The Food and Drug Administration (FDA) on Thursday published a draft policy guidance document, explaining how the agency would approach regulation of food from genetically modified animals.
In large part, FDA would treat the genetic modification like it would treat a new veterinary drug. A company would have to prove that the new product is safe for human consumption, and it would have to prepare an environmental assessment. If these documents seemed satisfactory, FDA would "exercise discretion" by allowing the product to market under existing regulations, even though those regulations don't address genetic engineering specifically. FDA would retain the right to regulate a genetically engineered animal product more strictly at a later date, if health or environmental problems became apparent later.
Some concerns have been raised about the FDA draft guidance. For example, Michael Hansen from Consumers Union pointed out that the draft guidance says nothing about labeling genetically modified meat and dairy products, so consumers who care about this issue would not necessarily be able to identify the genetically modified foods. Gregory Jaffe from the Center for Science in the Public Interest asked whether, for example, FDA would on its own be able to assess the environmental impact of a new genetically modified breed of salmon, whose rapid growth could threaten natural wild populations.
The public may comment on the draft guidance through November 18.