Biotechnology has brought major production efficiencies to some U.S. crops, and is regulated by three federal agencies under a coordinated framework to ensure the safety of genetically modified crops.


Background:
Genetically modified (GM) crops are widely grown around the world, and in the United States they constitute a large majority of several major field crops. Farmers have improved crop varieties through breeding over thousands of years; biotechnology uses modern science to introduce beneficial traits such as tolerance to particular herbicides or insect protection. The resulting production efficiencies mean lower costs for farmers, less use of synthetic chemicals in many cases, and affordable food supplies for consumers. While GM technology has sometimes been controversial, most U.S. farmers have argued that the opportunity to better feed the world’s growing population should not be forgone on the basis of fear that is unaccompanied by evidence.

biotech-iconIn 2014, GM crops accounted for 94% of soybeans planted in the U.S., 96% of all cotton and 93% of corn. Widespread adoption testifies to the advantages of these crops. Herbicide-tolerant crops offer environmental and management benefits, while insect-protected crops may increase yields or reduce insecticide costs. Some GM crops also make it more feasible for farmers to practice conservation tillage, leaving more crop residue in the field and thus reducing soil erosion, cutting down on water and chemical runoff, while also adding organic matter to soils.

Program Operation: Biotechnology products in the United States are regulated according to a system, the Coordinated Framework, established by the Office of Science and Technology Policy in 1986. The regulation of agricultural biotechnology products is handled by three agencies:

  • U.S. Department of Agriculture Animal and Plant Health Inspection Service – APHIS’ role is to ensure that plants with introduced traits are safe for agriculture and the environment. The agency has oversight of field testing, interstate movement and importation of plants developed through biotechnology. It reviews scientific information prior to authorizing field-testing of biotechnology-derived plants through either a permitting or notification process to ensure field trials are safely conducted. Prior to unrestricted commercialization, APHIS must complete a plant pest risk and an environmental risk assessment, with an opportunity for public input.
  • The Environmental Protection Agency – The EPA regulates any pesticide that may be present in food and sets tolerance levels (or exemptions from tolerance) to provide a high margin of safety for consumers. This includes plants developed through biotechnology. EPA has responsibility to assess the safety of a protein or trait that confers a pesticidal property in terms of human and animal consumption, as well as for the environmental and non-target organisms. EPA also regulates the use of herbicides over new plant varieties that are tolerant to that herbicide, as part of its overall regulatory authority over herbicides.
  • Food and Drug Administration, Center for Food Safety and Nutrition – The FDA’s CFSAN imposes on foods developed through biotechnology the same regulatory requirements it uses to safeguard all foods in the marketplace. The FDA has both pre-market and post-market authority to regulate the safety and labeling of all foods and animal feed. Foods from biotechnology are judged on their individual safety and nutrition, not the methods used to produce them. Under federal law, the producer of a food is legally required to ensure its safety for consumers, and FDA may pull from the market any foods found to be unsafe. Since 1992, FDA has used a voluntary review process for biotechnology foods to determine whether these foods are substantially equivalent to their traditional counterparts. Over 100 such products have been reviewed, and none has been found to pose a safety concern. All foods and feeds from GM crops currently on the market have undergone a prior consultation process with FDA to make certain that they meet FDA’s standards.

Administration and Enforcement: Authority is shared among the Animal and Plant Health Inspection Service (APHIS) of the Department of Agriculture, the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) of the Department of Health and Human Services.

Statutory Authority: 7 U.S.C. 104, 7 U.S.C. 136-136y, 21 U.S.C. 346a, 21 U.S.C. 301-399a

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