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Animal and Plant Health Inspection Service
U.S. Department of Agriculture

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Implementing the SECURE Rule

Last Modified: Jun 2, 2020
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The SECURE 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.  The biotechnology community will have to learn some new processes and meet new requirements in accordance with the implementation schedule. We are available to support you through this process. It is our goal to minimize regulatory burden and help you comply with our regulations.


MORE INFORMATION BELOW

  • Regulatory activities remain unchanged for 90 days

"AM I REGULATED?" REQUEST

  • The "Am I Regulated?" (AIR) Process is discontinued. APHIS no longer accepts AIR requests.

PERMITTING/ NOTIFICATIONS

  • Developers continue using the preexisting permitting and notification processes until April 4, 2021.


PETITIONS

  • Developers continue to use the preexisting petition process until April 4, 2021.

EXEMPTIONS AND CONFIRMATIONS

  • The new exemptions and confirmation process takes effect, and replace the “Am I Regulated?” process and extension processes. If the organism doesn’t qualify for exemption, applicants can continue to use the existing petition process.


PERMITTING

  • For plants and organisms developed using genetic engineering that fall within the scope of the regulations, applicants continue to use the preexisting permitting and notification processes until April 4, 2021.


§§ 340.3, 340.4, 340.6, 340.7, 340.8

  • With exception of the permitting and RSR process, all other aspects of the rule are implemented (definitions, record retention, compliance, CBI, costs)

PERMITTING

  • The notification process is discontinued. Applicants begin following the new permitting process described in § 340.5.


PETITIONS/RSR

  • The Regulatory Status Review (RSR) process described in § 340.4 is implemented for certain crops, including corn, soybean, cotton, potato, tomato, and alfalfa. APHIS will continue accepting petitions for all other crops until September 30, 2021.

PETITIONS/RSR

  • The RSR process takes effect for all crops.  APHIS will no longer accept any petitions.
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