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USDA Announces Availability of Biotechnology Quality Management System
WASHINGTON, Oct. 5, 2010 – The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) is advising the public that it has developed an audit standard for its Biotechnology Quality Management System Program (BQMS Program). The BQMS Program fulfills one of the provisions of the 2008 U.S. Farm Bill, directing APHIS to improve management and oversight of biotechnology, research and development.
In fiscal year 2009, APHIS completed work with five organizations on the initial BQMS pilot. The pilot participants provided input on the draft audit standard, training workshops and procedures established for the BQMS Program.
Using the audit standard, regulated entities implement procedures to:
- Improve management of regulated activities;
- Maintain a positive chain of custody;
- Maintain records;
- Account for genetically engineered material;
- Conduct periodic audits;
- Establish an appropriate training program;
- Provide contingency and corrective action plans; and
- Submit required reports to APHIS in a timely fashion.
Each organization that voluntarily implements the BQMS Program conduct internal audits to make sure that its quality management system is being followed at all levels. The organization is also audited by an independent third party.
The audit standard will be used by regulated entities to facilitate compliance with the regulatory requirements for field trials and movements of regulated genetically engineered organisms by developing and implementing sound management practices.
The BQMS audit standard and the comment evaluation document, as well as additional information about the BQMS Program, may be found on the APHIS website at www.aphis.usda.gov/biotechnology/news_bqms.shtml.
Notice of this action is published in today’s Oct. 5 Federal Register.