Isu Institutional Biosafety Committee

ISU INSTITUTIONAL BIOSAFETY COMMITTEE

FIELD RELEASE REVIEW FORM

SECTION I: GENERAL INFORMATION

Assurance

·  I certify that the information provided in this application is complete and accurate and consistent with any proposal(s) submitted to external funding agencies.

·  I will follow applicable biosafety level requirements and comply with all shipping requirements and required waste management practices.

·  I will ensure that all personnel have appropriate training including but not limited to: biosafety principles and techniques, accidental spills, shipping regulations, proper handing of biohazardous materials and waste management, and regulatory permit requirements.

Signatures

Signature of Principal Investigator Date

Signature of Department Chair Date

For Institutional Biosafety Committee (IBC) Use Only:

Chair’s signature below indicates that the project has been approved by the IBC.

IBC Approval Signature Date

PLEASE NOTE: Any changes to an approved protocol must be submitted to the appropriate committee(s) before the changes may be implemented.

Key Personnel

List all members and relevant experience of the project personnel (PI, associates, students, and technicians) who will be involved. This information is intended to inform the committee of the training and background of the investigators and key personnel.

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Funding Information

Yes No Is this project federally funded?

If Yes, please list source:

Collection or Receipt of Samples

Will you be: (please check all that apply)

Yes No Receiving samples from outside of ISU? See examples below.

Yes No Sending samples outside of ISU? See examples below.

Examples include genetically modified organisms, body fluids, tissue samples, blood samples, pathogens.

If you will be receiving samples from or sending samples outside of ISU, please identify the name and location of the outside organization(s) and the identity of the samples you will be sending or receiving outside of ISU:

SECTION II: FIELD RELEASE

Note: If planning multiple introductions, please answer the questions for each regulated article.

1)  If the appropriate permits have already been obtained, please list the applicable permit numbers and fax copies of all applications, letters of notification, permits (and phytosanitary certificates for import permits) to 294-4267. The Department of Environmental Health and Safety (EH&S), 294-5359, can assist you in determining permit requirements and obtaining any necessary permits.

2)  Describe the purpose of the field release.

3)  Describe the items that will be field released:

a)  List the recipient plant or plants. Provide the common name, scientific name, and cultivar name.

b)  List the inserted genetic material. Identify all sources of DNA.

Yes No Are there Cas9 and gRNA involved?

If yes, please describe the construct:

Yes No Will the Cas9 and gRNA elements persist in the germline?

If yes, please describe any special containment practices:

Guidance for the Use of Gene Drive Technology in Research

c)  List the method or methods of transformation.

d)  List the quantity of plants and the size of the plots in square feet or acres.

e)  Describe the novel proteins or RNA expressed in the plants.

f)  Please indicate where the material to be planted was obtained (e.g., outside company, Plant Transformation Facility, made in your lab, etc.). If this material was made in your lab, please indicate the IBC approval number under which the planting material was created.

g)  How does expression of the altered genetic material differ from the unmodified parental organism? For example, morphological or structural characteristics, physiological activities and processes, number of copies of inserted genetic material and the physical state of this material inside the recipient organism (integrated or extrachromosomal), products and secretions, growth characteristics. Indicate possible toxicity or other hazards, if any.

h)  If a pharmaceutical or bioactive industrial compound will be synthesized in a food or feed crop, state the reason for choosing that crop.

4)  What is the duration of the field release or releases?

5)  Who will do the planting?

6)  Describe the proposed field site assignment. State the location, specifically the state, country, field address, and field size. For multiple releases, give the number of introductions and the maximum acreage per release.

7)  Describe information gained from laboratory and growth room or greenhouse experiments that would be relevant to assessing potential risks from field tests.

8)  Release of the transgenic material may take place through seed, vegetative propagation, or pollen. Briefly describe the procedures to prevent release or dissemination of the transgenic material into the environment. Identify steps to be taken to minimize or eliminate risks.

9)  Describe the method of final disposition of all plant material resulting from this field release, including material remaining on the field after harvest. Describe procedures to monitor for and eliminate any volunteer plants.

10a) Will plant material from the field be taken to the lab? Yes No

10b) If Yes, please indicate if the material will be immediately devitalized or if any further transgenic work will take place. If further transgenic work will take place, an IBC research application or amendment may need to be submitted for review and approval.

10c) If material will be immediately devitalized in the lab, please indicate the method of destruction of the regulated material.

The Office of the Vice President for Research and the Office for Responsible Research recommend that you develop a communication plan for immediate use in the event of accidental release of the transgenic material. This plan should be developed with the assistance of the Office of University Relations. Please contact Annette Hacker (294-3720) or Teddi Barron (294-4778).

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Office for Responsible Research

Revised: 4/11/2017