Shandong Luba Chemical Co.,Ltd Beijing Multigrass Formulation Co., Ltd. Seed IndustryGene Editing USDA: No plans to regulate gene-edited plants

Agriculture Secretary Sonny Perdue today issued a statement making it clear that USDA does not regulate, or have any plans to regulate, plants produced through new breeding tools such as genome editing, as long as they are not plant pests or developed using plant pests.

USDA said the new tools are increasingly being used to produce new plant varieties 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,” USDA said in a news release.

“With this approach, USDA seeks to allow innovation when there is no risk present,” Perdue said in the release. “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 added. “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.”

The Animal and Plant Health Inspection Service issued a statement with further details on the department's position. It included examples of the type of changes to plant varieties that USDA does not regulate or plan to regulate:

• 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 is one of three federal agencies that regulate products of food and agricultural technology. Along with the EPA and the Food and Drug Administration, the agencies work under a Coordinated Framework for the Regulation of Biotechnology designed to make sure 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.

USDA says it will continue 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,” it said.

The Biotechnology Innovation Organization (BIO) commended USDA for the clarification.

“Regulatory clarity and predictability is essential for all product developers, but is especially important for small company and public-sector plant breeders that are using gene editing tools to improve crop plants,” Karen Batra, BIO’s managing director for agriculture & environment communications, said in an email.

“USDA’s clarification of its regulatory oversight of gene-edited plant products will facilitate the sort of agricultural innovation that was highlighted in the President’s Task Force on Agriculture and Rural Prosperity,” she said.

The National Grain and Feed Association said the U.S. government must now use its influence to make sure other countries adopt 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.”

NGFA was referring to China's refusal in 2013 to accept cargoes of a genetically modified corn product which had been approved by the U.S. but not by China.

“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 and Drug Administration and Environmental Protection Agency,” said Randy Gordon, NGFA president and CEO. “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 also called on 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.”