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Biotechnology

Office of Compliance Assistance

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The Office of Compliance Assistance 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 inlcuding speaking engagements, webinars, and publications

Upcoming Speaking Engagements

  • USDA Regulatory Permitting and Compliance Education Workshop, May 13, 2013, at the University of Tennessee in Knoxville, TN.
  • USDA Regulatory Permitting and Compliance Education Workshop, June 4, 2013, at the University of Alabama in Huntsville, AL.
  • USDA Regulatory Permitting and Compliance Education Workshop, June 14, 2013, at Virginia Polytechnic Institute and State University in Blacksburg, VA.

For more information, email BRS.BQMS@aphis.usda.gov.

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

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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.

View ISO Certificate No. FS 589668

For more information, email BRS.BQMS@aphis.usda.gov.

 

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Last Modified: April 11, 2013


GovDelivery

An ISO certified program
ISO 9001:2008
FM 535173
FS 589668