USDA is updating its biotechnology regulations under the Plant Protection Act. This is the first comprehensive revision of the regulations since they were established in 1987. The Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient, or 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., USDA says.

The American Seed Trade 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. In the rule, USDA also recognizes the continuing evolution of the science of plant breeding and, thus, has included a mechanism for additional exemptions, ASTA says.

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. This 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.

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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 considered thousands of comments received in response to the proposed rule. 

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APHIS’ rule is final on the day it is published in the Federal Register. The new rule’s provisions become effective on key dates over the next 18 months. A complete overview of the effective dates for the provisions in the final rule and a description of the implementation process are on the APHIS website.

Comments

“USDA’s SECURE rule will streamline and modernize our regulatory system, facilitate science-based innovations, and provide our farmers with the tools they need to produce the world’s safest, most abundant, and most affordable food supply, which will help us continue to Do Right and Feed Everyone – safely," said Agriculture Secretary Sonny Perdue.

“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.

“We are pleased USDA has moved forward with the rulemaking process, following earlier guidelines to include new plant breeding technologies like gene editing and technologies like CRISPR," said National Sorghum Producers CEO Tim Lust. "USDA's approach is commensurate with the broadly acknowledged low-risk and substantial benefits associated with these breeding innovations. We are hopeful that EPA will follow USDA's lead so the improvements in pest and disease resistance can also be achieved through these techniques without and expansion of an unnecessary regulatory burden."

“We are pleased with USDA’s final rule streamlining the regulatory process for low-risk biotech crops to come to market,” said Kentucky soy grower Caleb Ragland, who chairs the American Soybean Association Regulatory Committee. “By establishing a common-sense regulatory process to ensure new biotech plants varieties are reviewed quickly with predictable timelines and allowed to go to market if they pose no risk, soybean growers can remain efficient and competitive through this continued access to innovation.”

“The SECURE rule strikes the right balance of protecting plant health while positioning U.S. agriculture at the forefront of innovation,” said House Agriculture Committee Ranking Member K. Michael Conaway, R-Texas. “I am also looking forward to updates to the regulatory framework for gene-edited animals that ends the misguided regulation that inaccurately defines animals as drugs.”

“The SECURE rule gives our scientists regulatory certainty so that their innovations addressing pest and disease pressures, food waste, and climate adaptation can be delivered to the marketplace," said Biotechnology, Horticulture, and Research Subcommittee Ranking Member Neal Dunn, R-Florida. "We are all now awaiting EPA and FDA to follow USDA’s leadership to enact pro-innovation biotechnology regulations."

“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 American Seed Trade Association 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.”

“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," said American Farm Bureau Federation President Zippy Duvall. "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.”