Biotech Updates

USDA Announces the Development of Biotech Quality Management System Program

October 15, 2010

The U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) announced that they have developed an audit standard for its Biotechnology Quality Management System (BQMS) Program. This program is in accordance with the 2008 U.S Farm Bill, which mandates APHIS to develop their system on the management and monitoring of biotechnology, research and development.

In fiscal year 2009, APHIS together with five organizations accomplished the initial BQMS pilot. The pilot participants contributed to the draft audit standard, training workshops, and procedures 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.

The regulated entities will use the audit standard to facilitate observance with the regulatory requirements for field trials and movements of regulated genetically engineered organisms by developing and implementing sound management practices.

For more information, read