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Coordinated Framework

How the Federal Government Regulates Biotech Plants

The Federal government has a coordinated, risk-based system to ensure that new biotechnology products are safe for the environment and human and animal health. Established as a formal policy in 1986, the Coordinated Framework for Regulation of Biotechnology describes the Federal system for evaluating products developed using modern biotechnology. The Coordinated Framework is based upon existing laws designed to protect public health and the environment. The U.S. government has written new regulations, policies, and guidance to apply these laws to biotechnology-derived products.

The U.S. Government agencies responsible for oversight of the products of agricultural modern biotechnology are the USDA's Animal and Plant Health Inspection Service (USDA-APHIS), the U.S. Environmental Protection Agency (EPA), and the Department of Health and Human Services' Food and Drug Administration (FDA). Depending on its characteristics, a product may be subject to the jurisdiction of one or more of these agencies. Regulatory officials from the three agencies regularly communicate and exchange information to ensure that any safety or regulatory issues that may arise are appropriately resolved.

Roles of U.S. Regulatory Agencies

USDA's Animal and Plant Health Inspection Service (APHIS)
Within USDA, the Animal and Plant Health Inspection Service (APHIS) is responsible for protecting agriculture from pests and diseases. Under the Plant Protection Act, USDA-APHIS has regulatory oversight over products of modern biotechnology that could pose such a risk. Accordingly, USDA-APHIS regulates organisms and products that are known or suspected to be plant pests or to pose a plant pest risk, including those that have been altered or produced through genetic engineering. These are called "regulated articles." USDA-APHIS regulates the import, handling, interstate movement, and release into the environment of regulated organisms that are products of biotechnology, including organisms undergoing confined experimental use or field trials. Regulated articles are reviewed to ensure that, under the proposed conditions of use, they do not present a plant pest risk through ensuring appropriate handling, confinement and disposal.

USDA-APHIS regulations provide a petition process for the determination of non regulated status. If a petition is granted, that organism will no longer be considered a "regulated article" and will no longer be subject to oversight by USDA-APHIS. The petitioner must supply information such as the biology of the recipient plant, experimental data and publications, genotypic and phenotypic descriptions of the genetically engineered organism, and field test reports. The agency evaluates a variety of issues including the potential for plant pest risk; disease and pest susceptibilities; the expression of gene products, new enzymes, or changes to plant metabolism; weediness and impact on sexually compatible plants; agricultural or cultivation practices; effects on non-target organisms; and the potential for gene transfer to other types of organisms. A notice is filed in the Federal Register and public comments are considered on the environmental assessment and determination written for the decision on granting the petition. Copies of the USDA-APHIS documents are available to the public.

For more information, visit: www.aphis.usda.gov/biotechnology/index.shtml.


U.S. Environmental Protection Agency (EPA) 
The EPA through a registration process regulates the sale, distribution and use of pesticides in order to protect health, and the environment, regardless of how the pesticide was made or its mode of action. This includes regulation of those pesticides that are produced by an organism through techniques of modern biotechnology. The Biopesticides and Pollution Prevention Division of the Office of Pesticide Programs, under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), regulates the distribution, sale, use and testing of pesticidal substances produced in plants and microbes. Generally, Experimental Use Permits are issued for field testing. Applicants must register pesticidal products prior to their sale and distribution, and the EPA may establish conditions for use as part of the registration. The EPA also sets tolerance limits for residues of pesticides on and in food and animal feed, or establishes an exemption from the requirement for a tolerance, under the Federal Food, Drug and Cosmetic Act.

For more information, visit: www.epa.gov/pesticides/biopesticides/pips/index.htm.


U.S. Food and Drug Administration (FDA)
The FDA is responsible for ensuring the safety and proper labeling of all plant-derived food and feed, including those developed through genetic engineering. All food and feed, whether imported or domestic and whether derived from crops modified by conventional breeding techniques or by genetic engineering techniques, must meet the same rigorous safety standards. Under the Federal Food, Drug, and Cosmetic Act, it is the responsibility of food and feed manufacturers to ensure that the products they market are safe and properly labeled. In addition, any food additive, including one introduced into food or feed by way of plant breeding, must receive FDA approval before marketing. (The term "food additive" refers to substances introduced into food that are not pesticides and are not generally recognized as safe by qualified scientific experts.)

The FDA ensures that food and feed manufacturers meet their obligations through its enforcement authority under the Federal Food, Drug, and Cosmetic Act. To help sponsors of food and feed derived from genetically engineered crops meet their legal obligations, the FDA encourages manufacturers to participate in its voluntary consultation process. Developers routinely consult with FDA prior to marketing. The goal of the consultation process is to ensure that human food and animal feed safety issues or other regulatory issues are resolved prior to commercial distribution.

For more information, visit:www.fda.gov/Food/FoodScienceResearch/Biotechnology/Submissions/default.htm.



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