Regulation of Agricultural Biotechnology
Federal Regulation
The Federal Government placed regulation of agricultural GE under the control of existing Federal agencies who had expertise with different aspects of the technology. The Federal Government's Office of Science and Technology Policy document, Coordinated Framework for the Regulation of Biotechnology, specifies that three Federal agencies are responsible for regulating biotechnology in the United States. These agencies are:
- U.S. Department of Agriculture's Animal and Plant Health Inspection Service (USDA-APHIS) - Responsible agricultural and environmental safety of crops including the control of plant pests
- Environmental Protection Agency (EPA) - Responsible for ensuring that pesticides, including those genetically engineered into living plants, can be safely consumed and used in the environment
- U.S. Department of Health and Human Services' Food and Drug Administration (FDA) - Responsible for ensuring the safety of food and food ingredients including those derived from genetic engineering
Permitting and Deregulation Process
Researchers must have government approval before they can move a plant from the laboratory into the open environment for field-testing. A detailed application is submitted to the Biotechnology Regulatory Services (BRS) unit of USDA-APHIS. Scientists review the application to determine if there are environmental risks and impose conditions for approval. Compliance with regulations and conditions are enforced by APHIS audits and inspections. Following adequate field-testing and data collection, developers file a petition for the determination of non-regulated status. (USDA deregulation fact sheet) Products that have been deregulated no longer fall under APHIS authority unless they become a plant pest in the future.
Plants that contain pesticides (Plant Incorporated Protectants - PIPs) or herbicide resistance fall under EPA regulation and must follow the EPA registration and permitting process. The EPA also regulates any plants that contain genetic material from different genera and these are treated as new organisms until the effects on humans and the environment are evaluated.
The FDA evaluates the safety of crops that are used for food and feeds. The GE food is evaluated for nutrition, risk of allergens, and the presence of toxins. Comparisons are made between the GE food and its non-GE form. One criticism is that the FDA uses a voluntary consultation process to assist producers in meeting their obligations for safety and labeling instead of a formal approval process. All the GE foods being used have gone through this process.
State Regulation of Agricultural Biotechnology
While state agencies do not have direct authority over GE products they are notified when APHIS recieves an application for field testing. The Hawaii Department of Agriculture (HDOA) works closely with BRS to determine the risk for environmental damage and advises the federal agenciy about approval and approval restrictions.
"BRS has never approved a field test permit over the objections of State counterparts or without accommodating additional permit conditions recommended by the States. Before approving any
permit, BRS consults with the Hawaii Department of
Agriculture (HDOA) officials who play an important role in
reviewing all proposed field trials." (USDA Regulation of
Biotechnology Field Tests in Hawaii Fact Sheet)