Genetically Modified Organisms Policy

Plant Teaching & Research Facility


The use of genetic manipulation and other techniques to produce genetically modified organisms (GMO’s) is common in plant science research. Transgenic plants and plant pests are subject to federal and state regulations, rules and guidelines.

At Duke University, authority over recombinant DNA research is held by the Institutional Biosafety Committee (IBC) which operates in the Biological Safety Division of the Occupational & Environmental Safety Office.  However, ultimately, responsibility for following all federal and state regulations and guidelines pertaining to the safe handling of GMO’s lies with the principal investigator (PI).    


Any experiment using GMO’s in the Plant Teaching & Research Facility (PTRF) must be registered with the Duke University Institutional Biosafety Committee

Also, the researcher should indicate on the greenhouse or phytotron space request form that the experiment will contain GMO’s.  The researcher, along with the IBC and the PTRF staff, will determine which biosafety level is appropriate for the experiment.  Containment and management strategies will then be formulated according to that biosafety level.  Containment and management measures are determined on a case-by-case basis.

“The PI is ultimately responsible for the research project and for ensuring compliance with biosafety standards.  The PI functions as project manager as well as researcher, being responsible for training and supervising personnel, communicating with the IBC, regulators, greenhouse manager and support staff, and correcting any operations that may result in a loss of containment.” (Adair, D. and R. Irwin. 2008.  A Practical Guide to Containment. Information Systems for Biotechnology.  VPI.  Blacksburg, VA.)

Regulatory Agencies

GMO’s are regulated by three U.S. agencies:  the Department of Agriculture, the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA).  In certain biosecurity situations the Department of Health and Human Service’s Center for Disease Control (CDC) may also be involved.

On the state level the regulatory agency for GMO’s is the Plant Protection Section of the N.C. Department of Agriculture and Consumer Affairs.

As previously stated, regulation of GMO’s at the local level is by the Duke University Institutional Biosafety Committee.


The primary regulatory reference is the National Institutes of Health’s Guidelines for Research Involving Recombinant DNA molecules (NIH Guidelines).  It is available online. Appendix P of the Guidelines addresses physical containment for plant work.

For pragmatic guidance, an excellent resource is A Practical Guide to Containment—Plant Biosafety in Research Greenhouses.  This manual is available online.