Studies in Ethics, Law, and Technology

Volume 4, Issue 1 2010 Article 2

Regulation and Safety Assessment of Genetically Engineered Food

Om V. Singh*

* Advance Academic Programs, Zanvyl Krieger School of Arts and Sciences, The Johns Hopkins University, 1717 Massachusetts Ave., NW, Washington, DC, 20036 Division of Biological and Health Sciences, University of Pittsburgh, Bradford, PA-16701

Recommended Citation: Om V. Singh (2010) "Regulation and Safety Assessment of Genetically Engineered Food," Studies in Ethics, Law, and Technology: Vol. 4 : Iss. 1, Article 2. Available at: http://www.bepress.com/selt/vol4/iss1/art2 DOI: 10.2202/1941-6008.1100 2010 Berkeley Electronic Press. All rights reserved.

Regulation and Safety Assessment of Genetically Engineered Food

Om V. Singh

Abstract
Transgenic technologies avails new ways that alter plants and animals to be better suited for applications in food, feed, and processing. The ability to express foreign genes and proteins opens the door to producing many commercially important industrial and pharmaceutical products. However, despite the promise of these technologies, there are many concerns about the environmental impact of genetically engineered (GE) food plants and how to contain them. Risk assessment and monitoring are vital for this industry: the regulatory agencies aimed to monitor the specific environment and public health hazards associated with GE food and organisms. In the United States, the FDA, USDA, and EPA are responsible for these regulations. Several agencies in other countries also monitor GE foods and frame guidelines for the safe application of recombinant genes in agro-industries. This article gives an overview on the tracking of GE DNA in foods and the general public's concerns about them. The role of regulatory agencies are also summarized in regulating GE products while ensuring the public health. KEYWORDS: FDA, regulations, DNA, genetically engineering (GE), genetically engineered food, safety assessment Author Notes: Technical support rendered by Rashmi Singh for preparing this manuscript is gratefully acknowledged. Address correspondence to: 300 Campus Drive, Department of Biological and Health Sciences, Bradford, PA-16701; Phone 814-362-7562; e-mail: osingh1@jhmi.edu, ovs11@pitt.edu.

Singh: Genetically Engineered Food and Regulations

1. Introduction Because the global population continues to grow, producing enough food for everyone on the planet will continue to be a major concern for the foreseeable future. Scientific advancements such as genetic engineering (GE) allow us to produce food that is more nutritious and easier to grow by manipulating existing resources. These technologies have made and will continue to make a significant impact on agriculture and the food market. Over the past quarter-century, conventional crops have been genetically modified (GM) to increase shelf life, improve nutritional value, and enhance agronomics performance and tolerance for various environmental conditions.1 GE plants were first introduced into the U.S. commercial market in 1996 and now appear in many processed food products worldwide. 2 Genetic engineerings greatest success has been in the area of increasing agricultural productivity to feed people in underdeveloped and developing countries.3,4,5 The U.S. Food and Drug Administration considers GE foods to be substantially equivalent to their conventional counterparts, and to date, no long-term side effects of consuming GE foods have been detected. 6 However, many concerns have been raised regarding the plants stability and safety in the environment. To avoid contamination of the environment, risk management of GE foods involves monitoring wild and weed populations that might be affected by escaped GE materials. This precautionary risk assessment and monitoring has been effective so far, but a legal framework is needed that can address the unique risks involved in GE and guard against new risks that may emerge. In the United States, crop-related products and growing environments are regulated by three government agencies: the Food and Drug Administration (FDA), which ensures that GE foods are safe to eat; the United States Department of Agriculture (USDA), which oversees growing conditions and practices; and the Environmental Protection Agency (EPA), which makes certain that pesticides introduced into crops are safe for consumption and for the environment. Agencies in other countries also monitor the release of GE organisms and recombinant genes to assure the safety of GE foods worldwide. This article will discuss the tracking technologies to detect GE DNA in foods and the concerns it raises for the general public including monitoring of GE crops by regulatory agencies. 2. Tracking of genetically engineered DNA in the environment GE DNA can be detected using both DNA and protein-based methods. Because inserted gene sequences usually include a promoter sequence, a structural gene, and a stop sequence for the gene, these sequences can be distinguished from the original DNA through various techniques. The Southern blot and polymerase

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chain reaction (PCR) are two of the better known and tested techniques for detecting GE DNA in the environment. An alternative Southern blot technology uses near infrared (NIR) fluorescent dyes and carbodiimide-reactive groups that directly bind to DNA in a 5-minute reaction.7 A detailed description of other GE tracking techniques such as chromatography, mass spectrometry, and NIR spectroscopy used to study GE crops in various circumstances (e.g., when the chemical composition of GE crops is significantly altered) has reviewed.8 PCR is a very effective approach to detecting transgenes in the environment.9 Genetically engineered food crops are commonly identified using PCR techniques such as multiplex PCR, quantitative competitive PCR (QC-PCR), and real-time PCR (RT-PCR).10 Another method was developed to detect onion yellow dwarf virus and Leek yellow stripe virus that combined immunocaptureRT-PCR (IC-RT-PCR) with the use of Taqman probes.11 In tests on commercial food samples with genetically engineered organism (GEO) content, using certified Roundup Ready soy flour mixtures for calibration, this method was able to detect as little as 0.1% GEO DNA in the sample. Microarray technology has been proposed for DNA analysis applications that require the detection of different nucleic acid targets simultaneously. A microarray approach was proposed to target GE products in food by carrying out multiplex PCR amplification via GEspecific primer extension and then hybridizing the resulting labeled templates to an oligonucleotide microarray. 12 The ligation detection reaction was combined with a universal array approach to detect and quantitate the PCR-amplified Cry1A(b) gene from BT-176 transgenic maize with excellent specificity and high sensitivity.13 An immono-PCR based method showed minimum detection limit 21.6436 ng to detect insecticidal protein Cry1Ac toxin, produced by Bacillus thuringiensis. 14 In a need to apply a screening method that is sensitive and unambiguous in identifying the different transformation events, a small amount of DNA required by TAIL-PCR was easily recovered from small transformant that allows rapid verification of T-DNA integration and detection of separate gene transfer event.15 A multiplex PCR-multiplex ligase chain reaction (LCR) (MPCRMLCR) technique was proposed to detect recombinant DNA segments (e.g. promoters, trait genes, and terminators), which allows efficient screening of GM crops.16 In another attempt, a gene expression profiling via serial analysis of gene expression (Long SAGE) was developed for detailed gene expression profiling in a non-model organism.17

http://www.bepress.com/selt/vol4/iss1/art2 DOI: 10.2202/1941-6008.1100

Singh: Genetically Engineered Food and Regulations

3. Safety concerns enforcing regulation of GE crops On many occasions scientific research has raised many questions about the safety of GE plants, animals, and foods for the environment and public health. Some dangers include reduced nutritional quality of food, modified proteins in GE foods becoming allergenic or harmful, development of more virulent viruses and resistant pests, negative effects on other species, increased invasiveness and weediness of crops, and most importantly, loss of biodiversity. 18 ,19 Using GE crops may make seed propagation difficult or impossible for farmers, and as in the recent StarLink case, there is the question of liability for harm caused by GE crops.20 However, in the briefings to the Minister for food safety, New Zealand - a review of report by Sralini et al. showed that New Zealand Food Safety Authority (NZFSA) considered that on the basis of the extensive pre-market safety assessments of MON863 corn 90-day rat feeding study 21 , there are no evidence found that can justify revising the previous conclusions of regulatory authorities on the safety of food derived from MON863 corn. To reduce the likelihood of transgenes escaping through seeds and recombinant molecules entering the food chain, plastids have become attractive targets for GE food; they significantly increase containment of transgenes that are not transmitted by pollen.22 Male sterile plant lines that produce no pollen are another possibility, and using non-food crops such as tobacco may reduce the likelihood of GE products entering the food chain. By linking fluorescent markers such as GFP or DsRed to transgenes, researchers can visually monitor the expression of those transgenes and trace them without molecular techniques in agronomic and ecological studies.23 Regulating GE crops is a further way to limit the risk to humans and the global ecology. 4. GE food regulation in the United States In the 1980s, the Coordinated Framework for Regulation of Biotechnology established that existing statutes were adequate to deal with genetic engineering processes and products. 24 In 1991, Vice President Dan Quayles Council on Competitiveness called for regulations on GE products, but did not address how genes were engineered.25 This produced the current system whereby the USDA, EPA, and FDA regulate GE crops and foods under existing laws, with the USDA overseeing plants, the EPA pesticides, and the FDA foods.

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4.1 FDA policy on GE versus conventional foods The FDA stated in 1992 that common food substances with genes added via GE technology should be considered Generally Recognized as Safe (GRAS) because the altered foods were for the most part the same as their conventional counterparts. 26 The FDA did not require testing for GRAS substances until evidence was presented that they might not be safe. However, when analysis of Monsantos Roundup Ready soybeans revealed more foreign DNA than the company or the government was aware of, this raised questions about equivalence between GE foods and conventional foods.27 The FDA began urging institutions seeking to commercialize GE foods to voluntarily notify the agency of their intention, then proposed a rule to make the notification mandatory.28 Under the mandatory notification, FDA still does not respond with an affirmation that the GE food is safe to eat. Without appropriate government regulation and assessing the risk associated with GE foods, the U.S. market raises bars on benefits of GE foods. FDA also proposed rule related to premarket notification of GE foods and guidance on voluntary labeling29. It stated that comprehensive safety testing and labeling were not mandatory for GE foods, even though a majority of Americans claimed their right to this information under the Freedom of Information Act 30 is necessary. Prior to this, FDA already dismissed labeling issues for GE versus conventional food by stating that it is not possible to test altered crops for all possible allergens produced by the donor genes.31 Later, the FDA issued guidelines on its consultation procedure for GE foods.32 These guidelines did not change the agencys policy or requirements, and clearly stated that the agency did not review scientific data generated by developers of GE food; thus, the institutions developing these foods were required to provide only summaries of their data. Also, the FDA put institutions on edge by making them, rather than the agency, responsible for any adverse consequences of GE food commercialization. 4.2 Agencies regulating bioengineered crops In the United States, the FDA regulates human biologics and drugs derived from GE plants through its Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER), under the authority of the Public Health Service Act 33 and the Federal Food, Drug, and Cosmetic Act. 34 Through its Center for Veterinary Medicine, the agency also regulates animal drugs derived from GE plants. The FDAs primary responsibilities regarding GE foods and crops are to ensure that they are safe to eat and determine labeling guidelines; the relevant regulations are found under Title 21 of the Code of Federal Regulations (21 CFR).

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Singh: Genetically Engineered Food and Regulations

The USDA regulates veterinary biologics through the Center for Veterinary Biologics under the authority of the Virus, Serum, and Toxins Act.35 The applicable USDA regulations are found under Title 9 of the Code of Federal Regulations (9 CFR), Parts 101-124. Under the Plant Protection Act, the USDAs Animal and Plant Health Inspection Service (APHIS) and Biotechnology Regulatory Services (BRS) regulate the importation, interstate movement, and release into the environment (e.g., field testing) of bioengineered pharmaceutical plants. 36 The APHIS/BRS regulations are found under Title 7 of the Code of Federal Regulations (7 CFR), in particular 7 CFR 340. Among other things, Part 340 also regulates the introduction of organisms and products altered or produced through GE that are plant pests or are believed to be plant pests. The introduction in to the U.S. of such articles also subjected to other regulations promulgated under the Plant Protection Act37 is found in 7CFR 319, 330, and 360. A permit is required for the importation of certain classes of nursery stock for their validity of GE under the regulation in subpart 7CFR 319.37-3. APHIS/BRS is also responsible for addressing the environmental safety issues posed by growing GE plants in fields and conducting National Environmental Policy Act (NEPA) assessments. 38 An institution needs APHIS permits in order to grow bioengineered pharmaceutical plants and conduct field trials before submitting a product application; this gives APHIS/BRS the opportunity to evaluate the environmental impact of growing the plants in question. Any concerns are then addressed by the regulatory agency responsible for review and approval of the product, National Environmental Policy Act.39 After an incident of GE cottonseed that was accidentally released into the environment, the Government Accountability Office (GAO) called on the USDA, FDA, and EPA to improve oversight. The GAO recommended three ways to improve oversight of GE crops: that the FDA publicize the results of its early food safety assessments of GE crops, that the USDA and FDA share information on GE crops that could present public health risks if released, and that all three agencies develop a risk-based strategy for monitoring all GE crops on the market.40 5. Global efforts toward regulation of GE crops Although they may share phenotypic traits, transgenic crops face many more regulatory requirements and market restrictions than traditionally bred crops, for the reasons already discussed.41 This makes the commercialization of transgenic crops much more costly.42 The global market for agricultural products and the projected expansion of GE crops share in that market are putting pressure on countries around the world to coordinate their regulation of GE crops. GE technology has great potential to improve the reliability and quality of the world

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food supply, but a biosafety system with clear guidelines, skilled personnel, an adequate review process, and mechanisms for feedback from farmers and consumers must be instituted before GE crops are introduced. Applications for releasing GE plants into the environment should then be evaluated one by one to determine whether the plant poses a risk of weediness, gene transfer, affecting wildlife disease susceptibility, and other such hazards.43 To ensure the food safety and specifically of GE foods, the European Union (EU) has established a legal framework. In this legal framework, a general framework for regulating GM food and feed is proposed under Regulation (EC) 1829/2003 of the European parliament and of the Council of 22 September 2003 on GM food and feed. This regulation further supplemented by regulation (EC) 1830/2003 which directs the labeling and traceability of GM organisms (GMOs) in market. The deliberate release of GMOs into the environment is outlined in directive 2001/18/EC. The regulation 1829/2003 also initiated centralized procedure of authorization by the European Commission i.e. the European Food Safety Authority (EFSA) that carried out the independent risk assessment of GMOs. This regulation also rules for the labeling of GM food and feed that limits the threshold for the presence of GM materials in rotational crops which is technically unavoidable. With the aim to share knowledge and current best practices in the risk assessment of GMOs, EFSA intend to bring Member States, Stakeholders and other participants on a common platform.44 A number of Member States in EU have invoked for safeguard for GMOs under previous Directive 90/220/EEC. Under this National Safeguard, a Member of State can consider to provisionally restrict or prohibit the use and/or sale of threat imposing GM products on its territory. Six Member States, Austria, France, Greece, Hungary, Germany and Luxembourg are currently applying for safeguard clauses on GMO events. In EU, the organization for Economic Co-operation and Development (OECD) task force engage in the safety of novel foods and feeds to promote international harmonization in the safety assessment and regulation.45 Many other countries have set up their own regulatory systems to address the challenges presented by GE crops (Table 1). Australias Genetic Manipulation Advisory Committee was established as a nonstatutory body to oversee new techniques in genetic science. Then, in June 2001, Australia passed the Gene Technology Act, which controls the research, manufacture, production, and importation of gene technology.46

http://www.bepress.com/selt/vol4/iss1/art2 DOI: 10.2202/1941-6008.1100

Singh: Genetically Engineered Food and Regulations

Table 1. Selected International world-wide internet links to GE crop information, regulatory agencies and their documented guidelines. Regulatory agencies
The Food and Agriculture Organization of the United Nations The World Health Organization The Codex Alimentarius Commission European Union Food Safety Policy Committee

Website (last visited: May 2009)

http://www.fao.org

http://www.who.int http://www.codexalimentarius.net/web/index_en.jsp http://www.efsa.europa.eu/EFSA/efsa_locale1178620753812_home.htm Foreign Agricultural service U.S. http://useu.usmission.gov/agri/usda.html

mission to the European Union

The World Food Safety Organization U.S. Food and Drug Administration U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition U.S. Environmental Protection Agency U.S. Department of Agriculture U.S. Department of Agriculture, National Agriculture Library Canadian Food Inspection agency UK Food standards Agency GM and Novel Foods Food standards Australia, New Zealand Agricultural and processed food products export development authority, India The Agriculture Network information center (AgNIC Porta) http://www.worldfoodsafety.org http://www.fda.gov http://www.cfsan.fda.gov http://www.epa.gov http://www.usda.gov http://www.nal.usda.gov/fnic http://www.inspection.gc.ca/english/toce.shtml http://www.food.gov.uk/gmfoods http://www.foodstandards.gov.au/ http://www.apeda.com/apedawebsite/index.asp http://www.agnic.org/about

The Office of the Gene Technology Regulator (OGTR) in Australia and Environmental Risk Management Authority (ERMA) in New Zealand comprehensively assess the environmental issues. Since June 2001, OGTR regulates activities with all GMOs whereas the Food Standards Australia New Zealand (FSANZ) board has responsibility to maintain the standards of GE food but does not have the authority to assess matters relating to environmental risks resulting from the release of GM crops into the environment. Any food material that uses GE technology is listed in the Food Standards Code Standard 1.5.2 Food produced using gene technology.47 In New Zealand, processed foods can contain GM ingredients but must be labeled accordingly, also no GM crops are grown commercially and no GM fruit, vegetables or meat are sold.
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In Australia, the current regulatory system includes a number of agencies e.g. FSANZ; The Office of the Gene Technology Regulator (OGTR); The Therapeutic Goods Administration (TGA); The National Registration Authority for Agricultural and Veterinary Chemicals (NRA); The Australian Quarantine and Inspection Service (AQIS), with specific roles in the control and regulation of GM products such as imports, food, agricultural and veterinary chemicals. The safety of GM foods continues to be assessed and regulated by FSANZ under the direction of the Australia New Zealand Food Regulation Ministerial Council comprising Health and Agricultural Ministers from the Commonwealth, each Australian State and Territory, and New Zealand. Certain Asian countries are also setting up legislative frameworks for the environmental and commercial release of GE crops. Japan issued guidelines to regulate the use of organisms derived from recombinant DNA technology in agriculture, forestry, fisheries, the food industry, and other related industries.48 India has established a Genetic Engineering Approval Committee (GEAC)49, and released protocols for food and feed safety assessment of GE crops.50 Basically, Indias current regulations to deal with GM crops are based on rules developed in 198951. Since then many international instruments such as Agenda 21 (1992)52, the UN convention on biological diversity (1992) 53 , the biosafety protocol (2001) 54 , the UNEP technical guidelines on biosafety (1995) 55 and the International treaty on plant genetic resources (2001)56 have been developed, and current regulation in India does not incorporate various principles of environmental jurisprudence like inter-generational equity and polluter-pays principle. Hence it is deemed necessary for developing countries, to act responsibly towards environment and human health in terms of GMOs safe approval. 6. Labeling of GE food in the United States In the US, labeling is required for GE foods only if they differ significantly in safety, composition, or nutritional content from their non-GE counterparts, or if they contain known allergens, unless data have shown that there is no allergy risk. The Federal Food, Drug, and Cosmetic Act (FDCA) is the law that dictates US food labeling practices. 57 The primary provisions of the FDCA that control labeling of GM foods are 21 U.S.C. 343 (misbranding) and 21 U.S.C. 348 (food additives).58 The primary provision regarding food safety is 21 U.S.C. 342 (adulterated food).59 In 1992, the FDA released a policy statement on how the FDCA applied to foods derived from new plant varieties, including plants developed by recombinant DNA techniques. The statement said that such foods would be regulated within the current FDCA framework and that the regulatory status of a

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Singh: Genetically Engineered Food and Regulations

food, irrespective of the method by which it is developed, is dependent upon objective characteristics of the food and the intended use of the food (or its components). It went on to say the following: In most cases, the substances expected to become components of food as a result of genetic modification of a plant will be the same as or substantially similar to substances commonly found in food, such as proteins, fats and oils, and carbohydrates FDA has determined that such substances should be subject to regulation under section 409 of the act in those cases when the objective characteristics of the substance raise questions of safety sufficient to warrant formal premarket review and approval by FDA.60 In other words, while some GE foods might require formal review, they were subject to the same process and regulations as all other foods. This raised concerns among those who were pro-regulation and pro-labeling. Although labeling is not required in the US today, consumer curiosity may motivate manufacturers, processors, and distributors to voluntarily provide truthful information about GE foods and their nutritional values. On the legal basis, FDA follow the First Amendment (Free Speech) to the Constitution that protects right to speak, including right not to forced to speak. This right applies both natural person and artificial ones, such as corporations. Therefore, any nonmisleading statements can be made as long as it meats with the criteria of health and safety of a consumer. Also, companies could not be forced to speak. This makes a legal difference while regulating GE food in the US and EU. In 2001, the FDA announced plans to draft labeling guidelines for manufacturers who wish to voluntarily label their foods as include or not to include GE ingredients.61 A measured, careful attitude toward commercializing GE crops that includes a comprehensive risk assessment could allow people to reap substantial benefits from GE crops while preventing the possible dangers involved. Regulatory hurdles are currently a significant factor that is delaying the commercial release of many new transgenic crops, although market acceptance and intellectual property issues contribute as well.62,63 7. Civilian legal action involving GE crops Civil organizations have taken legal action in several cases against inadequate regulatory oversight of GE foods. In May 1998, a coalition of scientists, religious leaders, health professionals, consumers, and chefs sued the FDA to obtain mandatory testing and labeling of GE foods.64 In response, the FDA made public over 44,000 pages of documents revealing that the agencys own scientists had serious reservations about grouping GE foods with conventional foods. However,

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in October 2000, a federal court held that the 1992 FDA policy on GE foods did not have a binding effect on food producers. This ruling equated FDA policy to agency inaction, which rendered it immune to challenge under several statutes. Another lawsuit was filed by environmentalists, farmers, and consumers against the EPA, alleging that widespread growth of GE plants producing Bt toxin would cause insects to develop resistance to the toxin and make Bt biopesticides useless.65 The plaintiffs called on the agency to cease approving new registrations of all Bt crops and perform a programmatic NEPA assessment of the cumulative environmental impact of all existing Bt plant registrations. Later, the lawsuit was dismissed affirming EPAs regulatory policies66 and no basis found to cancel Bt registration under Federal Insecticide, Fungicide and Rodenticide Act (FIRA).67 The Center for Food Safety (CFS) filed a challenge with the FDA in December 1998 to remove Monsantos rBGH from the market.68 Then, in January 1999, CFS and 24 other public interest organizations filed a legal petition asking that FDA approval for rBGH be withdrawn. In December 1999, a group of farmers filed a class-action lawsuit against Monsanto and other global biotechnology companies, alleging that the companies formed a cartel to fix prices on GE seeds and restrain trade in the GE corn and soybean seed markets (Higginbotham et al. v. Monsanto).69 Monsantos GE Roundup Ready alfalfa was approved in June 2005, for commercial sale by the USDA. This variety was designated to tolerate herbicides, and was the first GE perennial crop to be commercialized in U.S. This crop is suspected to impose special environmental, agricultural, and economical risks. The CFS initiated the legal action in Feb 2006 representing itself and the Coplaintiff including WORC, Dakota resource Council, National Family Farm Coalition, and others. A. U.S. appeals court refused to lift the ban on planting GE alfalfa in 2009 until federal government finishes its study on how the product could affect organic and conventional crops, the environment.70 8. Conclusion Biotechnology can be used to produce great agricultural, industrial, environmental, and health advances. Scientific innovations always bring risks and unintended outcomes; if we want to reap their benefits most effectively for the next generation, these negative outcomes must be predicted and prevented. As the technology becomes more powerful, it is necessary to inspect GE food products more carefully. Public opinion is currently divided on the safety of GE foods, but consumers are concerned about risks, and they want to know what their food contains. Labeling foods that include GE material is a reliable and efficient way of assuring quality that is important to manufacturers and control authorities.

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The FDAs mission is to protect the American public from food- and drugrelated harm. It ensures that GE foods are nutritionally equivalent to non-GE foods. If they are found to contain allergens, the FDA is willing to mandate labeling of GE food products. However, the problem with mandatory labeling is that consumers may see the GE label as undesirable and avoid products that carry it. Mandatory labeling might also increase manufacturing costs to a point where it would impose a serious burden on the food industry. Nevertheless, the right to know position has strong support from the public. The FDCA currently does not give the FDA the power to implement mandatory labeling; the way to solve this is to educate the public so that GE claims will not be seen as misbranding under the FDCA as required by the Nutrition labeling and Education Act.71 In summary, GE technology is a strong asset in the fight against world hunger if it is properly implemented. As a world leader in biotechnology and a responsible nation, the United States must remain open to the possibilities of GE food technology, and an important step in doing this is to put a successful labeling system into practice.

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6. ISB News Report, Genetically modified crops and foods: a report of the AMA Council on scientific affairs, available at http://www.isb.vt.edu/news/2001/Jan01.pdf (last visited May 14, 2009) 7. Stull, D., A feast of fluorescence, SCIENTIST Vol. 15 (2001) at 2021.

8. Singh, O.V. et al., Genetically modified crops: success, safety assessment, and public concern, APPL. MICROBIOL. BIOTECHNOL. Vol. 71 (2006) at 598-607. 9. Auer, C.A., Tracking genes from seed to supermarket: techniques and traits, TRENDS PLANT SCI. Vol. 8 (2003) at 59197. 10. Trifa, Y. & Zhang, D., DNA content in embryo and endospore of Maize kernel (Zea mays L): impact on GMO quantification, J. AGRIC FOOD CHEM. Vol. 52 (2004) at 1044 48. 11. Lunello, P. et al., Ultra-sensitive detection of two garlic potyvirus using a real-time fluorescent (Taqman) RT-PCR assay, J. VIROL. METHODS Vol. 118 (2004) at 15-21. 12. Rudi, K. et al., A novel multiplex quantitative DNA array based on PCR (MQDA-PCR) for quantification of transgenic maize in food and feed, NUCLEIC ACIDS RES. Vol. 31 (2003) at 1162. 13. Bordoni, R. et al., Detection and quantitation of genetically modified maize (Bt-176 transgenic maize) by applying ligation detection reaction and universal array technology, J. AGRIC FOOD CHEM. Vol. 52 (2004) at 104954. 14. Allen, R.C. et al., An immuno-PCR method for detecting Bacillus thuringiensis, J IMMUNOL METHODS. Vol. 308 (2006) at 109-115. 15. Hauhineva, K.J., Karenlampi, S.O., Production of transgenic strawberries by temporary immersion bioreactor system and verification by TAIL-PCR, BMC BIOTECHNOL. Vol. 7: 11 (2007). 16. Mano, J. et al., Simultaneous detection of recombinant DNA segments introduced into genetically modified crops with multiplex ligase chain reaction coupled with multiples polymerase chain reaction, J AGRIC FOOD CHEM. Vol. 57 (2009) at 2640-2646.

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17. Obermeier, C. et al., Gene expression profiling via LongSAGE in a nonmodel plant species: a case study in seeds of Brassica napus, BMC GENOMICS. Vol. 10 (2009) at 295. 18. Organic Consumer Association, Genetic Engineering and Biotechnology, available at http://www.organicconsumers.org/gelink.cfm#Science (last visited Feb. 12, 2009). 19. Union of Concerned Scientists, Failure to Yield: Evaluating the performance of genetically engineered plants, available at http://www.ucsusa.org/food_and_agriculture/science_and_impacts/science/failure -to-yield.html (last visited May 10, 2009). 20. Center for Rural Affairs, The Splice of Life: Implications of genetic engineering for family farmers, consumers, and the Environment, available at http://www.cfra.org/MSAWG-GE.htm (last visited May 12, 2009). 21. Seralini, G.E., et al., New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity, ARCH ENVIRON CONTAM TOXICOL. Vol. 52 (2007) at 596-602. 22. Bock, R. & Khan, M.S., Taming plastids for a green future, TRENDS BIOTECHNOL. Vol. 22 (2004) at 31118. 23. Harper, B.K. et al., Green fluorescent protein as a marker for expression of a second gene in transgenic plants, NATURE BIOTECHNOL. Vol. 17 (1999) at 112529. 24. Office of Science and Technology Policy. Coordinated Framework for Regulation of Biotechnology, Fed. Reg. Vol. 51, No. 123. 23306 (June 26, 1986). 25. 6 Claire Cummings. Testimony at the California Senate Natural Resources Committee and Select Committee on Higher Education hearing on The Environmental Implications of Genetic Engineering and the Corporatization of the University of California. 15 May 2000. 26. Department of Health and Human Services, Food and Drug Administration, Foods Derived From New Plant Varieties, Fed. Reg. Vol. 57, No. 104, 22984 (May 29, 1992).

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27. Meikle J., Soya gene find fuels doubts on GM crops, The Guardian (London). 31 May 2000, available at http://www.gene.ch/gentech/2000/Jun/msg00002.html (last visited May 12, 2009). 28. Department of Health and Human Services, Food and Drug Administration, Premarket notice concerning bioengineered foods, Fed. Reg. Vol. 66, No. 12, 4706. (Jan. 18, 2001). 29. Department of Health and Human Services. Draft Guidance for Industry: Voluntary labeling indicating whether foods have or have not been developed using bioengineering; availability. Fed. Reg. Vol. 66, No. 12, 4839 (Jan. 18, 2001). 30. The Freedom of Information Act, Pub. L. No. 104-231 552 (1996).

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