SECURE rule paves way for biotechnology innovation

From the U.S. Department of Agriculture

U.S. Secretary of Agriculture (USDA) Sonny Perdue announced last month a final rule updating and modernizing the USDA’s biotechnology regulations under the Plant Protection Act. The Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule will bring USDA’s plant biotechnology regulations into the 21st century by removing 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. This new rule will help provide America’s farmers access to these critical tools to help increase agricultural productivity and sustainability, improve the nutritional value and quality of crops, combat pests and diseases, and enhance food safety.

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 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.

The rule was published in the Federal Register on May 18. 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 is on APHIS’ website.