Biotechnology: The Regulatory Process

Biotech crops undergo more testing and oversight before commercialization than any other agricultural products, including conventional crops. Before we submit a biotech crop to regulatory agencies for approval, our research teams have put it through numerous tests to ensure and prove it’s as safe as its conventional equivalent. Here’s how the process works:

Characterizing a New Biotech Product

At this stage in the regulatory process, Monsanto must prove the gene inserted is safe and the protein produced by the inserted DNA is also safe.

This includes:

  • Verifying we’ve inserted only one copy of the gene, the copy is intact and we have not inserted any other portions of DNA.


Once this testing is complete and data has been generated, our Product Safety Center takes over for further testing—this time to conduct safety assessments to determine food and feed safety.

In some cases RNA interference is used to express a trait. RNAi is a mechanism used naturally by cells to regulate gene expression. It is recognized by the U.S. Food and Drug Administration (FDA) as “Generally Regarded as Safe” (GRAS) and as such, consumption is not regulated. Learn more about RNAi

Compositional Analysis

This stage includes a comparative safety assessment. With the comparative safety assessment, Monsanto seeks to establish substantial equivalence, meaning we’re testing to see if a biotech product (a soybean, for example) is compositionally and nutritionally the same as the conventional soybean (one without any biotech traits).

Animal Performance Assessments

Even if Monsanto knows the new biotech products are compositionally the same as their conventional counterparts, we generate additional assurances that food and feed from these products are as safe as food and feed from existing conventional products--through animal performance assessments.

Environmental Safety

A part of the regulatory process includes environmental safety testing. This involves a study of the plant’s impact on the environment including growth, development, interactions with insects, diseases and other stresses.