June 18, 2020

Dear BRS Stakeholder,

As part of its ongoing efforts to implement the new Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) biotechnology regulations, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) is making available guidance and hosting webinars to assist developers with submitting requests to confirm that plants meet established criteria for regulatory exemption.

Beginning on August, 17, 2020, developers will be able to start submitting confirmation requests. To help stakeholders prepare prior to the implementation date, APHIS has updated its Confidential Business Information (CBI) guidance and posted Questions and Answers to the APHIS SECURE webpage.

In addition, APHIS is hosting two technical webinars to review the confirmation of exemption process and give stakeholders the opportunity to ask questions. The webinars will be held on June 24, 2020, and August 5, 2020; from 1pm-2:30pm EDT on both days.

Registration for the June 24 and August 5 webinars is available on the APHIS website.

Under the SECURE rule, plants may be designated as exempt from regulation if they fall under one of three categories:

• plants with certain modifications that could otherwise have been achieved through conventional breeding;
• plants with crop/trait combinations that were previously reviewed and which are unlikely to pose an increased plant pest risk; and
• specific plants determined to not be regulated by APHIS pursuant to its “Am I Regulated?” process.

We hope you find these new resources helpful in understanding the exemptions and the confirmation process. If you have questions, we recommend discussing your request for confirmation of an exemption with APHIS prior to your first submission. You may request a discussion by sending a message to APHIS at ConfirmationRequests@usda.gov.