Qare genetically modified organisms safe for human consumption?

are genetically modified organisms safe for human consumption?

AExpert Answer

An overwhelming number of worldwide experts, including World Health Organization (WHO), American Dietetic Association and European Commission, agree that GMOs are safe for human consumption. In advance of a GMO product being commercialized, the innovation provider voluntarily submits to the U.S Food and Drug Administration (FDA) a dossier of compiled studies to be evaluated to determine the safety of the product as a food or food ingredient for consumers in the U.S. marketplace.

 

The FDA has well-established scientific procedures to evaluate the safety of GMOs with an expectation on developers of genetically engineered (GE) food to analyze the composition of new crop varieties. This is to ensure that any changes compared to the food’s conventionally derived counterpart are appropriately considered and addressed before marketing such foods. The FDA’s review and analysis includes consideration as to whether any newly introduced GMO may be allergenic or toxic and whether levels of important nutrients or anti-nutrients have been changed in a way that is important to food safety or nutritional value of that product.

 

Food growers, manufacturers and distributors all have a role in ensuring that food products marketed in the United States are safe. To help developers of GE food comply with their obligations under the Federal Food, Drug & Cosmetic (FD&C) Act and FDA regulations, the agency encourages them to participate in a voluntary consultation process with the FDA prior to commercial distribution. The goal of the voluntary premarket consultation process is to ensure that any safety or other regulatory issues associated with food from the new plant variety are resolved prior to commercial distribution.

 

It is important to note that the FD&C Act places a legal duty on developers, manufacturers, and distributors to ensure that the foods they market to consumers are safe and comply with all legal requirements.

 

The fact that participation in the process is voluntary should not mislead individuals to believe that the process does not provide for a rigorous food safety evaluation. It is not uncommon for the FDA to request additional data and information or clarification about the data and information submitted by the developer. This iterative process makes for a rigorous safety evaluation. The FDA considers a consultation to be complete only after all safety and other legal issues have been resolved.

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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