Testing the Safety of a Protein

The regulatory process for a biotech crop requires Monsanto to prove the gene that was inserted is safe and the protein produced by the inserted DNA is also safe. This is the process the company goes through to test the safety of a protein.

When looking at the safety of the protein, Monsanto looks for several things, the most important being a history of safe use.

There are four categories used to show a history of safe use.

  • Safety of the donor organism:  Does the gene—and therefore the protein—come from a bacterium that is already proven as safe for humans or animals?
  • Familiarity: Is the protein unique? Has it been in food and feed in one form or another before?
  • Exposure: Have people and animals come into contact with the protein before? Is it already in food and feed?
  • Estimated consumption rate: How much of the protein will actually be in food and feed—and therefore how much do people or animals have the potential to consume?

These will then be used to determine margins of exposure or safety.