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Volume 4, Issue 1 2010 Article 2

Studies in Ethics, Law, and

Technology

Regulation and Safety Assessment of

Genetically Engineered Food

Om V. Singh*

* Advance Academic Programs, Zanvyl Krieger School of Arts and Sciences, The Johns HopkinsUniversity, 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.

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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 theenvironmental 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:

[email protected], [email protected].

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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 foreseeablefuture. 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 significantimpact 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 enhanceagronomics performance and tolerance for various environmental conditions.

1GE

plants were first introduced into the U.S. commercial market in 1996 and now

appear in many processed food products worldwide.2

Genetic engineering’sgreatest 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 DrugAdministration 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 foodsinvolves 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 risksinvolved 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 ensuresthat GE foods are safe to eat; the United States Department of Agriculture

(USDA), which oversees growing conditions and practices; and theEnvironmental 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 recombinantgenes 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. Becauseinserted 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

1

Singh: Genetically Engineered Food and Regulations

Published by The Berkeley Electronic Press, 2010

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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 GEtracking 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.9Genetically engineered food crops are commonly identified using

PCR techniques such as multiplex PCR, quantitative competitive PCR (QC-PCR),and real-time PCR (RT-PCR).

10Another method was developed to detect onion

yellow dwarf virus and Leek yellow stripe virus that combined immunocapture-

RT-PCR (IC-RT-PCR) with the use of Taqman probes.11

In tests on commercialfood samples with genetically engineered organism (GEO) content, using certified

Roundup Ready soy flour mixtures for calibration, this method was able to detectas 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 GE-

specific primer extension and then hybridizing the resulting labeled templates toan oligonucleotide microarray.

12The 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 highsensitivity.

13

An immono-PCR based method showed minimum detection limit 21.6-

436 ng to detect insecticidal protein Cry1Ac toxin, produced by Bacillusthuringiensis.

14In 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) (MPCR-MLCR) 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 ina non-model organism.

17

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Studies in Ethics, Law, and Technology, Vol. 4, Iss. 1 [2010], Art. 2

http://www.bepress.com/selt/vol4/iss1/art2

DOI: 10.2202/1941-6008.1100

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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. Somedangers 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 andweediness of crops, and most importantly, loss of biodiversity.

18,19Using 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 GEcrops.

20However, in the briefings to the Minister for food safety, New Zealand - a

review of report by Séralini et al . showed that New Zealand Food Safety

Authority (NZFSA) considered that on the basis of the extensive pre-marketsafety assessments of MON863 corn 90-day rat feeding study

21, there are no

evidence found that can justify revising the previous conclusions of regulatoryauthorities 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 areanother 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 theexpression 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.

24In 1991, Vice President Dan Quayle’s 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 USDAoverseeing 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) becausethe 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 Monsanto’s 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 notrespond 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 pre-market notification of GE foods and guidance on voluntary labeling

29. 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 Act30

is necessary. Prior to this, FDA alreadydismissed 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 GEfoods.

32These guidelines did not change the agency’s 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 requiredto 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 thePublic Health Service Act

33and the Federal Food, Drug, and Cosmetic Act.

34

Through its Center for Veterinary Medicine, the agency also regulates animaldrugs derived from GE plants. The FDA’s primary responsibilities regarding GEfoods 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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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 USDA’sAnimal 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.

36The 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 producedthrough 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 isrequired 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 alsoresponsible 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 theenvironmental 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 toimprove 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 onGE 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 moreregulatory requirements and market restrictions than traditionally bred crops, for

the reasons already discussed.41 This makes the commercialization of transgeniccrops much more costly.

42The 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 todetermine 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 EuropeanUnion (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 2003on 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 indirective 2001/18/EC. The regulation 1829/2003 also initiated centralized

procedure of authorization by the European Commission i.e. the European FoodSafety 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 safeguardclauses 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). Australia‘s Genetic ManipulationAdvisory 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

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Table 1. Selected International world-wide internet links to GE crop information,

regulatory agencies and their documented guidelines.

Regulatory agencies Website (last visited: May 2009)

The Food and Agriculture Organization

of the United Nations

http://www.fao.org

The World Health Organization http://www.who.int

The Codex Alimentarius Commission http://www.codexalimentarius.net/web/index_en.jsp

European Union Food Safety Policy

Committee

http://www.efsa.europa.eu/EFSA/efsa_locale-

1178620753812_home.htm

Foreign Agricultural service U.S.

mission to the European Union

http://useu.usmission.gov/agri/usda.html

The World Food Safety Organization http://www.worldfoodsafety.org

U.S. Food and Drug Administration http://www.fda.gov U.S. Food and Drug Administration,

Center for Food Safety and Applied

Nutrition

http://www.cfsan.fda.gov

U.S. Environmental Protection Agency http://www.epa.gov

U.S. Department of Agriculture http://www.usda.gov

U.S. Department of Agriculture,

National Agriculture Library

http://www.nal.usda.gov/fnic

Canadian Food Inspection agency http://www.inspection.gc.ca/english/toce.shtml

UK Food standards Agency – GM and

Novel Foods

http://www.food.gov.uk/gmfoods

Food standards Australia, New Zealand http://www.foodstandards.gov.au/

Agricultural and processed food products export development authority,

India

http://www.apeda.com/apedawebsite/index.asp

The Agriculture Network information

center (AgNIC Porta)

http://www.agnic.org/about

The Office of the Gene Technology Regulator (OGTR) in Australia andEnvironmental Risk Management Authority (ERMA) in New Zealandcomprehensively assess the environmental issues. Since June 2001, OGTR regulates activities with all GMOs whereas the Food Standards Australia NewZealand (FSANZ) board has responsibility to maintain the standards of GE food

but does not have the authority to assess matters relating to environmental risksresulting from the release of GM crops into the environment. Any food materialthat 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 cancontain GM ingredients but must be labeled accordingly, also no GM crops aregrown 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 andInspection 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 thedirection 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 inagriculture, forestry, fisheries, the food industry, and other related industries.

48

India has established a Genetic Engineering Approval Committee (GEAC)49, andreleased protocols for food and feed safety assessment of GE crops.

50Basically,

India’s 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 theInternational treaty on plant genetic resources (2001)

56have 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 GMO’s 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).

58The 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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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 hasdetermined 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 sufficientto warrant formal premarket review and approval by FDA.

60

In other words, while some GE foods might require formal review, they weresubject 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 non-

misleading 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”. Thismakes 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 acceptanceand 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, religiousleaders, health professionals, consumers, and chefs sued the FDA to obtainmandatory testing and labeling of GE foods.

64In response, the FDA made public

over 44,000 pages of documents revealing that the agency’s 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 consumersagainst 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 registrationsof 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 EPA’s regulatory policies66

and no basis found to cancel Btregistration 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 Monsanto’s rBGH from the market.68

Then, in January1999, 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

Monsanto’s 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 Co-

plaintiff including WORC, Dakota resource Council, National Family Farm

Coalition, and others. A. U.S. appeals court refused to lift the ban on planting GEalfalfa 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 thetechnology becomes more powerful, it is necessary to inspect GE food products

more carefully. Public opinion is currently divided on the safety of GE foods, butconsumers are concerned about risks, and they want to know what their foodcontains. 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 FDA’s mission is to protect the American public from food- and drug-related harm. It ensures that GE foods are nutritionally equivalent to non-GEfoods. If they are found to contain allergens, the FDA is willing to mandate

labeling of GE food products. However, the problem with mandatory labeling isthat consumers may see the “GE” label as undesirable and avoid products thatcarry it. Mandatory labeling might also increase manufacturing costs to a pointwhere it would impose a serious burden on the food industry. Nevertheless, the“right to know” position has strong support from the public. The FDCA currentlydoes not give the FDA the power to implement mandatory labeling; the way tosolve this is to educate the public so that GE claims will not be seen asmisbranding under the FDCA as required by the Nutrition labeling and EducationAct.71 In summary, GE technology is a strong asset in the fight against worldhunger if it is properly implemented. As a world leader in biotechnology and aresponsible 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 labelingsystem into practice.

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