Genetically modified food

Definition

Genetically modified foods, GM foods or genetically engineered foods, are foods produced from organisms that have had changes introduced into their DNA using the methods of genetic engineering as opposed to traditional cross breeding. In the U.S., the Department of Agriculture (USDA) and the Food and Drug Administration (FDA) favor the use of "genetic engineering" over "genetic modification" as the more precise term; the USDA defines genetic modification to include "genetic engineering or other more traditional methods."

According to the World Health Organization, "Genetically modified organisms (GMOs) can be defined as organisms (i.e. plants, animals or microorganisms) in which the genetic material (DNA) has been altered in a way that does not occur naturally by mating and/or natural recombination. The technology is often called 'modern biotechnology' or 'gene technology', sometimes also 'recombinant DNA technology' or 'genetic engineering'. ... Foods produced from or using GM organisms are often referred to as GM foods."

History

Human-directed genetic manipulation of food began with the domestication of plants and animals through artificial selection at about 10,500 to 10,100 BC. The process of selective breeding, in which organisms with desired traits (and thus with the desired genes) are used to breed the next generation and organisms lacking the trait are not bred, is a precursor to the modern concept of genetic modification (GM). With the discovery of DNA in the early 1900s and various advancements in genetic techniques through the 1970s it became possible to directly alter the DNA and genes within food.

The first genetically modified plant was produced in 1983, using an antibiotic-resistant tobacco plant. Genetically modified microbial enzymes were the first application of genetically modified organisms in food production and were approved in 1988 by the US Food and Drug Administration. In the early 1990s, recombinant chymosin was approved for use in several countries. Cheese had typically been made using the enzyme complex rennet that had been extracted from cows' stomach lining. Scientists modified bacteria to produce chymosin, which was also able to clot milk, resulting in cheese curds.

The first genetically modified food approved for release was the Flavr Savr tomato in 1994. Developed by Calgene, it was engineered to have a longer shelf life by inserting an antisense gene that delayed ripening. China was the first country to commercialize a transgenic crop in 1993 with the introduction of virus-resistant tobacco. In 1995, Bacillus thuringiensis (Bt) Potato was approved for cultivation, making it the first pesticide producing crop to be approved in the USA. Other genetically modified crops receiving marketing approval in 1995 were: canola with modified oil composition, Bt maize, cotton resistant to the herbicide bromoxynil, Bt cotton, glyphosate-tolerant soybeans, virus-resistant squash, and another delayed ripening tomato.

With the creation of golden rice in 2000, scientists had genetically modified food to increase its nutrient value for the first time.

By 2010, 29 countries had planted commercialized biotech crops and a further 31 countries had granted regulatory approval for transgenic crops to be imported. The US was the leading country in the production of GM foods in 2011, with twenty-five GM crops having received regulatory approval. In 2015, 92% of corn, 94% of soybeans, and 94% of cotton produced in the US were genetically modified strains.

The first genetically modified animal to be approved for food use was AquAdvantage salmon in 2015. The salmon were transformed with a growth hormone-regulating gene from a Pacific Chinook salmon and a promoter from an ocean pout enabling it to grow year-round instead of only during spring and summer.

In April 2016, a white button mushroom (Agaricus bisporus) modified using the CRISPR technique received de facto approval in the United States, after the USDA said it would not have to go through the agency's regulatory process. The agency considers the mushroom exempt because the editing process did not involve the introduction of foreign DNA.

The most widely planted GMOs are designed to tolerate herbicides. By 2006 some weed populations had evolved to tolerate some of the same herbicides. Palmer amaranth is a weed that competes with cotton. A native of the southwestern US, it traveled east and was first found resistant to glyphosate in 2006, less than 10 years after GM cotton was introduced.

Process

Genetically engineered organisms are generated and tested in the laboratory for desired qualities. The most common modification is to add one or more genes to an organism's genome. Less commonly, genes are removed or their expression is increased or silenced or the number of copies of a gene is increased or decreased.

Once satisfactory strains are produced, the producer applies for regulatory approval to field-test them, called a "field release." Field-testing involves cultivating the plants on farm fields or growing animals in a controlled environment. If these field tests are successful, the producer applies for regulatory approval to grow and market the crop. Once approved, specimens (seeds, cuttings, breeding pairs, etc.) are cultivated and sold to farmers. The farmers cultivate and market the new strain. In some cases, the approval covers marketing but not cultivation.

According to the USDA, the number of field releases for genetically engineered organisms has grown from four in 1985 to an average of about 800 per year. Cumulatively, more than 17,000 releases had been approved through September 2013.

Fruits and vegetables

Papaya was genetically modified to resist the ringspot virus. 'SunUp' is a transgenic red-fleshed Sunset papaya cultivar that is homozygous for the coat protein gene PRSV; 'Rainbow' is a yellow-fleshed F1 hybrid developed by crossing 'SunUp' and nontransgenic yellow-fleshed 'Kapoho'. The New York Times stated, "in the early 1990s, Hawaii’s papaya industry was facing disaster because of the deadly papaya ringspot virus. Its single-handed savior was a breed engineered to be resistant to the virus. Without it, the state’s papaya industry would have collapsed. Today, 80% of Hawaiian papaya is genetically engineered, and there is still no conventional or organic method to control ringspot virus." The GM cultivar was approved in 1998. In China, a transgenic PRSV-resistant papaya was developed by South China Agricultural University and was first approved for commercial planting in 2006; as of 2012 95% of the papaya grown in Guangdong province and 40% of the papaya grown in Hainan province was genetically modified.

The New Leaf potato, a GM food developed using naturally occurring bacteria found in the soil known as Bacillus thuringiensis (Bt), was made to provide in-plant protection from the yield-robbing Colorado potato beetle. The New Leaf potato, brought to market by Monsanto in the late 1990s, was developed for the fast food market. It was withdrawn in 2001 after retailers rejected it and food processors ran into export problems.

As of 2005, about 13% of the Zucchini (a form of squash) grown in the US was genetically modified to resist three viruses; that strain is also grown in Canada.

In 2011, BASF requested the European Food Safety Authority's approval for cultivation and marketing of its Fortuna potato as feed and food. The potato was made resistant to late blight by adding resistant genes blb1 and blb2 that originate from the Mexican wild potato Solanum bulbocastanum. In February 2013, BASF withdrew its application.

In 2013, the USDA approved the import of a GM pineapple that is pink in color and that "overexpresses" a gene derived from tangerines and suppress other genes, increasing production of lycopene. The plant's flowering cycle was changed to provide for more uniform growth and quality. The fruit "does not have the ability to propagate and persist in the environment once they have been harvested," according to USDA APHIS. According to Del Monte's submission, the pineapples are commercially grown in a "monoculture" that prevents seed production, as the plant's flowers aren't exposed to compatible pollen sources. Importation into Hawaii is banned for "plant sanitation" reasons.

In 2014, the USDA approved a genetically modified potato developed by J.R. Simplot Company that contained ten genetic modifications that prevent bruising and produce less acrylamide when fried. The modifications eliminate specific proteins from the potatoes, via RNA interference, rather than introducing novel proteins.

In February 2015 Arctic Apples were approved by the USDA, becoming the first genetically modified apple approved for sale in the US. Gene silencing is used to reduce the expression of polyphenol oxidase (PPO), thus preventing the fruit from browning.

Corn

Corn used for food and ethanol has been genetically modified to tolerate various herbicides and to express a protein from Bacillus thuringiensis (Bt) that kills certain insects. About 90% of the corn grown in the U.S. was genetically modified in 2010. In the US in 2015, 81% of corn acreage contained the Bt trait and 89% of corn acreage contained the glyphosate-tolerant trait. Corn can be processed into grits, meal and flour as an ingredient in pancakes, muffins, doughnuts, breadings and batters, as well as baby foods, meat products, cereals and some fermented products. Corn-based masa flour and masa dough are used in the production of taco shells, corn chips and tortillas.

Soy

Genetically modified soybean has been modified to tolerate herbicides and produce healthier oils. In 2015, 94% of soybean acreage in the U.S. was genetically modified to be glyphosate-tolerant.

Corn starch and starch sugars, including syrups

Starch or amylum is a polysaccharide produced by all green plants as an energy store. Pure starch is a white, tasteless and odourless powder. It consists of two types of molecules: the linear and helical amylose and the branched amylopectin. Depending on the plant, starch generally contains 20 to 25% amylose and 75 to 80% amylopectin by weight.

Starch can be further modified to create modified starch for specific purposes, including creation of many of the sugars in processed foods. They include:

Lecithin

Lecithin is a naturally occurring lipid. It can be found in egg yolks and oil-producing plants. it is an emulsifier and thus is used in many foods. Corn, soy and safflower oil are sources of lecithin, though the majority of lecithin commercially available is derived from soy. Sufficiently processed lecithin is often undetectable with standard testing practices. According to the FDA, no evidence shows or suggests hazard to the public when lecithin is used at common levels. Lecithin added to foods amounts to only 2 to 10 percent of the 1 to 5 g of phosphoglycerides consumed daily on average. Nonetheless, consumer concerns about GM food extend to such products. This concern led to policy and regulatory changes in Europe in 2000, when Regulation (EC) 50/2000 was passed which required labelling of food containing additives derived from GMOs, including lecithin. Because of the difficulty of detecting the origin of derivatives like lecithin with current testing practices, European regulations require those who wish to sell lecithin in Europe to employ a comprehensive system of Identity preservation (IP).

Sugar

The US imports 10% of its sugar, while the remaining 90% is extracted from sugar beet and sugarcane. After deregulation in 2005, glyphosate-resistant sugar beet was extensively adopted in the United States. 95% of beet acres in the US were planted with glyphosate-resistant seed in 2011. GM sugar beets are approved for cultivation in the US, Canada and Japan; the vast majority are grown in the US. GM beets are approved for import and consumption in Australia, Canada, Colombia, EU, Japan, Korea, Mexico, New Zealand, Philippines, Russian Federation and Singapore. Pulp from the refining process is used as animal feed. The sugar produced from GM sugarbeets contains no DNA or protein—it is just sucrose that is chemically indistinguishable from sugar produced from non-GM sugarbeets. Independent analyses conducted by internationally recognized laboratories found that sugar from Roundup Ready sugar beets is identical to the sugar from comparably grown conventional (non-Roundup Ready) sugar beets. And, like all sugar, sugar from Roundup Ready sugar beets contains no genetic material or detectable protein (including the protein that provides glyphosate tolerance).

Vegetable oil

Most vegetable oil used in the US is produced from GM crops canola, corn, cotton and soybeans. Vegetable oil is sold directly to consumers as cooking oil, shortening and margarine and is used in prepared foods. There is a vanishingly small amount of protein or DNA from the original crop in vegetable oil. Vegetable oil is made of triglycerides extracted from plants or seeds and then refined and may be further processed via hydrogenation to turn liquid oils into solids. The refining process removes all, or nearly all non-triglyceride ingredients. Medium-chain triglycerides (MCTs) offer an alternative to conventional fats and oils. The length of a fatty acid influences its fat absorption during the digestive process. Fatty acids in the middle position on the glycerol molecules appear to be absorbed more easily and influence metabolism more than fatty acids on the end positions. Unlike ordinary fats, MCTs are metabolized like carbohydrates. They have exceptional oxidative stability, and prevent foods from turning rancid readily.

Animal feed

Livestock and poultry are raised on animal feed, much of which is composed of the leftovers from processing crops, including GM crops. For example, approximately 43% of a canola seed is oil. What remains after oil extraction is a meal that becomes an ingredient in animal feed and contains canola protein. Likewise, the bulk of the soybean crop is grown for oil and meal. The high-protein defatted and toasted soy meal becomes livestock feed and dog food. 98% of the US soybean crop goes for livestock feed. In 2011, 49% of the US maize harvest was used for livestock feed (including the percentage of waste from distillers grains). "Despite methods that are becoming more and more sensitive, tests have not yet been able to establish a difference in the meat, milk, or eggs of animals depending on the type of feed they are fed. It is impossible to tell if an animal was fed GM soy just by looking at the resulting meat, dairy, or egg products. The only way to verify the presence of GMOs in animal feed is to analyze the origin of the feed itself."

A 2012 literature review of studies evaluating the effect of GM feed on the health of animals did not find evidence that animals were adversely affected, although small biological differences were occasionally found. The studies included in the review ranged from 90 days to two years, with several of the longer studies considering reproductive and intergenerational effects.

Proteins

Rennet is a mixture of enzymes used to coagulate milk into cheese. Originally it was available only from the fourth stomach of calves, and was scarce and expensive, or was available from microbial sources, which often produced unpleasant tastes. Genetic engineering made it possible to extract rennet-producing genes from animal stomachs and insert them into bacteria, fungi or yeasts to make them produce chymosin, the key enzyme. The modified microorganism is killed after fermentation. Chymosin is isolated from the fermentation broth, so that the Fermentation-Produced Chymosin (FPC) used by cheese producers has an amino acid sequence that is identical to bovine rennet. The majority of the applied chymosin is retained in the whey. Trace quantities of chymosin may remain in cheese.

FPC was the first artificially produced enzyme to be approved by the US Food and Drug Administration. FPC products have been on the market since 1990 and as of 2015 had yet to be surpassed in commercial markets. In 1999, about 60% of US hard cheese was made with FPC. Its global market share approached 80%. By 2008, approximately 80% to 90% of commercially made cheeses in the US and Britain were made using FPC.

In some countries, recombinant (GM) bovine somatotropin (also called rBST, or bovine growth hormone or BGH) is approved for administration to increase milk production. rBST may be present in milk from rBST treated cows, but it is destroyed in the digestive system and even if directly injected into the human bloodstream, has no observable effect on humans. The FDA, World Health Organization, American Medical Association, American Dietetic Association and the National Institutes of Health have independently stated that dairy products and meat from rBST-treated cows are safe for human consumption. However, on 30 September 2010, the United States Court of Appeals, Sixth Circuit, analyzing submitted evidence, found a "compositional difference" between milk from rBGH-treated cows and milk from untreated cows. The court stated that milk from rBGH-treated cows has: increased levels of the hormone Insulin-like growth factor 1 (IGF-1); higher fat content and lower protein content when produced at certain points in the cow's lactation cycle; and more somatic cell counts, which may "make the milk turn sour more quickly."

Livestock

Genetically modified livestock are organisms from the group of cattle, sheep, pigs, goats, birds, horses and fish kept for human consumption, whose genetic material (DNA) has been altered using genetic engineering techniques. In some cases, the aim is to introduce a new trait to the animals which does not occur naturally in the species, i.e. transgenesis.

A 2003 review published on behalf of Food Standards Australia New Zealand examined transgenic experimentation on terrestrial livestock species as well as aquatic species such as fish and shellfish. The review examined the molecular techniques used for experimentation as well as techniques for tracing the transgenes in animals and products as well as issues regarding transgene stability.

Some mammals typically used for food production have been modified to produce non-food products, a practice sometimes called Pharming.

Salmon

A GM salmon, awaiting regulatory approval since 1997, was approved for human consumption by the American FDA in November 2015, to be raised in specific land-based hatcheries in Canada and Panama.

Recombinant food-grade organisms for healthcare

The use of genetically modified food-grade organisms as recombinant vaccine expression hosts and delivery vehicles can open new avenues for vaccinology. Considering that oral immunization is a beneficial approach in terms of costs, patient comfort, and protection of mucosal tissues, the use of food-grade organisms can lead to highly advantageous vaccines in terms of costs, easy administration, and safety. The organisms currently used for this purpose are bacteria (Lactobacillus and Bacillus), yeasts, algae, plants, and insect species. Several such organisms are under clinical evaluation, and the current adoption of this technology by the industry indicates a potential to benefit global healthcare systems.

Health and safety

There is a scientific consensus that currently available food derived from GM crops poses no greater risk to human health than conventional food, but that each GM food needs to be tested on a case-by-case basis before introduction. Nonetheless, members of the public are much less likely than scientists to perceive GM foods as safe. The legal and regulatory status of GM foods varies by country, with some nations banning or restricting them, and others permitting them with widely differing degrees of regulation.

Opponents claim that long-term health risks have not been adequately assessed and propose various combinations of additional testing, labeling or removal from the market. The advocacy group European Network of Scientists for Social and Environmental Responsibility (ENSSER), disputes the claim that "science" supports the safety of current GM foods, proposing that each GM food must be judged on case-by-case basis. The Canadian Association of Physicians for the Environment called for removing GM foods from the market pending long term health studies. Multiple disputed studies have claimed health effects relating to GM foods or to the pesticides used with them.

Testing

The legal and regulatory status of GM foods varies by country, with some nations banning or restricting them, and others permitting them with widely differing degrees of regulation. Countries such as the United States, Canada, Lebanon and Egypt use substantial equivalence to determine if further testing is required, while many countries such as those in the European Union, Brazil and China only authorize GMO cultivation on a case-by-case basis. In the U.S. the FDA determined that GMO's are "Generally Recognized as Safe" (GRAS) and therefore do not require additional testing if the GMO product is substantially equivalent to the non-modified product. If new substances are found, further testing may be required to satisfy concerns over potential toxicity, allergenicity, possible gene transfer to humans or genetic outcrossing to other organisms.

Regulation

Government regulation of GMO development and release varies widely between countries. Marked differences separate GMO regulation in the U.S. and GMO regulation in the European Union. Regulation also varies depending on the intended product's use. For example, a crop not intended for food use is generally not reviewed by authorities responsible for food safety.

United States regulations

In the U.S., three government organizations regulate GMOs. The FDA checks the chemical composition of organisms for potential allergens. The United States Department of Agriculture (USDA) supervises field testing and monitors the distribution of GM seeds. The United States Environmental Protection Agency (EPA) is responsible for monitoring pesticide usage, including plants modified to contain proteins toxic to insects. Like USDA, EPA also oversees field testing and the distribution of crops that have had contact with pesticides to ensure environmental safety. In 2015 the Obama administration announced that it would update the way the government regulated GM crops.

In 1992 FDA published "Statement of Policy: Foods derived from New Plant Varieties." This statement is a clarification of FDA's interpretation of the Food, Drug, and Cosmetic Act with respect to foods produced from new plant varieties developed using recombinant deoxyribonucleic acid (rDNA) technology. FDA encouraged developers to consult with the FDA regarding any bioengineered foods in development. The FDA says developers routinely do reach out for consultations. In 1996 FDA updated consultation procedures.

Labeling

As of 2015, 64 countries require labeling of GMO products in the marketplace.

US and Canadian national policy is to require a label only given significant composition differences or documented health impacts, although some individual US states (Vermont, Connecticut and Maine) enacted laws requiring them. In July 2016, Public Law 114-214 was enacted to regulate labeling of GMO food on a national basis.

In some jurisdictions, the labeling requirement depends on the relative quantity of GMO in the product. A study that investigated voluntary labeling in South Africa found that 31% of products labeled as GMO-free had a GM content above 1.0%.

In Europe all food (including processed food) or feed that contains greater than 0.9% GMOs must be labelled.

Detection

Testing on GMOs in food and feed is routinely done using molecular techniques such as PCR and bioinformatics.

In a January 2010 paper, the extraction and detection of DNA along a complete industrial soybean oil processing chain was described to monitor the presence of Roundup Ready (RR) soybean: "The amplification of soybean lectin gene by end-point polymerase chain reaction (PCR) was successfully achieved in all the steps of extraction and refining processes, until the fully refined soybean oil. The amplification of RR soybean by PCR assays using event-specific primers was also achieved for all the extraction and refining steps, except for the intermediate steps of refining (neutralisation, washing and bleaching) possibly due to sample instability. The real-time PCR assays using specific probes confirmed all the results and proved that it is possible to detect and quantify genetically modified organisms in the fully refined soybean oil. To our knowledge, this has never been reported before and represents an important accomplishment regarding the traceability of genetically modified organisms in refined oils."

According to Thomas Redick, detection and prevention of cross-pollination is possible through the suggestions offered by the Farm Service Agency (FSA) and Natural Resources Conservation Service (NRCS). Suggestions include educating farmers on the importance of coexistence, providing farmers with tools and incentives to promote coexistence, conduct research to understand and monitor gene flow, provide assurance of quality and diversity in crops, provide compensation for actual economic losses for farmers.

Controversies

The genetically modified foods controversy consists of a set of disputes over the use of food made from genetically modified crops. The disputes involve consumers, farmers, biotechnology companies, governmental regulators, non-governmental organizations, environmental and political activists and scientists. The major disagreements include whether GM foods can be safely consumed, harm the environment and/or are adequately tested and regulated. The objectivity of scientific research and publications has been challenged. Farming-related disputes include the use and impact of pesticides, seed production and use, side effects on non-GMO crops/farms, and potential control of the GM food supply by seed companies.

The conflicts have continued since GM foods were invented. They have occupied the media, the courts, local, regional and national governments and international organizations.