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 January 31, 2018
Thank you for your question. There are various aspects of your question. I assume your question refers to the use of Agrobacterium rhizogenes by scientists to intentionally transfer genes from the bacterium to plants. Infection and DNA transfer from this bacterium occurs in nature all the time to cause disease. Such transformed plants are not classified as GMOs since transfer occurred naturally. If this is done by scientists then it would be classified as a GMO. Rules and... Read More
Posted on March 1, 2018
I’m a Monsanto scientist who has more than 20 years of experience with genetic modification of plants. I will try to answer your question, even though I don’t ever do experiments on animals, certainly not on humans, of course! Can humans be genetically modified…but a much bigger question is should humans be genetically modified? There are two ways to think about genetic modification of humans (or any animal). One way is modification of somatic cells, and the other is the... Read More
Posted on May 10, 2017
The simple answer is that 20+ years of composition assessments of GMO crops have demonstrated that crop composition is not appreciably affected by the GM process (1). In addition, data collected through that time have indicated that general factors such as the growth environment can contribute to notable variation in component levels (2). Plant agglutinins (or lectins) and amylase inhibitors are examples of anti-nutritional compounds that may be present in crops. The relevance of such a... Read More