Washington, DC
January 19, 2009
The U.S. Department of
Agriculture's Animal and
Plant Health Inspection Service (APHIS) today introduced a
pilot of the biotechnology quality management system (BQMS). The
system is part of continued efforts to enhance compliance with
the regulatory requirements for field trials and movements of
certain genetically engineered (GE) organisms.
“Our goal with the biotechnology quality management system is to
give developers the tools they need to better comply with our
regulations,” said Michael Gregoire, deputy administrator for
APHIS’ biotechnology regulatory services program. “The pilot
project provides us with an opportunity to further develop and
improve the system before its full implementation.”
APHIS has accepted five volunteer participants into the pilot
project: Bayer CropScience, BASF Plant Science, J.R. Simplot
Plant Science, Pioneer Hi-Bred International and the University
of Nebraska at Lincoln. The participants will develop, implement
and maintain a quality management system within their
organization to proactively manage the movement and field
release of regulated GE organisms. As part of the process, they
will:
- Work to identify
vulnerabilities in their processes for working with GE
organisms,
- Develop or revise standard operating procedures that
address vulnerabilities,
- Properly train personnel on the standard operating
procedures and
- Undergo a third-party audit to determine effectiveness of
their quality management system.
The pilot project also will test
the feasibility of the BQMS audit standard and accompanying
guidelines, available at
http://www.aphis.usda.gov/biotechnology/news_bqms.shtml. The
guidelines will be used by the participants as they develop
their system. A formal comment period on the audit standard also
will be announced in the Federal Register.
APHIS regulates the importation, interstate movement and
release into the environment of certain GE organisms. APHIS
announced its intention of developing a voluntary compliance
assistance system in fall 2007 to help universities, small
businesses and large companies develop sound management
practices to enhance compliance with APHIS regulatory
requirements for GE organisms. BQMS is intended to supplement
existing APHIS regulatory and inspection requirements. |
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