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FDA's Voluntary Plant Biotechnology Consultation Program Eases Pathway to Marketplace

By: Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition (CFSAN), and Dennis Keefe, Ph.D., Director, Office of Food Additive Safety, CFSAN

Photo of Susan T. Mayne, Ph.D.
CFSAN Director, Susan Mayne, Ph.D.

Advancements in the field of plant biotechnology are bringing dynamic new food products to the marketplace. These foods help meet the needs of a growing world population and can help prevent food insecurity globally. The U.S. Food and Drug Administration (FDA) is committed to helping foster innovation in this field by working with developers to ensure that consumers can be confident that foods developed through the use of biotechnology meet the FDA’s high safety standards.

Plant biotechnology refers to certain methods scientists can use to introduce new traits or characteristics to a plant. For example, biotechnology may be used to produce plants with characteristics resulting in resistance to insect pests, reduced food waste, reduced levels of potentially harmful elements such as allergens or process-induced contaminants such as acrylamide or improved nutritional profiles.

The FDA’s voluntary premarket Plant Biotechnology Consultation Program provides developers the opportunity to engage with the FDA to help navigate the appropriate regulatory pathways and, ultimately, bring safe, innovative plant-based products to market. The program provides individualized advice from the agency’s knowledgeable biotech and food safety experts — before new plant-derived products are made available for human or animal consumption. As part of this program, the FDA works cooperatively with developers to help ensure foods made from new plant varieties are safe and lawful.

Developers of new plant varieties generally meet with the FDA early in their product development process to obtain preliminary feedback about their overall direction and potential food safety considerations as well as the kinds of data and information that would be important to consider in a safety assessment. After taking the FDA’s feedback into consideration, developers may modify their approach if needed to mitigate any safety concerns, such as potential increased allergenicity, or begin to gather the data and information needed to successfully complete a food safety assessment. Developers then submit a summary of their food safety assessment to the FDA, allowing the agency to formally evaluate the submission and its data and information as efficiently as possible. This phase of the consultation allows an opportunity for developers and the FDA to work through any potential unresolved food safety issues or other legal considerations.

Dennis Keefe, Ph.D.
Director, Office of Food Additive Safety, CFSAN, Dennis Keefe, Ph.D.

Once all safety and regulatory issues have been addressed, the FDA provides written confirmation that the agency has no further questions regarding the developer’s safety assessment and reminds the developer of their legal obligations as food producers to ensure the safety of the food products they bring to market. This consultation process provides for a rigorous safety evaluation based on the objective characteristics of the food under consideration and has helped to instill consumer confidence in plant biotechnology products evaluated by the FDA in the U.S. and around the world. The FDA has conducted 184 such consultations since 1995 with no food safety concerns emerging post-consultation.

We recently used the consultation program to engage with Calyxt Inc. on its FAD2KO high-oleic soybean — the first “genome-edited” plant to complete our voluntary premarket Plant Biotechnology Consultation Program. “Genome editing” is a term used to describe a relatively new set of technologies that enable one to make precise changes in the DNA of a plant, animal or other living organism. This soybean was developed to contain high levels of oleic acid, a common monosaturated fat found in products such as olive oil. High oleic acid edible oils, such as the oil produced from this soybean variety, do not contain trans fat, providing a healthier alternative to partially hydrogenated oils that are currently being phased out of the market.

During the consultation, the FDA evaluated data and information submitted by Calyxt, Inc. to assess the safety and nutritional profile of the FAD2KO soybean. We concluded that we had no further questions regarding Calyxt’s determination that oils produced using the FAD2KO soybean are similar to other high oleic oils that are currently on the market and safely consumed by humans, such as olive oil, high oleic sunflower oil, canola oil, safflower oil, and other soybean oils with increased oleic acid content. FDA’s evaluation of the data and information submitted as part of this consultation provides reassurance to the developer, foreign trading partners and consumers that foods derived from this new soybean variety are safe to eat. Further, this genome-edited product illustrates some of the opportunities and potential benefits of plant biotechnology, such as the targeted enhancement of specific nutritional properties of a product.

The FDA encourages developers of innovative products to utilize our voluntary consultation process as an efficient tool to help ensure the safety of plant biotechnology products, to instill public confidence in the use of such technologies and avoid unnecessary barriers to future innovations that could have potential health or other benefits.

Fostering Innovation in Biotechnology

In October 2018, FDA announced an action plan with steps we intend to take to foster innovations in the fields of plant and animal biotechnology. This Plant and Animal Biotechnology Innovation Action Plan reaffirms FDA’s commitment to promoting and encouraging innovation in this evolving space and lays out the policy priorities the agency is pursuing to clarify FDA’s science-and-risk-based approach to innovative plant and animal biotechnology products. The intent remains to prevent unnecessary barriers to future innovation in plant and animal biotechnology, while ensuring new advances in biotechnology meet FDA’s safety (and where applicable, efficacy) standards.

In accordance with the action plan, the FDA intends to publish guidance later this year clarifying the regulatory approach for food from plants developed with the newest tools of genome editing and building on the agency’s extensive experience providing world-class food safety evaluations as part of the voluntary premarket Plant Biotechnology Consultation Program. The goal of this guidance will be to provide the clarification necessary to help ensure that all developers, including small- and medium-size firms, can continue to explore innovations in the biotechnology sector with a greater understanding of their responsibilities under our regulatory framework.

The FDA recognizes that multiple federal agencies play important roles in regulating products of plant biotechnology. Under the Coordinated Framework for the Regulation of Biotechnology, the FDA works closely with other federal partners — particularly the Environmental Protection Agency (EPA) and the U.S. Department of Agriculture (USDA) — to oversee the safety of new varieties of plants. Each federal partner plays an integral role in ensuring the safety of biotechnology products in the marketplace. Generally, the FDA helps to ensure the safety and proper labeling of human and animal foods; EPA regulates the sale, distribution and use of pesticides in order to protect health and the environment including new plant varieties developed using plant biotechnology, and USDA is responsible for protecting agriculture from pests and diseases that may result from new plant varieties developed through plant biotechnology.

Collaboration and coordination among our federal partners helps ensure developers have the necessary tools to understand the appropriate regulatory pathways for commercialization of new plant varieties. This integrated system also allows developers to coordinate with the appropriate agencies on a product-by-product basis, helps to foster an efficient, effective review process, and allows the federal government to adapt to new technological advances in the dynamic biotechnology sector. The FDA is also committed to educating consumers about this technology and is currently developing an Agricultural Biotechnology Consumer Education Initiative, in partnership with USDA and EPA, that we hope to launch by early next year.

With the FDA’s science-based regulatory framework and over two decades of experience in the regulation of plant biotechnology products, the FDA has emerged as a trusted global leader in the regulation of these products. American farmers and biotechnology developers are leaders in providing safe and innovative food products at home and abroad, and the FDA remains committed to supporting innovation and doing our part to ensure that products that come into the U.S. food supply meet the FDA’s high safety standards.

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