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USDA won’t regulate genome editing

Secretary Perdue said decision allows new breeding techniques to proceed if no risk is present.

Under its biotechnology regulations, the U.S. Department of Agriculture 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 were developed using plant pests. In a statement, U.S. Agriculture Secretary Sonny Perdue said USDA will not offer regulatory oversight through innovative new breeding techniques, which include genome editing.

Plant breeders are increasingly using these new techniques 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,” Perdue said. “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.”

Perdue added, “Plant breeding innovation holds enormous promise for helping protect crops against drought and diseases while increasing nutritional value and eliminating allergens. 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.”

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, USDA said.  

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 — offspring of a genetically engineered plant that does not retain the change of its parent.

USDA is one of three federal agencies that regulate the products of food and agricultural technology. Together, USDA, the Environmental Protection Agency and the Food & Drug Administration have a Coordinated Framework for the Regulation of Biotechnology that is designed to ensure that 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 said it 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.

National Grain & Feed Assn. president and chief executive officer Randy Gordon said it is important for grain handlers, grain processors and exporters that the government exert strong and effective leadership in interacting with governmental authorities in other countries to urge adoption of science- and risk-based approaches to the regulatory treatment of plant breeding innovation so there is not a recurrence of the significant and costly international trade disruptions that occurred with some transgenic biotech traits.

Gordon said, "Time is of the essence, and we have every reason to believe USDA will do its part within a coordinated and robust U.S. government outreach effort that also needs to involve the U.S. Food & Drug Administration and Environmental Protection Agency. Engagement with these agencies' governmental counterparts in U.S. export markets is critical in bringing about development of a coherent international regulatory environment that preserves the benefits and efficiencies of a commingled, fungible grain and oilseed supply chain while enabling efficient, cost-effective trade to continue unabated."

Gordon added that it is important to communicate with consumers proactively about the safety and benefits of these new plant-breeding techniques. "It also is incumbent upon plant breeders and the seed industry to be forthcoming with accurate and timely information about the specific innovative plant breeding techniques being developed for commercial use in food and feed crops -- through a proactive, comprehensive advance notification and ongoing consultation process -- to enable the grain and food industries to respond to commercial demand and inquiries from domestic and international customers and consumers," he said.

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