List of Completed Consultations on Bioengineered Foods

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) (available in PDF - 2 MB). 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."

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), 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.

USDA/APHIS Regulation of Bioengineered Plants

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.

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. In the table below, FDA has used an asterisk (*) to identify each bioengineered food that contains a PIP. For additional information about EPA's regulation of bioengineered foods that contain a pesticidal substance, see EPA's Internet site.

The FDA List of Completed Consultations on Bioengineered Foods

The table below lists all completed consultations about bioengineered foods. This table:

• Identifies each consultation by a file number (biotechnology notification file no.; BNF No.);
• Provides the date when the developer submitted its scientific and regulatory assessment of the food;
• Identifies the developer, with a hyperlink to the developer's address;
• Identifies the application(s) of the food (e.g., in human food, animal feed, or both);
• Identifies the food crop that was modified;
• Uses an asterisk to identify a bioengineered food that contains an introduced pesticidal substance, which is subject to regulation by EPA;
• Identifies the product of the transferred gene, usually a protein, that confers the intended trait to the plant or the gene (or gene fragment) that was transferred to the bioengineered food;
• Identifies the original source of genetic material that was transferred to the bioengineered food;
• Describes the intended effect of the modification;
• Provides the developer's distinctive designation for the subject of the consultation;
• Provides the date of the agency's letter responding to the submission and a hyperlink to the text of that letter; and
• Provides the date of the agency's final memorandum regarding the submission and a hyperlink to the text of that memorandum. The memorandum contains detailed information about the new bioengineered plant.