(Adopted 05/23/2011--Updated 5/16/2014)
The National Institutes of Health (NIH) has established strict guidelines on the proper use and disposal of transgenic plants, seeds, materials and other forms of recombinant or synthetic nucleic acid molecules in research. The document entitled NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), outlines institutional and investigator responsibilities and can be accessed online at: http://osp.od.nih.gov/sites/default/files/NIH_Guidelines.html
Definition of Transgenic Plants
Transgenic plants are plants possessing a single or multiple genes, transferred from a different species or synthetically produced. Though nucleic acid molecules from another species can be integrated into a plants' genome via natural processes, the term "transgenic plants" refers to plants created in a laboratory using recombinant technology. Note:Transgenic plants that have been granted non-regulated status are exempt from the following policy.
Compliance with NIH Guidelines
All NIH funded projects involving rDNA must comply with NIH Guidelines. As per the NIH Guidelines, all non-NIH funded projects involving rDNA conducted at or sponsored by an institution that receives NIH funding must comply with NIH Guidelines.
Failure to follow NIH Guidelines can result in the suspension, limitation, or termination of NIH funds for all rDNA research at MU.
As an NIH-funded institution, MU’s Institutional Biosafety Committee (IBC) has developed both a policy and a protocol, outlined below, which investigators may obtain institutional authorization to work with transgenic plants. As an investigator working with transgenic plants, it is your responsibility to meet these requirements.
MU Policy on Transgenic Plant Research
It is the policy of the MU IBC that all research conducted on the MU campus, other MU facilities or sponsored by the University involving transgenic plants and seeds must receive approval from the Institutional Biosafety Committee (IBC) prior to the start of any work.
Although some projects may qualify as exempt from the NIH Guidelines (USDA & FDA approved), all projects that involve the Environmental Release of Transgenic Plants and Seeds must register by completing an IBC Application. Research projects will be assessed by the IBC on an individual basis.
MU-IBC Protocol for Institutional Approval
You must submit an application in order to initiate the IBC approval process. The Biosafety Section of Environmental Health & Safety (EHS) coordinates the application process. The IBC Application form may be obtained on the EHS Biological Safety web site at: http://ehs.missouri.edu/bio/index.html
IBC Application: http://ehs.missouri.edu/bio/forms/bio-material.doc
IBC Application instructions: http://ehs.missouri.edu/bio/forms/bio-material-instructions.doc
IBC Amendment form: http://ehs.missouri.edu/bio/forms/bio-amend.doc
If you have previously received IBC approval for your project, you are required to update the application information with a IBC Amendment form whenever there are substantial changes in the experimental procedures (i.e. changes in risks, facilities, or personnel,) associated with the project.
Containment of Transgenic Plants
The NIH guidelines specify several methods to prevent the dissemination of plants. Researchers may find it helpful to review Appendix P to review standard containment practices. The type of containment practice and laboratory procedures must be clearly indicated in the IBC Application. http://osp.od.nih.gov/sites/default/files/NIH_Guidelines.html#_Toc351276449
Disposal of Transgenic Plants
Transgenic plants and materials from transgenic plants including seeds and soil must be inactivated prior to disposal to prevent accidental environmental release. Typically, autoclave treatment is employed for transgenic plant, soil and seed inactivation. Disposal procedures must be clearly indicated in the IBC Application. There are no exceptions to this policy without prior notification and approval by the IBC.
NIH guidelines example: Appendix P-II-A-1-c-(1). "Experimental organisms shall be rendered biologically inactive by appropriate methods before disposal outside of the greenhouse facility."Environmental Release of Transgenic Plants and Seeds
The IBC is authorized to approve research of transgenic plants grown in labs, growth chambers or greenhouses. Any experiment conducted outside of these environments (i.e. field plots) constitutes a deliberate environmental release; for these experiments the researcher must obtain MU IBC approval as well as USDA APHIS Field Test Permit. The IBC requires copies of Field Test Plot information and Permits prior to experiment startup.
USDA-APHIS e-authorization: http://www.aphis.usda.gov/permits/ppq_epermits.shtml
Receiving: Complete an IBC Amendment if you are planning to receive transgenic plants and/or seeds from a previously unidentified collaborator.
Shipping: For shipping transgenic plants and/or seeds, refer to USDA-APHIS permitting and DOT requirements.
NIH and MU policy requires that significant research-related incidents be reported immediately to the IBC via the Biosafety Team at EHS. Incidents include research-related accidents and illnesses as well as inadvertent release or improper disposal of biohazardous or recombinant or synthetic nucleic acid moleculres: (Examples, personal injury, non-decontaminated plant parts, seeds, or roots in soil removed from a greenhouse).
If you have Questions or need assistance please contact the Biosafety team:
* 573-882-7018 or by e-mail: firstname.lastname@example.org
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Revised: 12 Apr. 2016.
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