Biotechnology

GIPSA Biotechnology Reference Laboratory

In 2001 GIPSA established a Biotechnology laboratory at the Technology and Science Division in Kansas City, Missouri. The Biotechnology group contributes to the agency’s mission by responding to genetically modified (GM) grain products that are inadvertently released into the marketplace, validating Polymerase Chain Reaction (PCR) methods for accurate detection and quantification of specific GM traits, administering the USDA-GIPSA Proficiency Program, and developing research projects that help promote international harmonization of biotech testing methods.

Support of APHIS (Animal and Plant Health Inspection Service) investigations

On occasion, a GM trait in grain or oilseeds that has not yet been approved for release is found or alleged to have been found in unapproved locations. This finding often has the effect of trade disruption in the suspect grain or oilseed. When such an “inadvertent release” occurs, the GIPSA Biotechnology laboratory provides technical expertise, sample evaluation, detection method valuation, and other available resources to assist APHIS in investigating and resolving the issue. The Biotechnology workgroup responds to inadvertently released products by performing third party verification of PCR methods and assessing other factors which contribute toward analytical variability including sampling, DNA extraction and quantification etc. After receiving methods from life science companies, the workgroup validates PCR methods to accurately quantify newly commercialized GM traits introduced into the market.

Rapid Test Kit Performance Evaluation Program

The grain industry needs fast, reliable tests to detect the presence of GM grains and oilseeds. To ensure that reliable, rapid tests are commercially available, GIPSA provides a program to verify the performance of commercial test kits designed to detect GM material in grain and oilseeds. GIPSA evaluates the performance of these rapid test kits and confirms that the test kits operate in accordance with manufacturers' claims. This program was initially used to evaluate rapid test kits developed to detect the presence of the Cry9C protein produced in Starlink™. Since that time, the program has expanded to include evaluation of test kits that detect a wide range of GM traits. For manufacturers interested in submitting a rapid test kit for verification, design criteria and test performance specifications can be found at: Biotech Criteria Documentation. Additional information regarding recent changes to the program can be found at: Biotech Test Kit Criteria Supporting Documentation.

Proficiency Program

In February 2002, GIPSA began offering a Corn and Soybean Proficiency Program to organizations testing for GM grains and oilseeds. Development of this program helped to reduce market disruptions resulting from the inadvertently released Starlink™ corn trait. The Proficiency Program assists organizations in identifying areas of concern and taking corrective actions to improve testing capability and reliability. Currently the program has roughly 200 participating organizations, approximately 100 of which participate in a given round of biannual sample dissemination. Through this program, USDA seeks to improve the overall performance of testing for GM grains and oilseeds in the United States. More information on this program can be found at GIPSA Proficiency Program.


For additional questions or to participate in the program, contact Mani Ramaswamy at 816-891-0418, or by e-mail at FGIS-CSPP@usda.gov

Sampling Guidelines

Recognizing that sampling is the single largest source of error in the analysis of grains, GIPSA developed and offered sampling guidelines to the grain-handling industry.

Marketing Documents