FGIS Biotechnology Reference Laboratory

In 2001 FGIS 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-FGIS 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 FGIS 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 contributing factors to 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 Evaluation (TKE)

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, FGIS provides a Rapid Test Kit Evaluation program to verify the performance of commercial test kits designed to detect GM material in grain and oilseeds. FGIS evaluates the performance of these rapid test kits and confirms that the test kits operate in accordance with manufacturers' claims. Initially this program evaluated 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.

Manufacturers interested in submitting a rapid test kit for verification should review our Biotech Criteria Documentation (pdf) for design criteria and test performance specifications.

Additional information regarding recent changes to the program are available in our Biotech Test Kit Criteria Supporting Documentation (pdf).

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For additional information regarding Biotech Rapid Test Kits please contact

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