USDA starts GE quality management pilot 19 Jan 2009
"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."
Five participants
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.
The guidelines will be used by the participants as they develop their system.
About APHIS
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 late 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.
