Biological Agents User Application Form Biological Toxins or rDNA Encoding a Biological Toxin

Revised 10/15

Name: Title: Today’s Date:

Department: Phone #:

Campus Address: E-mail:

Project Title:

This Project is: new IACUC / HIC Protocol # (if applicable):

Previously Approved by Biosafety Committee? yes If yes, approval #: If this is not an AIC or HIC protocol, list the funding source: Do you, your spouse/domestic partner, or any dependent children have a potential conflict of interest* with the sponsor of this project? no WSU conflict of interest definition & policy: http://research.wayne.edu/coi/index.php

Research Location(s): Please list any containment facilities, biological safety cabinets, growth chambers, or other special precautionary measures, and the most recent certification dates. Containment facilities Building Room # biosafety cabinets, etc. (specify) Certification Date(s) in vivo /in vitro not applicable not applicable not applicable

Biosafety level of containment for proposed project (check one): BSL1 BSL2 BSL3 Unsure of risk group/biosafety level assigned to your biological agent? www.absa.org/riskgroups/index.html Overview of biosafety containment levels: www.oehs.wayne.edu/biosafety/containment-levels.php

Research Summary

Please provide a brief summary (no more than 1 page) of the biological work you will perform as part of this project. Describe in your discussion the biological agent’s potential toxicity, routes of exposure and the hazards/risks associated with this experiment (eg: needlesticks, handling of the agent, any aerosolization that may occur, etc.):

1 Biological Toxins or rDNA that will encode a Toxin

1. Are you using a CDC Select Agent or USDA High Consequence Livestock Pathogen or Toxin?

Yes No

Unsure? See www.selectagents.gov, or call 577-1200.

2. What toxin (unfractionated mixture, purified conjugate, microbial culture capable of producing toxin) will be used in this experiment, and where will you get it?

3. What is the LD50 of the toxin?

4. How will this toxin be applied and what is the target molecule?

5. Where (room / building) will the toxin be produced, stored, weighed, and in what amount? What measures will be taken to assure containment and security of the toxin?

6. Does the experiment involve administration of toxin to animals? Yes No

7. Can toxin be released from animal into the environment? Yes No Unsure

8. Approximately how long after administration could the toxin be shed? * You must add this information in the AIC application, Animal Hazardous Agents Form Part II, if applicable

9. How will toxin-containing materials (urine, feces, blood, bedding, etc.) be inactivated?

10. Have all employees involved with the project received initial training and annual updates on procedures? Yes No

11. Is an antidote available for persons exposed to the toxin? Yes No

If yes, do you have a supply stored in your laboratory? Yes No

12. Laboratory Biosafety Standard Operating Procedures (SOPs) SOPs are a specific description of the potential biological exposure hazards and safety procedures that will be employed to minimize the risk. The following issues should be addressed; * Safe work practices * Disinfection procedures * Personal protective equipment * Safe transport procedures from room to room/bldg. to bldg. * Use of biological safety cabinet * Emergency response for exposures * Sharps and other waste disposal * Emergency response for spills If you already have written procedures that cover this information, you may attach that document, or you may use this template: Invivo-SOP template or Invitro-SOP template Principal Investigator’s Agreement I acknowledge responsibility for this project, and I agree to fully comply with all pertinent NIH, CDC and Wayne State University guidelines and policies. I assure that all faculty, staff and students involved in this project will be trained and qualified to carry out the research in a responsible manner in accordance with NIH, CDC and University policies and procedures.

2 X Date: Principal Investigator Signature

Faculty Supervisor/ Sponsor (if applicable) I have reviewed and approved the scientific and ethical aspects of this research project. I agree to supervise all compliance aspects associated with it and adhere to all applicable CDC, NIH and WSU biosafety guidelines.

X Date: Faculty Sponsor Signature

Chair/Dean/Director: In signing this description of the research project, the Department Chair or Institute/Center Director certifies that appropriate scientific and ethical oversight has and will be provided.

X Date: Chair/Dean/Director Signature Additional Personnel Signatures All staff listed on this protocol should be aware of the hazards involved. I have been informed of the hazards involved in this research and instructed on the appropriate methods to carry out the research in a safe and responsible manner.

Name (please print or type) Signature Date

Submit Completed Form To Rob Moon, Biosafety Officer: E-mail: [email protected] Fax: 313.993.4079 Mail: 5425 Woodward - Suite 300, Detroit, MI 48202 Phone: 313.577.1200

NOTE: You may e-mail a completed version of this form to the Biosafety Officer, but you must also print out this page, sign it and submit the original through campus mail.

WSU Biosafety Committee Use Only

Approved IBC Approval # Not Approved Approved with stipulations Describe Stipulations: AIC # HIC # Date of Lab Visit: Signed: Date:

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