Establishing the Safety of GM crops: The Regulatory Process

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Establishing the Safety of GM crops: The Regulatory Process


Are GMOs Safe?

Since 1994, more than 60 countries have concluded on more than 3800 separate occasions that GM crops are safe as conventional crops for food, feed and the environment by granting regulatory approval for cultivation and/or import. Additionally, more than 30 government bodies representing more than 70 countries typically review GM crops.

The US GM Crop Safety Review Process

In the US, for example, after extensive safety testing is completed at Monsanto, every genetically modified (GM) product goes through regulatory review as follows:

  • 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—nontoxic, nonallergenic, etc.
  • The United States Department of Agriculture (USDA) confirms that a GM trait will not pose a plant pest risk.
  • 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.


Global Regulatory Review

Monsanto has made regulatory submissions to select global regulatory bodies. Here are the regulatory decision documents by some regulatory bodies.

Additionally, all global approvals for GM crops are in this database by Crop Life International.

Third-party Experts on GM Crop and Food Safety

On top of the government safety approvals mentioned above, genetically-modified crop data has been reviewed by many third-party scientific expert bodies who have determined they’re as safe as conventional crops, including:

  • American Medical Association
    “Bioengineered foods [GMO food] have been consumed for close to 20 years, and during that time, no overt consequences on human health have been reported and/or substantiated in the peer-reviewed literature.”
  • The Royal Society
    We believe that the risks to human health associated with the use of specific viral DNA sequences in GM plants are negligible. Given the very long history of DNA consumption from a wide variety of sources, it is likely that such consumption poses no significant risk to human health, and that additional ingestion of GM DNA has no effect.” 
  • World Health Organization
    “GM foods currently available on the international market have passed safety assessments and are not likely to present risks for human health. In addition, no effects on human health have been shown as a result of the consumption of such foods by the general population in the countries where they have been approved.”
  • National Academy of Sciences
    “...the study committee found no substantiated evidence of a difference in risks to human health between currently commercialized genetically engineered (GE) crops and conventionally bred crops, nor did it find conclusive cause-and-effect evidence of environmental problems from the GE crops.”