USDA updates plant breeding regulations with SECURE rule

U.S. Secretary of Agriculture Sonny Perdue announced a final rule updating and modernizing the U.S. Department of Agriculture’s (USDA) biotechnology regulations under the Plant Protection Act. The Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule will remove duplicative and antiquated processes in order to facilitate the development and availability of these technologies through a transparent, consistent, science-based, and risk-proportionate regulatory system.

“EPA applauds USDA’s efforts to finalize the SECURE rule that will support our nation’s farmers,” said US EPA Administrator Andrew Wheeler. “EPA is continuing our own efforts to safely reduce unnecessary regulations and further break down barriers to support advancements in biotechnology. We plan to issue our proposed rule early this summer.”

“Alongside the USDA as they work to implement the SECURE rule, the FDA is committed to encouraging innovation in agricultural biotechnology while utilizing scientific risk-based approaches in our regulatory approach,” said FDA Commissioner Stephen Hahn, M.D.  “FDA is dedicated to making sure that American consumers have confidence in the safety of the food they feed their families.”

USDA’s previous regulations focused on whether a plant pest was used in the development of a plant using genetic engineering and required a lengthy deregulation process for those plants that did not pose increased pest risk. After 30 years of experience, USDA’s Animal Plant Health Inspection Service (APHIS) regulatory scientists know that simply using a plant pest in the development of a plant does not necessarily cause the plant to pose a risk to plant health. Thus, the final rule puts in place a more efficient process to identify plants that would be subject to regulation, focusing on the properties of the plant rather than on its method of production. APHIS will evaluate plants developed using genetic engineering for plant pest risk under a new process called a regulatory status review, regulating only those that plausibly pose an increased plant pest risk. This updated process aligns with the President’s Executive Order for Modernizing Biotechnology and the Coordinated Framework for Biotechnology, and will ensure the regulations keep pace with the latest science and technological advances, reduce regulatory burdens for developers of plants developed using genetic engineering that are unlikely to pose plant pest risks, and ensure that Agency resources are better focused on the prevention of plant pest risk. 

USDA undertook an extensive outreach effort in developing the proposed rule, traveling the nation and meeting with the public, members of academia, state departments of agriculture, grower and commodity-related organizations, and non-governmental organizations.  The Agency also considered comments received during public scoping and comment periods related to the 2008 and 2017 proposed rules, which were later withdrawn; comments on a 2018 Notice of Intent (NOI) to conduct a programmatic environmental impact statement (PEIS); comments on the proposed rule and the draft PEIS; certain provisions of the 2008 Farm Bill; and recommendations from the 2015 USDA Office of Inspector General (OIG) report on genetically engineered organisms. The Agency also met with foreign regulators and international stakeholders. In issuing the final SECURE rule, APHIS carefully considered each of the thousands of comments received in response to proposed rule.  

The rule will publish in the Federal Register on May 18, and will be final that day. The new rule’s provisions become effective on key dates over the next 18 months. USDA is providing an unofficial version of the final rule on its website as a courtesy to the public. The final rule published in the Federal Register constitutes the official version of the rule and may include technical formatting changes from this version. 

ASTA: "We need a science- and risk-based regulatory system"
The American Seed Trade Association (ASTA) shared a statement saying it greatly appreciates the efforts of Secretary Perdue and his team in working to provide clarity around USDA’s regulatory system for genetically engineered organisms.

“All of our nation’s agricultural producers deserve choice and access when it comes to the latest tools available to support the economic and environmental sustainability of their operations,” said ASTA President & CEO Andy LaVigne. “In order for America to remain a leader in innovation, and to address very-real challenges facing our agriculture and food production system—from climate change, to rapidly evolving pests and diseases—we need a science- and risk-based regulatory system that provides a clear pathway to commercialization for products that utilize the latest breeding, research and development tools.”

While ASTA is analyzing the full details of the SECURE rule, the association notes that the rule acknowledges that some applications of gene editing result in the development of plant varieties that are essentially equivalent to varieties developed through more traditional breeding methods and would thus treat these varieties in the same way from a policy standpoint. USDA also rightly recognizes the continuing evolution of the science of plant breeding and, thus, has included a mechanism for additional exemptions. A clear and transparent, science-based process for these future exemptions will be important to support continuing innovation so important to agriculture. The current COVID-19 crisis has further underscored the need for innovative solutions to address the very-real threats facing global food security and agriculture production now and in the future.

Farm Bureau: "Common-sense approach to encouraging innovation"
American Farm Bureau President Zippy Duvall commented: “We appreciate the USDA and Secretary Perdue for their common-sense approach to encouraging innovation. At a time when agriculture is facing many economic headwinds, the science-based rule provides the opportunity to solve current and future challenges for agricultural production and food security. This final rule will ensure the U.S. remains a leader in biotechnology while providing the safe, healthy and wholesome food supply America’s families deserve.”

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