by Ude Lu, UMN Law Student, MJLST Staff.
GMOs, genetically modified organisms, have long been a part of our daily diet. For example, most of the soybeans and corn on the supermarket shelves are GMOs. Currently, the issue of whether these GMOs should be labeled so that customers can make informed purchases is in a heated debate in California. California Proposition 37, which would require labeling of GMOs, will soon be voted in November this year. Proponents from both sides have poured millions of dollars into the campaign.
GMOs are plants that have been genetically engineered to be enhanced with characteristics that do not occur naturally, so that the harvest can be increased and the cost can be lowered. One example of a prominent GMO is soybean. Monsanto–a Missouri based chemical and agriculture company–introduced its genetically modified soybean, Roundup Ready, in 1996. Roundup Ready is infused with genes that resist weed-killers. In 2010, 93% of soybeans planted in the United States were Roundup Ready soybeans.
Although GMOs are one of the most promising solutions to address the sustainability of food supply in view of the growing global population, there are concerns in the public regarding their safety, and confusion as to which federal agency has responsibility for regulating them.
Amanda Welters in her article “Striking a balance: revising USDA regulations to promote competition without stifling innovation” published in the Minnesota Journal of Law, Science, and Technology explains the current regulatory scheme of GMOs. Three primary agencies regulate GMOs: the Food & Drug Administration (FDA), the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA). The FDA regulates GMOs in interstate commerce that are intended to be consumed by animals or humans as foods, the EPA monitors how growing of GMOs impacts the environment, and the USDA assesses the safety of growing GMO plants themselves.
Specifically, the Animal and Plant Health Inspection Service (APHIS) in the USDA is responsible for ensuring crops are free of pests and diseases. APHIS is currently in the process of revising its regulations for GMOs in an attempt to improve transparency, eliminate unnecessary regulations and enhance clarity of regulations. Under the proposed regulations there will be three types of permits for GMOs: interstate movement, importation, and environmental release.
Taking the position that GMOs are generally beneficial and unavoidable, Welters suggests that the USDA should frame a regulatory structure similar to the Hatch-Waxman Act and the Biosimilar Act to promote both innovation and competition. Readers interested in the regulatory issues of GMOs and the balance between the interests of patent innovators and generic follow-ons would find Welters’ article informative and insightful.