Genetically Engineered Plants for Food & Feed
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 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.
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.
Most bioengineered plants are considered "regulated articles" under regulations of the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA). At some stage of research and development of a regulated article that is intended for use as a food crop, a developer requests from APHIS a determination of the article's regulatory status. For additional information about APHIS' regulation of bioengineered plants, see APHIS' Role in Biotechnology on the USDA/APHIS Internet site.
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.
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.