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U.S. Government Safety Requirements

he food industry stands behind foods and food products that have been improved through biotechnology, and ensures that they meet all federal requirements for food quality and safety. Food companies have a critical stake in ensuring and safeguarding the integrity of their brands.

The U.S. Government as well plays an important role in ensuring food safety. In particular:

All foods must be safe to be marketed. Several federal agencies are involved in determining the safety of biotechnology in food and food production, and a coordinated framework to ensure human and environmental safety was put into place more than a decade ago. These agencies and their responsibilities are: the U.S. Food and Drug Administration (FDA), which has responsibility for the safety and labeling of whole foods and food ingredients, including food additives; the U.S. Department of Agriculture (USDA), which has authority over biotech plants and meat and poultry ingredient labeling, and production processes; and the U.S. Environmental Protection Agency (EPA), which registers the use of pesticides and herbicides.
Prior to commercialization, food and food products enhanced through biotechnology must conform with state and federal marketing requirements, including seed certification laws, the Federal Food, Drug, and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Plant Pest Act.
Since 1992 the FDA has determined that foods from plants produced through biotechnology are, as a class, as safe as those from plants developed through conventional breeding, and should therefore be regulated the same as any other foods entering the market. Accordingly, the FDA evaluates the application of biotechnology to food products on a case-by-case basis, as it does with any other food.
Under the Food, Drug and Cosmetic Act, the FDA usually focuses on the product, the food, or food ingredients rather than on the plant development processes used in their production, as the basis for regulation. The same holds true for food and ingredients derived from biotechnology. The FDA offers a decision-tree approach for companies developing plant-based biotech foods. These decision-trees represent a series of testing procedures that enable food processors to anticipate safety concerns and to consult with the FDA as necessary for regulatory review of new plant varieties and product testing under development.

The FDA assessment process focuses on the following areas:

The safety and nutritional value of newly introduced proteins.
The identity, composition and nutritional value of modified carbohydrates, fats or oils.
The concentration and bioavailability of important nutrients for which a food crop is consumed.
The potential for food allergens to be transferred from one food source to another.
Toxins characteristic of host and donor plants.

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.

Ecological Effects

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.

EPA Regulations

The EPA’s 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:

  • United Nations Food and Agriculture Organization
  • World Health Organization
  • National Research Council
  • American Medical Association
  • American Dietetic Association

U.S. Food and Drug AdministrationIFICEatright.OrgU.S. Department of Agriculture

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