The system in the United States use to evaluate and regulate genetically-modified organisms has been marked for change by the Obama administration. The current system, which involves three federal agencies, were first set in 1986. The overhaul is, in part, aimed to assure the public that GMOs are properly under government supervision and to “ensure public confidence in the regulatory system.”
The White House Office of Science Technology and Policy has ordered three government agencies that intersect with the issue to update the Coordinated Framework for the Regulation of Biotechnology. The Coordinated Framework outlines “a comprehensive Federal regulatory policy for ensuring the safety of biotechnology products.” The order from the White House points to several problems with the way to framework currently operates. Its convoluted nature can make it difficult “for the public to understand how the safety of biotechnology products is evaluated.” Biotech has progressed so quickly that the government is now faced with regulatory challenges that the framework did not anticipate. What’s more, small businesses can often have a very difficult time maneuvering within the framework to seek approval for their products and technologies.
As it stands, regulatory decisions are pieced together using three different roles of three different government agencies. The Food and Drug Administration evaluates whether GMOs are safe for human consumption. The Environmental Protection Agency, which oversees pesticides, gives approval to all crops that use insect-killing genetic factors. And the Department of Agriculture, which has an ongoing mandate to regulate “plant pests,” has approval over the release of all GMOs to ensure that they do no pose hazards to the environment. The current framework views GMOs as if they were any other food product, chemical, or crop.
Some question whether this viewpoint is appropriate. Do new crops developed through new technologies require new rules?
Since GMO crops are regulated like other food products, the FDA can order them to be removed from the market if it becomes known that they cause health issues. But FDA does not currently require that biotech companies submit their plants for approval before bringing them to market. However, biotech firms that create new GMO crops have typically waited for a certifying letter from the FDA that indicates that the plant has been “examined” and that no issues with health or safety were discovered.
In a press release, the Center for Science in the Public Interest notes that when the USDA considers a GMO crop for approval under the current regime, the decision only takes into account whether or not the GMO plant is likely to become a “pest.” The CSPI says that USDA should examine a much wider range of possible problems.
The updated framework will also have to consider new technologies that are outside of the existing system’s scope. For example, “gene editing” does not present brand-new genes, but instead slightly alters existing copies in DNA. There will be a public notice and comment in period Fall 2015 before the new rules are finalized.
However, the Office of Science and Technology Policy order makes no mention of genetically-modified animals. GM animals pose an entirely new set of questions and challenges that are very difficult to manage. For example, while more than 90% of soybeans grown in the United States are genetically-modified, GMO salmon, which grow bigger and faster than their “natural” counterparts, have been languishing in the regulatory process for over twenty years.
