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In the United States, genetically modified crops are regulated by three different agencies. The Department of Agriculture regulates field testing of GM crops for research. The Environmental Protection Agency regulates plants with pest-resistant properties. And the Food and Drug Administration regulates any GM crops that are eaten by humans or animals.
FDA oversight tends to get the most attention. There’s no specific law that regulates genetically modified foods. Instead, back in 1997 the agency created a voluntary “consultation” process for companies that want to sell new GM crops. The companies conduct a safety assessment that identifies the novel genetic traits and determines whether any of the new material could be toxic or allergenic. FDA scientists can ask for additional tests and data as needed. To date, some 96 crops have gone through this process.
Critics tend to focus on the fact that this safety assessment is voluntary — there are no laws requiring specific tests. Biotech companies often retort that it’s not that “voluntary” in practice. They end up carrying out a large number of tests and give the FDA whatever data the agency asks for. (After all, the FDA does have the authority to require pre-market review for any substances not generally recognized as safe.)
It’s worth noting that the European Union has had a much stricter regulatory policy in place since 2003. There, all GM foods must be strictly evaluated on a case-by-case basis before they’re marketed. And even after approval, individual EU countries can request to ban certain GM foods from their borders under a “safeguard” clause. As a result, Europe tends to have far fewer genetically modified crops and foods.