QWould you please post the actual safety data (not summaries) submitted to and reviewed by the FDA for the sweet corn event currently in the market?

Would you please post the actual safety data (not summaries) submitted to and reviewed by the FDA for the sweet corn event currently in the market?

AExpert Answer

Below are the links to the petitions for sweet corn that are posted on the USDA website.  USDA reviewed each of these petitions prior to deregulating these corn products and allowing seed companies to sell seed to U.S. farmers for planting.

 

While FDA does not post these petitions online, the USDA petitions are excellent references because they contain nearly all of the same information and data (including the details on our testing methods) that were submitted to FDA as part of the food safety consultation. The key difference is that the information in these petitions is presented in a context that is specific to USDA, which demonstrates that the product is not a plant pest.

 

The petitions for the GM traits that are in both Monsanto’s and Syngenta’s sweet corn hybrids are on the following USDA Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Service’s (BRS) website: http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml.

 

Specifically, the petitions for traits used in Seminis Performance Series sweet corn can be accessed at:

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 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 types... Read More