Dlam & Bsc Use Only

DLAM & BSC USE ONLY:

Amendment No.: Date ______

IACUC Approval: ______

BSC Approval: ______

Northeastern University

Biosafety and Animal Use Protocol Addendum

Only the Principal Investigator listed on the animal protocol and BSC application is permitted to make changes. Please note that certain changes to protocols/BSC application may affect other aspects of the project, and that this will be evaluated during review and reflected in this addendum. This addendum requires review and approval from both the Institutional Animal Care and Use Committee (IACUC) and the Biosafety Committee. Both committees reserve the right to determine whether proposed changes are substantive or not, and to request further information or a new protocol application, as appropriate. When submitting an addendum, the Principal Investigator is required to review all of the details of the original protocol to assure the committees that all details remain identical to the original protocol.

I. General Information

A. / Principal Investigator: / Title:
B. / Contact person*: / (if changed from original submission)
Name: / Title:
Address:
phone: / fax: / Cell #: / e-mail:
C. Protocol # & Project Title

* Contact person is the individual who will be contacted regarding an animal’s health or disposition when morbidity requires action. All correspondence from the IACUC will be sent to the PI.

II. HAZARD INFORMATION

A. Complete the table if you will be working with live animals and if the biohazardous materials listed on this registration will be administered to those animals. The PI or staff/student working with these animals must meet with the DLAM Director prior to ordering animals for these studies to establish specific responsibilities and safety requirements for these studies. Please provide a response for all items. First line is an example.

Species and Type of Animal / Biological Agent to be administered* / Biosafety Level / Route of Administration / Immune Status of Animal / Will the animals, their secretions or excretions be infectious or hazardous?
BALB/c mice / Salmonella typhimurium
ATCC 14028 / Select One:BSL-1BSL-2BSL-3None / Oral gavage / Immune competent / Yes
Select One:BSL-1BSL-2BSL-3None
Select One:BSL-1BSL-2BSL-3None
Select One:BSL-1BSL-2BSL-3None

* Include information for recombinant or synthetic nucleic acids, infectious agents or pathogens, human or non-human primate cells, tissues or material and toxins.

III. CONTROLS – For animal work.

A. The risk of exposure will be mitigated by the following (check all that apply and indicate the agent used):

Biological Agent Used and Procedure(s)*: / Biological Agent Used and Procedure(s)*: / Biological Agent Used and Procedure(s)*:
Personal Protective Equipment (PPE) / Personal Protective Equipment (PPE) / Personal Protective Equipment (PPE)
Gloves – specify type: / Gloves – specify type: / Gloves – specify type:
Lab coat / Lab coat / Lab coat
Disposable Lab Gown / Disposable Lab Gown / Disposable Lab Gown
Disposable Booties / Disposable Booties / Disposable Booties
Tyvek Suit / Tyvek Suit / Tyvek Suit
Surgical Mask / Surgical Mask / Surgical Mask
N-95 Respirator** / N-95 Respirator** / N-95 Respirator**
Eye Protection – specify type: / Eye Protection – specify type: / Eye Protection – specify type:
Other – specify / Other – specify / Other – specify

* Procedures: i.e. IV, SC, or IP injection, oral gavage, etc.

** Participation in the Respiratory Protection Program is required

B. Specify the safety engineered equipment to be used. This equipment must be included on the Biological Safety Registration Form.

C. For control of contamination, the following equipment and procedures must be used:

Investigator is responsible for providing animal husbandry following administration of the hazard for days. / A Hazardous Material Card will be posted on each cage to identify the agent used while there is a hazard risk.
All cages, wastes, etc. must be presented to DLAM to be autoclaved. / A Biohazard Sign must be posted on animal room door that identifies the Hazard, PI Name, and Contact information which includes a cell phone number of Primary Contact
All cages are to be decontaminated with/by prior to disposal or presentation to the DLAM staff / Cages will be housed in room for the duration of the study.
All animal manipulations must be done within a:
Biological safety cabinet
Chemical fume hood / Cage Type: Disposable; Ventilated;
Static with Microisolator Top.
Carcasses/waste are to be placed in a biohazard bag, sealed, labeled with the hazard, amount, date and investigator’s name and phone number before it is placed in the facility freezer for incineration. / Other:

D. Housing and Handling Inside of Animal Care Facility:

1. Will the animals be removed from the animal care facility? No Yes

a. If yes, justify and describe how will they be transported:

b. Will the animals be returned to the animal care facility? No Yes

2. Indicate the Animal Biosafety Level required post exposure to the biological materials:

ABSL-1 ABSL-2

Additional Information:

IV. DECONTAMINATION

Describe the processes involved in the decontamination and/or disposal of the following materials:

1. Animal Bedding:

2. Animal Cages:

3. Animal Carcasses:

V. References

Genetically Engineered Animals and the Institutional Biosafety Committee (IBC)

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Revised 4/2/2015