Better understand genetically engineered foods (GMOs)
Anyone marketing foods is responsible for complying with all applicable laws and regulations, including developers of new plant varieties derived from traditional breeding, genetic engineering, and genome editing. The FDA uses its Plant Biotechnology Consultation Program and its Early Food Safety Evaluation Program (New Protein Consultations) to work with developers of new plant varieties intended for use in human and animal foods to help ensure that their products are safe and lawful prior to marketing.
For additional information, plant developers should visit New Plant Variety Regulatory Information.
Plant Biotechnology Consultation Program
The FDA created the Plant Biotechnology Consultation Program in the 1990’s to cooperatively work with developers of new plant varieties to help them ensure foods made from their new varieties are safe and lawful prior to marketing. The agency issued guidance to industry on consultation procedures under FDA's Statement of Policy for Foods Derived from New Plant Varieties.
Although the consultation program is voluntary, developers of new plant varieties routinely participate in this program before bringing food from a new genetically engineered plant to market. The FDA completed its first plant biotechnology consultation in 1994. This program is also open to foods from genome edited plant varieties or any other plant varieties for which the developer would like to voluntarily consult the FDA. In February 2019, FDA completed its first consultation on a genome edited plant variety- a soybean variety modified to have increased levels of a fatty acid called oleic acid.
In FDA’s consultation process, a developer who intends to commercialize food from a new plant variety may meet with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the food in an initial consultation. During this initial consultation phase, the FDA can provide feedback about the kinds of data and information that would be important to consider in a safety and regulatory assessment.
With or without an initial consultation, the final consultation phase begins when a developer completes its safety and regulatory assessment and submits a summary of its assessment to the FDA. Submissions to the agency under the consultation program are designated biotechnology notification files (BNF).
The FDA evaluates the data and information in the summary to identify whether there are any unresolved food safety or regulatory considerations. Some examples of the questions the FDA considers as part of this evaluation include:
- Does food from the plant contain a new toxin or allergen?
- Is food from the plant nutritionally different from its traditionally bred counterpart?
If the FDA identifies a safety or regulatory issue that needs to be addressed, it works with the developers to obtain the information needed to resolve the issue.
When all safety and regulatory issues are resolved, , the FDA concludes the consultation with a letter to the plant developer. The letter explains that FDA has no questions about the developer’s safety and regulatory assessment and reminds the developer that they remain legally obligated to ensure the safety of the food products they bring to market. The FDA then posts the relevant information and documentation to the Consultations on Food from New Plant Varieties section of its website for public viewing. For more information, please also visit: Final Biotechnology Consultations.
Early Food Safety Evaluation Program (New Protein Consultations)
In June 2006, the FDA announced final guidance describing procedures for the early food safety evaluation of new non-pesticidal proteins produced by new plant varieties that are intended for food. Submissions to the agency under the early food safety evaluation guidance are designated new protein consultations (NPC). This program was developed because field testing of new genetically engineered plants could result in the inadvertent, intermittent, low-level presence in the food supply of proteins that have not been evaluated through the FDA's biotechnology consultation process. The FDA issued this guidance document to address this possibility. Submission of an early food safety evaluation for a new protein is not meant to substitute for a consultation under the plant biotechnology consultation program because the early food safety evaluation addresses only inadvertent, low-level presence of the new protein in food. If a developer decides to commercialize a new genetically engineered or genome edited plant variety, the FDA anticipates that the developer will participate in the plant biotechnology consultation process. The FDA maintains an inventory of completed new protein consultations, which includes the agency's response to the developer, as well as the developer's submission.
The FDA has also received and evaluated information about new plant varieties through other types of submissions. For example, in a small number of cases FDA has received submissions that were filed as Food Master Files or Food Additive Petitions. The FDA maintains an inventory of the agency's responses to these submissions as well.