<p> Biological Agents User Application Form Biological Toxins or rDNA Encoding a Biological Toxin</p><p>Revised 10/15</p><p>Name: Title: Today’s Date: </p><p>Department: Phone #: </p><p>Campus Address: E-mail: </p><p>Project Title: </p><p>This Project is: new IACUC / HIC Protocol # (if applicable): </p><p>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</p><p>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</p><p>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</p><p>Research Summary</p><p>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.):</p><p>1 Biological Toxins or rDNA that will encode a Toxin</p><p>1. Are you using a CDC Select Agent or USDA High Consequence Livestock Pathogen or Toxin?</p><p>Yes No</p><p>Unsure? See www.selectagents.gov, or call 577-1200.</p><p>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? </p><p>3. What is the LD50 of the toxin? </p><p>4. How will this toxin be applied and what is the target molecule? </p><p>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? </p><p>6. Does the experiment involve administration of toxin to animals? Yes No</p><p>7. Can toxin be released from animal into the environment? Yes No Unsure</p><p>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</p><p>9. How will toxin-containing materials (urine, feces, blood, bedding, etc.) be inactivated? </p><p>10. Have all employees involved with the project received initial training and annual updates on procedures? Yes No</p><p>11. Is an antidote available for persons exposed to the toxin? Yes No</p><p>If yes, do you have a supply stored in your laboratory? Yes No</p><p>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.</p><p>2 X Date: Principal Investigator Signature</p><p>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.</p><p>X Date: Faculty Sponsor Signature</p><p>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.</p><p>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.</p><p>Name (please print or type) Signature Date</p><p>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</p><p>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.</p><p>WSU Biosafety Committee Use Only</p><p>Approved IBC Approval # Not Approved Approved with stipulations Describe Stipulations: AIC # HIC # Date of Lab Visit: Signed: Date:</p><p>3</p>