Washington, DC
September 20, 2007
Acting Agriculture Secretary Chuck Conner today 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.
Trascript:
http://www.aphis.usda.gov/newsroom/content/2007/09/content/printable/BQMS_transcript.pdf
Fact Sheet:
http://www.usda.gov/documents/fs_bqms9-2007.pdf |
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