FDA proposes long-awaited biotechnology rule

The US Food and Drug Administration (FDA) on Wednesday issued a proposed rule and a draft guidance document concerning food developed through biotechnology. If cleared, the proposed rule would require food developers to notify the FDA at least 120 days in advance of their intent to market a food or animal feed developed through biotechnology and to provide information to show that the product is as safe as its conventional counterpart. In a bid to provide the consumer with "truthful and not misleading" information, the draft guidance document would provide advice to manufacturers who voluntarily wish to label their products as manufactured with or without ingredients developed through biotechnology. The FDA, eager to impose stricter guidelines, views the terms "derived through biotechnology" and "bioengineered" as acceptable but not "GM free", "GMO", and "modified." These guidelines, which contrast sharply with requirements commonplace in Europe, were heavily criticised by environmental and consumer groups that had been lobbying hard for mandatory labelling and pre-market testing of genetically modified foodstuffs. The Financial Times reported a comment from Charles Margulis at Greenpeace who maintained that the new rules could add to tensions between the US and Europe over agricultural biotechnology matters. "The US administration had been talking about working with Europe on this issue but this is going to make things very difficult . . . It's certainly not going to do anything to resolve the current trade impasse," he said. There will be a comment period but environmentalists say they are prepared to mount a legal challenge, the Financial Times concluded.