles >carried by wind, bees and other insects. Genetic contamination of >conventionally grown crops usually occurs when wind-blown pollen from >engineered corn and canola crops cross-pollinates with conventional crops in >nearby fields. There is not as much of a threat of contamination for plants >like soybeans that self-pollinate. > >The threat of unknown genetically engineered material flying through the air >to another farmer's land is very real. Organic farmers are especially >vulnerable. An organic farmer in Texas supplied organic corn to the >Wisconsin chip maker Terra Prima. But upon arrival in Europe last March, the >corn was returned after testing positive for genetically engineered >material. The genetically engineered material drifted from a neighboring >farm and cost the company nearly $300,000. Cissy Bowman, another organic >farmer, told the FDA that "I literally can be put out of business in one >breeze." > >So far, neither the EPA nor USDA are regulating problems associated with >genetic drift, and there are no existing regulations to deal with it. "It's >one of the GM [genetically modified] hot potatoes that nobody wants," says >Benbrook. > >Legislation is expected to be introduced in Congress next year that will >assign liability to the biotech companies in cases where genetic drift has >caused damage. > >USDA's Blind Field Tests >The USDA has played the role of cheerleader for the biotech industry, trying >to push open markets in other countries like the European Union, and >actually helping to develop new genetically engineered crops like the >"Terminator" technology -- in which seeds develop into plants which >themselves do not germinate, preventing farmers from saving the seed for >planting or trade. > >In 1998, USDA proposed standards to define what is "organically grown." USDA >received over 300,000 letters of opposition to a proposal that would have >allowed genetically modified crops to be labeled "organic," more comments >than any other proposed rule in U.S. history. But this consumer outcry has >apparently done nothing to dampen USDA's enthusiasm for GE crops. > >The USDA's most important regulatory role comes through its Animal and Plant >Health Inspection Service, which is responsible for evaluating the potential >environmental impacts of field tests of genetically engineered crops. The >USDA has received notices of 22,400 outdoor tests of new genetically >engineered crops, according to government estimates. The tests are >authorized under 5,100 permits and streamlined arrangements called >notifications, in which companies essentially tell the government what they >are planting -- but are not required to report the results. USDA has never >denied a notification for a biotech company. > >Pressure from other countries and U.S. environmental and consumer >organizations, as well as emerging science, may force the U.S. regulatory >agencies to make major changes in the coming year. The FDA is accepting >public comments through January to decide whether it needs to reconsider its >current policies. The agency is also the subject of a lawsuit challenging >its interpretation of the Food Drug and Cosmetic Act. > >Additionally, the EPA, also the subject of a lawsuit, may finally have to >face the emerging scientific consensus that genetically engineered crops >pose unique threats in the field. An EPA Advisory Panel recently recommended >that the agency require testing that looks at any harmful effects from >genetically engineered crops on mallard ducks, rainbow trout, honeybees and >other wildlife. The advisory panel's recommendations, expected in February, >could spur a change in EPA's current approach. > >Where the agencies are incapable of reorienting their own policies, Congress >may step in. Legislation is expected to be introduced this year that would >reconstitute the current regulatory structure. > >The U.S. regulatory system is balkanized and its approval of genetically >engineered crops seems premature to a growing proportion of consumers and >the citizenry. As scientific evidence concerning the crops' potential threat >to the environment and consumers continues to be discovered, biotech's >biggest boosters, including Senator Bond, will likely find it increasingly >difficult to convince the public to accept GE foods on the grounds that the >U.S. regulatory system has done its job. > > <A HREF="http://www.ctrl.org/">www.ctrl.org</A> DECLARATION & DISCLAIMER ========== CTRL is a discussion & informational exchange list. Proselytizing propagandic screeds are unwelcomed. Substance�not soap-boxing�please! 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