A new program should help universities, small businesses and large companies develop sound management practices to enhance compliance with regulatory requirements for field trials and movements of genetically engineered (GE) organisms, says acting Agriculture Secretary Chuck Conner.
The new Biotechnology Quality Management System, a voluntary compliance assistance program, is scheduled for initial implementation in spring 2008.
“Biotechnology is a key component of our growing agricultural economy,” said Conner. “USDA’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.”
USDA’s biotechnology initiative complements a program called “Excellence Through Stewardship,” which is already under way in the biotechnology industry. While industry’s program is focused on quality management to ensure product integrity of biotech-derived plant products throughout the product life cycle, USDA will emphasize the quality of the process for safely introducing these GE organisms in compliance with federal regulations.
The Biotechnology Quality Management System was developed to be as inclusive as possible so that a broad array of participants could participate. It will consist of two program levels, based on domestically and internationally recognized quality management systems. Specifically,
(1) Level-A program: This program will be designed for participants that do not have formal quality management systems in place. It will help them develop good management procedures and will be geared toward small businesses and universities.
(2) Level-B program: Companies and researchers that have formal management systems in place may choose to participate in the Level-B program. This program is intended for those participants that grow GE plants at multiple sites, often through the use of cooperators, and will include training guidelines and documentation procedures to ensure accountability at all levels by all involved parties.
USDA’s Animal and Plant Health Inspections Service intends to oversee the Biotechnology Quality Management System program in partnership with USDA’s Agricultural Marketing Service, which will manage the audit component of the program and accredit third party auditors. Audits will verify that participants have procedures in place, and that they are performed correctly to meet the regulatory requirements for any given GE field trial or movement. As part of the program’s emphasis on preventive measures, participants will be encouraged to correct deficiencies discovered in an audit before compliance problems develop.
The Biotechnology Quality Management System and its associated audits will complement, not replace, APHIS’ current regulatory compliance and inspection process by focusing on planning and good management practices that can improve a participant’s ability to meet regulatory requirements. The current inspection program will continue to cover specific permits and notifications to ensure compliance with regulations.
APHIS, in partnership with AMS, will implement the voluntary system through an agency notice and participation in the program will not be a regulatory requirement. APHIS also will work proactively to provide outreach and guidance to those companies and researchers that choose to participate and develop these quality management programs.
Currently there are several audit-based, quality verification systems in operation throughout USDA’s marketing and regulatory programs mission area, such as AMS’ Process Verified Programs. APHIS regulates the confined field release, interstate movement and importation of GE organisms.
APHIS currently ensures compliance with regulations through inspections conducted at critical stages, consistent and appropriate enforcement actions and comprehensive record keeping and reporting requirements.
Quality management systems are intended to improve regulatory compliance by fostering a company’s commitment to sound controls, quality management practices and effective compliance with federal regulatory requirements.
Additional information about the Biotechnology Quality Management System is available at www.aphis.usda.gov.