GMO foods have been available to consumers since the early 1990s. Since then, the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA) have worked together to ensure that crops produced through genetic engineering are safe for people, animals, and the environment.

Despite there being a wide range of foods—GMO and non-GMO—available to consumers, there is some confusion around what GMOs are and how they are used in our food supply.

What makes it a GMO?

A GMO (genetically modified organism) is a plant, animal, or microorganism that has had its genetic material (DNA) changed using technology that generally involves the specific modification of DNA, including the transfer of specific DNA from one organism to another. Scientists often refer to this process as genetic engineering.

Is it called GMO or something else?

"GMO” has become the common term consumers and popular media use to describe foods that have been created through genetic engineering. This term is not generally used to refer to plants or animals developed with selective breeding, like the common garden strawberries available today that were created from a cross between a species native to North America and a species native to South America. While “genetic engineering” is the term typically used by scientists, you will start seeing the “bioengineered” label on some of the foods we eat in the United States because of the new National Bioengineered Food Disclosure Standard.

What GMO crops are out there?

Only a few types of GMO crops are grown in the United States, but some of these GMOs make up a large percentage of the crop grown (e.g., soybeans, corn, sugar beets, canola, and cotton).

In 2018, GMO soybeans made up 94% of all soybeans planted, GMO cotton made up 94% of all cotton planted, and 92% of corn planted was GMO corn.

Most GMO crops are used in food for animals like cows, chickens, and fish. They are also used to make ingredients that are then used in food products like cereal, snack chips, and vegetable oils. Even though you won’t find many GMO fruits or vegetables in the produce section of your grocery store, GMOs are a common part of today’s food supply.

A complete list of GMO crops grown and sold in the United States:

Did you know?

As of 2017, GMO crops are grown in 24 countries around the world, such as Canada, Brazil, the Philippines, and Bangladesh. The approval process for GMO crops varies from country to country, but all regulations are based on the same objective that GMOs should be safe for human and animal health and the environment.

Why do we have GMOs?

Humans have used traditional ways to modify crops and animals to suit their needs and tastes for more than 10,000 years. Cross-breeding, selective breeding, and mutation breeding are examples of traditional ways to make these changes. These breeding methods often involve mixing all of the genes from two different sources. They are used to create common crops like modern corn varieties and seedless watermelon.

Modern technology now allows scientists to use genetic engineering to take just a beneficial gene, like insect resistance or drought tolerance, and transfer it into a plant. The reasons for genetic modification today are similar to what they were thousands of years ago: higher crop yields, less crop loss, longer storage life, better appearance, better nutrition, or some combination of these traits.

Do GMOs affect your health?

GMO foods are as healthful and safe to eat as their non-GMO counterparts. Some GMO plants have actually been modified to improve their nutritional value.

An example is GMO soybeans with healthier oils that can be used to replace oils that contain trans fats. Since GMO foods were introduced in the 1990s, research has shown that they are just as safe as non-GMO foods.

Additionally, research shows that GMO plants fed to farm animals are as safe as non-GMO animal food.

Do GMO plants reduce pesticide use?

Some GMO plants contain plant-incorporated protectants (PIPs) to make them resistant to insects, reducing the need for and use of many spray pesticides. As another safety measure, EPA works with developers and scientists to help develop GMOs that will resist insects for as long as possible through their Insect Resistance Management program. Other GMO plants are developed to tolerate certain weed killers, which allows farmers a wide variety of options for weed control. Some people are concerned that farmers who grow these GMOs will use more weed killer. While this is sometimes the case, EPA regulates the safety of all weed killers that farmers use on GMO crops and non-GMO crops alike. EPA also shares information to help farmers who are concerned about weeds developing resistance to weed killers.

Did you know that in agriculture, genomics enables farmers to accelerate and improve plant and animal breeding practices that have been in use for thousands of years?

The ability to read genome sequences coupled with technologies that introduce new genes or gene changes allows us to speed up the process of selecting desirable traits in plants and animals.

Let's say that you were a farmer thousands of years ago. If you found a couple of plants that were more productive than others, and you needed more food, you might experiment to see if you could combine (breed) those two plants in some way to get better seeds for a better yield in next year's harvest. If you were successful and able to plant those seeds, and then in future generations chose even more productive plants to breed together, over time most of the plants in your field would be even more productive. This is called selective breeding. From Mendel's experiments with peas, we learned that plants have genes that influence their traits such height, seed shape and color. From genome sequencing, we can now find specific variants in those genes that contribute to desirable traits and select for those genomic variants in future crops.

Genome Modification Techniques

The ability to read genome sequences coupled with technologies that introduce new genes or gene changes now allow people to speed up the ability to select for desirable traits in plants and animals. By mimicking natural processes, scientists can selectively add traits like resistance to herbicides in plants. The resulting offspring have been called genetically modified organisms (or GMOs). One example is "Golden Rice," which is a rice strain that has small bits of corn and bacterial DNA added to its genome. These extra genes allow the rice to produce beta carotene (a vitamin A precursor). The lack of vitamin A affects millions in Africa and Asia, causing blindness and immune system deficiencies.

Those who developed Golden Rice see it as a potential tool for fighting vitamin A deficiency and saving lives. In 2015, they were given the "Patents for Humanity" award by the U.S. government. However, as with other GMOs, there are practical hurdles and societal controversies that have prevented its widespread uptake. Golden Rice has not yet reached the yields of conventional rice in many of its field trials, posing a financial barrier for farmers who might want to switch. At the same time, protesters who do not believe that GMOs are safe for humans have vandalized some of the field trials. Many studies have shown that consuming GMO plants does not pose any more risk to humans than eating non-GMO plants, but the controversy continues in many countries.

Genome Sequencing for Better Breeding

Genome sequencing is also now used in cattle farming and with other animals, adding speed and precision to selective breeding methods. In Brazil, scientists are using genomics to characterize specific sequences in hundreds of bulls at a time, allowing them to select for increased meat production and use of pasture feeding (to avoid grain supplementation). They hope that this will lead to animals that grow faster and convert grass to meat in a more sustainable manner over time.

As the human population on earth grows, so too does the need for secure food supplies and delivery to billions of people. World hunger had been on the decline, but it is now on the rise. To meet these demands, farmers will continue to incorporate genomic technologies into their practices, whether through genome monitoring during conventional breeding or genomic modifications with older or newer technologies, like CRISPR/Cas. At the same time, scientists will continue to sequence the genomes of more and more crops, teaching us about differences among them related to their DNA.

One of the most important agricultural advances in the 20th century has been the ability to move food around the globe to people who need it. Unfortunately, food supplies sometimes have unwanted guests along for the ride, such as bacterial pathogens. When people eat the contaminated food, they can get very sick or even die, so it's important to find the pathogens and eliminate them. The U.S. Food and Drug Administration (FDA) has an entire network set up for whole genome sequencing of bacterial contaminants in food, called GenomeTrakr. In 2017, this database had over 5800 bacterial sequences added on average each month, as scientists tracked new outbreaks in the quest to keep our food safe. FDA scientists work closely with others from the U.S. Centers for Disease Control and Prevention, the U.S. Department of Agriculture's Food Safety and Inspection Service, and state health departments to identify bacteria that might cause outbreaks from food contamination. Rounding out this network, the National Center for Biotechnology Information keeps track of what foods are linked to each incident, as well as in human patients who got sick. These information sources have been crucial for lowering the impact of foodborne illnesses over time.

Am I eating foods that come from GMO crops?

It is very likely you are eating foods and food products that are made with ingredients that come from GMO crops. Many GMO crops are used to make ingredients that Americans eat such as cornstarch, corn syrup, corn oil, soybean oil, canola oil, or granulated sugar. A few fresh fruits and vegetables are available in GMO varieties, including potatoes, summer squash, apples, and papayas. Although GMOs are in a lot of the foods we eat, most of the GMO crops grown in the United States are used for animal food.

To make it easier for consumers to know if the foods they eat contain GMO ingredients, the U.S. Department of Agriculture maintains a list of bioengineered foods available throughout the world. Additionally, you will start seeing the “bioengineered” label on some of the foods we eat because of the new National Bioengineered Food Disclosure Standard.

What GMO crops are grown and sold in the United States?

Only a few types of GMO crops are grown in the United States, but some of these GMOs make up a large percentage of the crop grown (e.g., soybeans, corn, sugar beets, canola, and cotton).

In 2018, GMO soybeans made up 94% of all soybeans planted, GMO cotton made up 94% of all cotton planted, and 92% of corn planted was GMO corn.

In 2013, GMO canola made up 95% of canola planted while GMO sugar beets made up 99.9% of all sugar beets harvested.

Most GMO plants are used to make ingredients that are then used in other food products, for example, cornstarch made from GMO corn or sugar made from GMO sugar beets.

Corn:

Corn is the most commonly grown crop in the United States, and most of it is GMO. Most GMO corn is created to resist insect pests or tolerate herbicides. Bacillus thuringiensis (Bt) corn is a GMO corn that produces proteins that are toxic to certain insect pests but not to humans, pets, livestock, or other animals. These are the same types of proteins that organic farmers use to control insect pests, and they do not harm other, beneficial insects such as ladybugs. GMO Bt corn reduces the need for spraying insecticides while still preventing insect damage. While a lot of GMO corn goes into processed foods and drinks, most of it is used to feed livestock, like cows, and poultry, like chickens.

Soybean:

Most soy grown in the United States is GMO soy. Most GMO soy is used for food for animals, predominantly poultry and livestock, and making soybean oil. It is also used as ingredients (lecithin, emulsifiers, and proteins) in processed foods.

Cotton:

GMO cotton was created to be resistant to bollworms and helped revive the Alabama cotton industry. GMO cotton not only provides a reliable source of cotton for the textile industry, it is also used to make cottonseed oil, which is used in packaged foods and in many restaurants for frying. GMO cottonseed meal and hulls are also used in food for animals.

Potato:

Some GMO potatoes were developed to resist insect pests and disease. In addition, some GMO potato varieties have been developed to resist bruising and browning that can occur when potatoes are packaged, stored, and transported, or even cut in your kitchen. While browning does not change the quality of the potato, it often leads to food being unnecessarily thrown away because people mistakenly believe browned food is spoiled.

Papaya:

By the 1990s, ringspot virus disease had nearly wiped out Hawaii’s papaya crop, and in the process almost destroyed the papaya industry in Hawaii. A GMO papaya, named the Rainbow papaya, was created to resist ringspot virus. This GMO saved papaya farming on the Hawaiian Islands.

Summer Squash:

GMO summer squash is resistant to some plant viruses. Squash was one of the first GMOs on the market, but it is not widely grown.

Canola:

GMO canola is used mostly to make cooking oil and margarine. Canola seed meal can also be used in food for animals. Canola oil is used in many packaged foods to improve food consistency. Most GMO canola is resistant to herbicides and helps farmers to more easily control weeds in their fields.

Alfalfa:

GMO alfalfa is primarily used to feed cattle—mostly dairy cows. Most GMO alfalfa is resistant to herbicides, allowing farmers to spray the crops to protect them against destructive weeds that can reduce alfalfa production and lower the nutritional quality of the hay.

Apple:

A few varieties of GMO apples were developed to resist browning after being cut. This helps cut down on food waste, as many consumers think brown apples are spoiled.

Sugar Beet:

Sugar beets are used to make granulated sugar. More than half the granulated sugar packaged for grocery store shelves is made from GMO sugar beets. Because GMO sugar beets are resistant to herbicides, growing GMO sugar beets helps farmers control weeds in their fields.

What about animals that eat food made from GMO crops?

More than 95% of animals used for meat and dairy in the United States eat GMO crops. Independent studies show that there is no difference in how GMO and non-GMO foods affect the health and safety of animals. The DNA in the GMO food does not transfer to the animal that eats it. This means that animals that eat GMO food do not turn into GMOs. If it did, an animal would have the DNA of any food it ate, GMO or not. In other words, cows do not become the grass they eat and chickens don’t become the corn they eat.

Similarly, the DNA from GMO animal food does not make it into the meat, eggs, or milk from the animal. Research shows that foods like eggs, dairy products, and meat that come from animals that eat GMO food are equal in nutritional value, safety, and quality to foods made from animals that eat only non-GMO food.

Who makes sure animal food is safe?

The U.S. Food and Drug Administration (FDA) is the primary regulatory agency responsible for ensuring the safety of GMO and non-GMO food for animals. The FDA Center for Veterinary Medicine manages this responsibility. FDA requires that all food for animals, like food for human foods, be safe for animals to eat, be produced under clean conditions, contain no harmful substances, and be accurately labeled.

Are there GMO animals in the food supply?

There soon will be. FDA has approved an application that allows the marketing of the AquAdvantage Salmon, an Atlantic salmon that has been genetically modified to reach an important growth point faster. FDA determined that AquAdvantage Salmon is as safe to eat and as nutritious as non-GMO Atlantic salmon. FDA also found that its approval of the application for this salmon would not significantly impact the U.S. environment.

Are GMOs used to make anything besides food?

When you hear the term “GMO” you probably think of food. However, techniques used to create GMOs are important in creating some medicines as well. In fact, genetic engineering, which is the process used to create GMOs, was first used to make human insulin, a medicine used to treat diabetes. Medicines developed through genetic engineering go through an in-depth FDA approval process. All medicines must be proven to be safe and effective before they are approved for human use. GMOs are also used in the textile industry. Some GMO cotton plants are used to create cotton fiber that is then used to make fabric for clothing and other materials.

Traditional Crop Modification

Traditional methods of modifying plants, like selective breeding and crossbreeding, have been around for nearly 10,000 years. Most of the foods we eat today were originally created using a combination of traditional methods.

Genetic Engineering

Genetic engineering is a method that, among other things, enables scientists to copy a gene with a desired trait in one organism and put it into another. Genetic engineering has been used since the 1970s and builds on the scientific advances we have made in the study of DNA.

Genome Editing

Genome editing is a new method that gives scientists more precise and targeted ways to develop new crop varieties. Genome editing tools can make it easier and quicker to make changes that were previously done through traditional breeding.

Many people wonder what impacts GMO crops have on our world. “GMO” (genetically modified organism) is the common term consumers and popular media use to describe a plant, animal, or microorganism that has had its genetic material (DNA) changed using technology that generally involves the specific modification of DNA, including the transfer of specific DNA from one organism to another. Scientists often refer to this process as genetic engineering. Since the first genetically engineered crops, or GMOs, for sale to consumers were planted in the 1990s, researchers have tracked their impacts on and off the farm.

Why do farmers use GMO crops?

Most of the GMO crops grown today were developed to help farmers prevent crop loss. The three most common traits found in GMO crops are:

• Resistance to insect damage
• Tolerance to herbicides
• Resistance to plant viruses

For GMO crops that are resistant to insect damage, farmers can apply fewer spray pesticides to protect the crops. GMO crops that are tolerant to herbicides help farmers control weeds without damaging the crops. When farmers use these herbicide-tolerant crops they do not need to till the soil, which they normally do to get rid of weeds. This no-till planting helps to maintain soil health and lower fuel and labor use. Taken together, studies have shown positive economic and environmental impacts.

The GMO papaya, called the Rainbow papaya, is an example of a GMO crop developed to be resistant to a virus. When the ringspot virus threatened the Hawaii papaya industry and the livelihoods of Hawaiian papaya farmers, plant scientists developed the ringspot virus-resistant Rainbow papaya. The Rainbow papaya was commercially planted in 1998, and today it is grown all over Hawaii and exported to Japan.

Do GMOs have impacts beyond the farm?

The most common GMO crops were developed to address the needs of farmers, but in turn they can help foods become more accessible and affordable for consumers. Some GMO crops were developed specifically to benefit consumers. For example, a GMO soybean that is used to create a healthier oil is commercially grown and available. GMO apples that do not brown when cut are now available for sale and may help reduce food waste. Plant scientists continue to develop GMO crops that they hope will benefit consumers.

Do GMOs have impacts outside the United States?

GMOs also impact the lives of farmers in other parts of the world. The U.S. Agency for International Development (USAID) is working with partner countries to use genetic engineering to improve staple crops, the basic foods that make up a large portion of people’s diets. For example, a GMO eggplant developed to be insect resistant has been slowly released to farmers in Bangladesh since 2014. Farmers who grow GMO eggplants are earning more and have less exposure to pesticides. USAID is also working with partner countries in Africa and elsewhere on several staple crops, such as virus-resistant cassava, insect-resistant cowpea, and blight-resistant potato.

How has genetic engineering changed plant and animal breeding?

For thousands of years, humans have been using traditional modification methods like selective breeding and cross-breeding to breed plants and animals with more desirable traits. For example, early farmers developed cross-breeding methods to grow corn with a range of colors, sizes, and uses. Today’s strawberries are a cross between a strawberry species native to North America and a strawberry species native to South America.

Most of the foods we eat today were created through traditional breeding methods. But changing plants and animals through traditional breeding can take a long time, and it is difficult to make very specific changes. After scientists developed genetic engineering in the 1970s, they were able to make similar changes in a more specific way and in a shorter amount of time.

A Timeline of Genetic Modification in Agriculture

Circa 8000 BCE: Humans use traditional modification methods like selective breeding and cross-breeding to breed plants and animals with more desirable traits.

1866: Gregor Mendel, an Austrian monk, breeds two different types of peas and identifies the basic process of genetics.

1922: The first hybrid corn is produced and sold commercially.

1940: Plant breeders learn to use radiation or chemicals to randomly change an organism’s DNA.

1953: Building on the discoveries of chemist Rosalind Franklin, scientists James Watson and Francis Crick identify the structure of DNA.

1973: Biochemists Herbert Boyer and Stanley Cohen develop genetic engineering by inserting DNA from one bacteria into another.

1982: FDA approves the first consumer GMO product developed through genetic engineering: human insulin to treat diabetes.

1986: The federal government establishes the Coordinated Framework for the Regulation of Biotechnology. This policy describes how the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA) work together to regulate the safety of GMOs.

1992: FDA policy states that foods from GMO plants must meet the same requirements, including the same safety standards, as foods derived from traditionally bred plants.

1994: The first GMO produce created through genetic engineering—a GMO tomato—becomes available for sale after studies evaluated by federal agencies proved it to be as safe as traditionally bred tomatoes.

1990s: The first wave of GMO produce created through genetic engineering becomes available to consumers: summer squash, soybeans, cotton, corn, papayas, tomatoes, potatoes, and canola. Not all are still available for sale.

2003: The World Health Organization (WHO) and the Food and Agriculture Organization (FAO) of the United Nations develop international guidelines and standards to determine the safety of GMO foods.

2005: GMO alfalfa and sugar beets are available for sale in the United States.

2015: FDA approves an application for the first genetic modification in an animal for use as food, a genetically engineered salmon.

2016: Congress passes a law requiring labeling for some foods produced through genetic engineering and uses the term “bioengineered,” which will start to appear on some foods.

2017: GMO apples are available for sale in the U.S.

2019: FDA completes consultation on first food from a genome edited plant.

2020: GMO pink pineapple is available to U.S. consumers.

2020: Application for GalSafe pig was approved.

How are GMOs made?

“GMO” (genetically modified organism) has become the common term consumers and popular media use to describe foods that have been created through genetic engineering. Genetic engineering is a process that involves:

• Identifying the genetic information—or “gene”—that gives an organism (plant, animal, or microorganism) a desired trait
• Copying that information from the organism that has the trait
• Inserting that information into the DNA of another organism
• Then growing the new organism

Making a GMO Plant, Step by Step

The following example gives a general idea of the steps it takes to create a GMO plant. This example uses a type of insect-resistant corn called “Bt corn.” Keep in mind that the processes for creating a GMO plant, animal, or microorganism may be different.

The entire process of bringing a GMO plant to the marketplace takes several years.

What are the latest scientific advances in plant and animal breeding?

Scientists are developing new ways to create new varieties of crops and animals using a process called genome editing. These techniques can make changes more quickly and precisely than traditional breeding methods.

There are several genome editing tools, such as CRISPR. Scientists can use these newer genome editing tools to make crops more nutritious, drought tolerant, and resistant to insect pests and diseases.

Foods derived from new plant varieties developed using genetic engineering or genome editing are often referred to as “GMOs” (Genetically Modified Organisms) or as “bioengineered.” Although genetic engineering of plants began in the 1980s, there is a fair amount of confusion about how foods derived from these techniques — as well as from the more recent technique of genome editing — compare to foods from traditionally bred plants.

Science Q & A

Why do plant breeders use genetic engineering and genome editing over traditional breeding methods?

Plant breeders produce new plant varieties using genetic engineering and genome editing for many of the same reasons traditional breeding methods are used. For example, new varieties may be produced to resist insect pests, provide easier weed control for farmers, improve the nutritional profile of food and provide for flexibility in how foods are used (e.g., non-browning potatoes and apples).

Genetic engineering and genome editing are plant breeding processes that allow plant breeders to introduce desirable characteristics to an organism through genetic modification techniques that utilize modern biotechnology. Compared to traditional plant breeding practices, genetic engineering and genome editing tools provide plant breeders with greater specificity when modifying the characteristics of plants. Genome editing allows scientists to make changes at precise locations in the DNA of a plant, animal or other living organism. In addition, results that could take decades to achieve with traditional breeding methods, could take just a few years with genetic engineering and genome editing.

How are plants genetically engineered?

Genetic engineering copies a gene or genes from an organism with a desired trait and adds the gene or genes to a single plant cell in a laboratory. A new plant is generated from the plant cell containing the added DNA. By narrowing the introduction to only the desired genes from the donor organism, scientists can eliminate unwanted characteristics from the donor’s other genes that may be transferred to the new variety if traditional breeding techniques had been used. For instance, traditional breeding techniques include repeatedly cross-pollinating plants until the breeder identifies offspring with the desired combination of traits. During this breeding process a number of genes are introduced into the plant. These genes may include the gene responsible for the desired trait, as well as genes responsible for unwanted characteristics. The precision of genetic engineering allows developers to add only the gene of interest.

What is the difference between genetic engineering and genome editing?

“Genome editing” is a relatively new set of technologies that enable one to make precise changes in the DNA of a plant, animal or other living organism. The changes possible with genome editing may be as precise as a targeted single base-pair change in the plant’s DNA. The genetic engineering techniques currently in use do not enable genetic changes to be targeted to specific locations in the plant genome like genome editing techniques do.

What foods are made from genetically engineered plants?

Foods from GE plants were first introduced into our food supply in the 1990s. The majority of genetically engineered plants - corn, canola, soybean, and cotton - are typically used to make ingredients that are then used in other food products. Such ingredients include cornstarch in soups and sauces, corn syrup as a general-purpose sweetener, and cottonseed oil, canola oil, and soybean oil in mayonnaise, salad dressings, cereals, breads, and snack foods. There are also genetically engineered varieties of potatoes, summer squash, apples, papaya, alfalfa and sugar beets.

How long have foods from genetically engineered plants been on the market?

Foods from genetically engineered plants have been on the market for more than twenty-five years. The first food from a genetically engineered plant was marketed in 1994. The food was a tomato called the FLAVR-SAVR tomato. Since then genetically engineered varieties of corn, cotton, canola, soybeans, sugar beets, apples, potatoes, summer squash, alfalfa and papaya have been marketed.

Safety Q & A

Are foods from genetically engineered plants safe to eat?

Yes. Foods marketed from genetically engineered plants must meet the same requirements, including safety requirements, as foods from traditionally bred plants. Foods from genetically engineered plants intended to be sold in the United States that have been evaluated by the FDA through a voluntary consultation process have not gone on the market until the FDA’s questions about the safety of such products have been resolved.

Are foods from genetically engineered plants more likely to (1) cause an allergic reaction or (2) be toxic?

No. The foods we have evaluated through the consultation process have not been more likely to cause an allergic or toxic reaction than foods from traditionally bred plants. When new genetic traits are introduced into plants, the developer evaluates whether any new material could be (1) allergenic or (2) toxic if consumed in foods made from the plant.

Are there long-term health effects of foods from genetically engineered plants?

No. Any long-term health effects of consuming food from genetically engineered plants would be no different than those associated with consuming foods from similar traditionally-bred plants. A 2016 report from the National Academies of Sciences, Engineering and Medicine analyzed health and safety data on food from genetically engineered plants. The report concluded that the health and safety data do not indicate a higher risk to human health from genetically engineered foods compared to their non-genetically engineered counterparts. For a summary of the report, please visit the National Academies of Sciences website.

Are foods from genetically engineered plants less nutritious than comparable foods?

No. Nutritional assessments for foods from genetically engineered plants that have been evaluated through the FDA’s plant biotechnology consultation process have shown that foods from genetically engineered plants are as nutritious as foods from comparable traditionally bred plants.

How is the safety of genetically engineered plants evaluated by FDA?

Evaluating the safety of food from a genetically engineered plant is a comprehensive process that includes several steps. Generally, the developer identifies the distinguishing attributes of new genetic traits and assesses whether any new material that a person consumes in food made from the genetically engineered plants could be toxic or allergenic. The developer also compares the levels of nutrients in the food from the new genetically engineered plant to those in comparable traditionally bred plants. This analysis typically includes such components as fiber, protein, fat, vitamins, and minerals.

Developers of genetically engineered plants have routinely voluntarily consulted with the FDA about the safety of foods from their new varieties prior to them entering the marketplace. The consultation process helps to ensure that all safety and regulatory questions are resolved prior to marketing. The FDA has been using this process for more than 25 years to help ensure the safety of foods from genetically engineered plants. As of 2020, the FDA has completed consultations on more than 180 genetically engineered plant varieties.

Regulatory Q & A

How are genetically engineered foods regulated by the FDA?

The FDA regulates the safety of foods and food products from plants. Foods from new plant varieties derived from traditional breeding practices, genetic engineering, or genome editing, must meet the same legal requirements that apply to all foods. To help ensure that firms are meeting their obligation to market only safe and lawful foods, the FDA encourages developers of new plant varieties to voluntarily consult with the agency before marketing their products. This process helps developers determine the necessary steps to ensure their food products are safe and lawful and to ensure that any safety or other regulatory issues related to a food product are resolved before commercial distribution. For more information, please visit: Consultation Programs on Food from New Plant Varieties.

How are genetically engineered foods regulated by the U.S. Government overall?

The FDA regulates the safety of foods and food products from new plant varieties in conjunction with the U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA). The FDA enforces the U.S. food safety laws that prohibit unsafe food. Foods from new plant varieties must meet the same safety and legal requirements that apply to all food. The USDA’s Animal and Plant Health Inspection Service (APHIS) regulates the introduction of certain genetically engineered organisms that may pose a risk to plant health. The EPA regulates pesticides, including those genetically engineered into food crops, to make sure that pesticides are safe for human and animal consumption and won’t harm the environment.

For more information, please visit:

• Unified Website for Biotechnology Regulation
• EPA’s Biopesticides
• USDA’s Biotechnology Regulatory Services

Are foods from genetically engineered plants required to have certain labels?

In 2016, Congress passed the National Bioengineered Food Disclosure Law. This law directs the USDA to establish a national mandatory standard for disclosing foods that are bioengineered. To learn more, please visit the BE Disclosure page on USDA’s website.

1. What is Agricultural Biotechnology?

Agricultural biotechnology is a range of tools, including traditional breeding techniques, that alter living organisms, or parts of organisms, to make or modify products; improve plants or animals; or develop microorganisms for specific agricultural uses. Modern biotechnology today includes the tools of genetic engineering.

2. How is Agricultural Biotechnology being used?

Biotechnology provides farmers with tools that can make production cheaper and more manageable. For example, some biotechnology crops can be engineered to tolerate specific herbicides, which make weed control simpler and more efficient. Other crops have been engineered to be resistant to specific plant diseases and insect pests, which can make pest control more reliable and effective, and/or can decrease the use of synthetic pesticides. These crop production options can help countries keep pace with demands for food while reducing production costs. A number of biotechnology-derived crops that have been deregulated by the USDA and reviewed for food safety by the Food and Drug Administration (FDA) and/or the Environmental Protection Agency (EPA) have been adopted by growers.

Many other types of crops are now in the research and development stages. While it is not possible to know exactly which will come to fruition, certainly biotechnology will have highly varied uses for agriculture in the future. Advances in biotechnology may provide consumers with foods that are nutritionally-enriched or longer-lasting, or that contain lower levels of certain naturally occurring toxicants present in some food plants. Developers are using biotechnology to try to reduce saturated fats in cooking oils, reduce allergens in foods, and increase disease-fighting nutrients in foods. They are also researching ways to use genetically engineered crops in the production of new medicines, which may lead to a new plant-made pharmaceutical industry that could reduce the costs of production using a sustainable resource.

Genetically engineered plants are also being developed for a purpose known as phytoremediation in which the plants detoxify pollutants in the soil or absorb and accumulate polluting substances out of the soil so that the plants may be harvested and disposed of safely. In either case the result is improved soil quality at a polluted site. Biotechnology may also be used to conserve natural resources, enable animals to more effectively use nutrients present in feed, decrease nutrient runoff into rivers and bays, and help meet the increasing world food and land demands. Researchers are at work to produce hardier crops that will flourish in even the harshest environments and that will require less fuel, labor, fertilizer, and water, helping to decrease the pressures on land and wildlife habitats.

In addition to genetically engineered crops, biotechnology has helped make other improvements in agriculture not involving plants. Examples of such advances include making antibiotic production more efficient through microbial fermentation and producing new animal vaccines through genetic engineering for diseases such as foot and mouth disease and rabies.

3. What are the benefits of Agricultural Biotechnology?

The application of biotechnology in agriculture has resulted in benefits to farmers, producers, and consumers. Biotechnology has helped to make both insect pest control and weed management safer and easier while safeguarding crops against disease.

For example, genetically engineered insect-resistant cotton has allowed for a significant reduction in the use of persistent, synthetic pesticides that may contaminate groundwater and the environment.

In terms of improved weed control, herbicide-tolerant soybeans, cotton, and corn enable the use of reduced-risk herbicides that break down more quickly in soil and are non-toxic to wildlife and humans. Herbicide-tolerant crops are particularly compatible with no-till or reduced tillage agriculture systems that help preserve topsoil from erosion.

Agricultural biotechnology has been used to protect crops from devastating diseases. The papaya ringspot virus threatened to derail the Hawaiian papaya industry until papayas resistant to the disease were developed through genetic engineering. This saved the U.S. papaya industry. Research on potatoes, squash, tomatoes, and other crops continues in a similar manner to provide resistance to viral diseases that otherwise are very difficult to control.

Biotech crops can make farming more profitable by increasing crop quality and may in some cases increase yields. The use of some of these crops can simplify work and improve safety for farmers. This allows farmers to spend less of their time managing their crops and more time on other profitable activities.

Biotech crops may provide enhanced quality traits such as increased levels of beta-carotene in rice to aid in reducing vitamin A deficiencies and improved oil compositions in canola, soybean, and corn. Crops with the ability to grow in salty soils or better withstand drought conditions are also in the works and the first such products are just entering the marketplace. Such innovations may be increasingly important in adapting to or in some cases helping to mitigate the effects of climate change.

The tools of agricultural biotechnology have been invaluable for researchers in helping to understand the basic biology of living organisms. For example, scientists have identified the complete genetic structure of several strains of Listeria and Campylobacter, the bacteria often responsible for major outbreaks of food-borne illness in people. This genetic information is providing a wealth of opportunities that help researchers improve the safety of our food supply. The tools of biotechnology have "unlocked doors" and are also helping in the development of improved animal and plant varieties, both those produced by conventional means as well as those produced through genetic engineering.

4. What are the safety considerations with Agricultural Biotechnology?

Breeders have been evaluating new products developed through agricultural biotechnology for centuries. In addition to these efforts, the United States Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA) work to ensure that crops produced through genetic engineering for commercial use are properly tested and studied to make sure they pose no significant risk to consumers or the environment.

Crops produced through genetic engineering are the only ones formally reviewed to assess the potential for transfer of novel traits to wild relatives. When new traits are genetically engineered into a crop, the new plants are evaluated to ensure that they do not have characteristics of weeds. Where biotech crops are grown in proximity to related plants, the potential for the two plants to exchange traits via pollen must be evaluated before release. Crop plants of all kinds can exchange traits with their close wild relatives (which may be weeds or wildflowers) when they are in proximity. In the case of biotech-derived crops, the EPA and USDA perform risk assessments to evaluate this possibility and minimize potential harmful consequences, if any.

Other potential risks considered in the assessment of genetically engineered organisms include any environmental effects on birds, mammals, insects, worms, and other organisms, especially in the case of insect or disease resistance traits. This is why the USDA's Animal and Plant Health Inspection Service (APHIS) and the EPA review any environmental impacts of such pest-resistant biotechnology derived crops prior to approval of field-testing and commercial release. Testing on many types of organisms such as honeybees, other beneficial insects, earthworms, and fish is performed to ensure that there are no unintended consequences associated with these crops.

With respect to food safety, when new traits introduced to biotech-derived plants are examined by the EPA and the FDA, the proteins produced by these traits are studied for their potential toxicity and potential to cause an allergic response. Tests designed to examine the heat and digestive stability of these proteins, as well as their similarity to known allergenic proteins, are completed prior to entry into the food or feed supply. To put these considerations in perspective, it is useful to note that while the particular biotech traits being used are often new to crops in that they often do not come from plants (many are from bacteria and viruses), the same basic types of traits often can be found naturally in most plants. These basic traits, like insect and disease resistance, have allowed plants to survive and evolve over time.

5. How widely used are biotechnology crops?

According to the USDA's National Agricultural Statistics Service (NASS), biotechnology plantings as a percentage of total crop plantings in the United States in 2012 were about 88 percent for corn, 94 percent for cotton, and 93 percent for soybeans. NASS conducts an agricultural survey in all states in June of each year. The report issued from the survey contains a section specific to the major biotechnology derived field crops and provides additional detail on biotechnology plantings. The most recent report may be viewed at the following website: https://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us.aspx

For a summary of these data, see the USDA Economic Research Service data feature at: https://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us.aspx

The USDA does not maintain data on international usage of genetically engineered crops. The independent International Service for the Acquisition of Agri-biotech Applications (ISAAA), a not-for-profit organization, estimates that the global area of biotech crops for 2012 was 170.3 million hectares, grown by 17.3 million farmers in 28 countries, with an average annual growth in area cultivated of around 6 percent. More than 90 percent of farmers growing biotech crops are resource-poor farmers in developing countries. ISAAA reports various statistics on the global adoption and plantings of biotechnology derived crops. The ISAAA website is https://www.isaaa.org

Note: These terms and definitions are intended for general educational purposes only. They are not intended to replace any definitions currently in use in any U.S. Government laws or regulations, nor are they legally binding on the actions of any Government agency. For specific definitions that apply to any law or regulation of any Government agency, please consult directly with that agency.

Agricultural Biotechnology: A range of tools, including traditional breeding techniques, that alter living organisms, or parts of organisms, to make or modify products; improve plants or animals; or develop microorganisms for specific agricultural uses. Modern biotechnology today includes the tools of genetic engineering.

Allergen: A substance, usually a protein, that can cause an allergy or allergic reaction in the body.

Allergy: A reaction by the body's immune system after exposure to a particular substance, often a protein.

Bacillus thuringiensis (Bt): A soil bacterium that produces toxins that are deadly to some pests. The ability to produce Bt toxins has been engineered into some crops. See Bt crops.

Biopharming: The production of pharmaceuticals such as edible vaccines and antibodies in plants or domestic animals.

Bt crops: Crops that are genetically engineered to carry a gene from the soil bacterium Bacillus thuringiensis (Bt). The bacterium produces proteins that are toxic to some pests but non-toxic to humans and other mammals. Crops containing the Bt gene are able to produce this toxin, thereby providing protection for the plant. Bt corn and Bt cotton are examples of commercially available Bt crops.

Chromosome: The self-replicating genetic structure of cells, containing genes, which determines inheritance of traits. Chemically, each chromosome is composed of proteins and a long molecule of DNA.

Clone: A genetic replica of an organism created without sexual reproduction.

Cross-pollination: Fertilization of a plant with pollen from another plant. Pollen may be transferred by wind, insects, other organisms, or humans.

DNA (deoxyribonucleic acid): The chemical substance from which genes are made. DNA is a long, double-stranded helical molecule made up of nucleotides which are themselves composed of sugars, phosphates, and derivatives of the four bases adenine (A), guanine (G), cytosine (C), and thymine (T). The sequence order of the four bases in the DNA strands determines the genetic information contained.

Enzyme-linked immunosorbent assay (ELISA): A technique using antibodies for detecting specific proteins. Used to test for the presence of a particular genetically engineered organism.

Field trial: A test of a new technique or variety, including biotech-derived varieties, done outside the laboratory but with specific requirements on location, plot size, methodology, etc.

Gene: The fundamental physical and functional unit of heredity. A gene is typically a specific segment of a chromosome and encodes a specific functional product (such as a protein or RNA molecule).

Gene expression: The result of the activity of a gene or genes which influence the biochemistry and physiology of an organism and may change its outward appearance.

Gene flow: The movement of genes from one individual or population to another genetically compatible individual or population.

Gene mapping: Determining the relative physical locations of genes on a chromosome. Useful for plant and animal breeding.

Gene (DNA) sequencing: Determining the exact sequence of nucleotide bases in a strand of DNA to better understand the behavior of a gene.

Genetic engineering: Manipulation of an organism's genes by introducing, eliminating or rearranging specific genes using the methods of modern molecular biology, particularly those techniques referred to as recombinant DNA techniques.

Genetically engineered organism (GEO): An organism produced through genetic engineering.

Genetic modification: The production of heritable improvements in plants or animals for specific uses, via either genetic engineering or other more traditional methods. Some countries other than the United States use this term to refer specifically to genetic engineering.

Genetically modified organism (GMO): An organism produced through genetic modification.

Genetics: The study of the patterns of inheritance of specific traits.

Genome: All the genetic material in all the chromosomes of a particular organism.

Genomics: The mapping and sequencing of genetic material in the DNA of a particular organism as well as the use of that information to better understand what genes do, how they are controlled, how they work together, and what their physical locations are on the chromosome.

Genomic library: A collection of biomolecules made from DNA fragments of a genome that represent the genetic information of an organism that can be propagated and then systematically screened for particular properties. The DNA may be derived from the genomic DNA of an organism or from DNA copies made from messenger RNA molecules. A computer-based collection of genetic information from these biomolecules can be a "virtual genomic library."

Genotype: The genetic identity of an individual. Genotype often is evident by outward characteristics, but may also be reflected in more subtle biochemical ways not visually evident.

Herbicide-tolerant crops: Crops that have been developed to survive application(s) of particular herbicides by the incorporation of certain gene(s) either through genetic engineering or traditional breeding methods. The genes allow the herbicides to be applied to the crop to provide effective weed control without damaging the crop itself.

Hybrid: The offspring of any cross between two organisms of different genotypes.

Identity preservation: The segregation of one crop type from another at every stage from production and processing to distribution. This process is usually performed through audits and site visits and provides independent third-party verification of the segregation.

Insecticide resistance: The development or selection of heritable traits (genes) in an insect population that allow individuals expressing the trait to survive in the presence of levels of an insecticide (biological or chemical control agent) that would otherwise debilitate or kill this species of insect. The presence of such resistant insects makes the insecticide less useful for managing pest populations.

Insect-resistance management: A strategy for delaying the development of pesticide resistance by maintaining a portion of the pest population in a refuge that is free from contact with the insecticide. For Bt crops this allows the insects feeding on the Bt toxin to mate with insects not exposed to the toxin produced in the plants.

Insect-resistant crops: Plants with the ability to withstand, deter or repel insects and thereby prevent them from feeding on the plant. The traits (genes) determining resistance may be selected by plant breeders through cross-pollination with other varieties of this crop or through the introduction of novel genes such as Bt genes through genetic engineering.

Intellectual property rights: The legal protection for inventions, including new technologies or new organisms (such as new plant varieties). The owner of these rights can control their use and earn the rewards for their use. This encourages further innovation and creativity for the benefit of us all. Intellectual property rights protection includes various types of patents, trademarks, and copyrights.

Molecular biology: The study of the structure and function of proteins and nucleic acids in biological systems.

Mutation: Any heritable change in DNA structure or sequence. The identification and incorporation of useful mutations has been essential for traditional crop breeding.

Nucleotide: A subunit of DNA or RNA consisting of a nitrogenous base (adenine, guanine, thymine, or cytosine in DNA; adenine, guanine, uracil, or cytosine in RNA), a phosphate molecule, and a sugar molecule (deoxyribose in DNA and ribose in RNA). Many of nucleotides are linked to form a DNA or RNA molecule.

Organic agriculture: A concept and practice of agricultural production that focuses on production without the use of synthetic inputs and does not allow the use of transgenic organisms. USDA's National Organic Program has established a set of national standards for certified organic production which are available online.

Outcrossing: Mating between different populations or individuals of the same species that are not closely related. The term "outcrossing" can be used to describe unintended pollination by an outside source of the same crop during hybrid seed production.

Pest-resistant crops: Plants with the ability to withstand, deter or repel pests and thereby prevent them from damaging the plants. Plant pests may include insects, nematodes, fungi, viruses, bacteria, weeds, and other.

Pesticide resistance: The development or selection of heritable traits (genes) in a pest population that allow individuals expressing the trait to survive in the presence of levels of a pesticide (biological or chemical control agent) that would otherwise debilitate or kill this pest. The presence of such resistant pests makes the pesticide less useful for managing pest populations.

Phenotype: The visible and/or measurable characteristics of an organism (how it appears outwardly).

Plant breeding: The use of cross-pollination, selection, and certain other techniques involving crossing plants to produce varieties with particular desired characteristics (traits) that can be passed on to future plant generations.

Plant-incorporated protectants (PIPs): Pesticidal substances introduced into plants by genetic engineering that are produced and used by the plant to protect it from pests. The protein toxins of Bt are often used as PIPs in the formation of Bt crops.

Plant pests: Organisms that may directly or indirectly cause disease, spoilage, or damage to plants, plant parts or processed plant materials. Common examples include certain insects, mites, nematodes, fungi, molds, viruses, and bacteria.

Polymerase chain reaction (PCR): A technique used to create a large number of copies of a target DNA sequence of interest. One use of PCR is in the detection of DNA sequences that indicate the presence of a particular genetically engineered organism.

Promoter: A region of DNA that regulates the level of function of other genes.

Protein: A molecule composed of one or more chains of amino acids in a specific order. Proteins are required for the structure, function, and regulation of the body's cells, tissues, and organs, and each protein has a unique function.

Recombinant DNA (rDNA): A molecule of DNA formed by joining different DNA segments using recombinant DNA technology.

Recombinant DNA technology: Procedures used to join together DNA segments in a cell-free system (e.g. in a test tube outside living cells or organisms). Under appropriate conditions, a recombinant DNA molecule can be introduced into a cell and copy itself (replicate), either as an independent entity (autonomously) or as an integral part of a cellular chromosome.

Ribonucleic Acid (RNA): A chemical substance made up of nucleotides compound of sugars, phosphates, and derivatives of the four bases adenine (A), guanine (G), cytosine (C), and uracil (U). RNAs function in cells as messengers of information from DNA that are translated into protein or as molecules that have certain structural or catalytic functions in the synthesis of proteins. RNA is also the carrier of genetic information for certain viruses. RNAs may be single or double stranded.

Selectable marker: A gene, often encoding resistance to an antibiotic or an herbicide, introduced into a group of cells to allow identification of those cells that contain the gene of interest from the cells that do not. Selectable markers are used in genetic engineering to facilitate identification of cells that have incorporated another desirable trait that is not easy to identify in individual cells.

Selective breeding: Making deliberate crosses or matings of organisms so the offspring will have particular desired characteristics derived from one or both of the parents.

Traditional breeding: Modification of plants and animals through selective breeding. Practices used in traditional plant breeding may include aspects of biotechnology such as tissue culture and mutational breeding.

Transgene: A gene from one organism inserted into another organism by recombinant DNA techniques.

Transgenic organism: An organism resulting from the insertion of genetic material from another organism using recombinant DNA techniques.

Variety: A subdivision of a species for taxonomic classification also referred to as a 'cultivar.' A variety is a group of individual plants that is uniform, stable, and distinct genetically from other groups of individuals in the same species.

Vector: 1. A type of DNA element, such as a plasmid, or the genome of a bacteriophage, or virus, that is self-replicating and that can be used to transfer DNA segments into target cells. 2. An insect or other organism that provides a means of dispersal for a disease or parasite.