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Genetically modified foods
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This paper examined genetically engineered food in an even handed manner in which the benefits and risks and ethical issues surrounding genetic manipulation of crops and animals are examined and discussed
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Genetically Modified Food Thesis Statement Although some people insist cloned food is not thebest choice for consumers the food industry needs to develop cloned foodtechnology Many scientists insist that genetically modified foods are safe yetmany consumers are uncomfortable about eating them According to an articleby Valeria Jefferson published in Journal of Environmental Health genetically modified organisms are plants and animals that have had DNAintroduced into them other than by the combination of an egg and sperm Traditionally farmers have crossbred plants or
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"I think GM foods aregoing to be accepted by European consumers sometime in the next five to 1 years," says Julia Moore of the Woodrow Wilson International Center inWashington, D.C. Q. Hallfound more than facts. Have there been any tests to determine whether genetically engineered foods are safe?4. Once you grow it in the open environment, it contaminatesfood crops as well.Q. In the meantime, India has allowed no new shipments of U.S.corn-soya flour. commodity exports. FDA officials described three types of situations where theyhave requested additional data and companies have responded: (1) theabsence of a reliable or "validated" method for performing a test; (2)reliance on a prevailing scientific "assumption" that, when tested at FDA'srequest, was proven incorrect; and (3) inconsistent or incomplete data inthe final reports.The first situation involved the lack of a reliable method for testingtomatine, a naturally occurring toxin in tomatoes. Nutrition Health Review: The Consumer's Medical Journal, 16472 2, 2 2, Issue 84Database: MasterFILE Premier Our Genetically Modified Future Contents1. But the biotech industry and its supporters have always maintainedthat labeling would somehow stigmatize the product and have fought bitterlyto prohibit it. However, the U.S. These studies often run for 2 years or more, involvethousands of people and cost millions of dollars.could be cause for concern have been shown in tests to be rapidlydigested. But gene-spliced food willcontain genes from many sources that have never been part of the humandiet. After six months of stalemate, they had the sacks of flour shippedoff to Africa. We need a food system that allows us to beinformed by the best scientific thinking on food safety and environmentalrisk, but not one that requires people to take a 13-week course onmolecular biology in order to plan a meal or to sort out their feelingsabout genetic engineering."ILLUSTRATION (BLACK & WHITE)[pic]Copyright of USA Today Magazine is the property of Society for theAdvancement of Education and its content may not be copied or emailed tomultiple sites or posted to a listserv without the copyright holder'sexpress written permission. However, the agencybelieves the use of terms such as "Genetically Modified Food" in the titleand "GM food" in the text can be misleading and such foods are morecommonly referred to as bioengineered foods. Traditional crossbreeding, however, canbe very time-consuming because it may require breeding severalgenerations to obtain a desired trait and breed out numerous unwantedcharacteristics. And the vast majority of transgenic fieldtests -- 96 percent in the year 2 -- are conducted under these rules.What the transgenic compound is intended for determines how it isregulated; currently there are no rules specifically governing industrialtransgenic plants, though the U.S. Arecent report by food and health organizations affiliated with the UnitedNations also expresses skepticism about the feasibility of identifyinglongtermhealth effects from GM foods.This report contains recommendations to the Deputy Commissioner ofFood and Drugs for enhancing the effectiveness of FDA's safetyevaluations of GM foods. Earlier this year, the governmentadmitted that there were 3 secret test plots around the country wherepharmaceutical drugs and industrial chemicals were being spliced intocommon farm crops. The British Medical Associationand the World Health Organization (WHO) have said that these antibiotic-resistant marker genes should not be in foods and should be phased out asquickly as possible.Q. Q. Others view it as one of the most serious threats tohuman civilization. You start thinking aboutpollinators, such as bees, that are absolutely key to having plants grow.If you create a situation in which bees cannot survive, which is happeningnow, how are you going to pollinate? For example,25 The human body converts beta-carotene into vitamin A if the body isdeficient invitamin A.26 Pew Initiative on Food and Biotechnology, Harvest on the Horizon: FutureUses ofAgricultural Biotechnology, Washington, D. Keeping GM and non-GM grainsapart proved difficult in the case of StarLink. Food and Drug Administration. It hasenhanced food production by making plants less vulnerable to drought,frost, insects, and viruses and by enabling plants to compete moreeffectively against weeds for soil nutrients. Despite this fear,there are powerful profit interests here and we are going to have to havethis big fight. In thisreport, we will refer to food derived from genetically modified plants asGM foods.2 The U.S. The two most commonly engineered cropsare Round-Up®-ready crops, which are herbicide-resistant, and the BT-splice. The rule also notes thatproducts derived from this advanced biotechnology will present morecomplex safety and regulatory issues than those seen to date. "Wefigured China was our buddy on biotech," says a U.S. Between1997 and 2 , the average amount of pesticides increased with transgenicherbicide-resistant crops, USDA data reveals. Department of Agriculture has issued guidelines which saythat genetically modified foods cannot be labeled organic--despite protestsfrom some in the scientific community who argue that there is nothinginorganic about genetically modifying crops--an inadvertent system has beenset up to allow people to avoid eating genetically modified foods."If this is enough to protect their right to opt out of geneticallyengineered foods," Thompson suggests, "then perhaps we can have aproductive conversation about genetically engineered food with the other 8 or 9 % who basically want to know whether agricultural biotechnology issafe and environmentally sound. government has not been able to find any health relatedproblems with genetically modified corn. An enormous number of changescan be made through molecular manipulation. If the scientists want to tinkeraround in the laboratory under strict confinement, that's one thing;unfortunately, what they have done is move right out into the openenvironment as quickly as possible, with little or no oversight, and haveprobably created pollution that is going to be with us for a very longtime, at least at background levels.Q. According to FDA officials, in addition to theirscientificcredentials, the consumer safety officers know what is needed for theadministrative record for each submission. Once genetically modifiedorganisms (GMOs) -- which can grow, reproduce, mutate and migrate -- arereleased into the environment, they cannot be removed. Beyond evolution. There are a hundredgenetically engineered medical drugs already, some of which are causingproblems, but the applicability of this technology is limited right now.The genetic mapping of plants is the type of knowledge that can be usedwith traditional cross-breeding or organic agriculture. I think (1) they are jumping ahead because they can and (2) a lot ofmoney is involved in this. Besides requiring nearly two sets of full-time staff, making suretheir corn is GMO-free has doubled the cost of the corn and increased theirmalt costs by 24 percent.Farmers who don't go to such trouble and expense to ensure their cropsremain uncontaminated are being harassed by biotech companies when thecompany suspects patent-protected transgenic plants are growing on thefarmer's land.Farmers like Percy Schmeiser, a Canadian canola grower, and the RodneyNelson family, wheat and soybean growers in North Dakota, are screamingfoul. DennisKucinich (D-Ohio)www.house.gov/kucinich/action/summary.henBiotechnology IndustryOrganizationwww.bio.orgILLUSTRATIONS (COLOR)~~~~~~~~By Karen CharmanKaren Charman is an award-winning investigative journalist. Scientists have diverging viewson the potential role of these new technologies: some view them as auseful supplement to existing tests, while others view them as a new, morecomprehensive way to assess the safety of all changes in GM foods.However, the lack of technical standards for these new technologies andproof of their reliability prevents their current use.Until now, most genetic modifications of plants have been aimed atincreasing or protecting crop yield. The stakes are high for U.S. Many eat less than the minimum quantity necessaryfor survival, resulting in a mortality rate of 36 million deaths per year(United Nations, 2 1). food aid. Q. corn harvest. The United Statesaccounts for about three-quarters of GM food crops planted globally.4 Laurate canola oil is a form of canola oil that contains lauric acid, afatty acid found intropical oils. Should we be ending hunger by causing genetic mutations wehave not anticipated, or moving toward the goal of ending world hungersafely through application of sound scientific principles?ReferencesAbout. It is eatenroutinely in some parts of the world, but few Americans would want to eatit. In1996, a soybean spliced with Brazil nuts by Pioneer Hybrid was pulled fromcommercialization shortly before it was supposed to be planted. Thompson, the Joyce and Edward E. 1. But by autumn that year, they'd decided to forgo the GMbeans because of low yields. Selected individual genes are transferred from one organism toanother between plants and between animals, but not between plants andanimals. Even the world's poor, it seems, don'twant America's grain, thank you very much. In the spring,officials began requiring labels on all imports of GM crops. These small moleculesinclude vitamins(with potential benefits for human health) and alkaloids (a major source oftoxicity inplants). After China developed GM strains oftobacco, Europe shut the door to Chinese imports in the 199 s. There are almost no regulations in place right now, other than informalconsultation and the supposed publishing of data. (2 1). USA Today Magazine, 1617389, Apr2 1, Vol. Well, we don't know. While perhaps the scientificcommunity refers to these foods as bioengineered, the lay public is morefamiliar with the term genetically modified foods. Even withthe development of baseline data and the detection of differences,scientists will still need to evaluate the significance of thesedifferencesfor human health. However, users may print, download, oremail articles for individual use.United States General Accounting OfficeGAOMay 2 2 GENETICALLYMODIFIED FOODSExperts View Regimenof Safety Tests asAdequate, but FDA'sEvaluation ProcessCould Be EnhancedGAO- 2-566Results in Brief 2Background 4GM Foods Share the Same Types of Health Risks as ConventionalFoods and Are Evaluated by Tests That Appear Adequate 9FDA Believes That It Obtains Necessary Safety Data for GM FoodEvaluations, but FDA's Overall Evaluation Process Could BeEnhanced 18Future Changes in GM Foods May Alter Their Composition andRequire New Testing Technologies for Assessing Safety 25Experts Maintain That Long-Term Monitoring of GM Foods IsNeither Necessary nor Feasible 3 Conclusions 32Recommendations for Executive Action 32Agency Comments 33Appendix I Objectives, Scope, and Methodology 35Appendix II Potential Use of Metabolic Profiling to Compare aGM Plant to Its Conventional Counterpart 38Appendix III Comments from the Department of Health andHuman Services 43Appendix IV GAO Contacts and Staff Acknowledgments 46Related GAO Products 47TablesTable 1: GM Foods for Human Consumption Evaluated by FDA 6FiguresFigure 1: Use of Biotechnology to Create a Pest-Resistant Plant 5Figure 2: Example of the Regimen of Tests Used for SafetyAssessments of GM Foods 13Figure 3: Metabolic Profiling of Three GM Mustard Plant Varietiesin Comparison with Baseline Data from TheirConventional Counterparts 39AbbreviationsAPHIS Animal and Plant Health Inspection ServiceCFSAN Center for Food Safety and Applied NutritionDNA deoxyribonucleic acidEPA Environmental Protection AgencyFAO Food and Agriculture OrganizationFDA Food and Drug AdministrationGM genetically modifiedPBN Pre-Market Biotechnology NoticeRNA ribonucleic acidUSDA U.S. "I'd rather die than eatsomething toxic," President Levy Mwanawasa told Sky News.Zambia's rejection, Greenpeace exulted, was "a triumph of nationalsovereignty." But to Hall, for one, it was almost a personal affront. The major advantage of gene chips overconventional testing techniques is that they allow small-scale analysis ofthousands of genes at the same time in a precise and quantitative manner.According to a university scientist, researchers are determining the extentto which this technology may be effective in assessing GM food safety.Proteomics is a biotechnology technique used to identify many proteinssimultaneously in a given organism. (2 1).Research section, program rationale. Are there any benefits?21. In 1995, a soil bacterium that was genetically engineered waspulled from commercialization.Most recently, there was contamination of food crops by pharmaceuticaldrugs that were spliced into corn in September and October of 2 2.Starlink corn in 2 (Editor's Note: see page 8) was pulled off the marketafter it contaminated the food supply. We are reducing the medicine cabinetfor all of humanity. Theeffort, which is modeled on their system for procuring organic soybeans,involves close collaboration with seed suppliers, 1 organic corn growers,and malting and milling companies. Somewhere in the world, a child dies ever)' sevenseconds, and the cause of death is directly or indirectly attributable tohunger (United Nations, 2 1). Ithink that they will run into the same problem-that this is a modernsociety in which people are not willing to be guinea pigs. As a result, FDAofficials suggested that the company find a more appropriate method. Using this approach,companies must show whether any allergens, toxins, or antinutrients havebeen introduced or enhanced. In general, these raw data are readily availablefrom companies. "At present, as long as your intent is not to useit for a pharmaceutical purpose -- it can be a research chemical or anindustrial solvent -- you can put it into the plants, do a simplenotification to APHIS with virtually no data, and then you cancommercialize it, as was done with avidin-producing corn. C., September 2 1.scientists have genetically modified wheat, one of the major allergenicfoods, to stimulate a gene that diminishes wheat's allergenic properties.Scientists are also seeking ways to reduce toxic substances, such asalkaloids in potatoes, by inserting genes that block their production.Preliminary findings have indicated that GM potatoes produced fewer ofthese alkaloids. Crop homelands need to be preserved,because that's where scientists go to look for traits to overcomecatastrophic pests or diseases, as was necessary in 197 when the Southerncorn leaf blight wiped out 15 percent of the U.S. According to a report published online by the U.S.General Accounting Office, by 2 1, genetically modified varietiesaccounted for about 26 percent of the corn, 68 percent of the soybeans, and69 percent of the cotton planted in the United States. It depends on what the vaccine was, but it is certainly something youwould never want to happen.Q. Lastly, the entire team must concur with the final draft of thememo to file, which is usually prepared by the consumer safety officer.In summary, FDA officials told us that the expertise of the BiotechnologyEvaluation Team members coupled with the multiple reviews ofinformation enables the team to adequately evaluate safety assessmentsand determine if and when more data is needed.According to agency officials, FDA's practice of varying its level ofevaluation based on the degree of novelty of the GM food submissionallows it to devote resources where they are most needed, thus assuringthat Biotechnology Evaluation Teams have time to obtain necessary safetydata. Nevertheless, the technology is developing quickly, andthe pressures to continue using it are great. Genetically modified foods. Although the government approvedBt cotton last March--after a bruising four-year battle--it has never OK'dGM corn or other edible crops. More companies are now offering certified non-engineered seeds. Geneticmodification of food, we are told, will enable us to save a growing worldpopulation from hunger and starvation. food agencies. Having once gone through the fullconsultation process for a specific genetic modification, such a companyis familiar with the kinds of safety information that FDA expects and thuscan proceed directly to preparing a final report for similar cases. Later submissions involving an herbicide-tolerantsugar beet and pest-resistant corn also showed a close adherence to the1992 policy statement.Evaluations of GM food safety submissions must include concurrencefrom every member of a highly qualified team known as the BiotechnologyEvaluation Team.2 The 1997 guidance states that the evaluation teamsgenerally will be composed of a consumer safety officer (who serves asthe project manager), molecular biologist, chemist, environmentalscientist, toxicologist, and nutritionist. Departmentof Agriculture, 2 1)The proliferation of biogenetic plants also poses a concern. In commenting on a draft of this report,FDA agreed with our recommendations and stated that therecommendations would increase the transparency of, and publicconfidence in, FDA's evaluations of GM foods. Biotech companies also are researching ways togenetically disable key plant functions so plants won't be able to developnormally without being sprayed with a special chemical the company alsohappens to sell. TheCouncil on Responsible Genetics has done a survey with seed companiesacross the U.S., and at least a hundred smaller seed companies are nowoffering non-genetically engineered seeds. With livestock also being injected with antibiotics as a growth hormone, do we run the risk of developing an immunity to antibiotics?9. 18 2, or visitclicksmart.com/nutrition.)[pic]Copyright of Nutrition Health Review: The Consumer's Medical Journal is theproperty of Vegetus Publications and its content may not be copied oremailed to multiple sites or posted to a listserv without the copyrightholder's express written permission. There is no commercialization of such foods yet, but some of these foodsare being tested in the open environment. Is there a danger that pesticides will become useless after a while?A. Guidelines issued by the22 U.S. What is the status of labeling laws that require a genetically modified label?17. health regulators haven't been able tofind anything wrong with eating Bt corn. Furtherdetailsof the scope and methodology of our review are discussed in appendix I.GM foods pose the same types of inherent risks to human health asconventional foods: they can contain allergens, toxins, and compoundsknown as antinutrients, which inhibit the absorption of nutrients. FDA also providedtechnical comments which we incorporated as appropriate.Modern agricultural biotechnology refers to various scientific techniques,most notably genetic engineering, used to modify plants, animals, ormicroorganisms by introducing into their genetic makeup genes forspecific desired traits, including genes from unrelated species. Basically, if the antibiotic does not killthe gene-food, then the splicing has been successful because the insertedantibiotic-resistant marker gene provides protection. Some consumer groups have pointed out thebrevity of some of the memos and described them as "perfunctory"summaries of company data that provide little or no insight into FDA'sevaluation of the data. Commoner also says the trillions of unmonitoredtransgenic plants now in farmers' fields virtually guarantee there will besome nasty surprises, though it is impossible to predict what they will beor when they will occur. Specifically, we reviewed submissions for a pest-resistantcorn; an herbicidetolerantsugar beet and soybean; and high oleic-acid soybean oil and laurate canolaoil.19 This GM soybean wasengineered to contain a substantially higher percentage of oleic acidin the 1992 policy statement. Are any regulations proposed to control this?A. agriculture--and trust neither. What is the difference between a food labeled "natural" and a foodlabeled "organic?"A. While some consumer groups, as well as somescientists from the European Union, have questioned the ethical orcultural appropriateness of genetically modifying foods, experts whom wecontacted from these organizations also believe the tests are adequate forassessing the safety of these foods.While FDA reports that its evaluation process includes the necessarycontrols for ensuring it obtains the safety data needed to evaluate GMfoods, some biotechnology experts state that aspects of its evaluationprocess could be enhanced. For example, FDA could include comments in thememos to file that better reflected the context of the evaluation (forinstance, its similarity to previous evaluations), the adequacy of thetestsperformed by the company, and the level of evaluation provided by FDA.For those memos to file on submissions for GM foods that are similar toGM foods previously evaluated, FDA could make reference to earlier,similar submissions having a more detailed memo to file.24 Guidelines for Ensuring and Maximizing the Quality, Utility, andIntegrity ofInformation Disseminated by Federal Agencies (Office of Management andBudget,Washington, D. Neither of these was properly monitored orcontained. Q. Are any foods engineered with vaccines?11. For example,researchers found that a lifestyle typified by a faulty diet, sedentaryliving,or unrestrained weight gain exacerbated disease risk factors andinfluenced the occurrence of cardiovascular problems.Without a plausible hypothesis such as that used in the Framingham study,most scientists we contacted said that epidemiological studies on GMfoods would not provide any useful information. We are finding in the recent tests ofchicken and poultry that are sold in supermarkets-the nonorganic ones-thatmost of these animals are riddled not only with bacteria but also withbacteria that resist commonly used antibiotics. In countries such as the United States, where labeling is notrequired for GM foods, reliably identifying such control groups would bevirtually impossible.. In whatFDA calls the "initial" phase of the consultation, FDA and companyofficials discuss what safety data will be needed for a GM foodsubmission. FDA's documentationof its evaluation presented background information on thesemodifications, a point-by-point evaluation of the company's food safetyassessment, and FDA's conclusion that the tomato was not significantlydifferent from conventional tomatoes.By contrast, FDA officials stated that evaluations of company submissionsfor GM foods similar to GM foods previously evaluated by the agency(such as a virus-resistant squash and various herbicide-tolerant corns)required fewer agency resources because these submissions skipped theinitial consultation and proceeded to the final consultation. The modified cell is used to create a new type of modified plant.DIAGRAM: One method of changing tomato plant's genetic code.PHOTO (COLOR): The loneliest man: Tony Hall can't persuade Zambia to takeU.S. Nevertheless, Monsanto accused the Nelsons ofplanting more than they bought, a charge the family vehemently denied.After hundreds of thousands of dollars in legal bills and tremendous stresson the family, the Nelsons reached a confidential settlement with Monsantoearlier this year.A JUST AND DEMOCRATIC TECHNOLOGY?Crop diversity is already threatened by our modern industrial farmingsystem that plants a relatively small number of varieties across millionsof acres. That is reallyquestionable from a medical standpoint, because you have to regulate thedosage of a vaccine or else it becomes dangerous. GM crops that produce additional nutrientsor that are able to grow in poor soil conditions could benefit people whomight otherwise suffer from malnutrition, as would crops engineered to bemore resistant to disease. Animals may suffer as a result of geneticmodifications or modifications to their genetic material. What would happen if somebody ate a giant bag of vaccinated peanuts?A. Andthat a year's worth of U.S. There are nolong-term tests relating to human health risks associate with GM foods.Unfortunately, what is also true is that there are almost no regulations inplace right now relating to GM food. Q. Retrieved September 15, 2 4,from http://ods-dds-ny.un.org/doc/UNDOC/GEN/N 1/465/52/PDF/N 146552.pdf?OpenElement.U.S. It is the traditional method of quality control in science.the evaluation; this documentation is then available for the whole team toevaluate. These scientistsand officials also stated that it would be very difficult, if notimpossible, todevelop a process for monitoring the long-term health risks of GM foodsbecause of the technical challenges in developing such a system. That wouldhave set off life-threatening allergies in people who are allergic toBrazil nuts. Government Accountability Office. Are there any benefits?A. Arguably his best shot at harnessing America's vast grainharvest for the world's greater good came last fall, when he arrived inRome as the U.S. FDA's controls include (1) communicatingclearly-through the agency's 1992 policy statement and subsequentguidance-what safety data are necessary for its evaluations of GM foodsafety; (2) having teams of FDA experts in diverse disciplines evaluatecompany submissions for GM foods and request additional safety data, ifnecessary; and (3) tailoring the level of evaluation to match the degree ofeach submission's novelty, thereby assuring that staff have time to obtainnecessary safety data. These officials viewed thisas another strength of the evaluation process. Terminator was first developed as a way to protect biotech companies'intellectual property, and it continues to spark outrage around the world.Terminator and traitor technologies are much more complicated than anytransgenic crops on the market today, and it is not clear how well theywill work, says Hope Shand, research director of the action group onErosion, Technology and Concentration, a nonprofit organization advocatingsustainable uses of technology. Genetically Engineered Food ©2 by Ronnie Cummins and BenLilliston. GOOD FOR FARMERS?4. Vexing nature?: On the ethical case againstagricultural biotechnology. biotechnologists cut, modify andsplice genes from one species into another species, expecting the insertedgenes to perform specific functions and behave predictably in their newhomes.Over the last 4 years, a substantial body of evidence has emerged,indicating that the processes defining, separating and enabling species tofunction normally are much more complicated than Crick's central dogma.Commoner writes that this theory "collapsed under the weight of fact" withthe Human Genome Project's discovery in 2 1, which found that there werefar too few human genes to account for the complexity of our traits or forthe genetic differences between people and plants. Accordingly, the report concludes that the identification of long-termeffects specifically attributable to GM foods is highly unlikely.Given the challenges to long-term monitoring, federal regulatory officials,as well as some U.S. Inaddition, GM corn has no discernable difference in flavor and GM cornplants enjoy reduced maturation time combined with improved resistance todiseases and pests (Guterl). If you wanted to get your own nongenetically modified seeds, would yoube able to tell the difference?A. biotechnology industry working with GM food isprimarily regulated by the U.S. Instead, biotech companies have been doing their ownevaluations and presenting summaries to the FDA in a "consultationprocess." This procedure came out of the agency's 1992 decision to regardgene-spliced food as "substantially equivalent,"--i.e., no different thanfood produced through conventional breeding techniques. cornPHOTO (COLOR): Frankenfoods: Corn, tomatoes, soybeans and a mustard plantPHOTO (COLOR): Food Fights: GM crops are buried in Belgium; Zambians reston U.S. More specifically,opponents of GM argue that the U.S. TheU.S. soyexports to China slipped 2 percent for the year. As a result, the UnitedStates published a Coordinated Framework for Regulation ofBiotechnology in 1986. The Nelsonsacknowledge they planted and paid for the company's herbicide-resistantsoybeans in 1999. Retrieved September 1 , 2 4, fromhttp://www.ars.usda.gov/research/programs/programs.htm?np%5fcode=3 1&docid=79 .~~~~~~~~By Valeria Jefferson, R.E.H.S., C.F.S.P., M.P.A., President, NationalCapital Area Environmental Health Association, 89 5 Clayton Lane, Clinton,MD 2 735. What's to keep GM corncrops, with their powerful added gene, from overtaking weaker natural cornstrains--especially when Chinese peasants, mindful of their pest-repellingqualities, plant them surreptitiously in their gardens? These people aren't going torevise their beliefs just because science has a better theory."Thompson says society has a moral and ethical responsibility to make surethat these individuals aren't forced by the marketplace to eat foods thatthey are opposed to. In a few cases, it has alsoimproved the quality and nutrition of foods by altering their composition.Table 1 shows that the majority of modifications have been aimed atincreasing crop yields for farmers by engineering a food plant to tolerateherbicides or attacks from pests such as insects and viruses (48 out of 62modifications). The GSA report notes that it is essential that new andmore sophisticated tests be developed and mandated by the FDA to evaluatethe increasingly complex compositional changes expected in the nextgeneration of GM food. While some GM foodshave contained allergens, toxins, and antinutrients, the levels have beencomparable to those foods' conventional counterparts. Chai Hongliang and his brotherZhenbo, who farm cotton in Langfang, about 3 miles southeast of Beijing,used to dump tons of pesticides on their crops to keep the bugs fromdestroying their harvest. Opponents argue that government agencies areviolating their religious and consumer rights, while proponents have takena utilitarian approach, arguing that the economic and social benefits ofGMF far outweigh any possible negative consequences. However, industry determined that the totalintake of laurate in the diet would not change significantly bysubstitutingthe improved canola oil for the tropical oil. The resulting effort, comprisingmore than 1 , participants over two generations (more than 5 years),developed groundbreaking information on the major risk factorsassociated with heart disease, stroke, and other diseases. In addition, we believe occasional data verificationby a federal agency is necessary to (1) identify the risk of the agency'sreceiving faulty data from external sources and (2) ensure that no oneagent is allowed to control every key aspect of a safety assessment.22FDA officials stated that they do not believe it is necessary for theagencyto routinely review raw data for two reasons. Chinese cotton farmers increasedtheir productivity by 1 percent last year, by some estimates.But overall, Chinese farmers still could not compete against cheaper U.S.crops, now available after the country joined the WTO. And the controversy over cotton has onlystiffened resistance. Brewer DistinguishedProfessor in Applied Ethics, Purdue University, West Lafayette, Ind., andauthor of Food Biotechnology in Ethical Perspective, says even those wholabel foods as unnatural don't always have an exact explanation for whythey think the way they do. TheFederal Food, Drug, and Cosmetic Act establishes the standard for foodcompany's initial submission of data was insufficient, FDA was able tospecify and obtain additional data from the company.For a GM food, the evaluation process, known as a consultation, generallylasts between 18 months and 3 years, according to FDA officials. I do not think that vaccine-spliced foods are going to ever becommercialized on any scale.Q. The most widelyused GM crops--namely, cotton and corn--have this Bt gene.As the U.S. agriculture is endangered.Greater emphasis should be placed on conservationof germplasm through international cooperation.Development and maintenance of stable biologicalcommunities in the natural environment should bea high priority goal worldwide. (Another government organization laterpronounced the report unreliable and had it recalled.)There are signs that the Chinese public is beginning to have doubts. In evaluating the measurements of tomatine submitted by thecompany, FDA officials found these data unconvincing. For instance, the genetic makeup of plants can be altered to produceinsect-resistant plants. In the United States, there is no mandatorylabeling of GM food, which is required in most other industrializedcountries. Many of these products subsequently madetheir way into the U.S. exports would fill a train of hopper cars fromParis to Beijing, by way of Calcutta? It has reduced the amount of pesticide needed to growcorn successfully. "The government realized the[economic] impact biosafety concerns could have."China's turnaround has underscored just how isolated Washington now is. (U.S. corn and soybeans. According to Shand, patents on Terminatorand traitor technologies have been issued to Monsanto, DuPont, Syngenta,BASF, Delta Pine & Land Co., the U.S. Even the NationalAcademy of Sciences noted this was a glaring loophole that needs to beclosed," Hansen says.GOOD FOR FARMERS?Unyielding consumer opposition to GMOs around the world has severelylimited export markets for U.S. For example, a 1996 submission for a GM soybean19shows step-by-step adherence to the allergenicity decision tree established18 The five submissions reviewed are representative of the three main typesof GM plantsevaluated as of April 2 2: pest-resistant plants, herbicide-tolerantplants, and plants havingmodified oils. According toscientists at one company involved in developing metabolic profiling, thistechnique can determine whether a specific, intended change in a smallmolecule has been achieved. Right now the last thing even the hungriest parts of theworld want is genetically modified American food, like Ohio's golden corn.Europe has for years turned its nose up at American products like corn,tomatoes and soy, which scientists have engineered to contain unnaturalgenes. Frankenfood?Section: Science & TechnologyOne by one, countries are coming out against crops with engineered genes.America is isolated.Tony Hall's career has always depended on his command of certain factsabout corn. Ships loadedup with 1 million tons of soybeans slated for export to China sat in U.S.ports for weeks. What is a genetically modified food?2. They need to clean up their actwith the vaccines they are already using before they move into this newarea.Supposedly the vaccines are being tested in the environment first to seewhether they work and so on. Europeans deny arm-twisting other regions. He says the Human GenomeProject not only destroyed the scientific foundation of geneticengineering, but also nullified biotech's claim that its methods ofgenetically modifying food crops are precise, predictable and safe.The gene splicers rearranging the genetic codes of untold species areoperating blindly, he says. In a February 2 2 article in Harper's magazine.Commoner, who directs the Critical Genetics Project at Queens College inNew York, writes that the scientific justification for genetic engineeringis based on a now-discredited, 44-year-old theory.Dubbed "the central dogma" by its creator, Francis Crick, the theoryreduces inheritance to identifiable molecular processes strictly governedby DNA, where one gene is responsible for creating one correspondingprotein. As for superbugs --agricultural pests or bacteria that have become immune to pesticides orantibiotics from overuse -- he says inadequate effort has been made todetect them. FDA asked the companyto prove the accuracy of this assumption. This year the EU is putting in place labelingrules. (See app. If you wanted to get your own nongenetically modified seeds, would you be able to tell the difference?18. A JUST AND DEMOCRATIC TECHNOLOGY?5. Biotechnology companies and other advocates of geneticallyengineered food suggest that this technology is simply a more precise wayto improve crops which is something that farmer have been doing using cross-breeding techniques for thousands of years. Food and DrugAdministration does not require safety tests for transgenic food before itgoes on the market. "Because they are not known as allergens, they can't be definitivelytested for allergenicity in advance," says Jean Halloran, director of theConsumer Policy Institute. The U.S. and European scientists, state that the best defenseagainst long-term health risks from GM foods is an effective pre-marketsafety assessment process.Biotechnology experts believe that the current regimen of tests has beenadequate for ensuring that GM foods marketed to consumers are as safe asconventional foods. Some of the differences will stemfrom the tremendous natural variations in all plants caused by factors suchas the maturity of the plants and a wide range of environmentalconditions, such as temperature, moisture, amount of daylight, and uniquesoil conditions that vary by region of the country. farmers because they can be produced moreefficiently, at lower costs, with less risk of damage or loss of the cropto common problems including draught, disease and insects. Q. A recentreport by the United Nations also expresses skepticism about thefeasibility of identifying long-term health effects from GM foods.The scientists and federal regulatory officials generally agreed thatbecause there is no scientific evidence that GM foods cause long-termharm, such as increased cancer rates, there is no plausible hypothesis ofharm. Once better regulations are inplace, attitudes may soften. The government has tried to get around this by saying that theseare not actually food additives. By addressing these issues,FDA's assurance to consumers that GM foods are safe could bestrengthened.To enhance FDA's safety evaluations of GM foods, we recommend that theDeputy Commissioner of Food and Drugs direct the agency's Center forFood Safety and Applied Nutrition to3 FAO/WHO (2 b) Safety Aspects of Genetically Modified Foods of PlantOrigin. Each follows specific protocols toguarantee that the corn is protected from transgenic contamination. If peoplebegan to select their offspring's traits, what would that mean for thefuture of human evolution, hundreds of thousands of years down the line?A. Appendix II provides more information regardingadvancements in the development of baseline information and theexperimental use of metabolic profiling to assess the safety of GM foods.Scientists and federal regulatory officials we contacted generally agreedthat long-term monitoring of the human health risks of GM foods throughepidemiological studies29 is not necessary because there is no scientificevidence suggesting any long-term harm from these foods. increasing the transparency of the evaluation process.Biotechnology experts from consumer groups and academia state thatFDA's evaluation process could be enhanced if the agency validatedcompanies' test results on proposed GM products by reviewing raw data(e.g., the actual, unverified test results). They also statedthat the canola plant was modified to have a domestic source for lauratecooking oil.4 Because soybean oil is the most commonly consumed plantoil worldwide, scientists say that the new oil could significantly improvethe health of millions of people.For three key crops grown in the United States-corn, soybeans, andcotton-a large number of farmers have chosen to plant GM varieties. FDA Consumer Magazine, 35(2). These applicationsworry many farmers, since transgenic traits don't stay put once they arereleased into the environment, and so these compounds could end up in ourfood.In an attempt to tackle this problem, the biotech sector is busy working tocreate plants that produce seeds that won't germinate, the so-called"Terminator" technology. grain, GM or otherwise, was suspected of contamination--andloudly opposed.China's recent about-face on GM foods also has as much to do with politicsas with science. First, there are a large number of proteinsthat need to be analyzed in any given plant. Further, the two GM food plants reviewed that producedmodified oils-soybean and canola-had nutritional profiles that weresimilar to or better than their conventional counterparts. Recently, a pig vaccine got into the food supply via soybeans and corn.Scientists are apparently experimenting with a wide range of vaccinesagainst hepatitis, diarrhea, and so on. 8 Apr 2 8
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