What is the Approval Process for a GMO to Come to Market?

GM seeds undergo testing for safety, health and nutritional value – and regulation is overseen by The Food and Drug Administration (FDA), The U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA). Each GM seed variety takes an average of $136 million and 13 years to bring to market due to research, safety studies and regulatory approval processes. No other type of new seed that comes to market from other breeding methods goes through the extensive approval process, including the thousands of conventional and organic seeds developed. GMOs are required to be reviewed by the following:

  • USDA conducts a mandatory review on all GMOs to prove they are safe to grow.
  • EPA conducts a mandatory review of GMOs that contain a trait related to “regulated articles”, such as being resistant to insects or herbicide tolerant to prove GMOs are safe for the environment.
  • FDA conducts a voluntary review to prove GMOs are safe to eat. All data submitted for these approvals can be made publicly available. Further, if new studies from any source come to light that show any harmful effects of an existing GM product, they must be submitted to the regulatory agencies for further review. To date, the FDA has reviewed many studies that questioned the safety of today’s GMOs and have found them not scientifically valid.

“FDA has no basis for concluding that bioengineered foods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding,” according to FDA.

Currently there are 10 GE crops commercially: artic apple, alfalfa, canola, corn (field and sweet), cotton, papaya, potatoes, soybeans, squash and sugar beets.