Modernizing the Regulatory System for Biotechnology Products
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.
We regulate human and animal food from genetically engineered (GE) plants like we regulate all food. 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.
FDA’s role is to ensure that everyone in the farm to table continuum is meeting this obligation. We encourage producers of new foods and food ingredients to consult with FDA when there is a question about an ingredient’s regulatory status. This general practice extends to foods produced using genetic engineering techniques.
Plant Biotechnology Consultation Program
FDA created the Plant Biotechnology Consultation Program in the 1990’s to cooperatively work with GE plant developers to help them ensure foods made from their new GE plant varieties are safe and lawful. In this program, we evaluate the safety of food from the new GE crop before it enters the market.
Although the consultation program is voluntary, GE plant developers routinely participate in it before bringing a new GE plant to market. FDA completed its first plant biotechnology consultation in 1994. Thus far, we have evaluated more than 150 GE plant varieties through this program. For a list of completed consultations, see our Biotechnology Consultations database.
How the Program Works
During the initial consultation phase, GE plant developers meet with FDA and explain their GE product to FDA. FDA can then provide feedback about the kinds of data and information that would be important to consider in a safety assessment.
The final consultation phase begins once a GE plant developer completes its safety assessment and submits a summary of the assessment to FDA.
FDA evaluates the data and information in the summary to identify any unresolved food safety and nutritional issues or other legal considerations. Some examples of questions we ask in this evaluation include:
- Does food from the GE plant contain a new toxin or allergen?
- Is food from the GE plant as nutritious as that from its traditionally bred counterpart?
If FDA identifies an issue that needs to be addressed, we work with the developers to get the information needed to resolve it.
When all safety and other regulatory issues are resolved, and the data and information logically support the conclusion that food from the new plant variety will be as safe as food from conventionally bred varieties, we conclude the consultation with a letter to the GE plant developer. The letter reminds the developer that they remain legally obligated to ensure the safety of the food products they bring to market.
Finally, FDA posts the relevant information and documentation to the Biotechnology Consultations on Food from GE Plant Varieties section of its website for public viewing. The posting includes the following items:
- Submission date
- Developer name and contact information
- Basic information about the GE plant variety
- The FDA response letter
- A memo summarizing the data and information FDA evaluated
This is only a brief summary of the consultation process. For detailed guidance, GE plant developers should read our Guidance on Consultation Procedures – Foods Derived from New Plant Varieties.
Benefits of the Program
- Helps FDA promote a safe food supply by ensuring that foods from GE plants are safe and lawful.
- Allows FDA to collect valuable data and information about new foods from food producers.