APHIS Announces Final Notice on Additional Exemptions for the Movement of Organisms Modified or Produced Through Genetic Engineering

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WASHINGTON, November 12, 2024 –The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) is sharing its final notice describing additional modifications plants can have and qualify for exemption from the regulations at 7 CFR part 340 because the modifications could be achieved through conventional breeding.  This notice becomes effective upon publication in the Federal Register on November 13, 2024. APHIS has also updated its guide to assist developers with requesting a confirmation of exemption from regulation.   

  1. APHIS received and considered nearly 6,500 comments on the proposal it published in November 2023, and is now finalizing two additional modifications that:provide additional flexibilities in how developers can use biotechnology to create modified plants that could have been achieved through conventional breeding; and 
  2. increase the number of modifications a plant can contain, from one modification to as many as twelve modifications, and qualify for exemption from regulation.

This notice brings APHIS’ biotechnology regulations up to date with advances in science, technology, and conventional breeding techniques and ensures that plants with similar characteristics are treated similarly from a regulatory perspective.

APHIS anticipates that expanding the scope of modifications that plants can contain and be exempt from its regulations will foster innovation, enable a larger number of smaller businesses and academic institutions to engage in innovative agricultural product development, and expand the number and variety of new crops being developed through biotechnology. 

Under 7 CFR part 340, developers can review our exemptions to determine if their modified plant meets the criteria for regulatory exemption. They can also voluntarily request that APHIS confirm their modified plant meets the criteria for regulatory exemption.  To learn more about these additional modifications plants can contain and qualify for exemption from regulation, please consider registering to attend our stakeholder meeting on November 14.

View Federal Register Final Notice 

View Guide for Requesting a Confirmation of Exemption

View Updated Agenda and Register for the APHIS BRS Stakeholder Meeting

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APHIS protects the health of U.S. agriculture and natural resources against invasive pests and diseases, regulates genetically engineered crops, administers the Animal Welfare Act, and helps people and wildlife coexist. We also certify the health of U.S. agricultural exports and resolve phytosanitary and sanitary issues to open, expand, and maintain markets for U.S plant and animal products.

USDA touches the lives of all Americans each day in so many positive ways. In the Biden-Harris Administration, USDA is transforming America’s food system with a greater focus on more resilient local and regional food production, fairer markets for all producers, ensuring access to safe, healthy and nutritious food in all communities, building new markets and streams of income for farmers and producers using climate smart food and forestry practices, making historic investments in infrastructure and clean energy capabilities in rural America, and committing to equity across the Department by removing systemic barriers and building a workforce more representative of America. To learn more, visit www.usda.gov.