Institutional Biosafety Committee Biosafety Application

Instructions: All research at the MBL involving biohazards must be documented and submitted to the Institutional Biosafety Committee (IBC) for review and approval prior to the initiation of work. Approved protocols are valid for three years. For the purposes of the IBC, biohazards are defined as potentially infectious agents, organisms or materials; biological toxins; organisms containing recombinant DNA, or other genetically altered organisms and agents. Please note: if you plan on using or collecting biological agents, samples, etc. from live vertebrates or cephalopods or identifiable human sources, or if your research will involve radiation/radioactive isotopes, you will also need approval from the Institutional Animal Care and Use Committee (IACUC), Institutional Review Board (IRB), or Radiation Safety Committee (RSC).

* indicates a required field.
Nature of Submission:*

New SubmissionRenewalAmended Protocol
Has work been reviewed by the IBC of another institution?*

YesNo
If yes, please attach copy of approval.

Cancelof

Is this application being submitted in addition to:*

	Yes	Pending	No	If yes, Protocol #
IACUC Application (Animal subjects)
IRB Application (Human subjects)
RSC Application (Radioactive materials)

	Yes	No	If yes, please specify permit:
Are there any permit requirements for this work (USDA, U.S. Fish & Wildlife, etc.)?

Section II. Facilities, Safety and Equipment
1. List building and room numbers where the work will be conducted:*
2. List equipment needed for safe handling of biohazards (chemical hood, biological safety cabinet, etc):*
3. Is this equipment available in the rooms listed above?*

YesNoDon't Know

Section IV - Infectious Agents / Parasites
1. List infectious agents or parasites (Use Latin binomials and, when appropriate, strain or isolate identifier, biosafety levels, and risk group classifications):*
2. Describe specific dangers to human health. *
3. Describe procedures to mitigate risk during experiments and storage.*
4. Describe how each infectious agents or parasite will be inactivated or destroyed (autoclave, incineration through MBL vendor, freezing, etc).*

Section V - Mammalian cells, blood, body fluids or tissues, or Other Potentially Infectious Materials
1. Describe the origin of the material (When possible use Latin binomials and strain or isolate identifier).*
2. Describe specific dangers to human health. *
3. Describe procedures to mitigate risk during experiments and storage.*
4. Describe how the material will be inactivated or destroyed (autoclave, incineration through MBL vendor, freezing, etc).*
5. Bloodborne Pathogen Training - Have all necessary faculty, staff, and/or students taken a formal Bloodborne Pathogen Training?*

YesNo
If no, please describe how personnel will be trained before the commencement of research.*

Section VI - Select Agents or Biological Toxins
1. List the specific Select Agents or biological toxins to be used, the amount that will be used at any one time, and the total amount you will be using. A complete list of federal select agents and toxins can be found here.
List the specific Select Agents or biological toxins to be used.
2. Describe how you will minimize the risk of human exposure during experiments and storage.*
3. Describe how the agent or toxin will be inactivated or destroyed.*
4. Select Agent Training - All users of select agents must be properly trained. Have all faculty and staff taken a formal select agent training course? If no, you must schedule training at the MBL prior to commencing work.*

YesNo

Section VII - Non-Native Organisms, or Transgenic Organisms or Cells Brought to MBL
1. List species with Latin binomials and, when appropriate, strain or isolate identifier, or cell line designation.*
2. For non-native species, describe the home range and potential to survive in the local environment. For transgenics, describe the nature of the modification, including genotype and phenotype.*
3. Describe where the organisms or cells will be used (building and room number) and procedures to ensure containment.*
4. Describe where the organisms or cells will be stored/maintained/housed (building and room number) and procedures to ensure containment.*
5. How will you dispose of the organisms? If you are planning on using MBL sponsored facilities (NXR, Zebrafish Facility, Cephalopod Facility), you are encouraged to contact the facility for proper guidelines.*

Organisms will be placed into ziplock bag, labeled with name and date and then placed into freezer in Rowe 107 or Loeb G11.Material (such as embryos, small tissues, or cells) will be exposed to 10% bleach solution for 30 minutes prior to sink disposal.Other
6. Have all necessary faculty, staff, and/or students been trained or have knowledge with containment procedures, or issues of risk for introduction of exotic species to environment?*

YesNo
7. If no, please describe how personnel will be trained before the commencement of research.*
8. Please describe any additional safety procedures or training necessary for this project, otherwise please answer “No additional safety procedures or training is necessary".*

Section VIII - Danger to Human or Environmental Health
1. Describe any specific danger(s) to human or environmental health, not covered above. Enter “N/A” if not applicable.*
2. Please describe how personnel will be trained to mitigate these potential risks before commencing this research. Enter “N/A” if not applicable.*
3. Please describe any additional safety procedures or training necessary for this project, otherwise please answer “No additional safety procedures or training is necessary". Enter “N/A” if not applicable.*

Section VIII End

Section IX - Signature and Date
I attest that the information contained in this registration is accurate and complete. I am familiar with and agree to abide by the NIH guidelines, as applicable, and other specific granting agency instructions pertaining to the proposed project as well as any modifications of these guidelines subsequently issued by the Commonwealth of Massachusetts, the Federal Government, and the Marine Biological Laboratory. All research personnel will be familiar with and understand the potential biohazards; relevant biosafety practices, techniques and emergency procedures required to ensure safety will be followed. I accept responsibility for the training of all personnel involved in the proposed project. I will not carry out the work described in this registration until it has been filed with and, if necessary, approved by the Institutional Biosafety Committee.
Signature of Responsible Researcher*

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Registration Number:
Date Received:
Date Approved:
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Hazard Classification:
David Mark Welch, Chair, MBL IBC

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