In order to protect plant health, Biotechnology Regulatory Services (BRS) implements the 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.
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.
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.
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.