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UNL part of national project to develop biotechnology quality standards

Nebraska

The University of Nebraska-Lincoln is the only university selected to participate in a U.S. Department of Agriculture pilot project to develop quality management standards for field releases of regulated genetically-engineered crops.

UNL was selected by USDA's Animal and Plant Health Inspection Service following an application process, said Dan Duncan, assistant dean of UNL's Agricultural Research Division. Four other participants selected for the biotechnology quality management system pilot project are private companies.

"When you're the only university selected in the nation picked to work on this it's recognition of the good, safe work a lot of our faculty have done," Duncan said.

The purpose of the project is to identify how APHIS regulations for the field release and movement of regulated genetically-engineered crops can be fine-tuned, Duncan said. Currently, APHIS strictly regulates the movement of genetically-engineered organisms from labs to greenhouses to fields. Regulations cover such things as labeling, record-keeping, shipping and storage of the materials and are meant to prevent any potential environmental problems.

UNL has conducted numerous field release trials of genetically-enhanced material for several years. The field trials are an important part of UNL's biotechnology pipeline that links research, insertion of traits and the field testing of those traits, Duncan said.

"Ultimately, our goal is to develop new products that when commercialized will benefit Nebraska's agriculture industry," Duncan said. "This BQMS process helps ensure that UNL remains a national leader in this area."

The USDA wants to determine if the regulations are reasonable or overly burdensome for both universities and private industry, Duncan said.

"Our goal with the biotechnology quality management system is to give developers the tool they need to better comply with our regulations," Michael Gregoire, deputy administrator for APHIS' biotechnology regulatory services program, said in a USDA news release.

USDA intended to select only one university for the project, and UNL was selected because it does more field releases of genetically-engineered organisms than any other institution, Duncan said. UNL also has a good relationship with APHIS, he said.

The four others involved in the project are Bayer CropScience, BASF Plant Science, J.R. Simplot Plant Science and Pioneer Hi-Bred International.

The five participants will: work to identify vulnerabilities in their processes for working with genetically-engineered organisms; develop or revise procedures addressing vulnerabilities; train personnel on standard operating procedures; and undergo a third-party audit to determine effectiveness of their quality management system.

Duncan is working on the project with Tom Clemente, a faculty member in the Department of Agronomy and Horticulture and head of UNL's Plant Transformation Core Research Facility, and Pat Tenopir, research coordinator for field releases at UNL's Center for Biotechnology.

ARD is a division of UNL's Institute of Agriculture and Natural Resources.



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