The U.S. government's system for regulating the products of biotechnology, including GMOs, or genetically modified organisms, was born in 1986, and it has been controversial from the start. Now, it will be getting a makeover — in part to assure the public that GMOs really are adequately regulated.
The White House has ordered three federal agencies with a hand in biotech regulation to "update" this system, which is formally called the Coordinated Framework for the Regulation of Biotechnology. The White House directive says there are several problems with the current system. Its complexity "can make it difficult for the public to understand how the safety of biotechnology products is evaluated," small companies can have a difficult time navigating the process, and new technologies are emerging that existing rules didn't anticipate.
The current system is cobbled together using traditional roles of three different agencies. The U.S. Department of Agriculture, with existing authority to regulate "plant pests," approves all releases of GMOs to make sure that they don't create an environmental hazard. The Environmental Protection Agency, with authority over pesticides, must approve all crops that contain insect-killing genes. And the Food and Drug Administration is responsible for evaluating whether GMOs are safe to eat. In general, the system treats GMOs like any other crop, food, or pesticide.
Some critics feel that this approach is wrong-headed, and that new crops demand new rules.
The Center for Science in the Public Interest, for instance, pointed out in a press release that when the USDA evaluates crops that have been modified to tolerate weedkillers, the agency currently is supposed to decide only if the crop might become a "plant pest." According to the CSPI, the agency should look at a wider range of risks, such as whether widespread planting of the crop might lead to overuse of herbicides.
Similarly, GMO crops are treated much like any other food. If it turns out that they cause health problems, the FDA can order them taken off the market, but the FDA does not currently require biotech companies to submit these crops for approval before they go on the market. In practice, though, biotech companies that develop a new GMO have waited for the FDA to issue a letter certifying that the agency has looked at the product and found no safety issues with it.
Greg Jaffe, director of CSPI's biotechnology project, tells The Salt that he welcomes the update of the regulation. It's "positive," he says, that the White House recognizes that it needs to show the public that its biotechnology regulations are, in fact, protecting public health and the environment.
Jaffe says that the update also will give regulators a chance to figure out how they will handle new technologies such as "gene editing." These techniques don't introduce novel genes, but use genetic "scissors" to alter a plant's existing DNA.