Compliance Assistance

Compliance Assistance

Biotechnology Regulatory Services provides compliance assistance to organizations involved in biotechnology research and development, including small businesses and academic researchers, to facilitate compliance with APHIS regulations (7 CFR part 340) for the import, interstate movement, and field release of regulated genetically engineered (GE) organisms. Compliance assistance is provided to the regulated community through a variety of mechanisms including education, template procedures and forms, the Biotechnology Quality Management System (BQMS) Program, and collaboration with academia and private and public stakeholders.


Education
Education is an important mechanism used to provide compliance assistance to the regulated community. Education is provided through a variety of activities including speaking engagements, webinars, and publications.

Upcoming Speaking Engagements

None at this time.  Please check back later.

Sign-up to become a BRS Stakeholder to receive information regarding upcoming workshops and other BRS news and information.

Publications


Template Procedures and Forms
A variety of template procedures and forms are available for use by the regulated community to facilitate compliance.

  • Template for Notification Design Protocols: This template may be used by organizations for the development of standard operating procedures for the introduction of regulated articles under 7 CFR part 340.3: Notification for the introduction of certain regulated articles.
  • Template for Permit Design Protocols: This template may be used by organizations for the development of standard operating procedures for the introduction of regulated articles under 7 CFR § 340.4: Permits for the introduction of a regulated article.
  • BQMS Program Development Tools: These tools, while designed to assist BQMS Program participants in developing their own BQMS, can be used by any organization interested in developing a documented quality management system to facilitate compliance to the APHIS regulations.


BQMS Program
The Biotechnology Quality Management System (BQMS) Program provides participants with the tools and guidance needed to develop a BQMS that is tailored to their organization's needs and to better maintain compliance with APHIS regulations for the import, interstate movement, and field release of regulated genetically engineered (GE) organisms.

List of BQMS Participating Organizations

Register as a BRS Stakeholder to receive automatic notifications of compliance assistance activities.


For more information, e-mail BRS.BQMS@aphis.usda.gov.

 

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