September 1, 2015 | By

Safety and Oversight: How Genetically Engineered Crops are Regulated in the United States

Science & Our Food Commentary Series
By Marcus Glassman, Research Associate, Global Agriculture & Food, The Chicago Council on Global Affairs
In the United States, the safety of GE crops is regulated at the federal level by three agencies: the United States Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). The legal mechanisms by which these three agencies regulate GE foods and plants can be complicated, and as the Obama Administration has pointed out, it’s not perfect. But given the level of angst, uncertainty, and mistrust many consumer feel towards genetic engineering, it’s important to understand that these products are regulated; the safety of these foods and plants is part of the federal regulatory framework; and the framework, though extensive, does have some holes in it—though they are smaller than many GE critics fear.
The framework that outlines the governance of GE foods today was established in 1992 by the updated Coordinated Framework for Regulation of Biotechnology. Within the Framework, GE products are not regulated under novel laws specifically designed to regulate the genetic engineering process. Rather, each GE product is regulated under existing laws as applicable based on the nature of that GE product. This approach creates a complicated and nuanced regulatory structure, with the following basic structure:
The USDA has authority to regulate GE plants through its Animal and Plant Health Inspection Service (APHIS), which is charged through the Plant Protection Act to regulate possible plant pests. Typically, a “plant pest” refers to an insect, virus, bacteria, or other disease-causing organism that could harm plants or plant products. GE plants, however, fall under “plant pest” jurisdiction when either a plant pests’ bacterial gene is inserted into a plant’s genome, or when an agrobacterium is used in the genetic engineering process itself—a common method of moving genes into new genomes.
The FDA is responsible for the safety of all GE foods in the US under the Federal Food, Drug, and Cosmetic Act. This law allows the agency to classify substances added to foods as either “food additives,” which require agency approval before they are added to foods, or as generally recognized as safe (GRAS). For GRAS substances, preapproval is not needed from the agency to add those substances to foods. It has been agency policy since 1992 that most foods derived from GE plants are considered GRAS, although some GE foods that contain novel characteristics require premarket approval from the agency.
The EPA is responsible for the safety of pesticides, including those produced by GE crops, such as Bt corn and cotton. The agency regulates the  biological pesticides produced by those crops for both their environmental and human health safety, per its authority under the Federal Insecticide, Fungicide, and Rodenticide Act. This Act requires that all pesticides be registered with the agency before commercialization, which includes biological pesticides that are engineered into a crop.
Taken together, the regulatory framework for GE crops and foods is extensive and rigorous. Many of the most popular GE plants and foods on the market—like commercial corn—require oversight by three federal agencies: their planting is regulated by the USDA; the safety of their food is regulated by the FDA; and the safety of any pesticide attributes are regulated by the EPA. But the system is not foolproof: Not all steps of regulation are required—FDA’s consultation process, for example, is voluntary—nor does every GE plant and product need regulation by all three agencies.
Exemption from regulation is not immediate cause for concern: If a GE plant doesn’t produce food—like a glow-in-the-dark houseplant under development—then it’s logical that it is exempt from FDA’s food safety regulations. But some exemptions are more extensive. In 2011, a brand of herbicide-resistant turf grass was developed using a type of genetic engineering that uses a “gene gun”—a machine that shoots genetic material into a plant’s cell—in lieu of more traditional genetic engineering techniques that use bacterial or viral components. This herbicide-resistant grass is non-pesticide producing, therefore exempt from EPA regulations; non-food producing, therefore exempt from FDA regulation; and not produced using any “plant pest” DNA, and therefore exempt from USDA regulation. This herbicide-resistant grass is still undergoing testing by its developer and not commercially available, but for the moment it is free of regulation.
As genetic engineering technology advances, the regulatory structure surrounding GE foods, as well as the trust that consumers and the international community have in those government safeguards, will be tested. Although there are faults in the current system, it is, for the moment, quite rigorous and wide-reaching. However, to maintain and build domestic and global trust in its conclusions of food safety, the regulatory structure must, as the White House has urged, prepare for the future.
Read additional posts in the Science & Our Food series:  


The Global Food and Agriculture Program aims to inform the development of US policy on global agricultural development and food security by raising awareness and providing resources, information, and policy analysis to the US Administration, Congress, and interested experts and organizations.

The Global Food and Agriculture Program is housed within the Chicago Council on Global Affairs, an independent, nonpartisan organization that provides insight – and influences the public discourse – on critical global issues. The Council on Global Affairs convenes leading global voices and conducts independent research to bring clarity and offer solutions to challenges and opportunities across the globe. The Council is committed to engaging the public and raising global awareness of issues that transcend borders and transform how people, business, and governments engage the world.

Support for the Global Food and Agriculture Program is generously provided by the Bill & Melinda Gates Foundation.


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