Acting Agriculture Secretary Chuck Conner announced a new program to
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.
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 underway 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 (APHIS) intends to
oversee the Biotechnology Quality Management System program in
partnership with USDA's Agricultural Marketing Service (AMS), 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]