QHow long does it take on average for a new GMO variety to be approved by the USDA, FDA and EPA? What are the general steps that are part of this process? Thank you.

How long does it take on average for a new GMO variety to be approved by the USDA, FDA and EPA? What are the general steps that are part of this process? Thank you.

AExpert Answer

According to an opinion piece by Washington farmer Mark Wagoner written earlier this year, it can take the U.S. more than three years to grant approval of a new biotech product. 

  • USDA conducts a mandatory review of GM plants to assess whether or not they will impact the environment and will be safe to grow.
  • EPA conducts a mandatory review of GM plants that are insect or herbicide resistant to assess whether or not they will impact the environment. The EPA also regulates the use of all crop protection products that control weeds and provide protection against insects and disease that are used on crops grown in the U.S.
  • FDA conducts a review to assess if GM plants are safe to eat. All GM crops on the market have gone through this process.


That’s just agency review and approval process in the United States though. As a company, we start thinking about regulatory requirements early in our product development process. We conduct more than 75 regulatory science studies over a five-to-seven year period in order to answer questions like: What is the sequence of the genetic insertion? Does the trait do what we expected? And if so, at what level? Does a plant with this trait work the way we want and grow like normal? 


Researchers also carefully evaluate product safety, verifying that the new GMO product: 

  • Doesn’t introduce any toxins or allergens; 
  • Is nutritionally the same as its non-GE counterpart; and
  • Has no effect on non-target organisms like beneficial insects, birds and other wildlife 


It’s important to note that any new product concept not meeting these standards are discarded and are not pursued for commercialization.


All of these studies are conducted following international guidelines for good laboratory practices and scientific methods, and then the results are peer-reviewed by the multiple authorities in the more than 70 countries where GMOs are grown or imported. 

Posted on February 2, 2018
A former response to a similar question answered by Dave Kovalic, Regulatory New Technology Lead at Monsanto, also provides information on scientific advancements and how they [Monsanto] affirm safety prior to targeted vector insertion.   “For context, it is important to recognize that random genome insertions have been naturally occurring in crops over the ~10,000-year history of agriculture.  In some crops, more than 90 percent of the genome consists of these... Read More
Posted on February 2, 2018
In terms of the science behind the technology to create GMOs, scientists have a much better understanding how a transgene is delivered and stably integrated into a chromosome (or genome). Many GMO products, such as Bt corn, were made using Agrobacterium cells to deliver useful trait genes into the plant cells. Scientists were able to dissect the different steps of this natural gene delivery system encoded by Agrobacterium. We now have a good understanding of the interactions between... Read More
Posted on January 2, 2018
Thank you for your questions, we would like to address these individually.   Why are GMOs created if scientists are not aware if it is really harmful? and Are GMOs really safe if you’re mixing to different DNA strands? yes GMOs are safe. In fact, according to this response, “the overwhelming consensus of scientific experts and major scientific authorities around the world, including the World Health Organization, Food and Agriculture Organization of the United Nations, and... Read More

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