Genetically modified food in the United States

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The United States is the largest grower of commercial crops that have been genetically engineered in the world, but not without domestic and international opposition.

Contents

Monsanto, based in Creve Coeur, Missouri in the United States, is the leading producer of genetically engineered seed; it sells 90% of the world's GE seeds. [1]

Legislation

See Farmer Assurance Provision. (This bill is commonly referred to as the “Monsanto Protection Act” by its critics. [2] [3] [4] )

Lawsuits

In 1983, environmental groups and protestors delayed the field tests of the genetically modified ice-minus strain of P. syringae with legal challenges. [5] Foundation on Economic Trends v. Heckler, 756 F.2d 143 (D.C. Cir. 1985).

Alliance for Bio-Integrity v. Shalala

In this case, the plaintiff argued both for mandatory labeling on the basis of consumer demand, and that GMO foods should undergo the same testing requirements as food additives because they are "materially changed" and have potentially unidentified health risks. The plaintiff also alleged that the FDA did not follow the Administrative Procedures Act in formulating and disseminating its policy on GMO's. The federal district court rejected all of those arguments and found that the FDA's determination that GMO's are Generally Recognized as Safe was neither arbitrary nor capricious. The court gave deference to the FDA's process on all issues, leaving future plaintiffs little legal recourse to challenge the FDA's policy on GMO's. [6] [7] (pp. 755–756) Alliance for Bio-Integrity v Shalala, 116 F.Supp.2d 166 (D.D.C. 2000).

Diamond v. Chakrabarty

Diamond v. Chakrabarty, 447 U.S. 303 (1980), was a United States Supreme Court case dealing with whether genetically modified organisms can be patented. [8] The Court held that a living, man-made micro-organism is patentable subject matter as a "manufacture" or "composition of matter" within the meaning of the Patent Act of 1952. The fact that the organism sought to be patented is alive is no bar to patentability.

Revenue

Opposition

Numerous organizations based in the U.S. oppose or have concerns about genetic engineering for various reasons. Groups such as the Center for Food Safety, the nonprofit science advocacy group Union of Concerned Scientists, Greenpeace and the World Wildlife Fund have expressed concerns about the FDA's lack of a requirement for additional testing for GMO's, lack of required labeling and the presumption that GMO's are "Generally Recognized as Safe" (GRAS). Some of these groups have questioned whether the FDA is too close to companies that seek approval for their products. [6]

Health concerns

Although there have been no recorded instances of harm to human health due to the consumption of genetically engineered foods, there is concern over their impact on health. One of the largest food recalls in US history, was the Taco Bell GMO recall, where a Bt corn plant not approved for human consumption due its risk as an allergen, had contaminated food products like the tacos at Taco Bell, and a huge percentage of US's seed supply. No health problems were linked to Starlink corn, [9] and subsequent evaluations of the Bt trait determined that there is medium risk to human health. [10]

Regulation

The USA is the largest commercial grower of genetically modified crops in the world. [11] United States regulatory policy is governed by the Coordinated Framework for Regulation of Biotechnology. [12] The United States is not a signatory to the Cartagena Protocol on Biosafety. [13] For a genetically modified organism to be approved for release it is assessed by the USDA, the FDA and the EPA. USDA evaluates the plant's potential to become weeds, the FDA reviews plants that could enter or alter the food supply and the EPA regulates the genetically modified plants with pesticide properties. Most developed genetically modified plants are reviewed by at least two of the agencies, with many subject to all three. [14] Final approval can still be denied by individual counties within each state. In 2004, Mendocino County, California became the first and only county to impose a ban on the "Propagation, Cultivation, Raising, and Growing of Genetically Modified Organisms", the measure passing with a 57% majority. [15] (See Mendocino County GMO Ban)

U.S. Department of Agriculture

The Biotechnology Regulatory Services program of the Animal and Plant Health Inspection Service (APHIS) agency within the USDA is concerned with protecting agriculture and the environment from potential pests under the Plant Protection Act of 2000 (part of the Agriculture Risk Protection Act) and the National Environmental Policy Act (NEPA). [14] [16] Each transgenic event is regulated separately as the transgene insertion locus varies even when using identical constructs and host genotypes. This could result in different expression patterns or could affect the function of other endogenous genes within the host. The USDA is responsible for approving field trials of GM plants under either the notification or permit procedures. [14] The notification procedure is a streamlined process for the simplest or most familiar genetically engineered plants that meet six criteria (is not a noxious weed, the function of the genetic material is known and characterized, stable integration, no significant risk of creating new viruses and that no animal or human pathogen sequences are present). [17] Most field trials are approved under the notification procedure. [14] The permit procedure is much more elaborate and is required for all genetically engineered organisms that do not meet the notification requirements or any plant-made pharmaceuticals or plant-made industrial products.

APHIS officials are responsible for inspecting the field trials. At least one inspection is carried out for each state listed on a permit, while inspection of field trials authorized by notification is conducted based on the relative risk of each trial. [18] For field trials of organisms that contain pharmaceutical or industrial compounds, inspections are carried out more frequently (five times during establishment and twice yearly after that). If the inspectors are satisfied that there are no regulatory concerns they issue a Notice of Compliance. If the regulations are not being adhered to the inspectors will issue a Notice of Non-Compliance requesting that the deviations be fixed, or for more serious breaches a warning letter requiring a written response and corrective action to be taken within a given time frame. [18] Formal investigations are carried out on developers who may not be adhering to regulations, permit conditions, or other requirements, which can result in civil penalties or criminal charges.

In 1993, the USDA proposal to remove regulatory oversight from GM organisms deemed environmentally benign was approved and four GM plants (Flavr Savr tomato, virus-resistant squash, bromoxynil-tolerant cotton and glyphosate-tolerant soybean) obtained non-regulatory status that year. [14] Non-regulated status means that permits and notifications are no longer required for introductions of this organism. Applicants can petition APHIS for non-regulated status if the GM organism poses no more of a plant pest risk than an equivalent non-GM organism. [19] APHIS will prepare at least two documents (an Environmental Assessment and a determination of non-regulatory status) under the NEPA while considering the application.

Four federal district court suits have been brought against APHIS challenging their regulation of GM plants. Two involved field trials (herbicide-tolerant turfgrass in Oregon; pharmaceutical-producing corn and sugar in Hawaii) and the other two were the deregulation of GM alfalfa and GM Sugar Beet. [14] APHIS initially lost all four cases, with the judges ruling they failed to diligently follow the NEPA guidelines. However, the Supreme Court overturned the nationwide ban on GM alfalfa [20] and an appeal court allowed the partial deregulation of GM sugar beet crops. [21] After APHIS prepared Environmental Impact Statements for both crops they were deregulated again. [22] [23]

Food and Drug Administration

The FDA is responsible for the safety and security of human and animal food and drugs, including any that are genetically modified. The FDA was responsible for approving the first commercialized GMO, Genetech's genetically modified human insulin (Humulin) in 1982 and the first commercialized GM whole food, Calgene's Flavr Savr tomato in 1994. When evaluating new GM foods or feed the FDA looks for the presence of any new or altered allergens and toxicants and examines changes in the levels of nutritional and anti-nutritional substances. [14] Food and feed that is identical or nearly identical in composition to current products is deemed to be substantially equivalent [24] and is not required to undergo review by the FDA. [25] The FDA has been criticized for using substantial equivalence, with a major accusation being that FDA review is essentially voluntary as almost all GM products are substantially equivalent. [26] However, all GM food and feed currently on the US market (as of 2008) have undergone a FDA consultation, where the developer submits the compositional data and FDA scientist compare it to regular food and feed. [14] [27]

The FDA consultation focuses on whether the new food or feed contains any new allergens or toxic substances and whether the nutritional components of the food or feed have increased or decreased. [14] The developer submits documentation to the FDA describing the food or feed and a FDA assigned caseworker can then request additional information on expected dietary exposure, in particular if any risk groups (children, elderly etc.) might be exposed. As of 2007, the FDA has not identified any genetically modified foods with unexpected changes in the nutrient composition or levels of allergens or toxic substances. [14] However, allergic proteins have been detected when some GM products have undergone testing. Pioneer Hi-Bred inserted a gene from the Brazil nut into transgenic soybean resulting in soy with an enhanced nutritional profile. The inserted gene did not translate into a known allergen at the time, but when tested with serum from people who are allergic to Brazil nut the allergenic nature of the protein was discovered. [28] The development of the transgenic soybean expressing a Brazil nut allergen was stopped after these tests. The FDA consultation process is relatively (when compared to the other agencies regulating GM) informal and they do not approve new GM products. Instead they issue a memo stating whether the new food is the same as or different from the non-modified variety. [14]

The Center for Veterinary Medicine of the FDA regulates genetically modified animals in consultation with Centers at the FDA responsible for regulating pharmaceuticals or other medical products derived from biopharm animals. [29] The FDA also has extra guidelines that apply to genetically modified animals that will be used in the manufacturing and testing of therapeutic products and xenotransplantation. [29] The FDA guidance documents do not establish legally binding laws and are viewed as recommendations, unless specific regulatory or statutory requirements are cited. Any relevant federal, State, or local laws and regulations must also be adhered to. [29]

Environmental Protection Agency

The EPA regulates substances with pesticide characteristics, looking at potential threats to human health or the environment. [14] They claim not to regulate the genetically modified plants, but the pesticides produced by the plants or properties that change the usage of applied pesticides . This includes; plants engineered to produce resistance to herbicides (e.g. Roundup Ready), plants that produce their own pesticides (e.g. BT) and virus resistant plants. Authority to regulate the pesticide properties in genetically modified organisms was granted in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). The EPA published regulations in 1994 and begun acting on them in 1995. In 1994 they proposed the exemption of three categories of genetically modified plants under their regulation. These were plants where the genetic material originated in sexually compatible plants (cisgenic), plants that used physical barriers to prevent the target pest from attaching itself, and plants expressing viral coat proteins to protect against virus infection. [14] In 2001, rules regarding exemption of cisgenic plants had been finalised. The other two proposed exemptions were still under review in 2010.

The EPA evaluated each submission on a case-by-case basis. The EPA assesses data concerning the characterisation of the end-product of the engineered organism (presently all plants evaluated produce proteins), as well as data on mammalian toxicity, effects on non-target organisms and environmental metabolism. [14] For Bt products the producer must also supply an insect resistance management program. For herbicide resistant plants the EPA co-ordinates with the USDA and FDA, but does not regulate the plant itself. Instead it regulates the herbicide and its use on the new cultivar. [14] The EPA examines the construct used to transform the plant and the biology of recipient plant. The sequence of the resulting protein must be described, expression pattern and intensity verified and any modifications to the protein reported. The EPA considers the potential allergenicity of the product, issues surrounding gene flow into wild species, possible effects on non-target organisms, likelihood of it persisting in the environment and the potential for insect resistance developing when assessing submissions. [14]

See also

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<span class="mw-page-title-main">Genetically modified maize</span> Genetically modified crop

Genetically modified maize (corn) is a genetically modified crop. Specific maize strains have been genetically engineered to express agriculturally-desirable traits, including resistance to pests and to herbicides. Maize strains with both traits are now in use in multiple countries. GM maize has also caused controversy with respect to possible health effects, impact on other insects and impact on other plants via gene flow. One strain, called Starlink, was approved only for animal feed in the US but was found in food, leading to a series of recalls starting in 2000.

<span class="mw-page-title-main">Genetically modified organism</span> Organisms whose genetic material has been altered using genetic engineering methods

A genetically modified organism (GMO) is any organism whose genetic material has been altered using genetic engineering techniques. The exact definition of a genetically modified organism and what constitutes genetic engineering varies, with the most common being an organism altered in a way that "does not occur naturally by mating and/or natural recombination". A wide variety of organisms have been genetically modified (GM), including animals, plants, and microorganisms.

Agricultural biotechnology, also known as agritech, is an area of agricultural science involving the use of scientific tools and techniques, including genetic engineering, molecular markers, molecular diagnostics, vaccines, and tissue culture, to modify living organisms: plants, animals, and microorganisms. Crop biotechnology is one aspect of agricultural biotechnology which has been greatly developed upon in recent times. Desired trait are exported from a particular species of Crop to an entirely different species. These transgene crops possess desirable characteristics in terms of flavor, color of flowers, growth rate, size of harvested products and resistance to diseases and pests.

<span class="mw-page-title-main">Genetically modified food</span> Foods produced from organisms that have had changes introduced into their DNA

Genetically modified foods, also known as genetically engineered foods, or bioengineered foods are foods produced from organisms that have had changes introduced into their DNA using various methods of genetic engineering. Genetic engineering techniques allow for the introduction of new traits as well as greater control over traits when compared to previous methods, such as selective breeding and mutation breeding.

<span class="mw-page-title-main">Genetically modified crops</span> Plants used in agriculture

Genetically modified crops are plants used in agriculture, the DNA of which has been modified using genetic engineering methods. Plant genomes can be engineered by physical methods or by use of Agrobacterium for the delivery of sequences hosted in T-DNA binary vectors. In most cases, the aim is to introduce a new trait to the plant which does not occur naturally in the species. Examples in food crops include resistance to certain pests, diseases, environmental conditions, reduction of spoilage, resistance to chemical treatments, or improving the nutrient profile of the crop. Examples in non-food crops include production of pharmaceutical agents, biofuels, and other industrially useful goods, as well as for bioremediation.

Since the advent of genetic engineering in the 1970s, concerns have been raised about the dangers of the technology. Laws, regulations, and treaties were created in the years following to contain genetically modified organisms and prevent their escape. Nevertheless, there are several examples of failure to keep GM crops separate from conventional ones.

<span class="mw-page-title-main">Genetically modified food controversies</span>

Genetically modified food controversies are disputes over the use of foods and other goods derived from genetically modified crops instead of conventional crops, and other uses of genetic engineering in food production. The disputes involve consumers, farmers, biotechnology companies, governmental regulators, non-governmental organizations, and scientists. The key areas of controversy related to genetically modified food are whether such food should be labeled, the role of government regulators, the objectivity of scientific research and publication, the effect of genetically modified crops on health and the environment, the effect on pesticide resistance, the impact of such crops for farmers, and the role of the crops in feeding the world population. In addition, products derived from GMO organisms play a role in the production of ethanol fuels and pharmaceuticals.

<span class="mw-page-title-main">Plant Protection Act</span> United States legislation (2000)

The Plant Protection Act (PPA) is a US statute relating to plant pests and noxious weeds introduced in 2000. It is currently codified at 7 U.S.C. 7701 et seq. It consolidates related responsibilities that were previously spread over various legislative statutes, including the Plant Quarantine Act, the Federal Plant Pest Act and the Federal Noxious Weed Act of 1974.

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<span class="mw-page-title-main">Genetically modified soybean</span> Soybean that has had DNA introduced into it using genetic engineering techniques

A genetically modified soybean is a soybean that has had DNA introduced into it using genetic engineering techniques. In 1996, the first genetically modified soybean was introduced to the U.S. by Monsanto. In 2014, 90.7 million hectares of GM soybeans were planted worldwide, making up 82% of the total soybeans cultivation area.

Genetically modified canola is a genetically modified crop. The first strain, Roundup Ready canola, was developed by Monsanto for tolerance to glyphosate, the active ingredient in the commonly used herbicide Roundup.

The Center for Food Safety (CFS) is a 501(c)(3), U.S. non-profit advocacy organization, based in Washington, D.C. It maintains an office in San Francisco, California, and Portland, Oregon. CFS's mission is to empower people, support farmers, and protect the earth from the harmful impacts of industrial agriculture through groundbreaking legal, scientific, and grassroots action. It was founded in 1997.

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Monsanto Co. v. Geertson Seed Farms, 561 U.S. 139 (2010), is a United States Supreme Court case decided 7-1 in favor of Monsanto. The decision allowed Monsanto to sell genetically modified alfalfa seeds to farmers, and allowed farmers to plant them, grow crops, harvest them, and sell the crop into the food supply. The case came about because the use of the seeds was approved by regulatory authorities; the approval was challenged in district court by Geertson Seed Farms and other groups who were concerned that the genetically modified alfalfa would spread too easily, and the challengers won. Monsanto appealed the district court decision and lost, and appealed again to the Supreme Court, where Monsanto won, thus upholding the original approval and allowing the seeds to be sold.

<span class="mw-page-title-main">Regulation of genetic engineering</span>

The regulation of genetic engineering varies widely by country. Countries such as the United States, Canada, Lebanon and Egypt use substantial equivalence as the starting point when assessing safety, while many countries such as those in the European Union, Brazil and China authorize GMO cultivation on a case-by-case basis. Many countries allow the import of GM food with authorization, but either do not allow its cultivation or have provisions for cultivation, but no GM products are yet produced. Most countries that do not allow for GMO cultivation do permit research. Most (85%) of the world's GMO crops are grown in the Americas. One of the key issues concerning regulators is whether GM products should be labeled. Labeling of GMO products in the marketplace is required in 64 countries. Labeling can be mandatory up to a threshold GM content level or voluntary. A study investigating voluntary labeling in South Africa found that 31% of products labeled as GMO-free had a GM content above 1.0%. In Canada and the US labeling of GM food is voluntary, while in Europe all food or feed which contains greater than 0.9% of approved GMOs must be labelled.

Genetic engineering in the European Union has varying degrees of regulation.

<span class="mw-page-title-main">March Against Monsanto</span> International protest movement

The March Against Monsanto was an international grassroots movement and protest against Monsanto, a producer of genetically modified organisms (GMOs) and Roundup, a glyphosate-based herbicide. The movement was founded by Tami Canal in response to the failure of California Proposition 37, a ballot initiative which would have required labeling food products made from GMOs. Advocates support mandatory labeling laws for food made from GMOs.

A genetically modified sugar beet is a sugar beet that has been genetically engineered by the direct modification of its genome using biotechnology. Commercialized GM sugar beets make use of a glyphosate-resistance modification developed by Monsanto and KWS Saat. These glyphosate-resistant beets, also called 'Roundup Ready' sugar beets, were developed by 2000, but not commercialized until 2007. For international trade, sugar beets have a Maximum Residue Limit of glyphosate of 15 mg/Kg at harvest. As of 2016, GMO sugar beets are grown in the United States and Canada. In the United States, they play an important role in domestic sugar production. Studies have concluded the sugar from glyphosate-resistant sugar beets is molecularly identical to and so has the same nutritional value as sugar from conventional (non-GMO) sugar beets.

Genetic engineering in North America is any genetic engineering activities in North America

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