Resources for You
- Biotechnology Safety Assessments - Guidance Documents
- Draft Guidance: Format of Regulatory Submissions to the Office of Food Additive Safety
- Draft Guidance: Submission Format Information Specific to Final Biotechnology Consultations
- Draft Guidance: Submission Format Information Specific to New Protein Consultations
Submissions on Bioengineered New Plant Varieties
In the 1992 policy on new plant varieties, FDA recommended that developers consult with FDA about bioengineered foods under development; since issuance of the 1992 policy, developers have routinely done so. To date, FDA's interactions with developers have taken three forms: biotechnology final consultations, new protein consultations, and rarely, establishment of a food master file or submission of a food additive petition.
Biotechnology Final Consultations
The process for biotechnology consultations is described in FDA's 1997 guidance to industry. In this process, a developer who intends to commercialize a bioengineered food may meet with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the bioengineered food in an initial consultation. With or without an initial consultation, a developer may submit to FDA a summary of its scientific and regulatory assessment of the food (the final consultation). Submissions to the agency under the 1997 guidance are designated biotechnology notification files (BNF). FDA evaluates the submission and responds to the developer by letter. FDA maintains an inventory of completed consultations, which includes the agency's response to the developer and the text of the agency's final memorandum regarding the submission.
In the Federal Register of January 18, 2001 (the premarket notification proposal; 66 FR 4706, available as text and 193 KB PDF), FDA proposed a 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 recommended that developers continue the practice of consulting with the agency before submitting a premarket notice.
New Protein Consultations
In June 2006, 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, for example, proteins produced in bioengineered plants. Submissions to the agency under the early food safety evaluation guidance are designated new protein consultations (NPC). Submission of an early food safety evaluation for a new protein is not meant to substitute for a biotechnology final consultation with FDA about a food derived from a new bioengineered plant variety. If a developer decides to commercialize a new bioengineered plant variety, FDA expects that the developer will participate in the consultation process. Field testing of new bioengineered plants could result in the inadvertent, intermittent, low-level presence in the food supply of proteins that have not been evaluated through FDA's biotechnology consultation process. FDA issued this guidance document to address this possibility. FDA maintains an inventory of completed new protein consultations, which includes the text of agency's response to the developer, as well as the developer's submission.
From time to time, FDA has also received and evaluated information about bioengineered new plant varieties through other types of submissions. FDA maintains an inventory of the agency's responses to these submissions as well.