T H E

CQResearcherPUBLISHED BY CONGRESSIONAL QUARTERLY INC. ◆ WINNER, 1999 SOCIETY OF PROFESSIONAL JOURNALISTS AWARD FOR EXCELLENCE Biotech Foods

Should they be more stringently regulated?

enetically engineered crops have made their way into most of the food consumed in the United States, and transgenic animals may be next on the dinner plate. The scientific

Gadvances could usher in an era of more nutritious food, I reduce pesticide use and perhaps even end world hunger, N THIS ISSUE advocates say. But opponents view genetic engineering as S THE ISSUES ...... 251 I one of the most reckless ventures of modern science, BACKGROUND ...... 258 D threatening to unleash new plant and animal species that CHRONOLOGY ...... 259 E could damage both human health and the environment. CURRENT SITUATION ...... 264 To guard against such potential calamities, the skeptics AT ISSUE ...... 265 want labeling for genetically altered foods and more OUTLOOK...... 267 BIBLIOGRAPHY ...... 269 stringent government regulation and testing. Meanwhile, THE NEXT STEP ...... 270 consumer protests, especially in Europe, are putting the future of genetically engineered food in doubt.

March 30, 2001 • Volume 11, No. 12 • Pages 249-272 OOKS B EW N See back cover BIOTECH FOODS T H CQE Researcher THE ISSUES OUTLOOK March 30, 2001 Volume 11, No. 12 • Should genetically Vaccines in a Peach? 251 267 The next generation of MANAGING EDITOR engineered foods be Thomas J. Colin labeled? biotech foods may carry vaccines for deadly diseases. ASSISTANT MANAGING EDITOR • Are genetically modified Kathy Koch foods needed to feed the STAFF WRITERS world? SIDEBARS AND Mary H. Cooper • Is it safe to create geneti- GRAPHICS Brian Hansen cally modified animals? Kenneth Jost 252 Big Rise in Biotech Crops David Masci BACKGROUND Biotech crops made up more PRODUCTION EDITOR than half the soybean Olu B. Davis acreage in the U.S. in 2000. In the Beginning ASSISTANT EDITOR Scott D. Kuzner 258 Austrian monk Gregor Global Genetic Farming Mendel paved the way for 253 Increased biotech agriculture. Nearly 100 million acres of CQ PRESS biotech crops were cultivated A Division of Breaking the Code in 1999. Congressional Quarterly Inc. 258 In 1972, researchers U.S. Grows Most Geneti- VICE PRESIDENT AND GENERAL MANAGER spliced together DNA from 254 John A. Jenkins a bacterium and a virus, cally Modified Crops Nearly three-quarters of the DIRECTOR, LIBRARY PUBLISHING creating a “recombinant” world’s biotech farmland is in Kathryn Suarez DNA molecule. the U.S. DIRECTOR, OPERATIONS Sandra D. Adams Safety Concerns Chronology 262 They have been raised 259 Key events since the 1800s. ever since researchers CONGRESSIONAL QUARTERLY INC. Biotech Foods Widely began experimenting with 260 CHAIRMAN recombinant DNA. Considered Safe Andrew Barnes The consensus in the scien- tific community is that they VICE CHAIRMAN CURRENT SITUATION don’t threaten human health. Andrew P. Corty PRESIDENT AND PUBLISHER Is Milk Safe . . . Robert W. Merry 264 Proposals in Congress 262 From hormone-injected Some lawmakers want cows? biotech foods to be Copyright 2001 Congressional Quarterly Inc. (CQ). labeled and subjected to At Issue CQ reserves all copyright and other rights herein, safety tests. 265 Should the FDA step up unless previously specified in writing. No part of regulation of genetically this publication may be reproduced electronically Convincing Consumers engineered food? or otherwise, without prior written permission. 266 Unauthorized reproduction or transmission of CQ Consumers in the United copyrighted material is a violation of federal law States and other countries FOR MORE carrying civil fines of up to $100,000. may make the ultimate decision on the future INFORMATION The CQ Researcher (ISSN 1056-2036) is printed on viability of biotech food. acid-free paper. Published weekly, except Jan. 5, 269 Bibliography June 29, July 6, July 20, Aug. 10, Aug. 17, Nov. 30 Pressure for Labeling Selected sources used. and Dec. 28, by Congressional Quarterly Inc. 267 Consumer and environ- Annual subscription rate for libraries, businesses The Next Step and government is $500. Single issues are available mental groups are pressing 270 Additional articles from for $10 (subscribers) or $20 (non-subscribers). for mandatory labeling. current periodicals. Quantity discounts apply to orders over 10. Addi- tional rates furnished upon request. Periodicals postage paid at Washington, D.C., and additional Cover: About two-thirds of the processed foods on grocery store shelves contain genetically mailing offices. POSTMASTER: Send address modified ingredients, such as soft drinks sweetened with corn syrup from insect-resistant corn changes to The CQ Researcher, 1414 22nd St., and crackers made with oil from weedkiller-resistant soybeans. (CQ Photo/Scott J. Ferrell) N.W., Washington, D.C. 20037.

250 CQ Researcher Biotech Foods BY DAVID HOSANSKY

“There’s no question when THE ISSUES I go to a Chinese restaurant, I’m probably eating a lot of homas O. McGarity soy that’s been genetically distrusts genetically modified,” McGarity con- T engineered foods. The cedes. “I just live with that.” University of Texas law pro- But even as bioengineered fessor is rankled by the fact products become more and that most processed foods more prevalent, they face a now contain genetically growing and potentially fatal modified corn, soybeans and backlash from consumer and other ingredients, but don’t environmental advocates here say so on the labels. and abroad. Fears about He blames the agricul- “Frankenfoods,” as they are tural industry for trying to called by European opponents,

AP Photos/Seth Perlman force a new and potentially Some U.S. grain elevators last fall began charging came to a head in the United dangerous technology onto producers of genetically engineered crops extra because States last year after environ- unknowing American con- of the need to segregate the new crops from conventional mentalists discovered that nu- sumers. “Why the hell are grains. Segregating biotech crops became an urgent issue merous corn-based processed after a genetically modified feed corn, called StarLink, we making these foods?” he which hadn’t been approved for human consumption, foods had been contaminated asks. “I really get burned accidentally got into the nation’s food supply. Several with a genetically modified when the industry forces consumers claim to have suffered allergic reactions feed corn known as StarLink, consumers to do something after eating StarLink-contaminated corn products. which was never approved for they don’t want.” human consumption. But biologist Adrianne Following an international Massey, a biotechnology consultant in ment. To guard against such potential outcry, more than 300 potentially con- Chapel Hill, N.C., believes that altering calamities, the opponents want geneti- taminated corn products were recalled the DNA of crops has allowed farmers cally altered plants and animals labeled from around the world, and major food to increase yields using fewer harmful and more stringently regulated. companies pledged to avoid certain ge- pesticides while producing far more But both sides agree on one thing: netically modified foods. In reaction, nutritious foods than those created A technology that was only science U.S. corn exports declined. through conventional hybridization. fiction just a few years ago has trans- The StarLink incident exemplifies “I personally am in love with DNA formed much of what Americans eat how increasingly difficult, if not impos- and the elegance of that molecule,” today. Since the 1994 introduction of sible, it is for U.S. farmers to segregate she says. the Flavr Savr tomato, engineered for genetically modified crops from con- These clashing views reflect the deep a longer shelf life, about 45 gene- ventional ones because of pollen drift divisions — not just in the United States altered products — such as corn, and the residue of seeds left on farm but around the world — over foods soybeans, cotton, canola and pota- equipment and grain elevators. Some created by transferring a gene from one toes — have been marketed in the farmers have stopped growing certain organism into the genetic material, or U.S. Today, about two-thirds of U.S. types of genetically engineered crops, DNA, of another. On one side, advo- processed foods contain genetically such as herbicide-resistant soybeans, cates say genetically engineered crops modified ingredients. 1 because grain elevators levy a charge to are perfectly safe for human consump- Consumers, many without realiz- separate them from conventional crops. tion, are hardier and more pest-resis- ing it, ingest genetically modified The segregation problem cropped tant than conventional crops and could organisms every day, mostly in pro- up in the United States again this year, help end world hunger. Opponents cessed foods containing corn and after small amounts of StarLink were view genetic engineering as one of the soybean by-products. For example, detected in conventional seeds about most reckless ventures of modern sci- soft drinks could contain syrup made to be planted. Farmers and grain ex- ence, threatening to unleash new plant from insect-resistant corn, and crack- porters feared massive losses, so the and animal species that could damage ers may contain oil from weedkiller- U.S. Department of Agriculture (USDA) both human health and the environ- resistant soybeans. announced earlier this month it would

CQ on the Web: www.cq.com March 30, 2001 251 BIOTECH FOODS

and animals. The researchers first iden- Big Rise in U.S. Biotech Crops tify which genes of one organism con- tain useful traits and insert those genes U.S. farmers have adopted genetically modified crop varieties into another organism, not necessarily at a rapid rate since their introduction in 1996, driven by of the same species. The resulting crops expectations of lower production costs, higher yields and typically are resistant to insects, herbi- cides or disease. reduced pesticide use. Herbicide-tolerant (HT) soybeans, for By first marketing new, easier-to- example, expanded from about 17 percent of soybean acreage grow crops that may need fewer pes- in 1997 to more than 50 percent in 2000. ticides, the biotech companies have won over so many farmers that more than half of the nation’s soybeans Percentage Percentage of Genetically and 25 percent of the corn grown last of Total Modified Crops in U.S. 2 Acreage year were genetically modified. Now scientists are turning their at- 60% HT Soybeans tention to more ambitious uses of food Bt Corn biotechnology. The Agriculture Depart- Bt Cotton* 50 ment and private companies are experi- HT Cotton* menting with manipulating the genes HT Corn of common farm animals, such as pigs 40 and cows, to produce leaner and tastier cuts of meat and more disease-resistant livestock. Companies also are focusing 30 on solving world hunger by creating drought-resistant seeds or nutritionally 20 superior Third World staples. For ex- ample, in 1999 researchers in Europe announced that they had genetically 10 engineered a highly nutritious “golden rice” that could combat Vitamin A defi- ciencies, a major cause of blindness in 0 1996 1997 1998 1999 2000 poor countries. On another front, scientists are de- *Bt crops contain Bacillus thuringiengis, a naturally occurring soil bacteria that veloping bananas and tomatoes that can kills insects. deliver vaccines, potentially saving mil- Sources: Economic Research Service; U.S. Department of Agriculture lions of lives in developing countries. “Agricultural biotechnology has come use disaster-relief funds to buy back However, consumers claiming they of age,” Rep. Nick Smith, R-Mich., chair- 300,000 to 400,000 bags of potentially ate StarLink-contaminated foods and man of the House Science Committee’s contaminated corn seed — despite criti- then suffered potentially deadly al- Basic Research Subcommittee, wrote to cism from some environmentalists who lergic reactions have filed several a colleague last year. “The potential said the government should not be lawsuits, including a class action suit benefits to mankind are limited only by bailing out the biotechnology industry. in Chicago. The Food and Drug the resourcefulness of our scientists.” 3 Scientists generally believe that the Administration (FDA) is investigating Nevertheless, public confidence in public is overly skittish about the new whether the adverse reactions were the technology’s environmental safety technology. “The bottom line is that no indeed caused by the StarLink. Some has been shaken ever since a 1999 one has died of eating genetically modi- observers predict the outcome could Cornell University study indicated that fied crops,” notes Peter Day, director of have enormous ramifications for the pesticide-producing corn plants could Rutgers University’s Biotechnology Cen- future of genetically modified foods. harm monarch butterflies. Although ter for Agriculture and the Environment. Biotech foods are created using re- later research cast doubt on the study, “And people die all the time from eat- combinant DNA and related techniques the damage to biotech’s credibility ing contaminated food.” to change the genetic makeup of plants was done.

252 CQ Researcher The butterfly study fueled worldwide easily put together a scenario where anti-biotech campaigns by environmen- Genetic Farming food biotech is dead in five years.” tal groups like Greenpeace, which claim Increased Worldwide The issue of genetically engineered genetically modified organisms (GMOs) foods is stirring lukewarm congressional could increase resistance to pesticides Nearly 100 million acres of debate. Some lawmakers want stricter or transform the genes of wild organ- genetically modified crops safety regulations, while biotech advo- isms, creating highly resistant weeds. were under cultivation cates believe the government needs to Indeed, bioengineered canola spread do more to reassure consumers. As the into the wild from a northern Canada around the world in 1999, a debate continues, here are some of the farm in 1998, where it resisted three 42 percent increase over the questions being asked: herbicides before finally being eradi- previous year. cated by a fourth. 4 Should genetically engineered Some public health and consumer Acres (in millions) foods be labeled? groups, who want more assurances Consumer advocates contend that that the foods are safe to eat, point 1996 4.3 genetically modified foods should be to a scathing study by the Royal labeled so Americans who want to Society of Canada — the country’s 1997 27.5 avoid them — whether for allergenic, foremost scientific body — that be- 1998 69.5 philosophical or religious reasons — seeched regulators to test the prod- can do so. Bowing to similar demands ucts more carefully. 5 1999 98.6 by environmentalists and consumer In Europe, anti-biotechnology sen- advocates, the EU and some Asian timent led the European Union (EU) Sources: Clive James, International countries already require labels, and the to impose an unofficial moratorium Service for the Acquisition of Agri- United States is coming under increas- on GMO imports, which it lifted in Biotech Applications; American Farm ing pressure to do the same. February. But it is devising strict rules Bureau Federation, 1999 In January, the U.S.-EU Biotechnol- for the testing, planting and sales of ogy Consultative Forum, a panel of U.S. the crops, and this spring is expected ogy companies. “We’ve done thousands and European biotech experts, recom- to toughen its rules on labeling and of field trials, thousands of compositional mended safety testing and mandatory tracing biotech foods. 6 analyses. . . . The data clearly support labeling for bioengineered foods. “Con- American consumers have not raised that the products are absolutely safe.” sumers should have the right of in- as much fuss over bioengineered foods Trying to strike a balance, the FDA formed choice regarding the selection as their European counterparts, and U.S. in January proposed requiring com- of what they want to consume,” the policy-makers, who generally support panies to notify the agency before panel’s report stated. 7 the biotech industry, have resisted calls introducing a genetically modified “American consumers should have for more regulation or labeling. None- product and make some of their as much information as they desire theless, public interest groups want more safety tests public. Consumer advo- about their foods,” says Joseph stringent premarketing safety testing. cates complain that the plan fails to Mendelson, legal director of the Center Currently, any testing is conducted require independent safety reviews. for Food Safety, a public interest group. by the industry rather than by indepen- Meanwhile, the latest revelation “It’s a fundamental right to know.” dent researchers. “This is a new tech- that StarLink corn had accidentally Consumer advocates cite strong evi- nology,” says Jane Rissler, senior staff entered the food supply, and the dence that the public wants GMO foods scientist with the Union of Concerned resultant public outcry, have led some labeled, including an internal FDA re- Scientists. “All we are asking is that we agricultural experts to wonder if the port showing that consumers in 12 fo- conclude they are safe based on data expensive technology will disappear cus groups overwhelmingly favored and experience, not on theory.” amid demands for conventional labeling and felt “outrage” when they But biotech companies and food pro- foods. learned how many supermarket prod- cessors say GMOs already undergo strin- “This is a very costly process that the ucts already contain genetically modi- gent testing. “Biotech foods are actually companies are going through. If they fied products. the most tested foods on grocery don’t get a revenue stream, they’re dead “Virtually all participants said that shelves,” says Brian Hurley, a spokes- in the water,” says Neil Harl, director of bioengineered foods should be labeled man for Monsanto Corp., one of the Iowa State University’s Center for Inter- as such so they could tell whether a world’s largest agricultural biotechnol- national Agricultural Finance. “I can given food was a product of the new

CQ on the Web: www.cq.com March 30, 2001 253 BIOTECH FOODS

a conventional product,” says Carol U.S. Grows Most Genetically Modified Crops Tucker Foreman, director of the The United States accounts for nearly three-quarters of the land Consumer Federation of America’s Food Policy Institute and a former around the world being used for genetically modified crops. assistant secretary of Agriculture in China, Australia and the Jimmy Carter administration. Activists point out that there are some Other Countries real differences between plant hybrid- 1% ization and bioengineering. Hybrid Canada plants have the same number of genes as the parent plants, arranged in an 10% orderly sequence. But gene splicing increases the number of genes, and genetic engineers have little control Argentina over where the new DNA will wind up. Thus, random insertion can lead to 17% potentially dangerous secondary ef- fects, by either inactivating or activating United States a nearby gene. These secondary effects, called pleio- 72% tropic effects, could cause increased production or accumulation of toxins in edible plant material. Furthermore, they could produce allergens that could 9 Sources: American Farm Bureau Federation; Clive James, International Service for pose a risk to sensitive individuals. the Acquisition of Agri-Biotech Applications, 1999 Furthermore, critics point out that bioengineered crops cross species bar- technology,” said the report. “They Organization (BIO), a consortium of riers far more dramatically than do thought it would allow them to make biotechnology companies. “We support cross-bred crops. Scientists combine the more informed decisions about whether the science-based, content-based label- genes of plants and animals that would or not to buy a product.” 8 ing system that the FDA has put in place. never breed with one another in na- But industry officials counter with If food is changed in composition, if it ture, resulting in such products as a their own polls, which show that has a different nutritional value, if an strawberry that contains a cold-water consumers do not favor labeling once allergen has been added, then it should fish gene to increase its refrigerated shelf they learn that crops have been ge- be labeled.” life. The final product, critics warn, ends netically modified through cross- Biotech consultant Massey says up as part-plant, part-virus, or part- breeding for many centuries. labels would only confuse consum- plant, part-animal. The FDA, biotech companies and ers, because even conventionally “Before we do this experiment on food processors insist there is no need bred crops are genetically altered the entire food supply, it might be a to label genetically engineered foods through crossbreeding techniques. “A good idea to answer the question about because they have the same nutritional label that says this food has been the frequency of unexpected results,” values as conventionally bred crops. genetically modified is misleading says Sheldon Krimsky, a professor of Under FDA rules, labels are required because everything in the store is,” urban and environmental policy at Tufts only for foods that contain an allergen she says. “You’d have to say it’s been University. “Are the changes likely to or are not “substantially equivalent” to modified with recombinant DNA be more dramatic when you’re crossing traditional products. techniques, which most people genes across species and across king- “Because these foods are indistin- wouldn’t understand.” doms than if it’s within a family?” guishable from foods produced through But critics vehemently deny that Critics also point out that biotech conventional means, it would be mis- genetically modified foods are the companies seek patents for the ge- leading to consumers to label them,” same as plant hybrids. “If it is made netic modifications based on the says Lisa Dry, director of communica- of new genetic material, the product contention that the foods are unique tions for the Biotechnology Industry is, in my dictionary, not the same as inventions. “There’s sort of a discon-

254 CQ Researcher nect here,” says Mendelson of the mation there for scientific reasons, the irrelevant. “It doesn’t matter where a Center for Food Safety. “If we’re label becomes meaningless.” gene comes from. It matters what it making changes in the food that are But labeling proponents note that does,” Massey says. so great that we’re allowing patents irradiated foods must be labeled, even But public-interest advocates fume on them, then it’s clearly disingenu- though the government says they are that industry has no business making ous for another agency to say these substantially the same as non-irradi- such a decision for consumers. “I’m changes are insignificant.” ated products. a consumer, and I’m offended by the Bowing to international pressure, Labeling is particularly important assertion by the biotechnology in- the United States last year agreed to for those with food allergies, who dustry that they don’t want to con- an international protocol requiring worry that the altered ingredients fuse me with the facts,” says McGarity exporters to place a label stating “may could trigger a severe reaction. The of the University of Texas. contain living modified organisms” FDA says it requires labels for any on all shipments containing geneti- potentially allergenic GMO, but some Are genetically modified foods cally altered products. critics wonder how the industry needed to feed the world? But so far, the FDA has resisted de- would know if humans are allergic to European researchers made head- mands for mandatory labeling for prod- a newly created bioengineered food lines in 1999 when they announced ucts used domestically. Instead, it pro- if it is made with genes from foods the development of “golden rice,” a posed voluntary guidelines in January not normally eaten by humans, such genetically modified rice strain con- for companies wishing to state whether as petunias or hedgehogs. “It may taining high levels of beta-carotene their products were made with geneti- not be possible to screen for every- — which serves as a building block cally modified ingredients. Vague de- thing,” Krimsky warns. for vitamin A. The new rice could scriptions such as “modified” or “GM Biotechnology advocates, how- have an enormous impact in poor free,” would be prohibited, but ever, point out that there have been countries, they said, where Vitamin A “bioengineered” would be acceptable. no reports of anyone having an aller- deficiencies lead to the deaths of up If mandatory labels do become gic reaction to a genetically engi- to 2 million children yearly and cause U.S. government policy, a wide range neered product that was approved blindness in about 500,000 others. of foods would have to carry them. for human consumption. “Do they The rice could become commercially Genetically modified ingredients are look at every single compound in the available within a few years, and a Brit- already in processed foods contain- plant? No,” says biotech consultant ish biotechnology firm may donate the ing cottonseed and other oils, soy, Massey. “But, because we know a lot seeds without charging royalties. “The corn sweetener, potato flour and about the biochemistry of plants, response from government agencies many other common ingredients, there are certain things that we can has been overwhelming,” said Ingo including the ubiquitous soy-based predict can happen.” Potrykus, a researcher with the Swiss preservative lecithin. And meat from Labeling is also important for veg- Federal Institute of Technology’s Insti- livestock fed on genetically altered etarians, who want to keep their diet tute for Plant Sciences, which helped crops might also have to be labeled. pure from animal products. Others — invent the rice. “There will always be Food industry representatives like Jews, Muslims and Hindus, who skeptics, especially in Europe, but this worry that labels might scare away avoid pork or beef for religious reasons is a humanitarian exercise.” 11 consumers who don’t know much — may not want to eat foods with genes Golden rice may be only the first about biotechnology. Labeling GMOs from those animals. “The Hebrew wave of bioengineered foods designed could also open the floodgates to scriptures . . . along with rabbinical to combat world hunger. Besides boost- other labeling requirements, such as tradition . . . prompt me to avoid all ing the nutritional content of food, re- stating whether food was gathered genetically engineered foods in general, searchers are developing crops that can by migrant workers, they say. even if the food does not contain genes be grown in arid countries or in regions “Once you start using labels not from species that are specifically pro- with poor soil. With an eye to increas- based on science, where does it stop?” hibited,” Rabbi Alan Green of Winnipeg, ing yields, researchers also want to de- asks Peter Cleary, manager of public Canada, stated in a 1998 U.S. federal sign new insect- and disease-resistant policy communications at the Grocery court case over labeling. 10 Most reli- crops, or crops that can be grown more Manufacturers of America, which rep- gious leaders, however, have not taken densely as more of the world’s farm- resents more than 400 food, beverage such a stringent position. land is being lost to development. and consumer product companies. Scientists contend that, biologically “We’re going to [need] new tools in “When you go beyond putting infor- speaking, the origin of a gene is farming to address the needs for in-

CQ on the Web: www.cq.com March 30, 2001 255 BIOTECH FOODS creased yields,” says Judith A. Kjelstrom, “This is a guilt trip to sell the tech- Biotech opponents believe that de- associate director of the biotechnology nology to well-to-do people,” she veloping countries should place a program at the University of California contends. “They said the same thing greater emphasis on inexpensive, tradi- at Davis. “We have marginal lands in about pesticides, and people are still tional agricultural techniques — like ro- Africa and in many lands in Asia. That’s starving. The problem with feeding tating crops to enrich the soil — instead where we’re going to need very unique the world is not a technological one. of using potentially costly technology seeds for crops that are drought-resis- It’s primarily one of poverty.” that could pose environmental risks. tant, salt-tolerant and heat-resistant.” Rissler also questions whether “We like silver bullets, [but] most of But consumer and environmental golden rice is as nutritionally benefi- these silver bullets are not what they’re groups say poverty causes hunger in cial as originally touted. cracked up to be,” warns Thomas developing countries and that new Skeptics like Rissler point out that Dobbs, an agricultural economist with types of crops will do little to relieve the the world currently is producing more South Dakota State University. situation unless poor farmers can pay than enough food to feed everybody. However, many food experts be- for them. “The problem in Third World In fact, producing more food could lieve that the promise of improved countries, in a word, nutrition and increased is income,” says Iowa yields is too great to be State University’s ignored. Harl. “The people Les Crawford, direc- cannot afford to eat. tor of food and nutri- And they cannot af- tion policy studies at ford the GMO [geneti- Georgetown Univer- cally modified organ- sity, says world hunger ism] foods any better is caused by the failure than the non-GMO of nations to distribute foods.” food to regions that Indeed, econo- most need it. The best mists wrestle with way to solve the distri- how to distribute ge- bution problem, he netically engineered contends, is to grow seeds to countries that genetically engineered cannot afford them. crops in those impov- The International erished areas. “We Food Policy Research need to produce food Institute, an interna- Corbis Images in places that are food Confidence in the safety of biotech agriculture was shaken by a 1999 tional anti-hunger or- Cornell University study indicating that pesticide-producing corn plants deficient, and that are ganization based in could harm monarch butterflies. The study bolstered environmentalists’ not hospitable to food Washington, D.C., ad- arguments for stricter controls on biotechnology because of fear that production,” he says. vocates that the tech- biotech plants can degrade the soil, kill beneficial insects and “With biotechnology, nology be made avail- encourage the creation of new viruses. you can double the able through special amount of food with- arrangements between government actually worsen economic conditions out increasing the use of fertilizers agencies and biotechnology compa- for U.S. farmers and those in other and pesticides.” nies. “The technology should be freely developed countries, who are already But environmentalists in poor coun- available to the farmers,” says the struggling to stay afloat amid plum- tries are worried about the ecological organization’s director-general, Per meting world prices for abundant impact of growing GMOs. In India, for Pinstrup-Andersen. commodities. instance, environmentalists have sued Rissler of the Union of Concerned “There’s a two-edged sword to the to stop Monsanto from testing geneti- Scientists says the idea of using bio- issue,” Harl says. “On the one hand, cally modified cotton, and Philippine technology to feed starving people some parts of the world would be able farmers have demonstrated against field has come to the fore recently be- to grow crops where they can’t today. tests of corn containing genes from an cause the industry is trying to win But it would also exacerbate the prob- insecticide. The activists point to the over U.S. and European skeptics. lem of an oversupply of grains.” cautionary lesson of high-yield Miracle

256 CQ Researcher Rice, which was widely adopted in “Not only can you raise a product mal drugs for environmental im- Southeast Asia in the 1960s. The result that yields healthier food for the con- pacts.” 13 was a rice monoculture highly vulner- sumer, but you can also do it with lower Environmentalists mostly fear en- able to insects and disease. 12 costs,” explains Barbara Glenn, execu- gineered animals escaping into the Even so, countries that historically tive vice president and scientific liaison wild and, through cross-breeding, face massive food shortages, like China, of the Federation for Animal Science passing on disruptive genes to wild are investing heavily in biotech’s new Societies, which tracks animal research. animals — much as African “killer yield-increasing technology. None of these animals is commer- bees” spread their aggressive traits Meanwhile, some hunger experts cially available yet. But environmen- after escaping from a Brazilian re- criticize U.S. environmental and con- talists worry that the government is search facility in 1957. Or the oppo- sumer groups for trying to block the not prepared to safely regulate the site could occur: The modified ani- technology. “Only the well-fed have the fledgling technology and, as a result, mal could destroy its own species luxury of establishing little camps and genetically engineered animals could entirely. This theory, known as the arguing among themselves whether it’s drive their wild cousins to extinction “Trojan gene effect,” holds that fast- one agriculture or another,” says if they escape from their pens. growing fish might enjoy a competi- Pinstrup-Andersen. “We should not tell “In many ways, I’m more con- tive advantage in the wild, but pro- developing countries that just because cerned about bioengineered animals duce offspring that cannot survive. [we] don’t want it in our countries, they than plants because they have more “This could locally take a popula- can’t have it. A thousand children die mobility,” says Larry Bohlen, director tion to extinction,” warned Purdue every hour from malnutrition. Poor of health and environment programs University geneticist William M. Muir, people need access to the best ap- at Friends of the Earth. “They could who produced computer modeling proach to solve their problems.” pose a threat to endangered species.” to show how it could happen. 14 So far, the FDA is the only govern- Such scenarios are hardly far- Is it safe to create genetically ment agency claiming regulatory au- fetched. “The issue of escape and modified animals? thority over such animals. Its oversight interbreeding with wild species is an Genetically modified salmon may be is based on a decision that the imported inevitability,” warns Brian Halweil, a landing on dinner tables within a couple genes, which in the salmon’s case pro- staff researcher with the environmen- of years. The salmon — being devel- duce a growth hormone, amount to a tal organization Worldwatch Institute. oped by Aqua Bounty Farms of drug for animals. “Fish farms lose fish every day.” Waltham, Mass. — contain genetic But public-interest advocates be- Even more controversial is the pros- material from another fish, the bottom- lieve that a government agency with pect of “bio-bugs” — genetically altered dwelling ocean pout, which cause it to more wildlife-protection experience, insects that would be released by the grow to market size in 18 months, about such as the Department of the Inte- millions in order to fight harmful in- twice as fast as normal Atlantic salmon. rior, could better judge whether such sects or reduce the threat of diseases Such creatures are at the leading creatures can create an ecological like malaria. European researchers, for edge of what is being called a “blue disturbance. “At the FDA, they don’t example, believe they can modify a revolution” (blue for the ocean) of know the environmental impacts,” mosquito to deliver a vaccine every time genetically modified fish and other contends the Center for Food Safety’s it bites someone. In Latin America, re- sea creatures that are expected to be Mendelson. “It’s really an issue that searchers hope to modify an insect cheaper to raise and more nutritious cuts across a lot of federal agencies.” known as the kissing bug in order to to eat. Although environmentalists FDA officials say they are up to stop it from spreading parasites that warn that such organisms can wreak the task. John Matheson, senior regu- cause Chagas’ disease, which kills about havoc on wild ecosystems, research- latory-review scientist at the agency’s 50,000 people a year. ers are creating virus-resistant oysters Center for Veterinary Medicine, said “Transgenic insects have the poten- and fast-growing, genetically modi- the FDA routinely investigates the tial for making a big difference to hu- fied catfish and trout. environmental impact of new drugs. man health,” said Kathryn Aultman, a Eventually, scientists believe that “We look at the environmental im- National Institutes of Health program genetic engineering will also be used pacts of approving an antibiotic, how officer. 15 on farms, creating livestock that will much is released into the environ- The danger, of course, is that such be disease-resistant, excrete less en- ment, what [it] does,” Matheson said. bugs would have to be released into vironmentally harmful waste and “I don’t have any more discomfort the wild, where they would breed with produce leaner meat. about this than reviewing other ani- non-engineered insects. Once they scat-

CQ on the Web: www.cq.com March 30, 2001 257 BIOTECH FOODS ter, they could not be recalled if they makeup has been altered so radically. were later found to be harmful. However, science did not discover Breaking the Code Researchers also are studying modi- the logic behind the inheritance of traits fying livestock in order to create anti- until the middle of the 19th century. enetic researchers since the gens and proteins that can be used in Gregor Johann Mendel, an Augustinian G 1930s had speculated that deox- human medicine, or to grow organs that monk in Austria, began his famous stud- yribonucleic acid, or DNA, was the would not be rejected when trans- ies on garden peas in a small monastery critical constituent of genes. In 1953, planted into people. But livestock ex- garden in 1856. By examining traits such American biochemist James Watson periments spark ethical concerns, in part as plant height, flower color and seed and British biophysicist Francis Crick because of potential harm to the ani- and pod shape, he showed that charac- described the double helix structure mals. For example, an Agriculture De- teristics are inherited in a logical and of DNA, a breakthrough that set the partment experiment in the 1980s predictable manner. Although his dis- stage for deciphering the genetic code yielded a pig that was so arthritic and coveries were first reported in 1866, they and ultimately earned the two men a lethargic that it could hardly stand up. received little attention before the early Nobel Prize. “In the quest for higher production 20th century. What he called “factors” Genetics took another giant leap of say, milk or eggs, one must take into of heredity were identified as genes in forward in 1972 when Stanford Uni- account the welfare of the animals dur- 1905. versity researchers cut DNA from two ing their lifetime and the quality of their Mendel’s experiments paved the way different sources — a bacterium and lives,” said LeRoy Walters, a bioethicist for modern agriculture. In 1905, an a virus — and spliced them together at Georgetown University. 16 English researcher named Roland Biffen into a functional hybrid, or “recom- Biotechnology advocates are hop- illustrated that the ability of a type of binant,” DNA molecule. A year later, ing to avoid some of the controver- wheat to resist a rust fungus could be scientists successfully transferred a sies that have flared up over geneti- passed to later generations. Since then, recombinant molecule into a bacte- cally modified food by emphasizing numerous crops, including types of rium, thereby creating the first ge- the benefits to society. “I think we potatoes, corn and alfalfa, have been netically engineered organism. 17 have learned,” says Joe Miller, live- bred to resist insects or diseases. Con- But while single-celled, rapidly re- stock policy specialist at the Ameri- ventional breeding techniques are part producing organisms such as bacte- can Farm Bureau Federation. “I think of the reason world food production ria yielded relatively easily to the anything that goes on from this point has doubled since 1960. This increased genetic engineer’s manipulations, it forward will be looked at in terms of production, stoked by pesticides, fertil- took years for scientists to find a how it benefits the consumer.” izer and irrigated water, is known as successful method for the genetic the “Green Revolution.” transformation of plants. Agricultural experts, however, In the early 1980s, scientists at the warn that conventional breeding tech- Max Planck Institute for Plant Breed- BACKGROUND niques, which are highly labor-inten- ing in Cologne, Germany, pioneered sive and take up to 10 years to de- a method for creating transgenic velop a variety, are not efficient plants. Not surprisingly, the tech- enough to keep up with the world’s nique relied on a bacterium for its In the Beginning growing population. success. The scientists modified the “Conventional breeding will likely bacterium known as agrobacterium continue to play an essential role in the tumefaciens, which is responsible for ince the beginning of agriculture, improvement of agricultural crops,” a common plant disease. They re- S farmers have modified crops. Gen- concluded a National Academy of Sci- moved its disease-causing DNA and erations of selecting seeds from the ences report in 2000. “However, many replaced it with DNA producing re- most desirable plants and crossbreed- believe that traditional breeding meth- sistance to kanamycin, an antibiotic. ing different plants in order to pro- ods will not be sufficient to meet in- The disarmed bacterium successfully duce new traits have resulted in crops creasing demands in developing coun- invaded the cells of the target plants, that have little in common with their tries for staple crops.” Accordingly, plant in essence “infecting” the plants with wild ancestors. In some cases, re- researchers are focusing their energies antibiotic resistance. 18 searchers have not even been able to on more sophisticated — and contro- Agricultural companies swiftly find the wild relatives of domesti- versial — genetic-modification tech- turned to the new technology in a cated plants because the genetic niques. Continued on p. 260

258 CQ Researcher Chronology

1983 1998 Mid-1900s Researchers transfer new DNA European Union, prompted by Scientists identify genes and into plants, paving the way for health and environmental con- begin speculating about the role the creation of genetically cerns, begins unofficial morato- of DNA. Sophisticated cross- modified crops. rium on biotech foods and seeds. breeding techniques, along with synthetic pesticides, increase 1986 1999 worldwide crop production in The first field test of a geneti- Cornell University study indicates what becomes known as the cally engineered crop — a type that pesticide-producing corn “green revolution.” of canola — takes place in plants could harm monarch Belgium. butterflies, stoking environmental 1953 worries about biotechnology. American biochemist James 1989 Watson and British biophysicist Calgene Inc. in Davis, Calif., • Francis Crick describe the double begins conversations with the helix structure of DNA, a break- FDA about seeking approval for through that sets the stage for its genetically engineered to- deciphering the genetic code. mato. 2000s Genetically engineered foods face mount- 1967 ing criticism. • The U.S. Department of Agricul- ture unveils the Lenape potato, a Jan. 29, 2000 new variety bred for high solids Bowing to international de- content. But in an early indication 1990s Biotech foods mands, the United States agrees that genetic engineering can have are sold to the public despite to label genetically modified unforeseen effects, the potato is environmental and health agricultural commodities that are withdrawn after the discovery that concerns. shipped across borders. it contains high levels of a toxin. 1992 Sept. 18, 2001 FDA publishes its policy on food Friends of the Earth reports that • biotechnology, including a StarLink corn has made its way controversial decision not to into the food supply, sparking require premarket notification or worldwide protests and recalls of 1970s-1980s labeling for most genetically corn products. Scientists develop recombinant engineered foods from plants. DNA technology and begin Jan. 17, 2001 experimenting with the genetic 1993 FDA releases a draft plan to step transformation of plants and An FDA decision to allow the up oversight of genetically animals. use of bovine growth hormone modified foods and create a in cows sparks protests. voluntary labeling system. 1973 Scientists successfully transfer a 1994 Feb. 14, 2001 recombinant molecule into a FDA approves Calgene’s Flavr European Union adopts strict bacterium, creating the first Savr tomato, the first genetically rules governing genetically genetically engineered organism. engineered whole food ap- modified foods. proved for the market. 1979 Feb. 28, 2001 Cornell University initiates the first 1996 Small amounts of StarLink corn study on the effect of recombi- Monsanto introduces Roundup are found in conventional corn nant bovine somatotropin (bovine Ready soybeans, the first of a seeds, prompting concerns that growth hormone) in stimulating highly popular series of herbicide- U.S. farmers may be unable to dairy cow milk production. resistant crops. export their harvests.

CQ on the Web: www.cq.com March 30, 2001 259 BIOTECH FOODS

Biotech Foods Widely Considered Safe . . .

hen you pour dressing on your salad, drink a soda corn. The investigations are complicated because or snack on potato chips, chances are you are researchers may be unable to conclusively demonstrate W ingesting genetically modified organisms without the corn or something else caused the allergic reactions. even knowing it. That’s because such everyday ingredients Keith Finger, a Florida optometrist who said he suffered as corn sweetener and vegetable oil are derived from a serious allergic reaction after eating tortillas, beans and genetically altered crops. rice in September, filed a report with the FDA and joined Does this affect your health? in a lawsuit against Aventis, the manufacturer of StarLink. Although consumer groups warn that splicing a gene from “It’s scary to think people might have reactions to one organism into the DNA of another has the potential to something they don’t even know is in their food,” he said. produce toxins or allergens, the consensus in the scientific “This needs to get cleared up soon.” 1 community is that genetically modified foods, at least for now, Aventis, however, insists that StarLink could not have pose no threat to human health. On the contrary, scientists caused such allergic reactions, partly because potential believe that such foods can eventually be engineered to be allergens would have been destroyed in the food- more nutritious and contain fewer harmful microbes as scientists manufacturing process. And some scientists contend that learn more about the traits of individual plant genes. biotechnology, far from causing allergic reactions, has the “People may worry about the issues and risks of potential to improve food safety, as researchers focus on biotechnology, but on a scientific level, it’s boring,” says creating non-allergenic foods. Adrienne Massey, a biotechnology consultant in North Carolina. “Biotechnology has the capability of taking away the gene “I have seen nothing that would indicate that genetically that produces that allergy,” explains Les Crawford, director modified foods are a safety issue, and that has been of food and nutrition policy studies at Georgetown University. supported by just about every national academy of science Now that genetically modified ingredients have made across the world,” agrees Judith A. Kjelstrom, assistant their way into an estimated two-thirds or so of processed director of biotechnology at the University of California at food in the United States, several highly regarded scientific Davis. “There has been no recall of a genetically modified organizations are taking a close look at the potential crop based on someone becoming ill. It’s like anything effects on public health. Their almost unanimous verdict: else new. People are just afraid of it.” The foods are safe, but government regulators should But some health-care advocates believe that the government consider stepping up safety tests. is playing with fire by not insisting on more stringent safety In 2000, the National Research Council, an arm of the tests. They point out that no one knows the types of proteins Academy of Sciences, stated that it was “not aware of any and other substances that could result from taking a gene evidence that foods on the market are unsafe to eat as a from one organism and putting it inside another. result of genetic modification.” 2 “This is a new technology. We have very little experience An American Medical Association committee also gave with it,” says Jane Rissler, senior staff scientist for the a thumbs-up. “From all the research that’s been done and Union of Concerned Scientists. “It’s dramatically different all the information we have to date, genetically altered from conventional breeding. We believe the food should foods appear to be quite safe,” said Roy Altman of Miami, be subject to rigorous safety testing.” who presented the report on behalf of the medical The debate over the safety of genetically altered food association’s Council on Scientific Affairs. 3 has taken on new urgency since last year’s revelations that Other respected organizations from the World Health genetically modified StarLink feed corn made its way into Organization to Consumers Union also have affirmed the the food system, even though it was never approved for safety of the food. human consumption. The Food and Drug Administration At the same time, however, many scientists warn that (FDA) and the Centers for Disease Control and Prevention the potential risks are worrisome enough for government (CDC) are investigating several dozen complaints of people regulators to test more carefully for allergens and toxins. who say they suffered severe allergic reactions after eating Issuing an especially sharp warning, the prestigious Royal products, such as tortillas, that may have contained StarLink Society of Canada concluded in February that international

Continued from p. 258 engineered to slow the ripening pro- a ripening tomato to produce the bid to make crops resistant to pesti- cess, came from a plant that con- enzyme that degrades pectin, leading cides or diseases, or have a longer tained an extra bit of tomato DNA the tomato to soften and rot. How- shelf life. In 1989, Calgene Corp. that had been altered in the lab. The ever, in this case, the gene was “re- began consulting with the FDA over new DNA was a transformed version versed” to block, rather than pro- its Flavr Savr tomato. The tomato, of a gene that would normally cause mote, production of the enzyme.

260 CQ Researcher . . . But Some Critics Want More Testing

standards for the testing of genetically modified foods are make sense to me as a scientist, rationally, that one crop “scientifically unjustifiable.” The society criticized that’s been in the food supply has one new gene added, government regulators for presuming that the foods are and you know everything about that gene, then that crop safe, and warned that the biotechnology industry has too is a danger,” Massey says. much sway over the regulatory process. Other scientists agree. The National Research Council’s “The public interest in a regulatory system that is science- 2000 report, for example, stated that the risks posed by based is significantly compromised when that openness is genetically engineered crops are “the same in kind” as negotiated away by regulators in exchange for cordial and those posed by crops that are modified through supportive relationships with the industries being conventional cross-breeding techniques. regulated,” the report stated. 4 But even conventionally bred crops are not without risks. The reason for such concerns: genetic engineers, while In 1967, the Department of Agriculture unveiled the Lenape extraordinarily capable of isolating and transferring a single potato, which was bred for high solids content. Two years gene, have little control over where that gene will wind up in later, a Canadian plant breeder became ill after consuming the target food. Random insertion, in other words, could activate the potatoes, which were found to contain high levels of or inactivate a nearby gene, leading to secondary effects. solamine, a toxic organic substance. The potato, which was In addition, the gene-splicing process involves the use withdrawn from the market, remains an enduring example of of powerful chemicals, such as a viral promoter known as the unexpected consequences of mixing plant genes. 7 the Cauliflower Mosaic Virus. As a result, the cells in In the case of genetically engineered foods, advocates genetically changed foods can begin manufacturing new are particularly concerned that the government relies on proteins, or they can produce existing proteins in such industry statements about the safety of the new organisms quantities as to cause a toxic reaction in humans. instead of conducting its own tests. “The present system The modified foods also have the potential to cause assumes that there will never be human error and that dangerous allergic reactions. This almost caused a health human greed will never overcome good judgment,” says problem in the mid-1990s, when an agricultural company Carol Tucker Foreman, director of the Consumer Federation named Pioneer Hi-Bred (since bought by DuPont) was of America’s Food Policy Institute. “That’s a mistake.” preparing to market soybeans that contained DNA from But Peter Day, director of Rutgers University’s Biotechnology Brazil nuts. The company dropped its plans when University Center for Agriculture and the Environment, says consumers of Nebraska researchers reported that the soybeans could should have more faith in the biotechnology industry. induce fatal reactions in people who were allergic to “I’m satisfied that major, responsible companies who Brazil nuts. 5 are willing to undertake the costs of the research are Genetically engineered salmon and other fish, which sufficiently astute to protect their own interests to avoid may become commercially available within a couple of being sued by people for any harm,” he says. years, pose similar risks. Because some species of fish are known to contain toxins, advocates warn that an introduced 1 Marc Kaufman, “Biotech Corn is Test Case for Industry,” The gene may inadvertently “turn on” an inactive gene for the Washington Post, March 19, 2001. production of toxins in target fish. 6 2 From the National Research Council’s report: “Genetically Modified Many in the scientific community believe that such Pest-Protected Plants: Science and Regulation,” 2000. fears are overblown. They point out that farmers have 3 Robyn Suriano, “Genetically Modified Food Called ‘Quite Safe,’” The Orlando Sentinel, Dec. 4, 2000. been cross-breeding plants for thousands of years, creating 4 Peter Calamai, “Ottawa rapped in GM food report,” The Toronto new types of plants that rarely threaten human health. If Star, Feb. 5, 2001. the risks are minimal from traditional cross-breeding, which 5 Ronnie Cummins and Ben Lilliston, Genetically Engineered Food, involves the shuffling of thousands of genes, why worry Marlowe & Co. (2000), p. 36. about the splicing of a single gene? 6 Susan C. Phillips, “Genetically Engineered Foods,” The CQ Researcher, “If we’re going to assume that conventionally bred crops Aug. 5, 1994, p. 685. that appear with 10,000 new genes are safe, then it doesn’t 7 Ibid.

In 1994, Flavr Savr became the In the mid-1990s, farmers began foods on U.S. supermarket shelves first genetically engineered food to buying genetically altered crop contained genetically modified in- reach the marketplace. It was a com- seeds, including herbicide-resistant gredients, mainly corn or soybeans. mercial failure, in part because of its soybeans and insect-resistant corn, Among the most common geneti- high cost, but it paved the way for cotton and potatoes. By 2000, more cally modified products were future biotech products. than two-thirds of the processed Roundup Ready soybeans, which are

CQ on the Web: www.cq.com March 30, 2001 261 BIOTECH FOODS

Is Milk Safe . . .

hen Monsanto rolled out a synthetic growth that country’s FDA — banned rBGH, primarily for reasons hormone for cows in the early 1990s, Maine’s of animal cruelty. largest milk processor made a calculated marketing Health Canada said the substance poses a “sufficient and W 2 decision. It refused to buy dairy products from farmers unacceptable threat to the safety of dairy cows.” Posilac who used it. injections increase by 50 percent the chances of a cow The strategy paid off. The family-owned $70 million developing fertility or foot problems, and the risk of the company regularly hears from customers who are grateful animal developing an udder inflammation known as mastitis that their milk is free of the controversial hormone. increases by 25 percent, it said. 3 Some medical experts “We’ve never made any claims about the pros and cons worry that the inflammation is treated with antibiotics, which of these various chemicals, but our feeling is that the last can be excreted into milk, potentially causing allergic reactions thing our industry needs is something added to the milk that and antibiotic resistance among consumers. can create concern,” says Oakhurst Dairy President Stanley The Canadian report followed nearly a decade of heated Bennett. “We’re in the business of marketing milk, not drugs.” debate over the hormone. The controversy was punctuated The hormone, which boosts milk production 10-15 percent, in 1998 by testimony before a Canadian Senate committee in won Food and Drug Administration (FDA) approval in 1993 which government scientists said critical rBGH documents and is now injected into about a third of the nation’s dairy had disappeared or were locked away from researchers, who cows. Yet consumer advocates still question its safety for were pressured by superiors to approve the drug. Further, both cows and humans, reflecting the continuing controversies they alleged, Monsanto had offered Health Canada officials that beset food-related biotech products $1 million in research funding — which Monsanto later Marketed as Posilac and scientifically known as denied — while approval was pending. 4 recombinant bovine somatotropin — rBST or rBGH for In its final report, Health Canada criticized the FDA for short — bovine growth hormone was the first genetically taking some of Monsanto’s conclusions “at face value.” engineered product to reach the market. However, due in Specifically, it said, the FDA ignored evidence from a part to lingering doubts about the product’s safety, sales Monsanto-commissioned study showing that 20-30 percent have fallen far short of initial expectations of $1 billion of rats fed high doses of the hormone over a 90-day period per year. Nevertheless, Posilac is profitable, with rising had absorbed the hormone into their bloodstream. Plus, sales that reached an estimated $230 million in 1999. 1 male rats developed thyroid cysts and had elevated levels of Posilac’s maker, St. Louis-based Monsanto, insists that rBGH the hormone in their prostates. That should have indicated does not harm either cows or humans. “This is the same, safe to the FDA, Health Canada said, that the hormone survives milk,” says Jay Byrne, a Monsanto spokesman. He insists that human digestion, signaling that long-term toxicity tests needed any bovine health problems reportedly linked to its usage to be done before rBGH is considered completely safe. 5 result from poor dairy management practices, not the hormone. After the Canadians exposed the rat study, Vermont However, health officials in other industrialized countries Sens. James M. Jeffords, a Republican, and Democrat Patrick are not convinced. In 1999, following years of controversy Leahy asked the FDA to review its 1993 approval of rBGH. and citing continued gaps in the scientific research, both Following a page-by-page audit of its decision, the FDA the 15-nation European Union (EU) and Health Canada — reaffirmed that “milk from cows treated with rBGH is safe resistant to Monsanto’s Roundup sure of control over the world’s ag- herbicide, and corn and cotton con- riculture. The concerns deepened in Safety Concerns taining a naturally occurring soil 1998 with the announcement that microbe, Bacillus thuringiensis, Monsanto was considering buying ver since researchers began ex- which kills insects. the rights to the process for devel- E perimenting with recombinant At the same time, the three big- oping genetically engineered “ter- DNA, safety concerns have been gest multinational biotechnology minator” seeds, which do not germi- raised about genetically engineered companies — Monsanto, DuPont nate, thus requiring farmers to buy organisms. As early as 1970, a pro- and Novartis — rapidly bought up new seeds every year. 19 fessor at a private research center on smaller seed companies around the The widespread outcry against the Long Island named Robert Pollack world, and the seed industry be- technology prompted Monsanto’s tried to dissuade a Stanford Univer- came increasingly consolidated, announcement in 1999 that it would sity graduate student from transfer- sparking concerns that a handful of not pursue terminator seed technol- ring genes from a monkey virus to a companies could gain a large mea- ogy. bacterium, warning that such an ex-

262 CQ Researcher . . . From Hormone-Injected Cows?

for human consumption,” and charged that “Canadian market their products as hormone-free. Labels on Ben & reviewers did not interpret relevant data correctly.” 6 Jerry’s ice cream products, for example, state: “We Oppose Monsanto continues to insist rBGH is safe, and is Recombinant Bovine Growth Hormone.” By law, their labels supported by the American Medical Association (AMA), the must state that the FDA has found “no significant difference” American Cancer Society and the World Health Organization. between milk from rBGH-treated and untreated cows. “Agricultural biotechnology of this kind is the future of Some consumers, meanwhile, are switching to organic food production in the United States and should not be milk, which does not contain added hormones. Nationwide feared or impeded,” the AMA said in 1993. sales of organic milk grew 92 percent from 1996 to 1997 After an eight-year study of the records from 340 dairy while conventional milk sales were flat. Sales of organic herds in the Northeast, Cornell University in New York milk are projected to be very strong through 2002, found no difference in the health of BGH-treated and according to the Organic Trade Association. 9 untreated cows. “The only difference in herds was that “Ultimately, this will play itself out in the marketplace,” those treated with BGH gave more milk,” said Dale Bauman, Dobbs said. 10 who supervised the study. 7 But after seven years, even opponents of the hormone But critics still raise questions. Michael Hansen, a biologist concede that it is probably here to stay. “Maybe we don’t at Consumers Union, in Yonkers, N.Y., warns that dairy cows like rBGH in the milk, but we’re going ahead and buying it,” injected with the hormone have increased levels of a substance says Thomas Dobbs, an agricultural economist with South called IGF-1, which promotes tumor growth. “We don’t have Dakota State University. “The battle is sort of won by attrition.” the evidence to say this stuff is hazardous to drink, but neither do we know for sure that it is safe,” Hansen said. “All 1 Robert Steyer, “Europe May Order a Permanent Ban on Monsanto we want are long-term toxicology studies.” 8 Milk Drug,” St. Louis Post Dispatch, Oct. 31, 1999. Hansen’s group, along with a consortium including the 2 Ibid. Center for Food Safety, petitioned the FDA to pull rBGH off 3 “Hormones: Udder Confusion,” The Economist, 1999. the market until more long-term health studies are done. The 4 Annie McIlroy, Monsanto denies bribery allegation; Researcher testifies FDA denied the petition last June, calling the IGF-1 fears that the company may have tried to influence Health Canada over unfounded. The group is still considering filing a lawsuit. bovine growth hormone,” The Globe and Mail, Oct. 23, 1998. The product is also controversial because the FDA ruled 5 Greg Barrett, “One man, a crusade and the fight to wean milk from in the early 1990s that milk products containing rBGH did manmade hormones,” Gannett News Service, March 3, 2000. 6 not need to be labeled — a regulation widely reported to Findings related in a Jan. 21, 1999, letter from Health and Human Services Secretary Donna Shalala to Vermont’s two senators. have been drafted by a former Monsanto lawyer working 7 Jo Sandin, “Schism over BGH in milk only grows Banned in Europe, at the FDA. Canada, hormone use is a non-issue for many U.S. consumers,” The As a result, consumers and dairy marketers find themselves Milwaukee Journal Sentinel, April 12, 1999. in a quandary if they want to avoid rBGH-derived dairy 8 Barrett, op. cit. products. Many dairy processors ask suppliers not to use 9 Amy Martinez Starke, “Synthetic Hormones in Milk: Got Doubts?” rBGH, but must depend on suppliers’ honesty. The Portland Oregonian, April 11, 2000. Other companies have fought for the legal right to 10 The Associated Press, op. cit. periment could spawn dangerous mi- tered bacteria could not compete with tests by biotechnology opponents, crobes. In 1975, prominent research- more robust, naturally occurring the company developed other ers met at the Asilomar conference microbes. Satisfied that genetic re- bioengineered products and lobbied center in Pacific Grove, Calif., where search could be conducted safely, against stringent regulation of the in- they adopted stringent standards for the NIH lifted its restrictions in the dustry. In 1992, the biotech industry certain types of genetic research and mid-1980s. This opened the flood- scored a major victory when then established a committee at the Na- gates to the commercial introduction Vice President Dan Quayle an- tional Institutes of Health (NIH) to of hundreds of drugs, such as insulin nounced a policy that limited the review and approve all bioengineer- for diabetes, and spurred research regulatory reach of the FDA, effec- ing research projects. 20 into genetically modified agricultural tively ensuring that genetically engi- Within a few years, however, it products. neered foods would not face any became apparent that genetic engi- Monsanto led the way by creating greater regulatory barriers than foods neering tended to weaken bacteria, a bovine growth hormone to improve created through conventional cross- not strengthen them. Genetically al- milk production in cows. Despite pro- breeding.

CQ on the Web: www.cq.com March 30, 2001 263 BIOTECH FOODS

The decision set off a furor that vealed the StarLink contamination of D-Calif., on a plan to subject geneti- persists to this day. Alarmed by the the food supply. cally modified foods to premarketing lack of regulatory oversight or label- The StarLink incident dealt a stag- safety tests, similar to the way food ing of genetically engineered food, gering economic and public relations additives are tested. Jeremy Rifkin, a leading opponent of blow to the biotech industry. Hundreds “FDA’s current policy for geneti- biotechnology, launched a “pure of brands of taco shells, cornmeal and cally engineered food appears to do food” campaign and demanded a other food were recalled, and Kellogg more to protect the biotechnology global moratorium on genetic engi- and ConAgra shut down production industry than to protect consumers,” neering. Dozens of U.S. consumer, lines for more than a week to make Kucinich said when he introduced environmental and animal-rights sure their systems contained no his regulatory measure in 2000. 23 groups eventually joined the cam- StarLink. Some farmers have pared back The Clinton administration, after paign for stricter regulations. on their plantings of some types of ge- drawing fire from anti-biotechnology In Europe, protesters tore up GMO- netically modified seeds, such as Bt advocates for its close ties to planted fields and demonstrated in front corn, although most biotech crops re- Monsanto, proposed a rule in its final of television cameras. British supermar- main popular with planters. days to require companies to notify ket chains used the furor to competitive Aventis CropScience, which devel- the government 120 days before advantage by advertising their house oped StarLink corn, may postpone its bringing a GMO to market. Currently brands as “GMO-free.” By the late 1990s, planned 2003 release of genetically the FDA requires no notification, EU officials were refusing to sanction modified rice. In fact, the parent com- unless the food is substantially differ- new genetically engineered crops, pany, the Franco-German pharmaceu- ent than its conventional counter- sparking transatlantic trade battles. tical company Aventis, announced last parts or contains a potential allergen. Regulators in Australia, New Zealand, November that it plans to divest its In addition, the agency proposed Japan and Canada began drafting man- agricultural subsidiary. that company safety-test information datory labeling rules for genetically be made publicly available in order engineered products. to assuage consumer concerns. It also After resisting international restric- proposed the new voluntary labeling tions on genetically modified food, guidelines for those wanting to label the United States agreed at a 2000 their products as GMO-free. international conference in Montreal, CURRENT The proposal “will go a long way Canada, to finalize a biotechnology in assuring [consumers] that these agreement known as the Cartagena SITUATION products have undergone a rigorous Protocol on Biodiversity. It requires review by FDA scientists,” said FDA labels on genetically modified agri- Commissioner Jane Henney. 24 cultural commodities shipped across Although the food industry gener- borders and gives nations the right to Proposals in Congress ally praised the FDA’s plans, con- refuse imports of genetically modi- sumer advocates gave it poor reviews. fied food if there is little evidence to Kucinich dismissed it as “purely pub- show that the food is safe. rmed with polls showing that lic relations.” 25 However, U.S. negotiators managed A consumers want to know which Some consumer groups are con- to dilute the treaty. For example, bulk foods contain genetically modified sidering suing the FDA to force it to commodity shipments, seeds and ani- ingredients, some in Congress say the take a more stringent approach. “We mal feeds won’t have to be labeled for government should require the prod- think there needs to be a mandatory at least two years. And processed foods ucts to be labeled. “The most ratio- system of premarket review in which that contain genetically modified ingre- nal and safe thing to do is to label data are submitted to FDA, and FDA dients will not have to be labeled at all. something free of genetic modifica- does an independent review, as it In addition, the wording of the labels tion and let consumers make up their would with a food additive,” says the will say “may contain genetically modi- minds if it concerns them or not,” Center for Food Safety’s Mendelson. fied organisms” instead of “contains ge- said Rep. Dennis Kucinich, D-Ohio. 22 With George W. Bush in the White netically modified organisms.” 21 Kucinich failed to advance a GMO House, it appears unlikely that the Concerns about the risks of labeling bill in 2000, but he plans to government will decide on its own to bioengineered foods crystallized in reintroduce it this year. He also has impose stiffer regulations. Bush has 2000, when Friends of the Earth re- teamed up with Sen. Barbara Boxer, Continued on p. 266

264 CQ Researcher At Issue: Should the FDA step up regulation of genetically engineered food?

JOSEPH MENDELSON III L. VAL GIDDINGS, PH.D. LEGAL DIRECTOR, CENTER FOR FOOD SAFETY VICE PRESIDENT FOR FOOD AND AGRICULTURE BIOTECHNOLOGY INDUSTRY ORGANIZATION WRITTEN FOR THE CQ RESEARCHER, MARCH 2001 WRITTEN FOR THE CQ RESEARCHER, MARCH 2001 n mid-January, the Food and Drug Administration (FDA) proposed new regulations concerning genetically oods derived through biotechnology are among the i engineered (GE) foods that didn’t call for labeling. The most tested and regulated in the world — and proposal also reaffirmed a 1992 policy that GE foods are not f indistinguishable from foods created in any other subjected to mandatory premarket safety testing because manner. They are safe for human consumption. they are “generally recognized as safe.” The end result is a Says who? How about the National Academy of Sciences, proposal that further undermines the agency’s credibility on the American Medical Association, the Department of this issue and harms consumers. Agriculture, the Environmental Protection Agency and the The FDA’s regulatory position is contrary to assessments Food and Drug Administration. by its own scientific authorities. As a result of litigation Scientists for these respected bodies have determined that the brought by the Center for Food Safety, numerous documents focus of regulatory review should be on the content, and not have been released showing FDA scientists have significant the process by which the foods are developed, and use science concerns that “the processes of genetic engineering and rather than emotion and superstition to make approval decisions. traditional breeding are different, and . . . lead to different Opponents of biotechnology claim that the foods are not risks.” These unique risks include creating new toxins and tested or sufficiently regulated — but the opposite is true. allergens inyes food, undermining the effectiveness of therapeu- Biotech foods have no been subjected to more scrutiny, in tic antibiotics and lowering nutritional value. advance, than any other foods in history. Test data confirm No wonder the public is increasingly uneasy about the they pose no greater threat to the environment or human agency’s steadfast refusal to mandate premarket testing and health than plants modified by conventional breeding. labeling for all GE foods. In fact, in many cases, biotech crops and foods enhance Up to 60 percent of processed food contains genetically our environment and health by allowing farmers to reduce engineered ingredients, and the vast majority of consumers their use of chemical pesticides. This may seem surprising strongly support premarket testing and labeling. Yet under the since there are many who have created an aura of fear new FDA rules, the agency has kept a voluntary testing surrounding these foods, using the most frightening lan- consultation process in place and stated only that it will allow guage possible. Industry, consumers and regulators are all food producers not using biotechnology to voluntarily label involved in the open and public approval system: There are their foods as “not produced through biotechnology.” nine steps in the review process (which can take up to 10 This new proposal is grossly unfair to traditional food years and cost up to $10 million) where consumers and producers and does nothing to help the consumer. Voluntary government regulators can “just say no.” labeling will punish food providers not using genetic engineer- Initial application of biotechnology to agriculture has ing technology by putting the burden on them to certify, test focused on improving farming. These products directly and label their foods. Many food companies will not want, or benefit growers by reducing costs and boosting yields and be able, to undergo the considerable time, expense and liability indirectly benefit consumers by fostering more environmen- of voluntary labeling. Meanwhile, not a single GE food tally friendly farming practices, including reduced reliance producer will have to label their gene-altered foods. In the end, on chemical fertilizers and pesticides. the new regulations and guidelines will prevent consumers The next generation of biotech foods will benefit consum- from knowing which foods have been genetically engineered. ers through enriched nutrition, decreased allergenicity, lower Under the FDA’s new regulations, individuals and health fat content and improved freshness and taste. Also in professionals will not know if an allergic reaction to a food development are biotech foods that eventually will deliver was due to its being genetically engineered. medicines, such as vaccines that help prevent cancer. This is Similarly, no labeling deprives consumers of the critical especially important for developing nations. knowledge they need to hold GE food producers liable should We now have 10 years’ experience with the regulatory any of these novel foods be hazardous. Clearly, FDA’s new system governing foods improved through biotechnology — proposal serves a few biotechnology companies at the expense and not so much as a sniffle from any link to the foods. We of the rest of the food industry and American consumers. can safely say the system works.

CQ on the Web: www.cq.com March 30, 2001 265 BIOTECH FOODS

Continued from p. 264 them, the biotechnology industry without cutting down more wilder- strong anti-regulatory leanings and, could find itself in some trouble. ness areas.” like his Democratic and Republican “I think it [the future of genetically The council’s Web site (www. predecessors, he has expressed an modified foods] will be played out in whybiotech.com) contains reports on interest in helping the biotechnology the next three to five years and the the potential benefits of GMOs, updates industry move forward. consumer basically is going to de- on government biotechnology deci- “There are no limits [on what] re- cide,” says Iowa State’s Harl. “The sions and an introductory guide to the sponsible biotechnology can bring to consumer is king.” science of biotechnology. America and the world,” then-Texas Harl believes that the market even- Monsanto, which has come under Gov. Bush told a biotechnology gath- tually will be dominated by one kind fire for introducing new products with- ering last year. 26 of food or another — either conven- out much government oversight, is try- Environmentalists and consumer tional or genetically engineered — ing to reassure the public by develop- groups vow to continue pushing for because maintaining supplies of two ing products to benefit consumers, such labeling, despite losing a lawsuit last different types of agricultural systems as crops that produce vegetable oils year to force FDA to impose labeling. 27 is too expensive. “We’re not equipped with less fat. “We want to develop the But even some biotechnology al- to handle two-track systems,” he says. technology in a way that makes sense lies believe the government must take The prospect of consumers demand- and delivers benefits, but also takes into steps to allay concerns about geneti- ing stiffer regulations alarms the bio- account the concerns,” says Monsanto’s cally modified foods. technology industry. When companies Hurley. One of the top biotechnology advo- such as Monsanto and Aventis began cates in Congress, Rep. Smith of Michi- introducing genetically modified crops gan, says labeling is “a possibility” as in the mid-1990s, they focused on win- long as labels don’t send a “skull and ning over the agricultural market. Their crossbones” message to consumers. But products, such as herbicide-resistant Pressure for Labeling Smith, who has grown genetically al- soybeans and cotton that contains an tered soybeans on his farm, says his top insecticide, were designed to help farm- coalition of consumer and envi- priority is to fund government research ers instead of shoppers. A ronmental organizations is launch- on the safety of biotechnology in order Belatedly, the manufacturers have ing its own campaign, ratcheting up to send a reassuring message. begun reaching out to consumers in the the pressure for mandatory labeling “We need to do what’s necessary last couple of years — an effort that has and more regulation. The group wants to make the American people com- taken on new urgency after the StarLink food companies such as Campbell fortable,” he says, “so we don’t go debacle. The industry has just launched Soup and Kellogg’s to remove GMOs down the [same] road as Europe, a multimillion-dollar advertising and from their products. Environmental where they say let’s stop everything information campaign in the United groups are concerned that bioengin- where something might go wrong.” States, which over the next three to five eered plants can degrade the soil, kill years will tout the benefits of geneti- “beneficial” insects and facilitate the cally engineered foods. It is considering creation of new types of viruses. They similar efforts overseas. also dispute the contention that the “We’re trying to assemble the best farmers who grow the plants use fewer Convincing Consumers information we can and make it avail- pesticides. able and accessible in a range of A much-discussed threat is “genetic n the end, consumers in the United ways,” says Linda Thrain, executive drift” — the prospect that genes from I States and other countries may director of the Council for Biotech- bioengineered plants and animals may make the ultimate decision on the nology Information, a consortium of enter natural ecosystems. “Genetically future viability of genetically engi- seven biotechnology companies engineered crops present profound neered food. If supermarket shop- sponsoring the campaign. “We need ecological concerns, and we have pers, knowingly or not, continue to to help people understand how ag- barely begun to study them,” says Rich- buy genetically modified products, riculture has progressed over the ard Caplan, an environmental advocate the technology is likely to dominate years so they can understand how for the U.S. Public Interest Research the non-organic food industry. But if biotech is part of this technology Group. “In terms of potential risks of genetically modified products are continuum that allows fewer farmers the technology on a scale of one to 10, labeled and consumers refuse to buy to grow more food for more people we should be at a concern level of 10.”

266 CQ Researcher Some scientists dismiss such fears, Despite the pressure from consumer Some believe the vaccines will also arguing that most genetically modified and environmental groups, the biotech- help reverse public skepticism about organisms would perish in the wild be- nology industry may be its own worst genetically modified food. “If the prod- cause their traits would not help them enemy. Critics say the industry has put ucts have some visible benefits, the outside of a controlled environment. itself into an untenable situation by urg- consumer will be much more inter- Biotechnology advocates point to a study ing consumers to believe in the benefits ested,” says Pinstrup-Andersen of the in England showing that genetically of biotech foods while opposing efforts Food Policy Research Institute. modified canola, potatoes, maize and to label or regulate them. Arntzen says he is within about three sugar beets did not spread to nearby “I think the industry is spending a years of creating vaccines for hepatitis meadows or forests over a 10-year pe- lot of money and buying a lot of grief B and diarrhea that could be delivered riod. In addition, say industry represen- for itself,” says Foreman of the Con- in dried fruit. But he cautions that it tatives, farmers create buffer zones be- sumer Federation of America. “I can may be years before regulatory agen- tween different biotech crops and others never understand why companies don’t cies approve them. “Each country has just to prevent such cross-fertilization. want the FDA’s approval.” its own regulatory standards,” he says. “These plants don’t out-compete the Unlike conventional vaccines, which wild types. They’re prima donnas,” says contain microorganisms that could Kjelstrom of the University of Califor- spring back to life and cause the very nia. “It’s like taking your house cat and OUTLOOK diseases that they are supposed to pre- putting it out in Africa.” vent, food vaccines would not contain To parry environmental attacks, in- genes that enable entire pathogens to dustry officials emphasize that biotech- form. By entering into the digestive tract, nology can reduce pesticide use and Vaccines in a Peach? they could also produce what is known alleviate the need to clear ecologically as mucosal immunity, which gives the sensitive areas, such as rain forests, for digestive and reproductive tracts greater new farms. “If you can reduce the hen University of Arizona plant resistance to diseases. chemical load in the environment, isn’t W biologist Charles J. Arntzen vis- “It can really wipe out the conven- that the type of thing that a consumer ited Bangkok, Thailand, in the early tional vaccination approach,” says Wil- would prefer?” argues Dry of BIO. 1990s, he noticed a mother soothing liam Langridge, a professor at the Cen- However, some biotech skeptics her crying baby with a piece of ba- ter of Molecular Biology and Gene want a nationwide debate over nana. “I knew at that point it would Therapy at the Loma Linda University whether it’s wise or ethical to allow be totally logical to put something School of Medicine in California. the unregulated creation of entirely useful into that fruit,” he said. 29 Langridge, who wants to use edible new part-plant, part-animal species, The result has been years of re- vaccines to combat autoimmune dis- or even perhaps one day to splice search by Arntzen and others into the eases, acknowledges that many ques- human genes into the genes of plants feasibility of creating bananas, toma- tions must still be resolved, such as or animals eaten by humans. Current toes or other produce containing life- whether edible vaccines will actually law does not forbid either. saving vaccines. If the technology protect people from diseases. But he A genetically engineered organism ever becomes available, it could revo- believes that the technical obstacles “is a radical transformation of the blue- lutionize health care in developing appear to be “surmountable.” print of life of that organism, a radical countries, where millions of unvacci- Other researchers say edible vaccines transformation that could never have nated children die every year from represent one of the most exciting de- occurred under natural circumstances,” diarrhea, measles and other diseases. velopments in the field of genetically said Steven Druker, executive director The future of genetically modified modified foods. They point out that the of the Alliance for Bio-Integrity, the organisms may be found in such World Health Organization has encour- Fairfield, Iowa, group that unsuccess- trailblazing ideas. Whereas the first aged the creation of inexpensive, oral, fully sued the FDA to force it to label wave of genetically altered crops of- non-refrigerated vaccines to safeguard biotech foods. He believes that such fered benefits to farmers and food the health of the estimated one infant in organisms threaten “the harmony of our manufacturers, the next generation five that does not receive vaccines. 30 relationship with nature.” 28 has the potential for battling or even “There are areas of the world, nota- Sensitive to such criticism, Monsanto eradicating microbes that cause diph- bly in Africa, where you cannot go in has pledged not to splice animal genes theria, whooping cough, tetanus and there with syringes and so forth and into crops. other potentially fatal diseases. either vaccinate animals or humans.

CQ on the Web: www.cq.com March 30, 2001 267 BIOTECH FOODS

You can’t get enough needles in, you can’t sterilize them, and so on,” Georgetown University’s Crawford says. “But if we can go into the Congo and American Farm Bureau Federation, 225 Touhy Ave., Park Ridge, Ill. give them some potatoes that would 60668; (847) 685-8600; www. fb.com. The federation promotes agricultural give them a polio vaccine, a malaria research and monitors domestic production, foreign assistance programs vaccine, that would be fantastic.” and rural development.

Biotechnology Industry Organization, 1625 K St., N.W., Suite 1100, Washington, D.C. 20006-1604; (202) 857-0244; www. bio.org. BIO moni- tors government activity and conducts workshops on biotech issues.

Notes Friends of the Earth, 1025 Vermont Ave., N.W., Suite 300, Washington, D.C. 20005-6303; (202) 783-7400; www.foe.org. FOE monitors legislation 1 Andrew Pollack, “F.D.A. Plans New Scru- and issues related to seed industry consolidation and agricultural biotech- tiny in Areas of Biotechnology,” The New nology and their effect on food production and the environment. York Times, Jan. 18, 2001, p. 12. 2 Ben Hirschler, “Switzerland: Davos-Monsanto Grocery Manufacturers of America, 1010 Wisconsin Ave., N.W., Suite sees U.S. bio-crop growth despite GM row,” 900, Washington, D.C. 20007; (202) 337-9400; www.gmabrands.com. Represents manufacturers of products sold through grocery stores. Reuters English News Service, Jan. 30, 2001. 3 Letter from Smith to Science Committee International Food Policy Research Institute, 2033 K St., N.W., Wash- Chairman Rep. James F. Sensenbrenner Jr., ington, D.C. 20006; (202) 862-5600; www.cgiar.org/ifpri. Research organi- R-Wis., April 13, 2000. zation that analyzes the world food situation and suggests ways of making 4 Gillian Steward, “A New Breed of Superweed,” food more available in developing countries. Toronto Globe and Mail, June 15, 2000. 5 Peter Calamai, “Ottawa Rapped in GM Food National Center for Food and Agricultural Policy, 1616 P St., N.W., Suite Report,” The Toronto Star, Feb. 5, 2001. 100, Washington, D.C. 20036; www.ncfap.org. Research and educational 6 Donald G. McNeil Jr., “Europe Approves organization concerned with international food and agricultural issues. New Genetically Modified Food Control,” The New York Times, Feb. 15, 2001. is drawn from two reports: “Genetically York Times, Jan. 18, 2001, p. 12. 7 Sarah Lueck and Scott Kilman, “Gene-Altered Modified Pest-Protected Plants: Science and 26 Andrew Park, “Biotech Companies to Face Food Needs Labels, Safety Reviews, Committee Regulation,” by the National Academy of Increasing Battles over Ethics, Property Says,” The Wall Street Journal, Dec. 19, 2000. Sciences, 2000; and “Seeds of Opportunity: Rights,” Knight-Ridder Tribune Business 8 Marc Kaufman, Consumers Want Engi- An Assessment of the Benefits, Safety and News, April 17, 2000. neered Food Labeled, The Washington Post, Oversight of Plant Genomics and Agricultural 27 Press release, Alliance for Bio-Integrity, Feb. 13, 2001, p. A9. Biotechnology,” by the House Science Sub- viewed at www.bio-integrity.org. The rul- 9 For background, see Susan C. Phillips, committee on Basic Research, April 13, 2000. ing was issued by the U.S. District Court for “Genetically Engineered Foods,” The CQ 18 Phillips, op. cit., p. 681. the District of Columbia in October 2000. Researcher, Aug. 5, 1994, pp. 673-696. 19 For background, see Kathy Koch, “Food 28 Herb Keinon and Brian Hendler, “What Beans 10 Green’s affidavit was filed with the U.S. District Safety Battle: Organic vs. Biotech,” The CQ Can Sprout,” The Jerusalem Post, May 19, 2000. Court for the District of Columbia in the case Researcher, Sept. 4, 1998, pp. 774-75. 29 Missy Globerman, “Bioengineering for the of Alliance for Bio-Integrity v. Donna Shalala. 20 This paragraph and the next two are drawn mouths of babes,” Red Herring, Jan. 16, 2001. 11 “Third World is Offered Genetically Altered partly from Kurt Eichenwald, “Redesigning 30 Ibid. Rice,” The Seattle Times, May 17, 2000, p. A16. Nature: Hard Lessons Learned,” The New York 12 J. Madeleine Nash, “Grains of Hope,” Times, Jan. 25, 2001. About the Author Time Asia, Feb. 12, 2001. 21 Cindy Snyder, “Montreal Pact Tries to 13 Carol Kaesuk Yoon, “Genetically engineered Catch Up with Genetic Industry,” The As- David Hosansky is a freelance fish might slip through regulatory net,” The San sociated Press, Feb. 16, 2000. writer in Denver who specializes Diego Union-Tribune, May 18, 2000. 22 Bill Lambrecht, “Magazine Reveals Food- in environmental issues. He previ- 14 Aaron Zitner, “Gene-Altered Catfish Raise Makers’ Secret,” St. Louis Post-Dispatch, Environmental, Legal Issues,” Los Angeles Aug. 22, 1999, p. A10. ously was a senior writer at CQ Times, Jan. 2, 2001, p. A1. 23 Kucinich press release, March 10, 2000. Weekly and a reporter at the 15 Scott Kilman, “Bioengineered Bugs Stir Hope,” 24 Julie Vorman, “USA: US Regulators Refuse Florida Times Union, where he The Wall Street Journal Europe, Jan. 30, 2001. to Require Labels for Bio-Foods,” Reuters was twice nominated for a Pulitzer 16 Shankar Vedantam, “Cloning Sparks De- English News Service, Jan. 17, 2001. Prize. His last CQ Researcher re- bate,” Denver Post, Feb. 24, 1997, p. A1. 25 Andrew Pollack, “F.D.A. Plans New Scru- port was “Mass Extinction.” 17 Much of this paragraph and the first section tiny in Areas of Biotechnology,” The New

268 CQ Researcher Bibliography Selected Sources Used

Books Shlachter, Barry, “Horn of Plenty or ‘Frankenfoods’?” The Fort Worth Star-Telegram, Jan. 28, 2001. Cummins, Ronnie, and Ben Lilliston, Genetically En- An unusually thorough discussion about the promise of gineered Food, Marlowe & Co., 2000. genetically engineered crops to improve human nutri- A highly critical account of the potential dangers of tion, and the possible perils of the technology. bioengineered foods by the director of the Organic Consumers Association and a health and environmental Starke, Amy Martinez, “Super Salmon,” Portland Or- writer. The book offers advice for consumers seeking to egonian, Sept. 26, 2000. steer clear of genetically engineered foods. Starke discusses the development of transgenic salmon that grow twice as fast as conventional salmon. Such McHughen, Alan, Pandora’s Picnic Basket, Oxford organisms can relieve the pressure on wild species of University Press, 2000. fish, but they pose a threat to the environment if they A Canadian researcher who has developed genetically escape from fish farms. modified plants, McHughen explains the technology of gene-splicing and discusses such issues as government Weiss, Rick, “Biotech Food Raises a Crop of Ques- regulation and labeling. tions,” The Washington Post, Aug. 15, 1999. Weiss provides a far-ranging analysis of the possible Rissler, Jane, and Margaret Mellon, The Ecological hazards of genetically engineered food, raising questions Risks of Engineered Crops, MIT Press, 1996. about the dearth of health studies about the new technology. Two scientists from the Union of Concerned Scientists examine the possible adverse effects when transgenic Reports crops cross-pollinate with wild relatives and create such offspring as herbicide-resistant weeds. “Breeding Distrust: An Assessment and Recommenda- tions For Improving the Regulation of Plant Derived Articles Genetically Modified Foods,” Consumer Federation of America’s Food Policy Institute, Jan. 11, 2001. Eichenwald, Kurt, “From the Lab to a Debacle,” The The report states that genetically modified foods offer New York Times, Jan. 25, 2001. great potential, but it urges government to greatly step up A scathing analysis of Monsanto Co.’s campaign to its regulation of them in order to ensure that the products minimize government regulations of genetically engi- are safe. neered foods — an approach that backfired when advo- cates began campaigning against the products. “Genetically Modified Pest-Protected Plants: Science and Regulation,” National Research Council, 2000. Kilman, Scott, “Bioengineered Bugs Stir Hopes,” The This straightforward and authoritative analysis by an Wall Street Journal Europe, Jan. 30, 2001. arm of the National Academy of Science concludes that The author looks at the potential benefits of bioengineered genetically engineered crops are safe to eat, but it urges bugs, as well as the risks of releasing the creatures into tighter regulations over the products. The report also the wild. calls for more research into the potential environmental effects of the crops. Langridge, William H. R., “Edible Vaccines,” Scien- tific American, September 2000. “Seeds of Opportunity: An Assessment of the Ben- A fascinating discussion of the research into genetically efits, Safety and Oversight of Plant Genomics and modifying tomatoes, bananas and other types of produce Agricultural Biotechnology,” House Science Subcom- in order to deliver edible vaccines. mittee on Basic Research, April 13, 2000. An informative but unabashedly pro-industry report Nash, J. Madeleine, “Grains of Hope,” Time Asia, Feb. that discusses the history and potential of genetically 12, 2001. engineered plants, while minimizing the risks of the new A detailed article that looks at the potential for golden technology. The report was overseen by subcommittee rice and other genetically engineered foods to feed Chairman Nick Smith, R-Mich., a farmer who has grown impoverished people in developing countries. bioengineered crops.

CQ on the Web: www.cq.com March 30, 2001 269 BIOTECH FOODS The Next Step

Corporations Government Agencies

Comander, Lauren, and James P. Miller, “Monsanto Abate, Tom, “Engineered Food Rules Proposed,” The Pledges Slower Pace with Gene-Altered Food; Critics San Francisco Chronicle, Jan. 18, 2001, p. B1. Contend Firm’s Steps not Enough, Chicago Tribune, Spurred by public concern, the U.S. Food and Drug Nov. 29, 2000, p. N1. Administration yesterday proposed mandatory reviews Monsanto Co., the biggest corporate booster of geneti- for genetically engineered crops but left it up to manu- cally altered food and a lightning rod for critics, is facturers to decide whether or not to label bioengineered promising to back off from some controversial technolo- foods. gies and take bigger steps to promote food safety. Avery, Dennis T., “Unnecessary Setback for Biotech Eichenwald, Kurt, “Hard Lessons Learned: Biotech- Corn,” Chicago Tribune, Nov. 26, 2000, p. C19. nology Food: From the Lab to a Debacle,” The New Why did the Environmental Protection Agency offer any York Times, Jan. 25, 2001, p. A1. approval at all for StarLink corn if it thought the geneti- In late 1986, four executives of the Monsanto Co., the cally engineered corn might trigger allergies? The poten- leader in agricultural biotechnology, paid a visit to Vice tial for the corn to leak into human consumption was too President George Bush at the White House to make an great. It was a regulatory bungle. unusual pitch. Monsanto wanted its new technology, genetically modified food, to be governed by rules issued Fulmer, Melinda, “FDA Proposes Regulations for in Washington — and wanted the White House to Bioengineered Crops; Biotech written notice would champion the idea. be required to introduce new varieties, but the agency stops short of ordering safety tests or food labels,” Glover, Mike, “Maker of Gene-Altered Feed Corn to Los Angeles Times, Jan. 18, 2001, p. C1. pay Millions; Compensation Slated to Offset Losses The federal government proposed regulations for From Contamination Scare,” Chicago Tribune, Jan. bioengineered crops, requiring written notice before 24, 2001, p. N6. new crops are introduced but stopping short of ordering The creator of a genetically modified corn that got into safety testing or labels for food products that contain the food supply and prompted the recall of taco shells genetically modified organisms. and other products has agreed to pay millions in com- pensation to farmers and grain elevators. Kaufman, Marc, “FDA Will Widen Probe Of Biotech Corn Misuse,” The Washington Post, Oct. 3, 2000, p. Manning, Anita, “Biotechnology ready to grow But A13. critics would shuck it all, even the less-fatty fries,” The Food and Drug Administration confirmed the pres- USA Today, Dec. 14, 2000, p. 11D. ence of unapproved genetically engineered corn in some With the first wave of genetically engineered foods — crops grocery taco shells yesterday, and announced plans to with built-in pesticides or herbicides — biotech companies begin testing other corn-based products to see if they in the 1990s focused on farmers, promising to reduce the cost have been contaminated, too. and labor of repeated applications of chemicals. Keeler, Barbara, and Marc Lappe, “Some Food for “Modify Biotech’s Sales Pitch Too,” Los Angeles Times, FDA Regulation,” Los Angeles Times, Jan. 7, 2001, p. March 9, 2001, p. B8. M2. The biotech industry fears that stricter regulation will Despite consumer pleas, the Food and Drug Adminis- somehow turn public sentiment against modified foods. tration has declined since 1992 to require that genetically Thus it has lobbied against an FDA rule proposed in modified food seeds be proved safe for consumption January to require agriculture companies to notify the before their release into the food supply. Nor does the agency four months before marketing a GM crop and to FDA require ingredient labels for genetically modified put the scientific data about the crop on the Internet. foods. Instead, the agency encourages producers to voluntarily submit safety data. Thomas, Ken, “16 States Urge More Action From Aventis Food; The firm looks to spin off unit respon- “Reject gene-altered corn,” USA Today, Dec. 7, 2000, sible for altered StarLink corn, but analysts downplay p. 18A. move,” Los Angeles Times, Nov. 16, 2000, p. C3. One of the easiest decisions any federal regulator will Sixteen state attorneys general are pressing the company ever get to make is stalled at the Environmental Protec- that developed StarLink corn to do more to compensate tion Agency (EPA), where officials are being asked to farmers and grain elevators for losses incurred after the approve for human consumption a type of corn that has genetically modified strain showed up in the food supply. been genetically altered to produce its own pesticide.

270 CQ Researcher Protests Fulmer, Melinda, “GMOs are Found in Morningstar Farms Food Products: Kellogg says discovery of ge- Burres, Charles, “UC Finalizes Pioneering Research Deal netically modified ingredients was an isolated inci- with Biotech Firm; Pie tossers leave taste of protest,” dent. No decision has been made on recalls,” Los The San Francisco Chronicle, Nov. 24, 1998, p. A17. Angeles Times, March 8, 2001, p. C1. Protests and pie throwing greeted the signing ceremony New laboratory tests have found that veggie burgers yesterday of a pioneering biotech partnership between and meat-free corn dogs made by natural foods brand the University of California at Berkeley and the Swiss- Morningstar Farms contain genetically modified soy and based drug and agribusiness giant Novartis AG. the controversial genetically altered feed corn StarLink.

Goozner, Merrill, “Multicultural March Protests Ge- Fulmer, Melinda, “ ‘Medium’ Chance StarLink Protein netically Altered Food, WTO Policies,” Chicago Tri- an Allergen,” Los Angeles Times, Dec. 6, 2000, p. C2. bune, Dec. 3, 1999, p. N29. An independent scientific panel told the government that Thousands of demonstrators protesting bioengineered there’s a “medium likelihood” that the pest-fighting protein foods marched peacefully through downtown Seattle. found in a controversial variety of genetically engineered corn will cause an allergic reaction in humans. Podger, Pamela J., “Organic farmer wants labels on altered products,” The San Francisco Chronicle, Dec. Hoban, Thomas, “Tacogate: There Is Barely A Kernel 13, 1999, p. A17. of Truth,” The Washington Post, Nov. 26, 2000, p. B2. Genetically modified foods have given rise to protests in Since StarLink genetically modified corn was found in Japan, and stringent European labeling requirements effec- American-made taco shells, thousands of the shells have tively ban genetically altered food from the United States. been stripped from store shelves in a recall that was But the Alliance for Better Foods says genetically modified widened last week to include more than 1.4 million foods will promote greater nutrition and less reliance on pounds of corn flour and other baking ingredients. chemical pesticides and combat global hunger. “Modified Corn Found in Japan,” The New York Times, Weiss, Rick, “In Europe, Cuisine du Gene Gets a Dec. 29, 2000, p. A2. Vehement Thumbs Down; Biotech Food Protests About 28,000 tons of a genetically modified corn, Reflect Cultural Contrasts, Health Fears,” The Wash- StarLink, was imported from the United States and used ington Post, April 24, 1999, p. A1. in food in Japan this year, health officials said. The corn They gathered at the edge of a field here late one night, has not been approved for human consumption. about 20 people wearing dark clothes and gardening gloves. When lookouts in three cars all gave the go-ahead Sachdev, Ameet, “Biotech Corn a Risk to Break U.S. via mobile phones, shadowy figures crept from behind Food Chain; Discovery of Genetically Modified Corn, the hawthorn hedgerows and began ripping every gene- Which is Banned for Human use, in a Brand of Corn altered plant from the earth. Dogs has Growers and Processors Fearing Foreign Customers may Slash Imports,” Chicago Tribune, StarLink Corn March 9, 2001, p. N1. The newest discovery of StarLink corn, approved only Cady, John R., “StarLink’s risks minuscule,” USA for animal feed, came in Kellogg-made frozen corn dogs, Today, Dec. 7, 2000, p. 18A. the environmental group Greenpeace said. The corn The presence of StarLink corn in human food products dogs, sold under the Morningstar Farms label, were — for which it currently is not licensed — is a regulatory purchased at a Baltimore supermarket last month. violation that should never have happened. But the overwhelming body of scientific evidence indicates that Vorman, Julie, “Bio-Corn Tainted 430 Million Bush- products containing StarLink corn pose no health risk to els, Its Maker Says; Agriculture Disclosure comes amid consumers. reports of investigations into possible human aller- gic reactions to the engineered grain,” Los Angeles Crenson, Matt, “Gene-Altered Corn Producing Bad Times, March 19, 2001, p. C1. Taste for Some Farmers,” Chicago Tribune, Dec. 3, More than 430 million bushels of corn in storage 2000, p. C7. nationwide have been contaminated with StarLink corn, Even though StarLink amounted to one-200th of the an unapproved biotech variety that caused a huge recall corn grown in the United States this year, that tiny of chips, flour and other foods, a senior executive of corn amount tainted billions of bushels. One expert estimated maker Aventis said. That figure greatly increases the that half of Iowa’s corn crop would end up mixed with estimate of the amount of U.S. corn inadvertently mixed StarLink. with StarLink, a variety prohibited from human foods.

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CHILDREN/YOUTH HEALTH CARE AND MEDICINE Immigration Reform, July 2000 Adoption Controversies, September 1999 Medical Marijuana, August 1999 Missile Defense, September 2000 Rethinking Ritalin, October 1999 Hunger in America, December 2000 The Federal Reserve, September 2000 Child Poverty, April 2000 Diet and Health, February 2001 Democracy in Latin America, Nov. 2000 Fatherhood Movement, June 2000 Diabetes Epidemic, February 2001 Redistricting, February 2001 Cell Phone Safety, March 2001 CRIMINAL JUSTICE TRANSPORTATION Policing the Police, March 2000 LEGAL ISSUES Traffic Congestion, August 1999 Drug-Policy Debate, July 2000 Closing In on Tobacco, November 1999 Airline Industry Problems, September 1999 Community Prosecution, December 2000 High-Impact Litigation, February 2000 Auto Industry’s Future, January 2000 Gay-Rights Update, April 2000 EDUCATION The Digital Divide, January 2000 MODERN CULTURE Zero Tolerance, March 2000 Islamic Fundamentalism, March 2000 Community Colleges, April 2000 Future of Computers, May 2000 Future Topics Cheating in Schools, September 2000 Future of Books, June 2000

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