The FDA assessment process focuses on the following areas:
Product Safety Data
To ensure safety, a variety of toxicological and other product safety data may need to be supplied to the FDA for food products or ingredients produced through the use of new plant varieties.
USDA and EPA currently have primary responsibility for assessing the ecological effects of new plants developed through biotechnology. The Animal and Plant Health Inspection Service (APHIS) within the USDA is the primary agency regulating the safety testing of biotechnology-enhanced plants that are not insect or disease resistant. APHIS approval generally must be obtained before proceeding to field-test or commercialize a biotechnology-derived plant.
In order to test a biotechnology-derived plant in the field, applicants seek from APHIS an environmental release permit. The applicant must include information on the plant, the origin of any new genes or gene products it contains and the purpose and method of conducting the test. APHIS evaluates the application and any potential environmental impact of the proposed test field. A streamlined notification process is also available, in which APHIS has 30 days to review the notification prior to any testing. The safety requirements for both procedures are the same.
Once testing is allowed, APHIS and state agriculture officials can inspect the test field throughout the process to ensure that tests are conducted safely.
Before biotechnology-enhanced crops can be grown commercially, a petition must be submitted to APHIS containing scientific details about the plant, results of field tests and any indirect effects on other plants. This petition is published in the Federal Register, allowing the public time to comment.
In addition to APHIS, the EPA, which also regulates herbicides, also has jurisdiction over crops that are insect and disease resistant under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Environmental exposure to pesticide substances produced in crops is regulated by the EPA to ensure that there are no unreasonable adverse effects on the environment, including non-targeted insects, birds, fish, deer and other species.
The EPAs regulations focus on the pesticide produced by the plant, rather than on the plant as a whole. Such pesticides are subject to registration requirements similar to other pesticides. The agency requires developers of new plant-pesticides to obtain experimental use permits, and EPA officials prior to any field testing must review and approve permit applications for genetically enhanced pesticides in crop plants containing pesticidal properties.
The safety of biotechnology has been supported by numerous national and international health organizations, including:
U.S. Food and Drug AdministrationIFICEatright.OrgU.S. Department of Agriculture
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