APHIS Seeks Participants in Biotech Quality Management System Program

The Animal and Plant Health Inspection Service (APHIS) has issued a notice requesting voluntary participation in a program designed to improve compliance with regulations pertaining to the importation, interstate movement and environmental release of genetically engineered (GE) organisms. APHIS conducted a pilot Biotechnology Quality Management System (BQMS) Program in 2009 and has since refined its draft audit standard and procedures and program training sessions.

The program is intended to help all regulated entities, including universities, small businesses and large companies, to develop “sound management practices through the creation and implementation of a customized biotechnology quality management system.” Participants will be expected to attend several training sessions, develop a BQMS within their organization, establish procedures addressing the movement and field testing of regulated GE organisms, participate in evaluations, and submit to a third-party verification audit. Letters of interest may be submitted at any time, but APHIS encourages submission as soon as possible because training sessions will be scheduled for summer and fall 2010. See Federal Register, July 19, 2010.