In order to protect plant health, Biotechnology Regulatory Services (BRS) implements APHIS regulations for certain genetically engineered (GE) organisms that may pose a risk to plant health. APHIS coordinates these responsibilities along with the other designated federal agencies as part of the Federal Coordinated Framework for the Regulation of Biotechnology.
Established as a formal policy in 1986, the Coordinated Framework for Regulation of Biotechnology describes the Federal system for evaluating products developed using modern biotechnology.
APHIS regulates the introduction (importation, interstate movement, or environmental release) of certain genetically engineered (GE) organisms. All regulated introductions of GE organisms must be authorized by APHIS under either its permitting or notification procedures.
BRS has a comprehensive system to help ensure that biotechnology organizations are maintaining compliance with APHIS’ biotechnology regulations.
The Biotechnology Quality Management System (BQMS) Program helps biotechnology researchers and organizations analyze the critical control points within their management systems to help them better maintain compliance with APHIS regulations.
A person may petition the agency that a particular regulated article is unlikely to pose a plant pest risk, and, therefore, is no longer regulated under the plant pest provisions of the Plant Protection Act or the regulations at 7 CFR part 340. The petitioner is required to provide information under § 340.6(c)(4) related to plant pest risk that the agency may use to determine whether the regulated article is unlikely to present a greater plant pest risk than the unmodified organism. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act when APHIS determines that it is unlikely to post a plant pest risk.
For more information on BRS' enhanced petition process, including information on transitioning pending petitions, please see our Petition Process Improvements Web page.
APHIS' Improved Petition Process
In November 2011, APHIS announced plans to improve the agency's process for making determinations on petitions for nonregulated status for GE organisms. To learn more about APHIS' improved petition process, click here.
Guidance for Petitions
If you can't find answers to your questions about the petition process here, please contact a BRS biotechnologist by sending your questions to email@example.com.