Regulatory Process
of GM Crops
At Bayer, we are consumers as well as scientists. We appreciate that the regulatory standards for GM crop products are as rigorous as they are because they help safeguard human and animal health and the environment. We take our responsibility for the safety of our products very seriously by conducting comprehensive safety studies according to scientific principles and high-quality standards. This is how we can meet the need for sustainable innovative solutions in agriculture that are also safe for humans, animals and the environment.
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How is safety demonstrated for regulators around the world?
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Before they are put on the market, genetically modified (GM) crops undergo more testing and oversight than any other agricultural product -- including conventional (or non-GM) crops. From the earliest phases of discovery, Bayer thoroughly tests its GM crop products for safety, including environmental and food safety.

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Before a gene is used to improve a GM crop, the protein expressed by that gene is assessed for food and feed safety, confirming the protein is not a known allergen.

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The gene is inserted into thousands of different varieties of the crop of interest. From those thousands of plants, many tests are conducted on these plants to select one variety that has the best chance to help farmers. This one is advanced for further development and safety testing.

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The selected GM crop is fully analyzed to demonstrate that it is as safe as its non-GM counterpart. This data is carefully reviewed by regulators around the world before they decide whether the new products may be sold to farmers for cultivation, or whether the grain from that crop can be imported from other countries.

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Protein, carbohydrates, fat, amino acids, fiber fractions, vitamins, and other components of each new GM crop are analyzed to ensure the GM variety is as safe and nutritious as the non-GM counterpart.

 

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13 Years
On average, each GMO product takes 13 years and costs $130 million for research, development, and governmental regulatory approval. The regulatory process alone can take 5-7 years.

GM crops also undergo environmental assessments to evaluate potential unintended effects and the potential for impacts on the environment. Field testing is performed to evaluate whether the plant is safe for the environment. This means safety testing is performed to ensure the crop is fundamentally unchanged from the conventional counterpart (with the exception of the introduced trait) and will not have adverse environmental effects. Agronomic evaluation, phenotypic evaluation, ecological interactions and impacts on non-target organism evaluations (like honey bees) are conducted.

 

The guidelines for establishing safety that are followed by Bayer and recognized by regulatory authorities globally were developed over many years by international scientific bodies like the Codex Alimentarius Commission and the Organization for Economic Development (OECD).

 

Only after Bayer has met internal safety testing requirements--using internationally recognized methods--is the GM crop submitted to global regulatory authorities for their review. In the US, for example, after extensive safety testing is completed at Bayer, every genetically modified product goes through regulatory review as follows:

 

 

Safe to Eat

The Food and Drug Administration (FDA) cooperatively works with GM crop developers to help them ensure foods made from their new varieties are safe for human consumption.

 

Safe to Grow 

The United States Department of Agriculture (USDA) confirms that a GM trait will not pose a plant pest risk.

 

Safe for the Environment

The Environmental Protection Agency (EPA) evaluates insect- and virus-resist GM crops thoroughly to ensure that the crop will not pose unreasonable risks of harm to human health or the environment.