We are exploring options to enhance the Biotechnology Quality Management System (BQMS) Program and are currently not accepting new participants for the program as it is described below. We expect to maintain some, but not all elements of the BQMS described below; however, any changes will be announced in a Federal Register notice. To receive that Federal Register notice automatically, along with other ongoing information about our biotechnology regulatory actions, please join our Biotechnology Regulatory Services (BRS) Stakeholder Registry. The description of BQMS below will be updated if any changes are finalized.
BRS will continue to provide compliance assistance to organizations involved in biotechnology research and development, including small businesses and academic researchers, to facilitate compliance with APHIS regulations at 7 CFR part 340 for the importation, interstate movement, and field release of regulated genetically engineered (GE) organisms.
For compliance assistance requests and related questions please contact us at BRS.BQMS@aphis.usda.gov. Thank you for your patience.
The Biotechnology Quality Management System (BQMS) Program helps organizations involved in biotechnology research and development, including small businesses and academic researchers, analyze the critical control points within their management systems to better maintain compliance with the APHIS regulations (7 CFR part 340) for the import, interstate movement, and field release of regulated genetically engineered (GE) organisms. In addition, the BQMS Program provides clarity and expectations of regulatory responsibilities to the regulated community.
Each participant's BQMS focuses on effective planning of activities, checking the results of planned activities, and taking action with a goal towards continuous improvement. The operation of the BQMS is constantly self-verified and further validated through third-party audits.
The Office of Compliance Assistance (OCA) provides participants with the tools and guidance needed to develop a BQMS that is tailored to their organization's culture and needs. Compliance assistance is provided through:
For more information, e-mail BRS.BQMS@aphis.usda.gov.
Participating in the BQMS Program
Learn if your organization is qualified to participate in the BQMS Program, the advantages of voluntarily implementing a BQMS, and the cost of participating.
BQMS Participant Information
Participants develop, implement, and maintain a BQMS within their organization to manage the movement and field release of regulated GE organisms. Specifically, organizations.
BQMS Program Operational Procedures
The Office of Compliance Assistance follows documented procedures, to ensure consistent delivery of the BQMS Program. In addition, BQMS Program auditors utilize the BQMS Program audit checklists and guidelines to ensure consistent auditing practices.