Transcript for Clip 1 -- Regulatory Process

A: Let's consider for example a corn plant that might have been made resistant to an insect. We would be looking to make sure that the new gene we had put into that plant was stable, it was the same gene that we put in there, it hadn't been rearranged, that it was still working the way we intended it too. So we would take samples from lots of different plant tissues and plants grown in different environments, and measure the amount of protein being produced just to assure ourselves that the product really was behaving as we expected it to. We'd then look at the safety of the protein itself and that would involve maybe a lot of biochemistry to produce enough protein so we could actually feed that to animals, usually we choose mice for example and feed them a huge excess of what any human might be exposed to when they ate that product. We would also assess the potential of the protein to be a toxin, again that should show up very quickly in a test on mice if this protein has any toxic effects. We also evaluate it to find out whether or not it has any potential to be a food allergen. Of course we're very concerned with avoiding anything that might be allergenic so that people don't develop new allergies or we don't cause people who are already allergic to something to become ill. We also have to look very closely at the properties of the crop itself. So we look at the composition of the crop very carefully we measure a large number of parameters; the protein composition, the amino acid composition, the oil profile, the carbohydrate profile, any natural toxicants that may be in the products. After all many of our food crops contain a lot of natural toxins and it's important to make sure that we haven't changed the composition of those natural toxins during the genetic engineering process. And of course we also want to know that these products are safe for people to eat and animals to feed on but also that they're not going to have adverse interactions with the environment. So we would test the crop or the protein against some representative species particularly insects that are beneficial in fields, things like ladybugs that eat aphids. We would test the proteins against ladybugs and make sure they're not adversely affected. We might also feed the crop to birds for example to make sure they don't have any adverse effect on wildlife. So it's a series of these environmental tests. Looking also at for instance how quickly does it break down in the soil because we don't want to put some materials into the soil that are going to stay there for a long period of time. We're also concerned that it wouldn't affect things like earthworms which are important in maintaining soil quality. So again we look at a whole spectrum of these soil invertebrates, make sure they're not adversely affected. Once we've gone through all these different tests aimed at food safety, feed safety, and environmental safety, then we can go to the federal agencies, the FDA, the USDA, the EPA, and ask them for approvals to put out products on the market and that process can take several years.