(Washington, D.C., March 28, 2018) – U.S. Secretary of Agriculture Sonny Perdue today issued a statement providing clarification on the U.S. Department of Agriculture’s (USDA) oversight of plants produced through innovative new breeding techniques which include techniques called genome editing.

Under its biotechnology regulations, USDA does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques as long as they are not plant pests or developed using plant pests. This includes a set of new techniques that are increasingly being used by plant breeders to produce new plant varieties that are indistinguishable from those developed through traditional breeding methods. The newest of these methods, such as genome editing, expand traditional plant breeding tools because they can introduce new plant traits more quickly and precisely, potentially saving years or even decades in bringing needed new varieties to farmers.

“With this approach, USDA seeks to allow innovation when there is no risk present,” said Secretary Perdue. “At the same time, I want to be clear to consumers that we will not be stepping away from our regulatory responsibilities. While these crops do not require regulatory oversight, we do have an important role to play in protecting plant health by evaluating products developed using modern biotechnology. This is a role USDA has played for more than 30 years, and one I will continue to take very seriously, as we work to modernize our technology-focused regulations.”

“Plant breeding innovation holds enormous promise for helping protect crops against drought and diseases while increasing nutritional value and eliminating allergens,” Perdue said. “Using this science, farmers can continue to meet consumer expectations for healthful, affordable food produced in a manner that consumes fewer natural resources. This new innovation will help farmers do what we aspire to do at USDA: do right and feed everyone.”

USDA is one of three federal agencies which regulate products of food and agricultural technology. Together, USDA, the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) have a Coordinated Framework for the Regulation of Biotechnology that ensures these products are safe for the environment and human health. USDA’s regulations focus on protecting plant health; FDA oversees food and feed safety; and EPA regulates the sale, distribution, and testing of pesticides in order to protect human health and the environment.

USDA continues to coordinate closely with its EPA and FDA partners to fulfill oversight responsibilities and provide the appropriate regulatory environment. This ensures the safety of products derived from new technologies, while fostering innovation at the same time.

 

Details on USDA Plant Breeding Innovations

USDA is committed to helping farmers produce healthy, affordable food in a sustainable manner that protects this country’s natural resources and offers more choices for consumers. Through innovative methods, plant scientists can now create new plant varieties that are indistinguishable from those developed through traditional breeding methods. These new approaches to plant breeding include methods like genome editing and present tremendous opportunities for farmers and consumers alike by making available plants with traits that may protect crops against threats like drought and diseases, increase nutritional value, and eliminate allergens.

In keeping with our responsibility to protect plant health, USDA has carefully reviewed products of these new technologies to determine whether they require regulatory oversight.

As USDA works to modernize its biotechnology regulations, the vision and direction of this Department will be to continue to focus regulatory initiatives on the basis of risk to plant health.  

Under its biotechnology regulations, USDA does not currently regulate, or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques as long as they are developed without the use of a plant pest as the donor or vector and they are not themselves plant pests. This can include plant varieties with the following changes:

• Deletions—the change to the plant is solely a genetic deletion of any size.
• Single base pair substitutions—the change to the plant is a single base pair substitution.
• Insertions from compatible plant relatives—the change to the plant solely introduces nucleic acid sequences from a compatible relative that could otherwise cross with the recipient organism and produce viable progeny through traditional breeding.
• Complete Null Segregants—off-spring of a genetically engineered plant that does not retain the change of its parent.

USDA will continue working with other Executive Branch Departments, our domestic stakeholders, trading partners and international organizations to advance this science-based and practical approach that protects plant health while allowing for technological advancements in accordance with the Report of the Interagency Task Force on Agriculture and Rural Prosperity.

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