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Animal and Plant Health Inspection Service
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USDA SECURE Rule: Guidance Available for Preparing Proposals to Exempt Plants with Additional Modifications

The U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) is sharing Guidance for Preparing Proposals to Exempt Plants with Additional Modifications from regulation under the Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule.

On August 17, 2020, exemptions from the SECURE rule became effective, as did a process for developers to request confirmation from APHIS that a modified plant meets the criteria for exemption from the biotechnology regulations in 7 CFR part 340.  Over time, APHIS expects new plant breeding innovations to evolve with advances in science and technology, along with further developments of scientific information related to conventional plant breeding.  To ensure they keep pace with these advances and developments, the biotechnology regulations include a process by which the Administrator can identify additional modifications that plants can contain and be exempt from the regulations, based on what could be achieved through conventional breeding.  This guidance document describes the process members of the public may use to prepare and submit proposals to exempt plants with additional modifications from regulation.  

This guidance document, along with additional information on this provision of the SECURE rule, can be found on the APHIS website.



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