Commonly Asked Questions about the Food Safety of GMOs

In recent years, people have become increasingly interested in where their food comes from and how it is produced. And unfortunately, despite a 20-year record of safety and almost 2,500 independent, global scientific reviews and approvals of GMO crops, there is still conflicting and confusing information about GMOs.

VIDEO: Monsanto Toxicologist Shawna Lemke discusses her role in food safety.

We realize you may have questions about the safety of our products, and following are answers to 10 of the questions we most commonly receive. Please feel free to contact us with other questions you may have.


What are biotechnology, genetic engineering, genetic modification and GMOs? And, why does Monsanto use it?

We use agricultural biotechnology, or genetic engineering of plants, to develop new varieties of plant seeds with a range of desirable characteristics, such as being able to resist certain insects or harsh weather conditions.

Genetically modified crops – also known as genetically modified organisms (GMOs), GE crops or biotech crops – include one or more genes from another organism, such as a bacterium or other microbe or other plant species. For plants, the inserted gene results in a beneficial characteristic in the plant, such as the ability to tolerate environmental pressures from damaging insects or drought. GMO is commonly used to refer to GM plants, as well as the food or ingredients from GM plants.

As a seed company, Monsanto studies, breeds, grows and sells GM seeds – as well as conventional seeds – to farmers around the world. Our research teams use traditional and advanced breeding techniques to develop new varieties; they use biotechnology to give those varieties an additional desirable characteristic (or beneficial trait) that often cannot be effectively developed through breeding practices alone.

The GM traits we develop typically help farmers increase yields on their farmland, while conserving resources such as soil and water. Examples of these traits are herbicide, insect and drought tolerance. However, we also work to develop traits that can contribute to an improvement in our diets, such as soybeans that produce fatty acids that provide better nutrition.

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Are foods and ingredients developed through biotechnology (or GMOs) safe to eat?

Yes. Plants and crops with GM traits have been tested more than any other crops—with no credible evidence of harm to humans or animals.

As consumers ourselves, we place the highest priority on the safety of our products and conduct rigorous and comprehensive testing on each. In fact, seeds with GM traits have been tested more than any other crops in the history of agriculture – with no credible evidence of harm to humans or animals.

Governmental regulatory agencies, scientific organizations and leading health associations worldwide agree that food grown from GM crops is safe to eat. The World Health Organization, the American Medical Association, the U.S. National Academy of Sciences, the British Royal Society, among others that have examined the evidence, all come to the same conclusion: consuming foods con¬taining ingredients derived from GM crops is safe to eat and no riskier than consuming the same foods containing ingredi¬ents from crop plants modified by conventional plant improvement techniques (i.e. plant breeding).

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Who makes sure biotech crops are safe to eat and safe for the environment?

Independent scientists and the companies that develop biotech crops conduct tests for food, feed and environmental safety. Scientists at regulatory agencies review this data and are responsible for regulating the crops.

Independent scientists at regulatory agencies worldwide review the data for each potential product and make their own scientific assessment of its food, feed and environmental safety. There is broad global agreement among food scientists, toxicology experts and regulatory food safety officials on how to evaluate the safety of GM foods; and this strong regulatory framework has successfully ensured the safety of GM seeds.

Since GM crops were first commercialized in 1996 (1996-2012), regulatory agencies in 59 countries have conducted extensive scientific reviews and affirmed the safety of GM crops with 2,497 approvals on 319 different GMO traits in 25 crops. The majority (1,129) of approvals on GM crops have been on the food safety of the product.

Monsanto makes submissions to regulatory agencies in countries where we plan to sell our seed or where the crop is commonly imported. Regulatory agencies in each country must approve a potential product before it can be sold to farmers, or imported for food and/or animal feed in their country. In the United States, for example, three agencies share responsibility for overseeing and approving GM crops based on their specific areas of scientific expertise:

  • The Food and Drug Administration (FDA) is responsible for the safety and appropriate labeling of food and feed products grown from GM crops. This includes a review of nutrient composition, non-nutrient composition and the potential presence of allergens.
  • The Department of Agriculture (USDA) is responsible for ensuring that GM crops are safe for agriculture. USDA oversees and regulates field testing, as well as the movement of GM crops and seeds.
  • The Environmental Protection Agency (EPA) is responsible for the safety of pesticides, and so is responsible for reviewing GM plants that produce proteins to protect the plants from insect pests and disease. The EPA oversees field testing, as well as the sale and distribution of pest-protected crops to ensure public and environmental health.

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Can consumers avoid GM foods in the grocery store if desired?

Yes. Consumers can look for and choose those products that are labeled “certified non-GM product” or “certified organic” products.

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Are foods and ingredients developed from genetically modified (GM) crops labeled?

Many countries have different approaches to food labeling, both on GM ingredients and other things. In the United States, all ingredients must be listed, and when there is a meaningful difference in the safety, composition or nutrition of the crop from which they were derived, that difference is properly reflected on the label.

Each country establishes its own food labeling laws. Within the United States, the FDA requires the labeling of ingredients. If there is a meaningful difference in the safety, composition or nutrition of the crop from which the ingredients were derived, the FDA could require additional information be added to the label. This is not the case for GM ingredients. Recently the American Medical Association re-affirmed that there is no scientific justification for special labeling of foods that contain GM ingredients; the American Association for the Advancement of Science stated a similar stance. We support these positions and the FDA’s approach.

However, we also support a food company’s right to voluntarily label its products to highlight or market attributes that are important to its customers, such as products that are certified organic or products labeled as not containing GM ingredients. FDA’s labeling laws allow for voluntary labeling as long as the information is accurate, truthful and avoids misleading consumers about the food. We support voluntary labeling and a consumer’s right to choose products based on the attributes that meet their individual preferences.

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Do GM crops provide any benefits?

Yes. GM crops can improve yields for farmers, reduce draws on natural resources and fossil fuels and provide nutritional benefits.

As demonstrated by the unprecedentedly rapid adoption of this technology among farmers, GM crops can provide farmers with the means to improve yields under weed and insect pressure; decrease tillage to protect soil and water resources; and reduce pesticide applications, thereby decreasing the use of fossil fuels. Some benefits, such as decreased insecticide applications, also are benefits recognized by consumers and environmentalists.

In addition, some GM crops provide nutritional benefits. For example, certain GM crops produce more nutritious oils (i.e. high oleic soybean oils), which can help people replace solid fat in their diets, potentially reducing saturated fat intake. Another example includes stearidonic acid (SDA)-containing soybeans, that produce healthful long chain omega-3 fatty acids like EPA.

In 2004, FDA issued a letter of enforcement discretion regarding use of the Qualified Health Claim statement, “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease”. (Docket No. 2003Q-0401)

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Has anyone studied the long-term health effects of GM crops (GMOs)?

Many studies are conducted to assess health effects of GM crops.

Since farmers first began growing biotech crops in 1996, there has been no credible evidence of harm to humans or animals. In addition, the following two studies assessed the long-term safety of GMOs:

  • In December 2010, the European Commission published a report summarizing the results of 50 research projects addressing the safety of GMOs for the environment as well as for animal and human health. These projects received funding of €200 million from the EU and are part of a 25-year long research effort on GMOs. In announcing the report, the Commission stated, “…there is, as of today, no scientific evidence associating GMOs with higher risks for the environment or for food and feed safety than conventional plants.”
  • In 2012, a literature review of well-designed, long-term and multigenerational animal feeding studies comparing GM and non-GM potatoes, soy, rice, corn and triticale found that GM crops and their non-GM counterparts are nutritionally equivalent and can be safely used in food and feed.

For more information on how Monsanto specifically establishes biotech crop safety, please see:

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In addition to animal feeding studies, are human clinical trials used to test the safety of biotech (GM) crops?

There are not currently any human clinical trials used to test the safety of GM crops. This is not unusual; no existing food or ingredient – GM or otherwise – has been the subject of human clinical trials. However, there is broad global agreement among food scientists, toxicology experts and regulatory food safety officials on how to evaluate the safety of GM foods. We follow these expert recommendations.

The starting point is identifying differences between GM crops and their conventional counterparts. The experts agree that components of GM crops that are the same as existing foods do not require testing. As a result, the focus is on what is different in the GM crop – the inserted DNA/RNA and the proteins resulting from gene insertion.

DNA and RNA are a normal part of every plant and animal, and therefore in virtually every meal we eat. DNA and RNA carry no dietary hazard and are “generally recognized as safe” (GRAS) in the United States, and are considered safe by food safety experts globally. Proteins are also a normal part of the human diet, are extensively digested, and generally present no hazards, but that must be confirmed for the specific proteins introduced in GM crops. To do this, an analysis of protein structure and function is performed and testing of digestibility is conducted to establish safety of the introduced proteins.

As long as the introduced gene protein is determined safe (an initial step in the safety assessment) and the GM and non-GM crops are alike in all respects, the GM crop is said to be substantially equivalent, or “equal to,” their conventional counterparts and are not expected to pose any health risks. Experts in the field of food safety are satisfied that this approach is sufficient and reliable to assure the GM crops are as safe their conventional counterparts. This expert community does not see a need and thus does not recommend long-term tests in humans in order to establish food safety.

Further, it is quite difficult and somewhat impractical to design a long-term safety test in humans. These types of tests using whole foods would require, for example, dietary intake of significantly large amounts of a particular food – amounts not typically consumed – over a very large span of time. This is, in part, why no existing whole foods—whether from organic, conventional or GM production – have been subjected to long-term human clinical trials.

For more information on how Monsanto, specifically, establishes biotech crop safety, please see:

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Is food grown with or developed from biotech seeds contributing to allergies in America?

The process of GM development has safeguards to prevent the introduction of new allergens. There is no evidence of any new allergens being introduced in GM foods.

Like anyone with products connected to food, we take food allergies very seriously. The process of GM development has safeguards to prevent the introduction of new allergens. There is no evidence of any new allergens being introduced in GM foods.

It is important to note that there are hundreds of thousands of different proteins in the human diet, and only a tiny fraction of these are significant food allergens. Thus, the risk of a new protein being a food allergen is very low. Regardless, in the initial stages of product development, Monsanto researchers avoid sources of known allergens, such as nuts and eggs, as potential gene sources for GM crops.

No matter the source of the gene though, we assess every new protein for certain characteristics to help avoid the introduction of potential allergens into a GM crop. Assessing for potential allergenicity of introduced proteins is an FDA-required component of the safety assessment of GM crops.

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I’ve seen reports of studies showing GM crops are safe and others saying they aren’t. Who and what do I believe?

It’s true that there is a lot of conflicting information out there. But when it comes to the scientific community that has studied the issue, there really isn’t any conflict – the broad consensus among scientists who have looked closely at GM crops is that they are as safe as any other crop.

When considering and comparing scientific data, there are several things we take into account:

  • Is the study designed and executed well and according to accepted methods?
  • Is it in alignment with other data on the same topic?
  • Do the results make scientific/biological sense?
  • Is the scope of the conclusions supported by the data?
  • What is the opinion of credible scientific organizations such as regulatory agencies, AMA, National Academy of Sciences?

There is a large body of documented scientific testing showing that the GM crops being grown and harvested are safe (Center for Environmental Risk Assessment). These studies focus on the wholesomeness and nutritional value of GM crops and upon the safety of the specific varieties used.

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