Biological Materials Registration Form

BIOLOGICAL MATERIALS REGISTRATION FORM

FOR IBC OFFICE USE ONLY
REGISTRATION #
APPROVAL DATE
EXPIRATION DATE

Tufts University & Tufts Medical Center

Institutional Biosafety Committee (IBC)

Tel: 617-636-4109, Fax: 617-636-8354

E-mail:

Website:

REGISTRATION TITLE

Mark the checkboxes as confirmation:

I am familiar with and agree to abide by the NIH Recombinant DNA Guidelines, CDC/NIH Biosafety Guidelines, OSHA Standards, institutional policies, and other federal, state and local regulations relating to this project.
I attest that the information contained in the attached registration is accurate and complete.
I accept responsibility for ensuring that all personnel involved in this project will be trained regarding the procedures approved, the potential biohazards, relevant biosafety practices, and emergency procedures. I confirm that the relevant Exposure Response Plan(s) will be followed.
I will submit written reports to the Institutional Biosafety Committee concerning:
1. Any accident that results in a known or potential exposure to recombinant DNA materials, infectious agents or biological toxins; or any incident resulting in the known or suspected release into the environment of recombinant DNA materials, infectious agents or biological toxins into the environment.
2. Any problems with physical or biological containment safety procedures or equipment, or facility failures.
3. Any new information bearing on the safety of this work such as technical data relating to hazard and safety procedures.
Signature of the Principal Investigator: / Date:
(Please submit an electronic signature)
INSTRUCTIONS for COMPLETING THIS FORM
- Please type responses within the space/box provided and mark the checkboxes when appropriate.
-Double-click on the checkboxes to mark your selections.
- Submit the completed draft electronically to the IBC Office e-mail ().
- A Biosafety Officer will pre-review the form and determine if the research requiresIBC Full Committee Approval or IBC Administrative Approval. Please be aware that it is in your best interest to submit the draft to the IBC office well in advance of the submission deadline for the IBC meeting.

1. CONTACT INFORMATION

PRINCIPAL INVESTIGATOR / DEGREE(S)
ACADEMIC POSITION/TITLE
DEPARTMENT/DIVISION
LAB ADDRESS
DIRECT PHONE # / EMERGENCY #
E-MAIL / FAX
LABORATORY CONTACT / DEGREE(S)
DIRECT PHONE # / EMERGENCY #
E-MAIL

2. LARGE SCALE RESEARCH

Will this research utilize viable organisms containing rDNA molecules in culture volumes of 10 liters or greater? / NO YES
*Research utilizing volumes greater than or equal to 10 litersis defined as “Large Scale” and requires special permission. If the project involves large scale work, please contact yourBiosafety Officer for additional information.

3. PROJECT PERSONNEL

All listed personnel must complete mandatory IBC training. See IBC Policy on Mandatory Biosafety Trainingand IBC website for information.
NAME / E-MAIL / PHONE #
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

4. BIOHAZARDOUS AGENT(S)

Provide the name of each agent/material to be used. For recombinant DNA (rDNA), mark the relevant Section of the NIH Guidelines under which it is described. Detailed definitions of each can be found in Appendix A. Identify the appropriate Biosafety Level (BSL) required for each agent proposed according to the NIH Guidelines at the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories 5th edition at
If you have questions regarding these categorizations, the Biosafety Officer will help you during the pre-review.
A. Recombinant DNA (rDNA)
Insert Name(s) / Biosafety Level / BSL1 BSL2 BSL3
Animal Biosafety Level (containment/housing) / ABSL1 ABSL2 ABSL3
Must check all that apply below:
Section III-F: Experiments that are exempt from NIH Guidelines, but covered by local regulations.
Section III-E: Experiments that require IBC notice simultaneous with initiation.
Section III-D: Experiments that require IBC approval PRIOR TO initiation of experiments.
Section III-C: Experiments that require IBC and Institutional Review Board (IRB) approvals and Recombinant DNA Advisory Committee (RAC) review before research participant enrollment.
Section III-B: Experiments that require NIH/OBA and IBC Approval BEFORE initiation of experiments.
Section III-A: Experiments that require IBC Approval, Recombinant DNA Advisory Committee (RAC) review, and NIH Director Approval PRIOR TO initiation of experiments.
B. Infectious Agent(s)
Insert Name(s) / Biosafety Level / BSL1 BSL2 BSL3
Animal Biosafety Level (containment/housing) / ABSL1 ABSL2 ABSL3
Pathology of Agent(s) / Agent Name: Human Pathogen Animal Pathogen Both Neither or N/A
Agent Name: Human Pathogen Animal Pathogen Both Neither or N/A
Agent Name: Human Pathogen Animal Pathogen Both Neither or N/A
Agent Name: Human Pathogen Animal Pathogen Both Neither or N/A
If a human pathogen, what is the infectious dose for a healthy human adult?
Is the agent attenuated or replication deficient? / Yes* No
*If yes, please describe in detail the testing that will be done to confirm attenuation or replication incompetence. Include the location of the records.
*If yes, please confirm that results of testing will be submitted to the IBC for review. / Yes No
C. Biological Toxin(s)
Insert Name(s) / Biosafety Level / BSL1 BSL2 BSL3
Animal Biosafety Level (containment/housing) / ABSL1 ABSL2 ABSL3
Toxicity of Agent(s) / Toxin Name: To humans To animals To both Neither or N/A
Toxin Name: To humans To animals To both Neither or N/A
What is the maximum quantity of toxin that will be present?
What is the LD50 of the toxin in humans?(state “unknown”, if applicable)
What is the LD50 of the toxin in animal species used?(state “unknown”, if applicable)
D. Select Agent or Toxin: To determine if your study falls within the Select Agent Rule, refer to
Insert Name(s) / Biosafety Level / BSL1 BSL2 BSL3
Animal Biosafety Level (containment/housing) / ABSL1 ABSL2 ABSL3
Pathology or Toxicity of Agent(s) / Agent Name: Human Animals Both Neither or N/A
Agent Name: Human Animals Both Neither or N/A
If a human pathogen, what is the infectious dose for a healthy human adult?
If a toxin, what is the maximum quantity that will be present?
What is the LD50 of the toxin for humans? (state “unknown”, if applicable)
What is the LD50 of the toxin for animal species used? (state “unknown”, if applicable)
E. Genetically Engineered Animals: See “Policy on Genetically Engineered Animals” for detailed information about the IBC review of genetic mutants and which type of review is required.
Species / Insert Name(s) / Animal Biosafety Level (containment/housing) / ABSL1 ABSL2 ABSL3
F. Human Source Material(s)
Employees of TUFTS MEDICAL CENTER are NOT required to be covered by the IBC for use of human source materials. If you are a TMC employee, provide the appropriate confirmation below.
I confirm that all research with human source materials is conducted in the Tufts Medical Center facilities and that annual Bloodborne Pathogen Training as a Tufts Medical Center employee is obtained.
OR
This does not apply to this registration.
Employees of TUFTS UNIVERSITYMUST register human source materials with the IBC. Provide the information below.
Human/Non-Human Primate (NHP) Blood, Body Fluids, Tissue, Organs / Insert Name(s) / Biosafety Level / BSL1 BSL2 BSL3
Animal Biosafety Level (containment/housing) / ABSL1 ABSL2 ABSL3
Human/Non-Human Primate (NHP) Cell Lines / Insert Name(s) / Biosafety Level / BSL1 BSL2 BSL3
Animal Biosafety Level (containment/housing) / ABSL1 ABSL2 ABSL3

5. NON-TECHNICAL SUMMARY OF PROPOSED RESEARCH

Provide a BRIEF description of the goal of the research and how the agents are to be used in the box below. Lay terminology must be used in place of field-specific terms and phrases.

6. EXPERIMENTAL DETAILS

In the following space, please summarize the intent of your proposed project. Provide enough information, so that the techniques and purposes of the experiments with the biohazardous agent(s) are clear. Indicate culture volumes, maximum concentrations, and other agent-specific information. Identify at what stage of the experiment the agent is inactivated. Be as concise as possible, using reasonably non-technical terms.

7. EXPERIMENTAL MANIPULATION

Will the experiment(s) result in the acquisition of new characteristics such as enhanced virulence, infectivity, drug resistance, or change in host range? / NO YES
If yes, please explain

8. LOCATION(S)

List ALL laboratories where research is to be conducted and the corresponding biosafety level. Include cold/warm rooms, equipment rooms, and location(s) of biosafety cabinets (BSC). For locations in the centralized animal facilities, please indicate either “DTRR” (Department of Teaching and Research Resources) for Grafton or “DLAM” (Department of Laboratory Animal Medicine) for Boston and Medford.
ROOM NUMBER for LABS / ROOM PURPOSE
(Main Lab, Storage, Tissue Culture, Procedure, etc.) / BIOSAFETY LEVEL

9. RISK ASSESSMENT

Hazardous processes used with agent
Check all that apply. / Centrifuge Sharps Animal Model Sonication
Pipetting Tissue harvesting Other: (specify)
Exposure route of agents
Check all that apply. / Ingestion Percutaneous Mucous Membrane
Inhalation
The risk of exposure will be mitigated by the following:
Check all that apply and indicate with what agent each is used andthe location of use (lab room #, animal facility, etc.). If using engineering controls, provide the date of certification.
Person Protective Equipment / Agent(s) and Location of Use
(please state N/A when appropriate)
Gloves
Lab Coat
Disposable Lab Gown
Disposable Booties
Tyvek Suit
N-95 Respirator
Surgical Mask
PAPR (Powered Air Purifying Respirator)
Safety Glasses
Other: (specify)
Engineering Controls / Date of Certification
Biosafety Cabinet (BSC)
Other: (specify)

10. EXPOSURE RESPONSE PLAN(S)

All labs working with biohazardous agents must have an agent and lab specific exposure control plan. Please list the titles of ALLExposure Response Plan(s) associated with this registration. Many plans are available for download on the IBC website. If the one you need is not there, please work with your Biosafety Officer to create one.
Title of eachExposure Response Plan to be utilized
If a specific plan has not been developed for the agent you are proposing to work with or if you require changes to the existing Exposure Response Plan, the Biosafety Officer will work directly with you at the time of pre-review to develop a specific Plan, if necessary. To aid in this process, please provide the following information:
Are there signs and symptoms of exposure?
Identify prophylactic medicines or vaccinations for this agent, if available.
Is there an increased risk to immunocompromised individuals exposed to this agent?

11. DECONTAMINATION

What chemical and/or thermal processes will be used for decontamination?
Describe the processes involved in the decontamination and/or disposal of the following:
Liquid waste
Contaminated solid waste
Cultures, plates, stocks, etc.
Animal bedding
(If handled by DLAM/DTRR, please check the box.) / Per standard ABSL-appropriate DLAM/DTRR procedures
Animal cages
(If handled by DLAM/DTRR, please check the box.) / Per standard ABSL-appropriate DLAM/DTRR procedures
Animal carcasses
(If handled by DLAM/DTRR, please check the box.) / Per standard ABSL-appropriate DLAM/DTRR procedures

12. USE OF RECOMBINANT DNA

Please answer the following questions in the space provided. Please write “N/A” for all items that do not apply.
A. Source of Gene,Gene Family,Insert, or Clone
Name the specific DNA/RNA source (or probe)(human, species of animal, plant, etc.).
What is the percent of viral genome in construct?
What is being expressed?
Provide information on any sequences that code for toxins.
B. Vectors and Host Cells
Identify the cloning/expression/transfection vectors used.
Identify the recipient bacterial strains and recipient host cell lines (human, species of animal, plant, etc.). Provide a restriction map of vector unless this is a commercially available vector. If commercially available, please indicate vendor.
Describe the location and type of promoters and other control sequences.
What is the percent of viral genome in construct?
If using viral vectors, indicate packaging cell lines and assay system used to measure helper virus titer or titer of replication competent virus (background) generated. Include host range of packaged viral vector. (If using retroviral or lentiviral vectors, additional requirements may apply.)
C. Use of Recombinant DNA in Animals or Plants.
For genetically engineered rodent breeding at ABSL1 only, information should be provided in the IACUC form. See “IBC Policy on Genetically Engineered Mutants.”
Please describe how rDNA will be used
If genetically engineered insects onlywill be used, provide information on the injected gene and vector below, as well as the recipient strain.
If genetically engineered plants onlywill be generated or used in this project, please note that here and provide information on the injected gene and vector below, as well as the recipient strain.
Name the insect or plant species to be used.
Provide the transgene name (or family) and function. If more than one, please list each separately.
Indicate the transgene source.
Name the vector(s) used.
What is the method of transformation?
Does the gene encode a toxin or other hazardous agent? If yes, please describe.
Provide location information for insects or plants. Include building and room number.

13. PROCEDURES WITH LIVE ANIMALS

Complete this section ONLY if the biohazardous agent(s) listed on this registration will be administered to animals. Please provide a response for all items. If a question does not apply, please write “N/A.”
A. Administration of Agent
Name of species to be exposed to agent
Are the animals immunosuppressed? / No Yes
Agent(s) and dose(s) administered
Route(s) of administration
Location(s) of administration (see directions above)
Will administration(s) be done inside a biosafety cabinet?
Will the biological agent or hazardous metabolite be excreted by urine, feces or wound drainage? Provide duration, if applicable.
B. Housing/Handling Inside and Outside of Centralized Facilities
Will animals be removed from the centralized facilities? / Yes* No
*If yes, will animals be returned to DLAM/DTRR post administration of the agent(s)? / Yes* No
*If yes, please indicate the Animal Biosafety Level necessary in the centralized facilities for the animals upon return. / ABSL1 ABSL2
Will a DLAM/DTRR biohazard cage card be used to identify the agent used? / Yes No*
*If no, will an alternative method be used to identify the biohazardous agent? / No Yes: describe method here
Will handling and disposal of bedding, cages, and animal carcasses be done by DLAM/DTRR staffin accordance with standard ABSL-appropriate DLAM/DTRR procedures? / Yes No*
*If no, will handling and disposal of bedding, cage, and animal carcasses be done by laboratory staff? / No Yes: describe method here

OTHER HELPFUL LINKS

Tufts University EHS Website /
Pathogen Safety Data Sheets /
Biosafety in Microbiological and Biomedical Laboratories (BMBL) /
NIH Recombinant DNA Guidelines /
Tufts OVP IBC Website /

APPENDIX A - NIH rDNA Categories

BIOHAZARDOUS MATERIALS REGISTRATION FORM

The NIH rDNA Guidelines identify six categories of experiments involving recombinant DNA:

(i)those that require Institutional Biosafety Committee (IBC) approval, RAC review, and NIH Director approval before initiation,

(ii)those that require NIH/OBA and Institutional Biosafety Committee approval before initiation,

(iii)those that require Institutional Biosafety Committee and Institutional Review Board approvals and RAC review before research participant enrollment,

(iv)those that require Institutional Biosafety Committee approval before initiation,

(v)those that require Institutional Biosafety Committee notification simultaneous with initiation, and

(vi)those that are exempt from the NIH Guidelines .

According to the Guidelines, the PI is responsible for identifying which category the proposed rDNA work falls under. The 6 categories are listed and defined below. Mark the box next to the category that you chose.

Section III-F Experiments that are exempt from NIH Guidelines but covered by local regulations. Exempt experiments must be registered with the Tufts University IBC or the TCSVM IBC as appropriate.

III-F-1 Recombinant DNA molecules that are not in organisms or viruses.

III-F-2 Recombinant DNA molecules that consist entirely of DNA segments from a single nonchromosomal or viral DNA source, though one or more of the segments may be a synthetic equivalent.

III-F-3 Recombinant DNA molecules that consist entirely of DNA from a prokaryotic host including its indigenous plasmids or viruses when propagated only in that host (or a closely related strain of the same species), or when transferred to another host by well established physiological means.

III-F-4 Recombinant DNA molecules that consist entirely of DNA from a eukaryotic host including its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or closely related strain of the same species).

III-F-5 Recombinant DNA molecules that consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent. See Appendix A-I through A-VI for a list of natural exchangers that are exempt from the “NIH Guidelines”.

III-F-6 Recombinant DNA experiments that do not present a significant risk to health or the environment as determined by the NIH Director, RAC and following appropriate notice and opportunity for public comment. See Appendix C of the NIH Guidelines.

Check the following classes of experiments that are exempt under Section III-F-6 Appendix C
C-1 / Recombinant DNA in Tissue Culture?
Recombinant DNA molecules containing less than one-half of any eukaryotic viral genome (all viruses from a single family being considered identical – see Appendix C-VII-E, Footnotes and References of Appendix C), that are propagated and maintained in cells in tissue culture are exempt from these NIH Guidelines with the exceptions listed in Appendix C-1-A.
C-2 / Escherichia coli K-12 Host-Vector Systems?
Experiments which use Escherichia coli K-12 host-vector system, with the exception of those experiments listed in Appendix C-II-A are exempt from the NIH Guidelines provided that: (i) the Escherichia coli host does not contain conjugation proficient plasmids or generalized transducing phages; or (ii) lambda or lambdoid of Ff bacteriophages or non-conjugative plasmids (see Appendix c-VI-B, Footnotes and References of Appendix C) shall be used as vectors. However, experiments involving the insertion into Escherichia coli K-12 of DNA from prokaryotes that exchange genetic information (see Appendix C-VI-C, Footnotes and References of Appendix C) with Escherichia coli may be performed with any Escherichia coli K-12 vector (e.g., conjugative plasmid). When a non-conjugative-proficient vector is used, the Escherichia coli K-12 host may contain conjugation-proficient plasmids either autonomous or integrated, or generalized transducing phages. For these exempt laboratory experiments, Biosafety Level 1 (BSL1) physical containment conditions are recommended. For large scale fermentation experiments, the appropriate physical containment conditions need not be greater than those for the host organism unmodified by recombinant DNA techniques; the Institutional Biosafety Committee can specify higher containment if deemed necessary.
C-III / Saccharomyces Host-Vector Systems?
Experiments involving Saccharomyces cerevisiae and Saccharomyces uvarum host-vector systems, with the exception listed in Appendix C-III-A, are Exempt from the NIH Guidelines. For these exempt experiments, BSL1 physical containment is recommended. For large scale fermentation experiments, the appropriate physical containment conditions need be no greater than those for the host organism unmodified by recombinant DNA techniques; the Institutional Biosafety Committee can specify higher containment if deemed necessary.
C-IV
C-V / Kluyveromyces Host-Vector Systems
Experiments involving Kluyveromyces lactis host-vector systems, with the exception of experiments listed in Appendix C-IV-A, are exempt from the NIH Guidelines provided laboratory-adapted strains are used (i.e. strains that have been adapted to growth under optimal or defined laboratory conditions). For these exempt experiments, BL1 physical containment is recommended. For large-scale fermentation experiments, the appropriate physical containment conditions need be no greater than those for the host organism unmodified by recombinant DNA techniques; the Institutional Biosafety Committee may specify higher containment if deemed necessary.
Bacillus subtilis or Bacillus licheniformis Host-Vector Systems?
Any asporogenic Bacillus subtilis or asporogenic Bacillus licheniformis strain which does not revert to a spore-former with a frequency greater than 107 may be used for cloning DNA with the exception of those experiments listed in Appendix C-IV-A, Exceptions. For these exempt laboratory experiments, BSL1 physical containment conditions are recommended. For large scale fermentation experiments, the appropriate physical containment conditions need be no greater than those for the host organism unmodified by recombinant DNA techniques; the Institutional Biosafety Committee can specify higher containment if deemed necessary.
Recombinant DNA molecules derived entirely from extrachromosomal elements of the organism listed below (including shuttle vectors constructed from vectors described in Appendix C), propagated and maintained in organisms listed below are exempt from these NIH Guidelines.
Appendix C-VI. Extrachromosomal Elements of Gram Positive Organisms
Recombinant DNA molecules derived entirely from extrachromosomal elements of the organisms listed below (including shuttle vectors constructed from vectors described in Appendix C), propagated and maintained in organisms listed below are exempt from these NIH Guidelines.
C-VII / The Purchase or Transfer of Transgenic Rodents?
The purchase or transfer of transgenic rodents for experiments that require ABSL1 containment (see Appendix G-III-M, Footnotes and References of Appendix G) are exempt from the NIH Guidelines.
Appendix C-VIII. Generation of BL1 Transgenic Rodents via Breeding
The breeding of two different transgenic rodents or the breeding of a transgenic rodent and a non-transgenic rodent with the intent of creating a new strain of transgenic rodent that can be housed at BL1 containment will be exempt from the NIH Guidelines if: (1) Both parental rodents can be housed under BL1 containment; and
(2) neither parental transgenic rodent contains the following genetic modifications: (i) incorporation of more than one-half of the genome of an exogenous eukaryotic virus from a single family of viruses; or (ii) incorporation of a transgene that is under the control of a gammaretroviral long terminal repeat (LTR); and
(3) the transgenic rodent that results from this breeding is not expected to contain more than one-half of an exogenous viral genome from a single family of viruses.
Section III-E Experiments that require IBC notice simultaneous with initiation.

III-E Experiments not included in Sections III-A, III-B, III-C, III-D, III-F and their subsections are considered in this section. All such experiments may be conducted at BSL 1.