U.S.D.A. to offer biotechnology management program

by Josh Sosland
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WASHINGTON — A voluntary compliance program designed to help universities and companies comply with regulatory requirements for field trials and movements of bioengineered organisms will be launched in spring 2008, the U.S. Department of Agriculture said Sept.20.

"Biotechnology is a key component of our growing agricultural economy," said Acting Agriculture Secretary Chuck Conner, announcing the new Biotechnology Quality Management System (B.Q.M.S.). "U.S.D.A.’s program will help the biotechnology sector become better stewards by focusing on the implementation of best management practices so that problems can be prevented."

The new program seeks to complete the existing "Excellence Through Stewardship," a program introduced in July by the Biotechnology Industry Organization.

"While industry’s program is focused on quality management to ensure product integrity of biotech-derived plant products throughout the product life cycle, U.S.D.A. will emphasize the quality of the process for safely introducing these genetically engineered organisms in compliance with federal regulation," the U.S.D.A. said.

The Department said the B.Q.M.S. has been crafted to accommodate a broad range of participants. Its two participation levels are based on quality management systems that are recognized locally and internationally.

o Level A program: Designed for participants without formal quality management systems in place. It will help them develop good management procedures and will be geared toward small businesses and universities.

o Level B program: Companies and researchers with formal management systems in place may choose to participate in the Level B grogram. This program is intended for participants that grow bioengineered plants at multiple sites, often though the use of cooperators, and will include training guidelines and documentation procedures to ensure accountability at all levels by all involved parties.

Oversight of the B.Q.M.S. will be handled within the Department by the Animal and Plant Health Inspections Service in partnership with U.S.D.A.’s Agricultural Marketing Service, which will measure audit components in the program. Audits, to be conduced by the A.M.S., will verify that participants have procedures in place and that they are performed correctly to meeting the regulatory environment of any biotechnology G.E. field trial or movement. Participants will be encouraged to correct deficiencies discovered in an audit before compliance problems develop.

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