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  1. Food Ingredients & Packaging

Food from New Plant Varieties

Consumer Info About Food From Genetically Engineered Plants

FDA regulates the safety of food for humans and animals, including foods produced from genetically engineered (GE) plants. Foods from GE plants must meet the same food safety requirements as foods derived from traditionally bred plants. Read more at Consumer Info About Food From Genetically Engineered Plants.

How FDA Regulates Food from Genetically Engineered Plants

The existing FDA safety requirements impose a clear legal duty on everyone in the farm to table continuum to market safe foods to consumers, regardless of the process by which such foods are created. It is unlawful to produce, process, store, ship or sell to consumers unsafe foods. Read more on How FDA Regulates Food from Genetically Engineered Plants.

FDA Requests Comments about Genome Editing in Plants

On January 18, 2017, FDA announced a Request for Comments (RFC) seeking public input to help inform its regulatory approach to human and animal foods derived from plants produced using genome editing. The RFC asks for data and information in response to questions about the safety of foods from genome edited plants, such as whether categories of genome edited plants present food safety risks different from other plants produced through traditional plant breeding.

Additionally, the agency is asking for information on how best to engage small businesses, including those that may be considering using genome editing to produce new plant varieties for use in human or animal food. Read more on Foods Derived From Plants Produced Using Genome Editing.

FDA's Biotechnology Policy

In the Federal Register of May 29, 1992 (57 FR 22984), FDA published its "Statement of Policy: Foods Derived from New Plant Varieties" (the 1992 policy). The 1992 policy clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with respect to human foods and animal feeds derived from new plant varieties and provided guidance to industry on scientific and regulatory issues related to these foods. The 1992 policy applied to all foods derived from all new plant varieties, including varieties that are developed using recombinant deoxyribonucleic acid (rDNA) technology. This site refers to foods derived from plant varieties that are developed using rDNA technology as "bioengineered foods."

In an ongoing effort to modernize the regulatory system for products of biotechnology, the Executive Office of the President, along with the FDA, the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA), has released the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. This final update was completed after reviewing public comments submitted in response to the Proposed Update to the Coordinated Framework, released on September 22, 2016. Read more on Modernizing the Regulatory System for Biotechnology Products.

Consultation Procedures

In the 1992 policy, FDA recommended that developers consult with FDA about bioengineered foods under development; since issuance of the 1992 policy, developers have routinely done so. In June 1996, FDA provided additional guidance to industry on procedures for these consultations (the consultation procedures). These procedures describe a process in which a developer who intends to commercialize a bioengineered food meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the bioengineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food; FDA evaluates the submission and responds to the developer by letter.

Premarket Notification Proposal

In the Federal Register of January 18, 2001 (the premarket notification proposal; 66 FR 4706, available as text and 193 KB PDF), FDA issued a proposed rule that would require that developers submit a scientific and regulatory assessment of the bioengineered food 120 days before the bioengineered food is marketed. In the premarket notification proposal, FDA recommends that developers continue the practice of consulting with the agency before submitting the required premarket notice. The comment period for the proposed rule ended on April 3, 2001.

Guidance for Submissions

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety

EPA Regulation of Pesticidal Substances

The safe use of pesticidal substances is regulated by the Environmental Protection Agency (EPA). Thus, a bioengineered food that is the subject of a consultation with FDA may contain an introduced pesticidal substance also known as a plant-incorporated protectant (PIP) that is subject to review by EPA. For additional information about EPA's regulation of bioengineered foods that contain a pesticidal substance, see EPA's Internet site.

International Plant Biotechnology Resources

FDA participates in international activities on foods derived from modern biotechnology including the safety assessment and regulation of GE plants and actively shares information with other participating countries.

International guidelines for risk analysis and safety assessments of foods from Genetically Engineered (recombinant-DNA) Plants:

From Codex Alimentarius

International safety assessments of food from GE Plants from the Food and Agriculture Organization of the United Nations

Antibiotic Resistance Draft Guidance

On May 6, 2015, FDA withdrew the Draft Guidance for Industry entitled: Use of Antibiotic Resistance Marker Genes in Transgenic Plants. The guidance was not finalized. If you have any questions about the use of antibiotic resistance marker genes in genetically engineered plants intended for use in human food, please contact the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition at 240-402-1226. If you have questions about the use of antibiotic resistance marker genes in genetically engineered plants intended for use in animal food, please contact the Division of Animal Feeds, Office of Surveillance and Compliance in the Center for Veterinary Medicine at (240) 402-7077.


Industry Guidance