QHello. I am an agricultural economists trying to get a succinct and accurate description of how GMOs are regulated, but I can't find a clear document by the FDA on this and FDA's Center for Food Safety and Applied Nutrition will not allow me to contact th

Hello. I am an agricultural economists trying to get a succinct and accurate description of how GMOs are regulated, but I can't find a clear document by the FDA on this and FDA's Center for Food Safety and Applied Nutrition will not allow me to contact them directly about this. So, I have patched together some notions (from various sources, none of which I can really cite) on how they are regulated and would greatly appreciate it if someone could tell me if it is a good description or how it could be improved. ____ A complex system of regulations has been constructed in the U.S., where GMOs are vetted by the United Stated Department of Agriculture (USDA), the Food and Drug Administration, and the Environmental Protection Agency (EPA). What follows are the most important features of the regulations in regards to human health, and mostly involves the FDA. The FDA does not assume that a GM crop variety is safe, nor do they deny it may be safe. For this reason the company producing the GM crop will communicate with the FDA throughout the products’ development so that they can answer any questions the FDA poses. What the company ultimately wants is a letter from the FDA indicating they have no further questions. This letter is considered to be “FDA’s blessing” by the company, though the FDA would certainly never use that term. Without this letter the company is more vulnerable to lawsuits and can be subject to an expensive product recall by the FDA. Although this process is sometimes depicted as voluntary, the FDA has such strong powers to recall a product that no company would go to market without the FDA letter. Also, during this process, if the FDA decides that the product may not be safe, then it can require pre-approval before the product is marketed. The process mainly involves determining whether the GM crop is “substantially equivalent” to other non-GM varieties and whether it poses an allergen risk. Seed companies submit data to the FDA on the genetic composition of a new crop, asking the agency’s opinion on whether it is substantially equivalent to conventional varieties. If a seed passes this test they are considered just another plant variety—not a new species. There is then no need for comprehensive tests of GM food, nor are businesses required to label the product as containing GM ingredients. ... Before a seed company can obtain the FDA’s blessing that the GM crop is substantially equivalent to conventional varieties, the DNA of the crop is compared to a database of around 500 allergens. One variety of Bt corn (StarLink) did not pass the allergy test, meaning regulators feared it might cause allergic reactions if directly consumed by humans. Starlink was therefore to be used only as animal feed—not for human consumption. ____ Thanks! Bailey Norwood Associate Professor Oklahoma State University fbaileynorwood.com

AExpert Answer


Seems like you‘ve grasped the overall summary of oversight in the US pretty well.  Additionally, Steve Savage’s response provides a great summary of the regulation of GMOs: http://gmoanswers.com/ask/how-are-gmo-foods-regulated.


“Working with the broader community of academic and commercial scientists, three US regulatory agencies hammered out a system of shared responsibility for the review of biotech crops. Called the “Coordinated Framework for Regulation of Biotechnology,” the system was instituted in 1986 – still 10 years before the first commercial acre was planted. The proactive involvement of three regulatory agencies is completely unprecedented making crops improved through genetic engineering the most carefully monitored foods in history.


The USDA considers whether there are any “plant pest” issues with the specific crop and trait such as the ability to cross with weedy relatives. The new crop cannot even be planted outdoors for testing purposes until the USDA determines that it is prudent to do so. The EPA gets involved if there is anything pesticide-related to do with the trait such as tolerance to a herbicide or the production of the Bt protein that protects the plant from insect damage. The FDA reviews the information that the producing company or other entity generates to show that the modified crop is “substantially equivalent” to the non-modified version. This step is technically voluntary, but that sort of data has been provided and reviewed for every biotech trait that has been commercialized in the US. The exact nature of the equivalency testing is, logically, customized based on the type of trait involved.”


With regard to GMOs, additional information from the FDA is available here:




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